A Phase 2 interventional study of Albiglutide (GSK716155) or exenatide in Diabetes Mellitus, Type 2, sponsored by GlaxoSmithKline. Completed at 163 sites in 3 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-12-16.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment
This study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus who are either taking no diabetes medication or who are taking metformin only. This study will investigate the safety, tolerability, and efficacy of Albiglutide (GSK716155) and will measure the levels of Albiglutide (GSK716155) in the bloodstream when it is given for 16 weeks. As a comparison, some subjects will receive exenatide instead of Albiglutide (GSK716155). The study will involve weekly visits for 17 weeks,and less frequent follow-up visits for an additional 10 weeks. Assessments include repeat blood sampling and monitoring of any side effects.
A 16-week, parallel-group, double-blind, randomized, placebo-controlled, multicenter, dose-ranging study to evaluate the efficacy, safety and tolerability of multiple doses and multiple treatment regimens of Albiglutide (GSK716155) with Byetta as an open-label active reference, in subjects with Type 2 Diabetes Mellitus.
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This study's enrollment of 361 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Exclusion Criteria:
Albiglutide weekly subcutaneous injection or exenatide twice daily injection
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 16 minus the value at Baseline. Based on ANCOVA: Change = treatment + Baseline HbA1c + prior therapy + gender + region. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Time frame: Baseline and Week 16
Change From Baseline in HbA1c at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the post-Baseline value minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Time frame: Baseline and Weeks 4, 5, 7, 8, 9, 12, 15, and 16
Number of Participants Who Achieved Target Values for HbA1c <6.5% and >=6.5% to <7% at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
The number of participants who achieved target values for HbA1c (i.e., HbA1c \<6.5% and \>=6.5% to \<7%) were assessed. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Time frame: Weeks (W) 4, 5, 7, 8, 9, 12, 15, and 16
Change From Baseline in Waist Circumference at Week 16
The Baseline value is the last non-missing value before the start of treatment. Change from Baseline in waist circumference was calculated as the value at Week 16 minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Time frame: Baseline and Week 16
Change From Baseline in Body Weight at Week 16
The Baseline value is the last non-missing value before the start of treatment. Change from Baseline in body weight was calculated as the value at Week 16 minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Time frame: Baseline and Week 16
Percent Change From Baseline in Body Weight at Week 16
The Baseline value is the last non-missing value before the start of treatment. Change from Baseline in body weight was calculated as the value at Week 16 minus the value at Baseline. Percent change from Baseline was calculated as the (\[value at Week 16 minus the Baseline value\] divided by the Baseline value) multiplied by 100. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Time frame: Baseline and Week 16
Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
The FPG test measures blood sugar levels after the participant has not eaten (fasted) for at least eight hours prior to the sampling. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline in FPG was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Time frame: Baseline and Weeks 4, 5, 7, 8, 9, 12, 15, and 16
Change From Baseline in Fasting Fructosamine at Weeks 5, 8, 12, and 16
Fasting fructosamine levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline fructosamine value is the last non-missing value before the start of treatment. Change from Baseline in fructosamine was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Time frame: Baseline and Weeks 5, 8, 12, and 16
Change From Baseline in Fasting C-peptide at Weeks 5, 8, 12, and 16
Fasting C-peptide levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline C-peptide value is the last non-missing value before the start of treatment. Change from Baseline in C-peptide was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Time frame: Baseline and Weeks 5, 8, 12, and 16
Change From Baseline in Fasting Glucagon at Weeks 5, 8, 12, and 16
Fasting glucagon levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline glucagon value is the last non-missing value before the start of treatment. Change from Baseline in glucagon was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Time frame: Baseline and Weeks 5, 8, 12, and 16
Change From Baseline in Fasting Insulin at Weeks 5, 8, 12, and 16
Fasting insulin levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline insulin value is the last non-missing value before the start of treatment. Change from Baseline in insulin was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Time frame: Baseline and Weeks 5, 8, 12, and 16
Change From Baseline in Triglycerides, Free Fatty Acids, Total Cholesterol, Low-density Lipoprotein Cholesterol, and High-density Lipoprotein Cholesterol at Weeks 5, 8, 12, and 16
Serum lipid components, including triglycerides (TG), free fatty acids (FFA), total cholesterol (CL), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C), were measured at Baseline and Weeks 5, 8, 12, and 16. The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Time frame: Baseline and Weeks 5, 8, 12, and 16
Change From Baseline in Functional Living Index - Emesis (FLIE) Scores at Week 16
The FLIE questionnaire is used to record the participant's feelings/opinions concerning the effects of nausea/vomiting on their quality of life during the past five days. Participants completed the questionnaire by responding to 18 questions. The first set of 9 questions refer to nausea, and the second set of 9 questions refer to vomiting. Each question is scored on a seven-point visual analog scale (1 to 7). On this scale, a score of 1 corresponds to 0 millimeters (mm), and a score of 7 correspond to 100 mm. Anything in between is marked at the appropriate point on the scale and is measured in mm. Data are reported in mm in this table. In FLIE questions (FLIEQ) 1, 2, 4, 5, 7, 8, 9, 10, 12, 13, 14, 16, and 17, a score of 1 indicates no effect on the quality of life, and a score of 7 indicates a great effect on the quality of life. In FLIEQ 3, 6, 11, 15, and 18, a score of 1 indicates a great effect on the quality of life, and a score of 7 indicates no effect on the quality of life.
Time frame: Baseline and Week 16
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
The HCFQ questionnaire is used to record how often participants have felt hungry or craved food, and how full participants felt after finishing meals, on average, in the past week. Participants answered the following seven questions with the response that best described their feelings of hunger, craving, and fullness: Q1, "In the past week I was hungry"; Q2, "In the past week I thought about food"; Q3, "In the past week I wanted to eat"; Q4, "In the past week I ate more than I should have"; Q5, "In the past week, I craved specific food"; Q6, "In the past week when finished meals I felt full"; Q7, "In the past week when finished meals I felt satisfied."
Time frame: Week 16
Mean Clearance of Albiglutide
Clearance is defined as the volume of plasma cleared of albiglutide per unit time. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose pharmacokinetic (PK) sampling was performed within 6 days of drug administration.
Time frame: Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27
Mean Volume of Distribution of Albiglutide
Volume of distribution is defined as the apparent volume in which albiglutide is distributed. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose (PK sampling was performed within 6 days of drug administration.
Time frame: Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27
Mean Absorption Rate of Albiglutide
Absorption rate is defined as the rate at which albiglutide enters the blood circulation. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose (PK sampling was performed within 6 days of drug administration.
Time frame: Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27
Mean Half-maximal Effective Concentration (EC50) of Albiglutide for HbA1c and FPG
EC50 is defined as the concentration of albiglutide that give a half-maximal HbA1c and FPG response. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose (PK sampling was performed within 6 days of drug administration. EC50 estimates used PK data as well as HbA1c and FPG efficacy data. EC50 was estimated from an inhibitory Emax (maximal possible effect of albiglutide) model.
