CompletedNCT00976391Updated Jan 11, 2017Results posted

A Study to Determine the Safety and Efficacy of Albiglutide Administered in Combination With Insulin Glargine

A Phase 3 interventional study of albiglutide + insulin glargine and insulin glargine + preprandial lispro insulin in Diabetes Mellitus, Type 2, sponsored by GlaxoSmithKline. Completed at 210 sites in 14 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-01-11.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 586
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study summary

This study will examine the safety and efficacy of albiglutide in combination with insulin glargine as compared with the combination of insulin glargine and preprandial lispro insulin in subjects with type 2 diabetes.

Read the detailed description

This randomized, open-label, active-controlled, parallel-group, multicenter study evaluates the safety and efficacy of a weekly subcutaneously injected dose of albiglutide in combination with insulin glargine as compared with the combination of insulin glargine and preprandial lispro insulin in subjects with type 2 diabetes. Subjects with a historical diagnosis of type 2 diabetes who are inadequately controlled despite the use of insulin glargine or other intermediate- or long-acting insulins for >/= 6 months but \< 5 years, with or without oral antidiabetic medications, who are unable to achieve a glycosylated hemoglobin value of \< 7% will be recruited into the study. Subjects must also be willing and capable of pursuing an intensive regimen of both basal and preprandial insulin.

Conditions studied

Diabetes Mellitus, Type 2

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Keywords

open-label
albiglutide
insulin glargine
preprandial insulin

In context

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 586 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

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.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Subjects with type 2 diabetes, currently treated with insulin glargine or other intermediate- or long-acting insulin, with or without oral antidiabetic medications, but experiencing inadequate glycemic control and willing and capable of participating in a regimen of intensive insulin administration. A subject who has been on an intermediate- or long acting insulin for >/=6 months but \<5 years, and, in spite of dosage adjustments based on home blood glucose monitoring, is unable to achieve a HbA1c of \<7%.
BMI >/= 20kg/m2 and \</=45 kg/m2
Fasting C-peptide >/=0.8 ng/mL (>/= 0.26 nmol/L)
HbA1c between 7.0% and 10.5%, inclusive
Use of oral or systemically injected glucocorticoids is generally not allowed within 3 months before randomization; inhaled, intra articular, and topical corticosteroids are allowed
Hemoglobin \</=11 g/dL for male subjects and >/=10 g/dL for female subjects
Creatinine clearance >60 mL/min (calculated using the Cockcroft Gault formula)
Thyroid stimulating hormone level is normal or clinically euthyroid as demonstrated by further thyroid tests (e.g., T4, T3, thyroid-binding globulin)
Female subjects of childbearing potential (i.e., not surgically sterile and/or not postmenopausal) must be practicing adequate contraception. Adequate contraception must be practiced for the duration of participation in the study including the 8 week Posttreatment Follow-up Period
Able and willing to monitor his or her own blood glucose concentrations with a home glucose monitor as per the protocol recommendations of self administration
No major illness or debility that in the investigator's opinion prohibits the subject from actively participating in their diabetes management and completing the study
Able and willing to provide written informed consent

Exclusion criteria

Exclusion Criteria:

