A Phase 2 interventional study of albiglutide and placebo in Diabetes Mellitus, Type 2, sponsored by GlaxoSmithKline. Completed at 30 sites in Japan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-01-13.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment
This is a randomized, double-blind, placebo-controlled, multicenter, 4-parallel-group, dose ranging study evaluating the dose response, efficacy and safety of subcutaneously injected GSK716155 (albiglutide) in Japanese subjects with type 2 diabetes mellitus.
This is a Phase IIb, randomized, double-blind, placebo-controlled, multicenter, 4-parallel-group, dose ranging, superiority study evaluating the dose response, efficacy and safety of weekly and every other week subcutaneously injected GSK716155 (albiglutide) in subjects with type 2 diabetes mellitus.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 215 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Clinically significantly cardiovascular and/or cerebrovascular disease including, but not limited to the following:
Has significant renal disease as manifested by one or more of the following:
once weekly subcutaneous injection of albiglutide 15mg
Biological: albiglutide
once weekly subcutaneous injection of albiglutide 30mg
Biological: albiglutide
subcutaneous injection of 30mg albiglutide every other week
Biological: albiglutide
once weekly subcutaneous injection of placebo to match albiglutide
Biological: placebo
subcutaneous injection of albiglutide
Also known as: placebo, albiglutide 30mg weekly, albiglutide 15mg weekly, albiglutide 30mg every other week
subcutaneous injection of placebo to match albiglutide
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 was calculated as the value at Week 16 minus the value at Baseline. Based on Analysis of Covariance (ANCOVA): Change = treatment + Baseline HbA1c + prior therapy. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. 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, 8, 12, 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 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 non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. 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; Week 4, Week 8, Week 12, and Week 16
Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 8, 12, and 16
The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; Week 4, Week 8, Week 12, and Week 16
Change From Baseline in Body Weight at Week 4, 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 weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values.
Time frame: Baseline; Week 4, Week 8, Week 12, and Week 16
Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5% and <7% at Weeks 4, 8, 12, and 16
The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of \<6.5% and \<7%) were assessed.
Time frame: Week 4, Week 8, Week 12, and 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, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, pharmacokinetic (PK) samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK.
Time frame: Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24
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, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK.
Time frame: Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24
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, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK.
Time frame: Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24
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, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. 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, 1, 4, 5, 8, 12, 13, 16, 20, and 24
| Milestone | Placebo | Albiglutide 15 mg Weekly | Albiglutide 30 mg Weekly | Albiglutide 30 mg Every Other Week |
|---|---|---|---|---|
| Started | 53 | 52 | 54 | 53 |
| Completed | 41 | 45 | 53 | 50 |
| Not completed | 12 | 7 | 1 | 3 |
| Withdrew: Persistent hypoglycemia | 10 | 2 | 0 | 0 |
| Withdrew: Adverse event | 1 | 2 | 1 | 3 |