Time frame: Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27
| Milestone | Placebo | Exenatide BID | Albiglutide 4 mg Weekly | Albiglutide 15 mg Weekly | Albiglutide 30 mg Weekly | Albiglutide 15 mg Bi-weekly | Albiglutide 30 mg Bi-weekly | Albiglutide 50 mg Bi-weekly | Albiglutide 50 mg Every 4 Weeks | Albiglutide 100 mg Every 4 Weeks |
|---|---|---|---|---|---|---|---|---|---|---|
| Started | 52 | 35 | 36 | 35 | 31 | 34 | 33 | 35 | 35 | 35 |
| Safety population | 51 | 35 | 35 | 35 | 31 | 33 | 32 | 35 | 35 | 34 |
| Completed | 40 | 29 | 19 | 24 | 21 | 19 | 25 | 20 | 30 | 20 |
| Not completed | 12 | 6 | 17 | 11 | 10 | 15 | 8 | 15 | 5 | 15 |
| Withdrew: Adverse event | 6 | 1 | 5 | 6 | 5 | 5 | 5 | 10 | 2 | 9 |
| Withdrew: Lost to follow-up | 0 | 0 | 2 | 3 | 1 | 3 | 0 | 1 | 1 | 1 |
| Withdrew: Protocol violation | 1 | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 1 | 5 | 0 | 2 | 1 | 0 | 2 | 1 | 3 |
| Withdrew: Lack of efficacy | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Non-compliance | 1 | 0 | 1 | 0 | 1 | 1 | 1 | 1 | 0 | 1 |
| Withdrew: Treatment eligibility criteria not met | 1 | 1 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 0 |
| Withdrew: Physician prescribed antidiabetic drug | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Different monotherapy diabetic drug | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Wrong monotherapy administered | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Violation of exclusion criteria | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Family emergency; had to go to england | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrew consent | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Moved out of state | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 16 minus the value at Baseline. Based on ANCOVA: Change = treatment + Baseline HbA1c + prior therapy + gender + region. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
| Percentage of HbA1c in the blood | Placebo | Exenatide BID | Albiglutide 4 mg Weekly | Albiglutide 15 mg Weekly | Albiglutide 30 mg Weekly | Albiglutide 15 mg Bi-weekly | Albiglutide 30 mg Bi-weekly | Albiglutide 50 mg Bi-weekly | Albiglutide 50 mg Every 4 Weeks | Albiglutide 100 mg Every 4 Weeks |
|---|---|---|---|---|---|---|---|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16 | -0.46 ± 0.136 | — | -0.25 ± 0.159 | -0.71 ± 0.160 | -1.08 ± 0.175 | -0.68 ± 0.167 | -1.01 ± 0.162 | -1.03 ± 0.159 | -0.80 ± 0.157 | -1.06 ± 0.161 |
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the post-Baseline value minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
| Percentage of HbA1c in the blood | Placebo | Exenatide BID | Albiglutide 4 mg Weekly | Albiglutide 15 mg Weekly | Albiglutide 30 mg Weekly | Albiglutide 15 mg Bi-weekly | Albiglutide 30 mg Bi-weekly | Albiglutide 50 mg Bi-weekly | Albiglutide 50 mg Every 4 Weeks | Albiglutide 100 mg Every 4 Weeks |
|---|---|---|---|---|---|---|---|---|---|---|
| Week 4, n=47,34,33,34,28,29,31,34,34,30 | -0.14 ± 0.538 | -0.23 ± 0.485 | -0.12 ± 0.658 | -0.33 ± 0.442 | -0.56 ± 0.401 | -0.35 ± 0.470 | -0.34 ± 0.678 | -0.45 ± 0.547 | -0.41 ± 0.429 | -0.42 ± 0.523 |
| Week 5, n=49,34,34,34,29,30,32,34,35,31 | -0.09 ± 0.570 | -0.32 ± 0.495 | -0.16 ± 0.758 | -0.39 ± 0.516 | -0.62 ± 0.439 | -0.42 ± 0.625 | -0.51 ± 0.756 | -0.58 ± 0.554 | -0.47 ± 0.608 | -0.65 ± 0.376 |
| Week 7, n=50,34,34,34,29,30,32,34,35,32 | -0.15 ± 0.749 | -0.36 ± 0.554 | -0.19 ± 0.855 | -0.44 ± 0.619 | -0.79 ± 0.474 | -0.52 ± 0.648 | 0.64 ± 0.890 | -0.68 ± 0.831 | -0.45 ± 0.801 | -0.63 ± 0.420 |
| Week 8, n=50,34,34,34,29,30,32,34,35,32 | -0.17 ± 0.793 | -0.45 ± 0.588 | -0.24 ± 0.897 | -0.50 ± 0.659 | -0.77 ± 0.494 | -0.54 ± 0.679 | -0.67 ± 0.928 | -0.71 ± 0.834 | -0.41 ± 0.823 | -0.68 ± 0.410 |
| Week 9, n=50,34,34,34,29,30,32,34,35,32 | -0.21 ± 0.842 | -0.51 ± 0.633 | -0.19 ± 0.947 | -0.55 ± 0.713 | -0.85 ± 0.559 | -0.56 ± 0.767 | -0.71 ± 0.929 | -0.77 ± 0.842 | -0.54 ± 0.836 | -0.82 ± 0.486 |
| Week 12, n=50,34,34,34,29,30,32,34,35,33 | -0.19 ± 0.892 | -0.56 ± 0.868 | -0.18 ± 1.025 | -0.58 ± 0.813 | -0.96 ± 0.649 | -0.59 ± 0.913 | -0.71 ± 1.003 | -0.79 ± 0.852 | -0.51 ± 0.942 | -0.84 ± 0.744 |
| Week 15, n=50,34,34,34,29,30,32,34,35,33 | -0.27 ± 0.948 | -0.53 ± 0.865 | -0.19 ± 0.989 | -0.49 ± 0.819 | -0.86 ± 0.607 | -0.61 ± 0.929 | -0.79 ± 1.044 | -0.80 ± 1.041 | -0.58 ± 1.016 | -0.88 ± 0.790 |
| Week 16, n=50,34,34,34,29,30,32,34,35,33 | -0.17 ± 1.006 | -0.54 ± 0.906 | -0.11 ± 1.156 | -0.49 ± 0.740 | -0.87 ± 0.652 | -0.56 ± 0.971 | -0.79 ± 0.978 | -0.79 ± 1.036 | -0.55 ± 1.012 | -0.87 ± 0.866 |
The number of participants who achieved target values for HbA1c (i.e., HbA1c \<6.5% and \>=6.5% to \<7%) were assessed. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
| Participants | Placebo | Exenatide BID | Albiglutide 4 mg Weekly | Albiglutide 15 mg Weekly | Albiglutide 30 mg Weekly | Albiglutide 15 mg Bi-weekly | Albiglutide 30 mg Bi-weekly | Albiglutide 50 mg Bi-weekly | Albiglutide 50 mg Every 4 Weeks | Albiglutide 100 mg Every 4 Weeks |
|---|---|---|---|---|---|---|---|---|---|---|
| W4: <6.5%, n=47,34,33,34,28,29,31,34,34,30 | 1 | 0 | 0 | 1 | 4 | 0 | 0 | 3 | 1 | 3 |
| W4: >=6.5% to <7%, n=47,34,33,34,28,29,31,34,34,30 | 8 | 5 | 5 | 8 | 8 | 6 | 8 | 5 | 6 | 6 |
| W5: <6.5%, n=49,34,34,34,29,30,32,34,35,31 | 2 | 0 | 1 | 2 | 4 | 1 | 1 | 2 | 1 | 4 |
| W5: >=6.5% to <7%, n=49,34,34,34,29,30,32,34,35,31 | 4 | 7 | 5 | 7 | 8 | 5 | 9 | 11 | 7 | 12 |
| W7: <6.5%, n=50,34,34,34,29,30,32,34,35,32 | 1 | 1 | 1 | 4 | 8 | 1 | 3 | 6 | 2 | 5 |
| W7: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32 | 9 | 9 | 4 | 4 | 5 | 9 | 11 | 9 | 8 | 8 |
| W8: <6.5%, n=50,34,34,34,29,30,32,34,35,32 | 1 | 2 | 1 | 4 | 6 | 1 | 4 | 7 | 2 | 5 |
| W8: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32 | 10 | 7 | 6 | 8 | 8 | 9 | 12 | 10 | 4 | 11 |
| W9: <6.5%, n=50,34,34,34,29,30,32,34,35,32 | 3 | 2 | 2 | 6 | 8 | 1 | 3 | 7 | 2 | 9 |
| W9: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32 | 9 | 9 | 5 | 7 | 5 | 10 | 11 | 10 | 9 | 8 |
| W12: <6.5%, n=50,34,34,34,29,30,32,34,35,33 | 3 | 3 | 2 | 5 | 11 | 3 | 3 | 8 | 2 | 7 |
| W12:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33 | 7 | 8 | 4 | 8 | 5 | 7 | 13 | 11 | 9 | 8 |
| W15: <6.5%, n=50,34,34,34,29,30,32,34,35,33 | 3 | 4 | 2 | 4 | 8 | 4 | 6 | 10 | 3 | 9 |
| W15:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33 | 8 | 6 | 5 | 8 | 7 | 7 | 8 | 9 | 8 | 7 |
| W16: <6.5%, n=50,34,34,34,29,30,32,34,35,33 | 2 | 4 | 3 | 4 | 10 | 5 | 4 | 10 | 3 | 8 |
| W16:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33 | 8 | 8 | 3 | 8 | 5 | 3 | 12 | 8 | 5 | 8 |
The Baseline value is the last non-missing value before the start of treatment. Change from Baseline in waist circumference was calculated as the value at Week 16 minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
| Centimeters | Placebo | Exenatide BID | Albiglutide 4 mg Weekly | Albiglutide 15 mg Weekly | Albiglutide 30 mg Weekly | Albiglutide 15 mg Bi-weekly | Albiglutide 30 mg Bi-weekly | Albiglutide 50 mg Bi-weekly | Albiglutide 50 mg Every 4 Weeks | Albiglutide 100 mg Every 4 Weeks |
|---|---|---|---|---|---|---|---|---|---|---|
| Change From Baseline in Waist Circumference at Week 16 | -0.51 ± 3.847 | -3.53 ± 8.532 | -1.50 ± 3.902 | -3.16 ± 6.901 | -1.14 ± 3.856 | -1.83 ± 3.392 | -0.47 ± 3.589 | -2.00 ± 5.454 | -0.88 ± 5.146 | -0.77 ± 4.161 |
The Baseline value is the last non-missing value before the start of treatment. Change from Baseline in body weight was calculated as the value at Week 16 minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
| Kilograms (Kg) | Placebo | Exenatide BID | Albiglutide 4 mg Weekly | Albiglutide 15 mg Weekly | Albiglutide 30 mg Weekly | Albiglutide 15 mg Bi-weekly | Albiglutide 30 mg Bi-weekly | Albiglutide 50 mg Bi-weekly | Albiglutide 50 mg Every 4 Weeks | Albiglutide 100 mg Every 4 Weeks |
|---|---|---|---|---|---|---|---|---|---|---|
| Change From Baseline in Body Weight at Week 16 | -0.71 ± 2.883 | -2.41 ± 3.527 | -0.91 ± 1.733 | -0.90 ± 2.901 | -1.43 ± 2.371 | -1.76 ± 2.828 | -1.59 ± 2.455 | -1.14 ± 2.872 | -1.08 ± 3.177 | -1.65 ± 3.570 |
The Baseline value is the last non-missing value before the start of treatment. Change from Baseline in body weight was calculated as the value at Week 16 minus the value at Baseline. Percent change from Baseline was calculated as the (\[value at Week 16 minus the Baseline value\] divided by the Baseline value) multiplied by 100. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
| Percent change | Placebo | Exenatide BID | Albiglutide 4 mg Weekly | Albiglutide 15 mg Weekly | Albiglutide 30 mg Weekly | Albiglutide 15 mg Bi-weekly | Albiglutide 30 mg Bi-weekly | Albiglutide 50 mg Bi-weekly | Albiglutide 50 mg Every 4 Weeks | Albiglutide 100 mg Every 4 Weeks |
|---|---|---|---|---|---|---|---|---|---|---|
| Percent Change From Baseline in Body Weight at Week 16 | -0.72 ± 3.403 | -2.53 ± 4.307 | -0.94 ± 1.838 | -1.04 ± 3.261 | -1.59 ± 2.663 | -1.97 ± 2.908 | -1.69 ± 2.773 | -1.32 ± 3.160 | -1.37 ± 3.571 | -1.89 ± 3.190 |
The FPG test measures blood sugar levels after the participant has not eaten (fasted) for at least eight hours prior to the sampling. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline in FPG was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
| Millimoles per liter (mmol/L) | Placebo | Exenatide BID | Albiglutide 4 mg Weekly | Albiglutide 15 mg Weekly | Albiglutide 30 mg Weekly | Albiglutide 15 mg Bi-weekly | Albiglutide 30 mg Bi-weekly | Albiglutide 50 mg Bi-weekly | Albiglutide 50 mg Every 4 Weeks | Albiglutide 100 mg Every 4 Weeks |
|---|---|---|---|---|---|---|---|---|---|---|
| Week 4, n=47,33,32,32,29,28,32,32,34,32 | -0.40 ± 2.565 | -1.11 ± 1.953 | -0.99 ± 3.037 | -0.58 ± 1.693 | -1.39 ± 1.968 | -1.06 ± 2.110 | -0.97 ± 1.629 | -1.35 ± 2.533 | -0.14 ± 3.192 | -0.61 ± 2.267 |
| Week 5, n=47,33,32,32,29,28,32,32,34,32 | -0.40 ± 2.774 | -1.06 ± 2.377 | -1.02 ± 2.964 | -1.05 ± 1.705 | -1.53 ± 1.898 | -1.41 ± 2.363 | -1.72 ± 1.933 | -2.17 ± 2.453 | -1.55 ± 3.032 | -2.12 ± 1.959 |
| Week 7, n=47,33,32,32,29,28,32,32,34,33 | -0.19 ± 2.924 | -1.25 ± 2.204 | -0.80 ± 2.942 | -0.13 ± 2.261 | -1.54 ± 1.723 | -1.16 ± 2.651 | -1.51 ± 2.065 | -1.87 ± 2.801 | -0.41 ± 2.844 | -1.07 ± 2.519 |
| Week 8, n=47,33,32,32,29,28,32,32,34,33 | -0.44 ± 2.689 | -1.43 ± 2.258 | -1.22 ± 2.958 | -0.80 ± 1.856 | -1.60 ± 1.925 | -1.29 ± 2.520 | -1.27 ± 2.092 | -1.29 ± 2.655 | -0.66 ± 2.202 | -1.29 ± 2.898 |
| Week 9, n=47,33,32,32,29,28,32,32,34,33 | -0.25 ± 3.185 | -1.54 ± 2.044 | -1.13 ± 2.915 | -0.71 ± 1.674 | -1.49 ± 2.122 | -1.29 ± 2.617 | -1.64 ± 2.505 | -1.68 ± 3.012 | -1.48 ± 2.887 | -2.25 ± 2.388 |
| Week 12, n=47,33,32,32,29,28,32,32,34,33 | -0.27 ± 2.833 | -1.32 ± 2.518 | -1.04 ± 2.863 | -0.70 ± 2.413 | -1.85 ± 1.722 | -1.11 ± 2.492 | -1.57 ± 2.196 | -1.49 ± 2.908 | -0.49 ± 3.103 | -1.50 ± 3.310 |
| Week 15, n=47,33,32,32,29,28,32,32,34,33 | -0.44 ± 2.733 | -1.27 ± 2.343 | -0.67 ± 2.984 | -0.70 ± 1.755 | -1.54 ± 1.680 | -1.45 ± 2.320 | -1.71 ± 2.133 | -1.66 ± 3.662 | -0.79 ± 2.757 | -1.27 ± 3.502 |
| Week 16, n=47,33,32,32,29,28,32,32,34,33 | -0.10 ± 2.895 | -0.80 ± 2.482 | -0.47 ± 3.118 | -0.72 ± 1.683 | -1.44 ± 2.027 | -1.28 ± 2.427 | -1.58 ± 2.059 | -1.32 ± 3.523 | -0.72 ± 2.765 | -1.22 ± 3.497 |
Fasting fructosamine levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline fructosamine value is the last non-missing value before the start of treatment. Change from Baseline in fructosamine was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