| Withdrew: Withdrawal by subject | 1 | 2 | 0 | 0 |
| Withdrew: Transferred to oita (japan) | 0 | 1 | 0 | 0 |
| Milestone | Placebo | Albiglutide 15 mg Weekly | Albiglutide 30 mg Weekly | Albiglutide 30 mg Every Other Week |
|---|---|---|---|---|
| Started | 52 | 52 | 53 | 52 |
| Completed | 52 | 49 | 52 | 52 |
| Not completed | 0 | 3 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 0 |
| Withdrew: Transferred to oita (japan) | 0 | 1 | 0 | 0 |
| Withdrew: Follow-up not conducted due to earthquak | 0 | 1 | 1 | 0 |
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 was calculated as the value at Week 16 minus the value at Baseline. Based on Analysis of Covariance (ANCOVA): Change = treatment + Baseline HbA1c + prior therapy. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. 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 | Albiglutide 15 mg Weekly | Albiglutide 30 mg Weekly | Albiglutide 30 mg Every Other Week |
|---|---|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16 | 0.28 ± 0.099 | -0.61 ± 0.097 | -1.27 ± 0.095 | -0.82 ± 0.096 |
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 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 non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. 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 | Albiglutide 15 mg Weekly | Albiglutide 30 mg Weekly | Albiglutide 30 mg Every Other Week |
|---|---|---|---|---|
| Week 4 | 0.03 ± 0.349 | -0.33 ± 0.301 | -0.61 ± 0.377 | -0.36 ± 0.383 |
| Week 8 | 0.20 ± 0.628 | -0.59 ± 0.430 | -1.07 ± 0.578 | -0.74 ± 0.618 |
| Week 12 | 0.24 ± 0.730 | -0.71 ± 0.464 | -1.26 ± 0.649 | -0.84 ± 0.720 |
| Week 16 | 0.27 ± 0.743 | -0.63 ± 0.548 | -1.29 ± 0.736 | -0.84 ± 0.875 |
The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
| Millimoles per liter (mmol/L) | Placebo | Albiglutide 15 mg Weekly | Albiglutide 30 mg Weekly | Albiglutide 30 mg Every Other Week |
|---|---|---|---|---|
| Week 4 | 0.30 ± 1.190 | -1.54 ± 1.378 | -2.27 ± 1.465 | -1.32 ± 1.271 |
| Week 8 | 0.41 ± 1.451 | -1.54 ± 1.585 | -2.27 ± 1.652 | -1.19 ± 1.458 |
| Week 12 | 0.38 ± 1.612 | -1.25 ± 1.511 | -1.92 ± 1.388 | -1.06 ± 1.555 |
| Week 16 | 0.50 ± 2.448 | -0.77 ± 1.583 | -1.92 ± 1.667 | -0.78 ± 1.821 |
The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values.
| Kilograms | Placebo | Albiglutide 15 mg Weekly | Albiglutide 30 mg Weekly | Albiglutide 30 mg Every Other Week |
|---|---|---|---|---|
| Week 4 | -0.16 ± 0.956 | -0.36 ± 0.752 | -0.25 ± 1.268 | -0.02 ± 1.120 |
| Week 8 | -0.29 ± 1.289 | -0.06 ± 0.926 | -0.46 ± 1.671 | -0.25 ± 1.684 |
| Week 12 | -0.43 ± 1.409 | 0.09 ± 1.277 | -0.20 ± 1.906 | -0.22 ± 1.459 |
| Week 16 | -0.65 ± 1.715 | 0.43 ± 1.468 | -0.20 ± 1.977 | -0.08 ± 1.740 |
The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of \<6.5% and \<7%) were assessed.
| Participants | Placebo | Albiglutide 15 mg Weekly | Albiglutide 30 mg Weekly | Albiglutide 30 mg Every Other Week |
|---|---|---|---|---|
| HbA1c <6.5%, Week 4 | 0 | 1 | 2 | 1 |
| HbA1c <6.5%, Week 8 | 0 | 5 | 15 | 5 |
| HbA1c <6.5%, Week 12 | 0 | 6 | 19 | 8 |
| HbA1c <6.5%, Week 16 | 0 | 5 | 18 | 8 |
| HbA1c <7%, Week 4 | 2 | 7 | 19 | 9 |
| HbA1c <7%, Week 8 | 4 | 12 | 27 | 18 |
| HbA1c <7%, Week 12 | 3 | 12 | 32 | 19 |
| HbA1c <7%, Week 16 | 3 | 9 | 34 | 21 |
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, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, pharmacokinetic (PK) samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK.
| milliliters per hour | Albiglutide 15/30 mg Weekly or 30 mg Every Other Week |
|---|---|
| Mean Clearance of Albiglutide | 47.8 (45.7 to 49.9) |
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, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK.
| Liters | Albiglutide 15/30 mg Weekly or 30 mg Every Other Week |
|---|---|
| Mean Volume of Distribution of Albiglutide | 9.34 (8.71 to 10.0) |
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, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK.