| Micromoles per liter (µmol/L) | Placebo | Exenatide BID | Albiglutide 4 mg Weekly | Albiglutide 15 mg Weekly | Albiglutide 30 mg Weekly | Albiglutide 15 mg Bi-weekly | Albiglutide 30 mg Bi-weekly | Albiglutide 50 mg Bi-weekly | Albiglutide 50 mg Every 4 Weeks | Albiglutide 100 mg Every 4 Weeks |
|---|---|---|---|---|---|---|---|---|---|---|
| Week 5, n=48,34,32,33,28,29,32,34,35,29 | -8.3 ± 38.68 | -24.7 ± 38.65 | -11.9 ± 50.55 | -23.8 ± 20.74 | -30.7 ± 31.28 | -21.3 ± 36.67 | -34.4 ± 41.71 | -30.1 ± 41.75 | -29.2 ± 46.57 | -32.5 ± 32.40 |
| Week 8, n=50,34,33,34,28,29,32,34,35,31 | -10.1 ± 41.37 | -30.6 ± 32.47 | -13.1 ± 50.64 | -25.7 ± 31.34 | -35.5 ± 26.97 | -28.9 ± 42.46 | -40.9 ± 43.73 | -32.7 ± 42.44 | -24.9 ± 40.03 | -29.5 ± 49.98 |
| Week 12, n=50,34,33,34,28,29,32,34,35,33 | -11.2 ± 41.61 | -30.1 ± 35.78 | -12.5 ± 55.41 | -26.7 ± 30.61 | -31.8 ± 35.07 | -25.2 ± 46.21 | -40.2 ± 43.37 | -32.7 ± 48.01 | -26.4 ± 46.85 | -31.1 ± 52.14 |
| Week 16, n=50,34,33,34,28,29,32,34,35,33 | -3.2 ± 46.33 | -24.6 ± 41.88 | -7.8 ± 56.38 | -18.2 ± 28.01 | -30.8 ± 31.05 | -23.0 ± 49.58 | -38.1 ± 43.17 | -29.4 ± 56.23 | -26.5 ± 40.27 | -24.9 ± 49.08 |
Fasting C-peptide levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline C-peptide value is the last non-missing value before the start of treatment. Change from Baseline in C-peptide was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
| Nanomoles per liter (nmol/L) | Placebo | Exenatide BID | Albiglutide 4 mg Weekly | Albiglutide 15 mg Weekly | Albiglutide 30 mg Weekly | Albiglutide 15 mg Bi-weekly | Albiglutide 30 mg Bi-weekly | Albiglutide 50 mg Bi-weekly | Albiglutide 50 mg Every 4 Weeks | Albiglutide 100 mg Every 4 Weeks |
|---|---|---|---|---|---|---|---|---|---|---|
| Week 5, n=48,33,32,33,27,28,32,33,35,30 | 0.004 ± 0.4464 | 0.274 ± 0.7431 | -0.020 ± 0.3374 | -0.034 ± 0.6149 | 0.089 ± 0.3459 | 0.015 ± 0.3782 | -0.128 ± 0.6990 | 0.004 ± 0.4130 | 0.072 ± 0.4130 | 0.230 ± 0.3595 |
| Week 8, n=50,34,33,34,28,29,32,33,35,31 | -0.019 ± 0.4044 | 0.104 ± 0.4643 | -0.073 ± 0.2813 | -0.026 ± 0.6237 | 0.095 ± 0.5520 | -0.038 ± 0.3931 | -0.015 ± 0.7842 | -0.062 ± 0.3735 | 0.031 ± 0.4738 | 0.007 ± 0.3363 |
| Week 12, n=50,34,33,34,28,29,32,33,35,33 | -0.092 ± 0.4264 | 0.174 ± 0.5445 | -0.044 ± 0.3426 | -0.046 ± 0.5904 | 0.023 ± 0.3698 | -0.098 ± 0.3773 | -0.153 ± 0.6463 | -0.076 ± 0.4458 | 0.155 ± 0.5257 | 0.062 ± 0.6038 |
| Week 16, n=50,34,33,34,28,29,32,33,35,33 | -0.091 ± 0.3149 | 0.216 ± 0.6786 | -0.051 ± 0.3877 | -0.075 ± 0.6046 | 0.171 ± 0.4400 | -0.059 ± 0.4010 | -0.137 ± 0.6540 | -0.066 ± 0.4025 | 0.076 ± 0.5365 | -0.005 ± 0.4312 |
Fasting glucagon levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline glucagon value is the last non-missing value before the start of treatment. Change from Baseline in glucagon was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
| Nanograms per liter (ng/L) | Placebo | Exenatide BID | Albiglutide 4 mg Weekly | Albiglutide 15 mg Weekly | Albiglutide 30 mg Weekly | Albiglutide 15 mg Bi-weekly | Albiglutide 30 mg Bi-weekly | Albiglutide 50 mg Bi-weekly | Albiglutide 50 mg Every 4 Weeks | Albiglutide 100 mg Every 4 Weeks |
|---|---|---|---|---|---|---|---|---|---|---|
| Week 5, n=48,33,33,33,27,28,32,34,35,30 | 3.8 ± 43.63 | -3.9 ± 39.26 | -3.2 ± 27.16 | -13.9 ± 29.05 | -3.6 ± 21.95 | -6.0 ± 26.83 | -7.6 ± 20.72 | -11.6 ± 29.48 | -9.3 ± 23.21 | 1.9 ± 30.27 |
| Week 8, n=50,34,34,34,28,29,32,34,35,31 | 6.9 ± 49.05 | -14.8 ± 38.34 | -5.6 ± 22.91 | -15.6 ± 32.75 | -2.4 ± 17.78 | -12.4 ± 32.17 | -3.1 ± 22.64 | -10.7 ± 34.48 | -0.3 ± 41.71 | 0.5 ± 27.94 |
| Week 12, n=50,34,34,34,28,29,32,34,35,33 | 0.1 ± 49.48 | -5.5 ± 32.41 | -8.6 ± 31.51 | -20.1 ± 36.53 | -4.5 ± 21.60 | -11.1 ± 39.08 | 0.2 ± 24.55 | -3.3 ± 35.85 | -3.7 ± 38.02 | -2.1 ± 23.58 |
| Week 16, n=50,34,34,34,28,29,32,34,35,33 | -2.1 ± 45.73 | -4.5 ± 41.10 | -3.9 ± 26.72 | -20.5 ± 36.06 | -2.6 ± 22.70 | -7.1 ± 32.75 | -5.0 ± 17.95 | -10.9 ± 34.41 | -11.5 ± 25.21 | -4.7 ± 18.59 |
Fasting insulin levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline insulin value is the last non-missing value before the start of treatment. Change from Baseline in insulin was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
| Picomoles per liter (pmol/L) | Placebo | Exenatide BID | Albiglutide 4 mg Weekly | Albiglutide 15 mg Weekly | Albiglutide 30 mg Weekly | Albiglutide 15 mg Bi-weekly | Albiglutide 30 mg Bi-weekly | Albiglutide 50 mg Bi-weekly | Albiglutide 50 mg Every 4 Weeks | Albiglutide 100 mg Every 4 Weeks |
|---|---|---|---|---|---|---|---|---|---|---|
| Week 5, n=47,31,32,33,27,28,31,30,33,30 | 5.1 ± 106.67 | 29.6 ± 104.29 | -12.4 ± 72.90 | -16.4 ± 114.61 | 0.4 ± 75.97 | 28.5 ± 99.26 | -38.3 ± 104.22 | -8.4 ± 75.38 | 11.1 ± 97.92 | 36.2 ± 115.31 |
| Week 8, n=49,32,33,34,28,29,32,31,33,31 | 9.2 ± 106.05 | 5.4 ± 52.47 | -16.5 ± 64.88 | -8.5 ± 116.41 | 2.4 ± 98.07 | 18.6 ± 102.92 | -14.4 ± 104.76 | -16.8 ± 84.12 | 12.9 ± 92.97 | 6.6 ± 62.90 |
| Week 12, n=49,32,33,34,28,29,32,31,33,33 | 8.8 ± 79.93 | 18.0 ± 60.31 | -12.4 ± 67.03 | -7.9 ± 106.19 | -1.1 ± 86.02 | 17.8 ± 99.18 | -26.1 ± 94.10 | 0.2 ± 90.27 | 38.0 ± 158.33 | 11.6 ± 73.33 |
| Week 16, n=49,32,33,34,28,29,32,31,33,33 | -5.8 ± 42.74 | 17.4 ± 52.62 | 2.9 ± 81.64 | -19.9 ± 112.32 | 25.1 ± 114.95 | 21.9 ± 99.41 | -24.0 ± 90.05 | -17.4 ± 80.04 | 12.9 ± 72.22 | 18.4 ± 80.83 |
Serum lipid components, including triglycerides (TG), free fatty acids (FFA), total cholesterol (CL), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C), were measured at Baseline and Weeks 5, 8, 12, and 16. The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
| mmol/L | Placebo | Exenatide BID | Albiglutide 4 mg Weekly | Albiglutide 15 mg Weekly | Albiglutide 30 mg Weekly | Albiglutide 15 mg Bi-weekly | Albiglutide 30 mg Bi-weekly | Albiglutide 50 mg Bi-weekly | Albiglutide 50 mg Every 4 Weeks | Albiglutide 100 mg Every 4 Weeks |
|---|---|---|---|---|---|---|---|---|---|---|
| TG, Week 5, n=45,31,34,31,27,29,31,34,35,30 | -0.225 ± 1.0354 | -0.068 ± 0.7288 | 0.303 ± 2.1539 | -0.376 ± 1.1387 | 0.112 ± 0.6974 | -0.266 ± 1.2296 | -0.147 ± 1.0251 | -1.423 ± 3.7638 | -0.725 ± 1.3749 | -0.184 ± 0.5912 |
| TG, Week 8, n=50,33,34,34,27,30,32,34,35,31 | -0.222 ± 1.5590 | -0.238 ± 0.6205 | 0.178 ± 2.1883 | -0.408 ± 1.3143 | -0.009 ± 0.6977 | -0.219 ± 1.0210 | -0.150 ± 0.9610 | -1.494 ± 3.8212 | -0.175 ± 1.6289 | -0.028 ± 1.1012 |
| TG, Week 12, n=50,34,34,34,28,30,32,34,35,33 | -0.329 ± 1.2941 | 0.094 ± 1.4597 | 0.221 ± 2.3056 | -0.341 ± 1.2139 | 0.106 ± 0.8936 | -0.380 ± 0.8947 | -0.269 ± 1.0358 | -1.539 ± 3.9093 | -0.362 ± 1.5880 | 0.070 ± 0.8288 |
| TG, Week 16, n=50,34,34,34,28,30,32,34,35,33 | -0.377 ± 1.6534 | -0.149 ± 0.8423 | 0.122 ± 2.1274 | -0.296 ± 1.2876 | 0.099 ± 0.9002 | -0.258 ± 0.9248 | -0.331 ± 0.9529 | -1.469 ± 3.8476 | -0.426 ± 1.7338 | -0.114 ± 1.1446 |
| FFA, Week 5, n=48,33,32,33,27,28,32,34,35,29 | 0.029 ± 0.1867 | -0.038 ± 0.2518 | -0.032 ± 0.1691 | -0.008 ± 0.1392 | 0.014 ± 0.1381 | 0.025 ± 0.1927 | -0.028 ± 0.2017 | -0.012 ± 0.2266 | -0.001 ± 0.1568 | 0.006 ± 0.2237 |
| FFA, Week 8, n=50,34,33,34,28,29,32,34,35,31 | 0.034 ± 0.2021 | -0.045 ± 0.2186 | 0.033 ± 0.1699 | -0.048 ± 0.1345 | 0.046 ± 0.1934 | 0.017 ± 0.1897 | -0.027 ± 0.1974 | -0.004 ± 0.2359 | 0.055 ± 0.1843 | 0.175 ± 0.8591 |
| FFA, Week 12, n=50,34,33,34,28,29,32,34,35,33 | 0.075 ± 0.2018 | -0.007 ± 0.1882 | 0.022 ± 0.2003 | -0.013 ± 0.1870 | 0.043 ± 0.1826 | 0.010 ± 0.1920 | -0.051 ± 0.2250 | 0.011 ± 0.2481 | -0.030 ± 0.1796 | 0.123 ± 0.8347 |
| FFA, Week 16, n=50,34,33,34,28,29,32,34,35,33 | 0.078 ± 0.2047 | -0.031 ± 0.1631 | 0.020 ± 0.2084 | 0.016 ± 0.2159 | 0.050 ± 0.1695 | 0.034 ± 0.2006 | -0.005 ± 0.2494 | 0.025 ± 0.2319 | 0.012 ± 0.2065 | 0.094 ± 0.8399 |
| Total CL, Week 5, n=45,31,34,31,27,29,31,34,35,30 | -0.023 ± 0.6128 | -0.239 ± 0.6613 | -0.153 ± 0.8765 | -0.139 ± 0.5795 | -0.113 ± 0.6588 | -0.372 ± 0.6998 | -0.140 ± 0.4168 | -0.451 ± 0.9158 | -0.407 ± 0.6393 | -0.245 ± 0.5284 |
| Total CL, Week 8, n=50,33,34,34,27,30,32,34,35,31 | -0.050 ± 0.5932 | -0.182 ± 0.6517 | -0.060 ± 0.9192 | -0.162 ± 0.4772 | 0.002 ± 0.5870 | -0.172 ± 0.6633 | -0.094 ± 0.4566 | -0.418 ± 0.8572 | -0.183 ± 0.8011 | 0.060 ± 0.6296 |
| Total CL, Week 12, n=50,34,34,34,28,30,32,34,35,33 | 0.045 ± 0.6465 | 0.054 ± 0.7723 | -0.025 ± 0.9136 | -0.140 ± 0.5686 | -0.020 ± 0.6926 | -0.190 ± 0.5975 | -0.092 ± 0.8249 | -0.338 ± 0.9449 | -0.134 ± 0.6620 | 0.015 ± 0.5786 |
| Total CL, Week 16, n=50,34,34,34,28,30,32,34,35,33 | 0.095 ± 0.7695 | -0.031 ± 0.8271 | -0.032 ± 0.9312 | -0.037 ± 0.5402 | 0.009 ± 0.5964 | -0.225 ± 0.5420 | -0.178 ± 0.4476 | -0.447 ± 0.8464 | -0.217 ± 0.7376 | 0.018 ± 0.5532 |
| LDL-C, Week 5, n=41,29,31,29,26,28,29,27,32,29 | 0.066 ± 0.5417 | -0.153 ± 0.5479 | -0.294 ± 0.7053 | -0.155 ± 0.5653 | -0.068 ± 0.6225 | -0.285 ± 0.5345 | -0.082 ± 0.3708 | 0.026 ± 0.5064 | -0.106 ± 0.4576 | -0.091 ± 0.4910 |
| LDL-C, Week 8, n=45,32,32,32,26,30,31,28,32,30 | 0.066 ± 0.5123 | -0.014 ± 0.5556 | -0.132 ± 0.7398 | -0.157 ± 0.5620 | 0.089 ± 0.6053 | -0.160 ± 0.5305 | -0.052 ± 0.4403 | 0.053 ± 0.4543 | -0.087 ± 0.4336 | 0.054 ± 0.5581 |
| LDL-C, Week 12, n=45,33,32,32,28,30,31,28,32,32 | 0.138 ± 0.4923 | 0.105 ± 0.6259 | -0.096 ± 0.6483 | -0.152 ± 0.6477 | 0.004 ± 0.6456 | -0.034 ± 0.5547 | -0.004 ± 0.7153 | 0.156 ± 0.4614 | -0.061 ± 0.3790 | 0.010 ± 0.4771 |
| LDL-C, Week 16, n=46,33,32,32,28,30,31,28,32,32 | 0.190 ± 0.6025 | 0.096 ± 0.6960 | -0.109 ± 0.6558 | -0.045 ± 0.6183 | 0.003 ± 0.6010 | -0.123 ± 0.5198 | -0.062 ± 0.3943 | 0.059 ± 0.5750 | -0.088 ± 0.5125 | 0.054 ± 0.4475 |
| HDL-C, Week 5, n=45,31,34,31,27,29,31,34,35,30 | -0.020 ± 0.1189 | -0.047 ± 0.1420 | 0.001 ± 0.1203 | -0.010 ± 0.1491 | -0.063 ± 0.1425 | -0.038 ± 0.1215 | -0.045 ± 0.1434 | -0.076 ± 0.1553 | -0.047 ± 0.1765 | -0.053 ± 0.1129 |
| HDL-C, Week 8, n=50,33,34,34,27,30,32,34,35,31 | -0.005 ± 0.1192 | -0.058 ± 0.1606 | 0.006 ± 0.1160 | 0.019 ± 0.1187 | -0.061 ± 0.1368 | -0.018 ± 0.1417 | -0.030 ± 0.1217 | -0.050 ± 0.1403 | -0.054 ± 0.1746 | -0.016 ± 0.1567 |
| HDL-C, Week 12, n=50,34,34,34,28,30,32,34,35,33 | -0.011 ± 0.1341 | -0.003 ± 0.2269 | 0.004 ± 0.1258 | -0.019 ± 0.1115 | -0.061 ± 0.1674 | -0.018 ± 0.1323 | -0.041 ± 0.1998 | -0.029 ± 0.1303 | -0.033 ± 0.1445 | -0.045 ± 0.1411 |
| HDL-C, Week 16, n=50,34,34,34,28,30,32,34,35,33 | -0.002 ± 0.1274 | -0.025 ± 0.2192 | -0.007 ± 0.1366 | -0.010 ± 0.1342 | -0.046 ± 0.1699 | -0.015 ± 0.1146 | -0.031 ± 0.1413 | -0.065 ± 0.1730 | -0.033 ± 0.1595 | -0.048 ± 0.1930 |
The FLIE questionnaire is used to record the participant's feelings/opinions concerning the effects of nausea/vomiting on their quality of life during the past five days. Participants completed the questionnaire by responding to 18 questions. The first set of 9 questions refer to nausea, and the second set of 9 questions refer to vomiting. Each question is scored on a seven-point visual analog scale (1 to 7). On this scale, a score of 1 corresponds to 0 millimeters (mm), and a score of 7 correspond to 100 mm. Anything in between is marked at the appropriate point on the scale and is measured in mm. Data are reported in mm in this table. In FLIE questions (FLIEQ) 1, 2, 4, 5, 7, 8, 9, 10, 12, 13, 14, 16, and 17, a score of 1 indicates no effect on the quality of life, and a score of 7 indicates a great effect on the quality of life. In FLIEQ 3, 6, 11, 15, and 18, a score of 1 indicates a great effect on the quality of life, and a score of 7 indicates no effect on the quality of life.