| hour^-1 | Albiglutide 15/30 mg Weekly or 30 mg Every Other Week |
|---|---|
| Mean Absorption Rate of Albiglutide | 0.0154 (0.0134 to 0.0183) |
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, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. 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 | Albiglutide 15/30 mg Weekly or 30 mg Every Other Week |
|---|---|
| HbA1c | 3360 (2440 to 5260) |
| FPG | 3850 (1420 to 6330) |
Collected over On-therapy serious adverse events (SAEs)/non-serious AEs, with a start date on/after the first day of study medication (SM) and within 56 days after the end of SM, were collected from the start of SM until Follow-up/Early Withdrawal (up to Study Day 168).. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 2/53 (3.8%) | 21/53 (39.6%) |
| Albiglutide 15 mg Weekly | — | 1/52 (1.9%) | 27/52 (51.9%) |
| Albiglutide 30 mg Weekly | — | 2/54 (3.7%) | 20/54 (37%) |
| Albiglutide 30 mg Every Other Week | — | 2/53 (3.8%) | 23/53 (43.4%) |
| Event | Placebo | Albiglutide 15 mg Weekly | Albiglutide 30 mg Weekly | Albiglutide 30 mg Every Other Week |
|---|---|---|---|---|
| Deafness neurosensoryEar and labyrinth disorders | 0/53 | 1/52 | 0/54 | 0/53 |
| Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/53 | 0/52 | 0/54 | 1/53 |
| Renal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/53 | 0/52 | 0/54 | 1/53 |
| Carotid artery stenosisNervous system disorders | 1/53 | 0/52 | 0/54 | 0/53 |
| Cerebral infarctionNervous system disorders | 1/53 | 0/52 | 0/54 | 0/53 |
| DepressionPsychiatric disorders | 1/53 | 0/52 | 0/54 | 0/53 |
| VertigoEar and labyrinth disorders | 0/53 | 0/52 | 1/54 | 0/53 |
| Organising pneumoniaRespiratory, thoracic and mediastinal disorders | 0/53 | 0/52 | 1/54 | 0/53 |
| Event | Placebo | Albiglutide 15 mg Weekly | Albiglutide 30 mg Weekly | Albiglutide 30 mg Every Other Week |
|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 8/53 | 16/52 | 9/54 | 10/53 |
| DiarrhoeaGastrointestinal disorders | 4/53 | 0/52 | 3/54 | 5/53 |
| ConstipationGastrointestinal disorders | 1/53 | 3/52 | 2/54 | 1/53 |
| Seasonal allergyImmune system disorders | 0/53 | 3/52 | 0/54 | 0/53 |
| Injection site reactionGeneral disorders | 2/53 | 2/52 | 3/54 | 3/53 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 1/53 | 1/52 | 0/54 | 3/53 |
| RhinitisInfections and infestations | 0/53 | 2/52 | 0/54 | 0/53 |
| NauseaGastrointestinal disorders | 1/53 | 2/52 | 1/54 | 2/53 |
| VomitingGastrointestinal disorders | 1/53 | 2/52 | 0/54 | 2/53 |
| GastritisGastrointestinal disorders | 1/53 | 2/52 | 0/54 | 0/53 |
| Age, Continuous(Years) | Placebo | Albiglutide 15 mg Weekly | Albiglutide 30 mg Weekly | Albiglutide 30 mg Every Other Week | Total |
|---|---|---|---|---|---|
| Mean | 57.5 ± 11.06 | 53.3 ± 10.29 | 58.0 ± 9.30 | 59.1 ± 8.49 | 57.0 ± 10.00 |
| Gender(Participants) | Placebo | Albiglutide 15 mg Weekly | Albiglutide 30 mg Weekly | Albiglutide 30 mg Every Other Week | Total |
|---|---|---|---|---|---|
| Female | 16 | 20 | 16 | 12 | 64 |
| Male | 37 | 32 | 38 | 41 | 148 |
| Race/Ethnicity, Customized(participants) | Placebo | Albiglutide 15 mg Weekly | Albiglutide 30 mg Weekly | Albiglutide 30 mg Every Other Week | Total |
|---|---|---|---|---|---|
| Asian - Japanese Heritage | 53 | 52 | 54 | 53 | 212 |
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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