| Score on a scale | Placebo | Exenatide BID | Albiglutide 4 mg Weekly | Albiglutide 15 mg Weekly | Albiglutide 30 mg Weekly | Albiglutide 15 mg Bi-weekly | Albiglutide 30 mg Bi-weekly | Albiglutide 50 mg Bi-weekly | Albiglutide 50 mg Every 4 Weeks | Albiglutide 100 mg Every 4 Weeks |
|---|---|---|---|---|---|---|---|---|---|---|
| FLIEQ1 | -0.1 ± 6.79 | -4.4 ± 19.25 | 5.7 ± 23.42 | 1.0 ± 19.54 | 4.6 ± 11.35 | 8.6 ± 24.35 | -1.0 ± 2.22 | 8.2 ± 22.66 | -0.3 ± 7.18 | -2.8 ± 8.30 |
| FLIEQ2 | 0.2 ± 2.15 | -3.5 ± 18.64 | 5.5 ± 23.42 | 2.6 ± 18.20 | 3.0 ± 11.67 | 5.9 ± 22.87 | -0.8 ± 4.03 | 4.7 ± 21.95 | -0.6 ± 3.21 | -0.2 ± 1.84 |
| FLIEQ3 | 15.6 ± 36.34 | 7.8 ± 25.52 | 10.3 ± 42.11 | -4.0 ± 19.64 | 18.6 ± 47.37 | 10.3 ± 45.34 | 3.9 ± 32.47 | 18.2 ± 39.83 | 4.5 ± 28.67 | 7.3 ± 29.72 |
| FLIEQ4 | 0.4 ± 2.06 | -3.5 ± 18.32 | 6.4 ± 24.11 | -2.8 ± 11.95 | 1.5 ± 5.16 | 5.6 ± 22.91 | -1.6 ± 8.84 | 5.9 ± 22.48 | -1.9 ± 16.90 | -1.8 ± 6.68 |
| FLIEQ5 | -0.3 ± 3.46 | -4.0 ± 18.21 | 6.4 ± 23.09 | -1.8 ± 7.18 | 2.9 ± 11.23 | 0.2 ± 33.34 | -1.3 ± 5.41 | 4.5 ± 21.97 | 1.5 ± 6.42 | -1.4 ± 6.03 |
| FLIEQ6 | 11.2 ± 38.64 | 3.6 ± 29.76 | 9.4 ± 40.77 | -0.5 ± 26.11 | 20.0 ± 44.44 | 10.2 ± 45.38 | 4.2 ± 31.38 | 18.0 ± 40.06 | 5.6 ± 26.54 | 3.9 ± 36.69 |
| FLIEQ7 | 0.4 ± 2.20 | -3.1 ± 19.16 | 5.7 ± 23.46 | 1.5 ± 16.77 | 0.2 ± 0.69 | 5.7 ± 22.88 | -1.0 ± 6.71 | 4.9 ± 21.93 | -0.1 ± 4.85 | -1.9 ± 6.44 |
| FLIEQ8 | -0.6 ± 4.46 | -3.5 ± 18.60 | 5.7 ± 23.36 | -1.0 ± 10.95 | 2.6 ± 9.80 | 10.1 ± 29.33 | -0.7 ± 3.14 | 6.2 ± 22.05 | -0.4 ± 4.91 | -2.3 ± 7.08 |
| FLIEQ9 | -0.1 ± 3.55 | -3.4 ± 17.86 | 5.3 ± 23.45 | -0.5 ± 3.64 | 2.3 ± 8.70 | 5.6 ± 22.91 | -0.7 ± 3.20 | 4.0 ± 22.33 | -0.1 ± 4.63 | -3.2 ± 9.80 |
| FLIEQ10 | -0.3 ± 3.27 | -4.9 ± 18.81 | 5.8 ± 22.70 | -1.6 ± 6.51 | -0.1 ± 3.55 | 4.5 ± 23.37 | -0.3 ± 1.81 | 4.3 ± 22.00 | 0.2 ± 1.90 | -2.0 ± 5.12 |
| FLIEQ11 | 15.3 ± 36.17 | 3.3 ± 30.36 | 13.8 ± 34.10 | -0.5 ± 38.39 | 21.9 ± 42.11 | 7.9 ± 46.96 | 3.6 ± 19.32 | 18.3 ± 40.27 | 7.2 ± 25.77 | 4.0 ± 36.47 |
| FLIEQ12 | 0.1 ± 1.52 | -3.1 ± 17.45 | 6.4 ± 23.00 | -0.8 ± 8.09 | 1.8 ± 6.40 | 5.3 ± 22.95 | -0.2 ± 2.26 | 4.4 ± 21.97 | -0.4 ± 3.17 | -0.8 ± 3.49 |
| FLIEQ13 | 0.1 ± 1.57 | -4.0 ± 18.31 | 6.3 ± 23.03 | -2.2 ± 8.43 | 1.0 ± 6.12 | 9.8 ± 29.41 | -0.3 ± 1.71 | 4.3 ± 22.02 | 0.0 ± 1.72 | -2.1 ± 6.55 |
| FLIEQ14 | -0.3 ± 2.95 | -4.1 ± 18.18 | 6.4 ± 23.12 | -1.4 ± 6.22 | 1.8 ± 6.15 | 5.3 ± 22.94 | -0.1 ± 1.61 | 4.3 ± 22.0 | -0.1 ± 1.81 | -2.1 ± 6.36 |
| FLIEQ15 | 15.5 ± 36.06 | 7.0 ± 23.57 | 14.2 ± 34.03 | -4.9 ± 18.87 | 19.7 ± 46.48 | 5.6 ± 50.36 | 3.5 ± 19.32 | 18.4 ± 40.22 | 1.5 ± 20.48 | 4.0 ± 36.71 |
| FLIEQ16 | -0.4 ± 2.58 | -3.8 ± 18.20 | 6.3 ± 23.02 | -1.4 ± 7.37 | -0.5 ± 3.66 | 8.2 ± 25.92 | -0.1 ± 1.80 | 4.5 ± 21.95 | 0.9 ± 5.55 | -1.5 ± 4.32 |
| FLIEQ17 | 0.1 ± 1.60 | -4.1 ± 18.14 | 6.3 ± 22.97 | -1.2 ± 6.08 | -1.2 ± 5.10 | 4.5 ± 23.36 | -0.2 ± 1.98 | 4.3 ± 22.02 | -1.1 ± 5.62 | -0.6 ± 3.89 |
| FLIEQ18 | 18.1 ± 37.82 | 6.9 ± 23.47 | 14.2 ± 33.91 | -3.2 ± 17.62 | 14.9 ± 34.45 | 10.1 ± 45.39 | 7.1 ± 26.96 | 18.5 ± 40.09 | 5.7 ± 26.48 | 6.9 ± 30.76 |
The HCFQ questionnaire is used to record how often participants have felt hungry or craved food, and how full participants felt after finishing meals, on average, in the past week. Participants answered the following seven questions with the response that best described their feelings of hunger, craving, and fullness: Q1, "In the past week I was hungry"; Q2, "In the past week I thought about food"; Q3, "In the past week I wanted to eat"; Q4, "In the past week I ate more than I should have"; Q5, "In the past week, I craved specific food"; Q6, "In the past week when finished meals I felt full"; Q7, "In the past week when finished meals I felt satisfied."
| Participants | Placebo | Exenatide BID | Albiglutide 4 mg Weekly | Albiglutide 15 mg Weekly | Albiglutide 30 mg Weekly | Albiglutide 15 mg Bi-weekly | Albiglutide 30 mg Bi-weekly | Albiglutide 50 mg Bi-weekly | Albiglutide 50 mg Every 4 Weeks | Albiglutide 100 mg Every 4 Weeks |
|---|---|---|---|---|---|---|---|---|---|---|
| Q1: Always | 1 | 0 | 0 | 0 | 0 | 2 | 2 | 2 | 2 | 1 |
| Q1: Often | 5 | 5 | 2 | 7 | 6 | 3 | 5 | 2 | 6 | 6 |
| Q1: Sometimes | 28 | 17 | 15 | 14 | 14 | 8 | 17 | 11 | 20 | 12 |
| Q1: Rarely | 4 | 7 | 3 | 4 | 2 | 6 | 0 | 4 | 2 | 2 |
| Q1: Never | 1 | 1 | 1 | 0 | 0 | 0 | 1 | 2 | 0 | 1 |
| Q2: Always | 1 | 1 | 0 | 0 | 0 | 1 | 3 | 2 | 3 | 2 |
| Q2: Often | 4 | 5 | 2 | 7 | 7 | 3 | 6 | 3 | 6 | 6 |
| Q2: Sometimes | 28 | 19 | 14 | 13 | 11 | 10 | 15 | 9 | 16 | 11 |
| Q2: Rarely | 5 | 4 | 5 | 5 | 4 | 4 | 0 | 4 | 4 | 2 |
| Q2: Never | 1 | 1 | 0 | 0 | 0 | 1 | 1 | 3 | 1 | 1 |
| Q3: Always | 3 | 0 | 0 | 1 | 1 | 1 | 4 | 3 | 3 | 0 |
| Q3: Often | 7 | 5 | 4 | 4 | 7 | 4 | 4 | 2 | 6 | 9 |
| Q3: Sometimes | 26 | 20 | 16 | 18 | 13 | 10 | 16 | 12 | 17 | 11 |
| Q3: Rarely | 3 | 5 | 1 | 2 | 1 | 4 | 1 | 2 | 4 | 1 |
| Q3: Never | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 1 |
| Q4: Yes, definitely | 4 | 1 | 0 | 2 | 2 | 2 | 2 | 2 | 7 | 3 |
| Q4: Yes, probably | 15 | 8 | 8 | 9 | 9 | 9 | 12 | 5 | 9 | 12 |
| Q4: I don't know | 10 | 5 | 2 | 1 | 1 | 2 | 4 | 2 | 2 | 2 |
| Q4: Probably not | 7 | 12 | 10 | 9 | 7 | 4 | 4 | 5 | 10 | 4 |
| Q4: Definitely not | 3 | 4 | 1 | 4 | 3 | 2 | 3 | 7 | 2 | 1 |
| Q5: Always | 1 | 1 | 0 | 0 | 2 | 0 | 2 | 0 | 0 | 0 |
| Q5: Often | 2 | 2 | 2 | 4 | 1 | 1 | 6 | 3 | 5 | 3 |
| Q5: Sometimes | 19 | 15 | 5 | 13 | 14 | 7 | 15 | 9 | 11 | 8 |
| Q5: Rarely | 16 | 8 | 11 | 4 | 5 | 8 | 2 | 6 | 9 | 8 |
| Q5: Never | 1 | 4 | 3 | 4 | 0 | 3 | 0 | 3 | 5 | 3 |
| Q6: Much too full | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 2 | 1 |
| Q6: Very full | 10 | 2 | 3 | 5 | 3 | 4 | 4 | 2 | 7 | 2 |
| Q6: Comfortably full | 26 | 28 | 18 | 17 | 18 | 13 | 20 | 18 | 18 | 17 |
| Q6: Slightly hungry | 3 | 0 | 0 | 2 | 1 | 2 | 0 | 0 | 2 | 2 |
| Q6: Very hungry | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Q7: Extremely satisfied | 3 | 0 | 1 | 1 | 1 | 0 | 2 | 1 | 2 | 1 |
| Q7: Satisfied | 27 | 27 | 17 | 17 | 19 | 15 | 22 | 15 | 23 | 14 |
| Q7: Neither satisfied nor dissatisfied | 9 | 3 | 3 | 5 | 1 | 3 | 1 | 5 | 4 | 5 |
| Q7: Dissatisfied | 0 | 0 | 0 | 2 | 1 | 1 | 0 | 0 | 1 | 2 |
| Q7: Extremely dissatisfied | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Clearance is defined as the volume of plasma cleared of albiglutide per unit time. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose pharmacokinetic (PK) sampling was performed within 6 days of drug administration.
| milliliters per hour | All Participants Receiving Any Dose of Albiglutide |
|---|---|
| Mean Clearance of Albiglutide | 94.2 (90.1 to 98.9) |
Volume of distribution is defined as the apparent volume in which albiglutide is distributed. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose (PK sampling was performed within 6 days of drug administration.
| Liters | All Participants Receiving Any Dose of Albiglutide |
|---|---|
| Mean Volume of Distribution of Albiglutide | 16400 (15600 to 17300) |
Absorption rate is defined as the rate at which albiglutide enters the blood circulation. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose (PK sampling was performed within 6 days of drug administration.
| hour^-1 | All Participants Receiving Any Dose of Albiglutide |
|---|---|
| Mean Absorption Rate of Albiglutide | 0.0193 (0.017 to 0.022) |
EC50 is defined as the concentration of albiglutide that give a half-maximal HbA1c and FPG response. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose (PK sampling was performed within 6 days of drug administration. EC50 estimates used PK data as well as HbA1c and FPG efficacy data. EC50 was estimated from an inhibitory Emax (maximal possible effect of albiglutide) model.
| nanograms per milliliter | All Participants Receiving Any Dose of Albiglutide |
|---|---|
| HbA1c, Treatment-naïve group | 1140 (483 to 2990) |
| HbA1c, Prior monotherapy group | 1230 (403 to 3560) |
| FPG | 1970 (950 to 5410) |
Collected over On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 2/51 (3.9%) | 29/51 (56.9%) |
| Exenatide BID | — | 1/35 (2.9%) | 22/35 (62.9%) |
| Albiglutide 4 mg Weekly | — | 0/35 (0%) | 24/35 (68.6%) |
| Albiglutide 15 mg Weekly | — | 3/35 (8.6%) | 20/35 (57.1%) |
| Albiglutide 30 mg Weekly | — | 7/31 (22.6%) | 22/31 (71%) |
| Albiglutide 15 mg Bi-weekly | — | 2/33 (6.1%) | 22/33 (66.7%) |
| Albiglutide 30 mg Bi-weekly | — | 5/32 (15.6%) | 25/32 (78.1%) |
| Albiglutide 50 mg Bi-weekly | — | 5/35 (14.3%) | 27/35 (77.1%) |
| Albiglutide 50 mg Every 4 Weeks | — | 7/35 (20%) | 27/35 (77.1%) |
| Albiglutide 100 mg Every 4 Weeks | — | 5/34 (14.7%) | 26/34 (76.5%) |
| Event | Placebo | Exenatide BID | Albiglutide 4 mg Weekly | Albiglutide 15 mg Weekly | Albiglutide 30 mg Weekly | Albiglutide 15 mg Bi-weekly | Albiglutide 30 mg Bi-weekly | Albiglutide 50 mg Bi-weekly | Albiglutide 50 mg Every 4 Weeks | Albiglutide 100 mg Every 4 Weeks |
|---|---|---|---|---|---|---|---|---|---|---|
| Injection site reactionGeneral disorders | 1/51 | 0/35 | 0/35 | 0/35 | 3/31 | 1/33 | 1/32 | 0/35 | 1/35 | 0/34 |
| Injection site rashGeneral disorders | 0/51 | 0/35 | 0/35 | 2/35 | 2/31 | 0/33 | 1/32 | 2/35 | 0/35 | 0/34 |
| Injection site erythemaGeneral disorders | 0/51 | 0/35 | 0/35 | 0/35 | 0/31 | 1/33 | 0/32 | 2/35 | 2/35 | 1/34 |
| HypersensitivityImmune system disorders | 0/51 | 0/35 | 0/35 | 0/35 | 0/31 | 0/33 | 0/32 | 0/35 | 2/35 | 0/34 |
| Postmenopausal haemorrhageReproductive system and breast disorders | 0/51 | 0/35 | 0/35 | 0/35 | 1/31 | 0/33 | 0/32 | 0/35 | 0/35 | 0/34 |
| RashSkin and subcutaneous tissue disorders | 0/51 | 0/35 | 0/35 | 0/35 | 1/31 | 0/33 | 0/32 | 0/35 | 0/35 | 0/34 |
| Injection site hypersensitivityGeneral disorders | 0/51 | 0/35 | 0/35 | 1/35 | 0/31 | 0/33 | 1/32 | 1/35 | 1/35 | 0/34 |
| Nerve compressionNervous system disorders | 0/51 | 0/35 | 0/35 | 0/35 | 0/31 | 0/33 | 1/32 | 0/35 | 0/35 | 0/34 |
| SyncopeNervous system disorders | 0/51 | 1/35 | 0/35 | 0/35 | 0/31 | 0/33 | 1/32 | 0/35 | 0/35 | 0/34 |
| Prinzmetal anginaCardiac disorders | 0/51 | 0/35 | 0/35 | 0/35 | 0/31 | 1/33 | 0/32 | 0/35 | 0/35 | 0/34 |
| Event | Placebo | Exenatide BID | Albiglutide 4 mg Weekly | Albiglutide 15 mg Weekly | Albiglutide 30 mg Weekly | Albiglutide 15 mg Bi-weekly | Albiglutide 30 mg Bi-weekly | Albiglutide 50 mg Bi-weekly | Albiglutide 50 mg Every 4 Weeks | Albiglutide 100 mg Every 4 Weeks |
|---|---|---|---|---|---|---|---|---|---|---|
| NauseaGastrointestinal disorders | 6/51 | 14/35 | 5/35 | 7/35 | 8/31 | 9/33 | 8/32 | 19/35 | 13/35 | 18/34 |
| VomitingGastrointestinal disorders | 1/51 | 6/35 | 0/35 | 3/35 | 4/31 | 3/33 | 3/32 | 10/35 | 6/35 | 14/34 |
| HeadacheNervous system disorders | 3/51 | 4/35 | 6/35 | 5/35 | 5/31 | 6/33 | 5/32 | 4/35 | 5/35 | 8/34 |
| DiarrhoeaGastrointestinal disorders | 2/51 | 8/35 | 5/35 | 2/35 | 5/31 | 4/33 | 7/32 | 6/35 | 6/35 | 7/34 |
| HyperglycaemiaMetabolism and nutrition disorders | 7/51 | 0/35 | 6/35 | 2/35 | 2/31 | 4/33 | 4/32 | 4/35 | 1/35 | 4/34 |
| Upper respiratory tract infectionInfections and infestations | 5/51 | 4/35 | 3/35 | 0/35 | 3/31 | 5/33 | 2/32 | 1/35 | 3/35 | 0/34 |
| DizzinessNervous system disorders | 4/51 | 3/35 | 5/35 | 2/35 | 2/31 | 2/33 | 2/32 | 2/35 | 5/35 | 2/34 |
| Back painMusculoskeletal and connective tissue disorders | 3/51 | 0/35 | 5/35 | 2/35 | 2/31 | 2/33 | 2/32 | 2/35 | 2/35 | 2/34 |
| Sinus congestionRespiratory, thoracic and mediastinal disorders | 0/51 | 1/35 | 0/35 | 0/35 | 4/31 | 1/33 | 0/32 | 0/35 | 1/35 | 0/34 |
| FlatulenceGastrointestinal disorders | 1/51 | 0/35 | 0/35 | 1/35 | 1/31 | 0/33 | 1/32 | 0/35 | 2/35 | 4/34 |
| Age, Continuous(Years) | Placebo | Exenatide BID | Albiglutide 4 mg Weekly | Albiglutide 15 mg Weekly | Albiglutide 30 mg Weekly | Albiglutide 15 mg Bi-weekly | Albiglutide 30 mg Bi-weekly | Albiglutide 50 mg Bi-weekly | Albiglutide 50 mg Every 4 Weeks | Albiglutide 100 mg Every 4 Weeks | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 54.0 ± 10.62 | 53.7 ± 9.38 | 50.4 ± 10.25 | 55.5 ± 10.48 | 54.2 ± 9.66 | 52.5 ± 9.55 | 55.5 ± 9.87 | 51.1 ± 10.25 | 54.1 ± 11.30 | 54.4 ± 9.89 | 53.5 ± 10.17 |
| Gender(Participants) | Placebo | Exenatide BID | Albiglutide 4 mg Weekly | Albiglutide 15 mg Weekly | Albiglutide 30 mg Weekly | Albiglutide 15 mg Bi-weekly | Albiglutide 30 mg Bi-weekly | Albiglutide 50 mg Bi-weekly | Albiglutide 50 mg Every 4 Weeks | Albiglutide 100 mg Every 4 Weeks | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Female | 23 | 19 | 20 | 17 | 23 | 19 | 16 | 16 | 18 | 15 | 186 |
| Male | 28 | 16 | 15 | 18 | 8 | 14 | 16 | 19 | 17 | 19 | 170 |
| Race/Ethnicity, Customized(Participants) | Placebo | Exenatide BID | Albiglutide 4 mg Weekly | Albiglutide 15 mg Weekly | Albiglutide 30 mg Weekly | Albiglutide 15 mg Bi-weekly | Albiglutide 30 mg Bi-weekly | Albiglutide 50 mg Bi-weekly | Albiglutide 50 mg Every 4 Weeks | Albiglutide 100 mg Every 4 Weeks | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| African American/African Heritage | 8 | 10 | 7 | 4 | 3 | 3 | 5 | 4 | 6 | 5 | 55 |
| American Indian or Alaskan Native | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 0 | 5 |
| Asian - Central/South Asian Heritage | 0 | 1 | 0 | 1 | 0 | 0 | 4 | 1 | 1 | 1 | 9 |
| Asian - East Asian Heritage | 2 | 0 | 1 | 0 | 1 | 1 | 1 | 1 | 1 | 0 | 8 |
| Asian - Japanese Heritage | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Asian - South East Asian Heritage | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 2 | 0 | 1 | 5 |
| Native Hawaiian or Other Pacific Islander | 1 | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 5 |
| White- Arabic/North African Heritage | 4 | 2 | 2 | 4 | 2 | 0 | 0 | 0 | 3 | 0 | 17 |
| White - White/Caucasian/European Heritage | 29 | 20 | 18 | 19 | 20 | 21 | 14 | 19 | 18 | 20 | 198 |
| Hispanic | 3 | 0 | 4 | 7 | 2 | 3 | 5 | 5 | 4 | 4 | 37 |
| Hispanic, Puerto Rican | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Mestizo | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 3 |
| Mexican | 3 | 0 | 0 | 0 | 1 | 2 | 1 | 1 | 0 | 0 | 8 |
| Mulatto | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 3 |
| Puerto Rican | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
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