History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 3 years before Screening.
History of treated diabetic gastroparesis
Current ongoing symptomatic biliary disease or history of pancreatitis
History of significant gastrointestinal surgery, including gastric bypass and banding, antrectomy, Roux en Y bypass, gastric vagotomy, small bowel resection, or surgeries thought to significantly affect upper gastrointestinal function
Recent clinically significant cardiovascular and/or cerebrovascular disease including but not limited to the following:
- Previous history of stroke or transient ischemic attack within 1 month before Screening.
- Acute coronary syndrome, which includes the following:
- Documented MI within the 2 months before Screening and during the period up until receiving the first dose of study medication
- Any cardiac surgery including percutaneous transluminal coronary angioplasty, coronary stent placement, or coronary artery bypass graft surgery within the 2 months before Screening and during the period up until receiving the first dose of study medication
- Unstable angina not responsive to nitroglycerin within the 2 months before Screening and during the period up until receiving the first dose of study medication
- Unstable cardiac rhythm, however, as an example, controlled atrial fibrillation is allowed
- Current or history of heart failure (New York Heart Association class I to IV).
- Resting systolic pressure is >160 mm Hg and/or diastolic pressure >100 mm Hg.
- QTc interval (Fridericia) >470 ms confirmed by a central reader at Screening
History of stroke or other central nervous system disorder that would negatively impact the subject's ability to participate in a program of intensive insulin management (eg, physically or mentally incapable of performing home blood glucose monitoring or administering and/or adjusting insulin dosage)
Hemoglobinopathy that may affect determination of HbA1c
History of human immunodeficiency virus infection
History of total bilirubin >1.5 × ULN unless the subject has a previously known history of Gilbert's syndrome and a fractionated bilirubin that shows conjugated bilirubin \<35% of total bilirubin
ALT or aspartate aminotransferase (AST) >2.5 ×ULN
Fasting triglyceride level >850 mg/dL at Screening or Week -1 (Visit 5).
Acute symptomatic (within 3 months before Screening) infection with hepatitis B or hepatitis C; however, subjects with past or chronic hepatitis B or hepatitis C are allowed provided the requirements for ALT, AST, and total bilirubin are met
History of a psychiatric disorder that will affect the subject's ability to participate in the study
History of alcohol or substance abuse within 1 year before Screening
Positive urine drug screen at Screening, unless the subject is taking a medically approved medication for which a positive drug screen simply verifies the use of this medication
Hypoglycemia unawareness which has impaired cognitive function and required outside assistance
Female subject is pregnant (confirmed by laboratory testing), lactating, or \<6 weeks postpartum
Known allergy to any GLP 1 analogue, insulin, other study medications' excipients, excipients of albiglutide, or Baker's yeast
Receipt of any investigational drug within the 30 days, or 5 half lives whichever is longer, before Screening or a history of receipt of an investigational antidiabetic drug within the 3 months before randomization, or receipt of albiglutide in previous studies
Current use of any GLP 1 analogue
History of type 1 diabetes mellitus, diabetic complications (e.g., active proliferative retinopathy or severe diabetic neuropathy) that in the opinion of the investigator would preclude effective participation in the study, or a history of ketoacidosis or hyperosmolar coma
Contraindications (as per the prescribing information) for the use of either background or potential randomized study medications (e.g., insulin glargine or lispro insulin)
History or family history of medullary carcinoma
History or family history of multiple endocrine neoplasia type 2

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 586 participants (actual)

Study arms

Active comparator
albiglutide + insulin glargine
albiglutide in combination with insulin glargine
Biological: albiglutide + insulin glargine
Active comparator
insulin glargine + preprandial lispro insulin
insulin glargine in combination with preprandial lispro insulin
Drug: insulin glargine + preprandial lispro insulin

Interventions

Biologicalalbiglutide + insulin glargine
albiglutide in combination with insulin glargine
Druginsulin glargine + preprandial lispro insulin
insulin glargine in combination with preprandial lispro insulin

What researchers measure

Primary outcomes

Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 26
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 BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 26 minus the value at BL. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (\<65 years versus ≥65 years) as factors and Baseline HbA1c as a continuous covariate.The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values.
Time frame: Baseline and Week 26

Secondary outcomes

Change From Baseline in HbA1c at Weeks 36, 48 and 52
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline is defined as the last available assessment on or prior to the first dose of study drug. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.
Time frame: Baseline and Weeks 36, 48 and 52
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
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. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + region
Time frame: Baseline and Week 26
Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 36, 48 and 52
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. Change from Baseline was calculated as the post-Baseline FPG minus the Baseline FPG. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.
Time frame: Baseline and Weeks 36, 48 and 52
Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 26
The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of \<6.5% and \<7.0% at Week 26) were assessed.
Time frame: Week 26
Time to Hyperglycemia Rescue
Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: HbA1c \>9.0% and \<0.5% decrease from Baseline between \>=Week 4 and \<Week 8; HbA1c \>9.0% and \<0.5% decrease from Baseline between \>=Week 8 and \<Week 12; HbA1c \>8.5% and \>=4 weeks since uptitration between \>=Week 12 and \<Week 16; HbA1c \>8.0% and \>=4 weeks since uptitration; HbA1c \>7.5% and \>=4 weeks between \>Week 26 and \>=Week 48 since uptitration. Participants could have been rescued at any time after Week 4. Time to hyperglycemia rescue is the time between the date of first dose and the date of hyperglycemia rescue plus 1 day, or the time between the date of first dose and the date of last visit during active treatment period plus 1 day for participants not requiring rescue. This time is divided by 7 to express the result in weeks.
Time frame: From the start of study medication until the end of the treatment (up to Week 52)
Change From Baseline in Body Weight at Week 26
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. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region + current oral antidiabetic therapy.
Time frame: Baseline and Week 26
Change From Baseline in Body Weight at Weeks 36, 48 and 52
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. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.
Time frame: Baseline and Weeks 36, 48 and 52

Results

Posted Jul 16, 2014

Participant flow

Treatment Period (52 Weeks)

Participant flow — Treatment Period (52 Weeks)
Milestone	Albiglutide 30 mg With Insulin Glargine	Preprandial Lispro Insulin With Insulin Glargine
Started	285	281
Completed	243	242
Not completed	42	39
Withdrew: Adverse event	16	2
Withdrew: Protocol violation	1	1
Withdrew: Noncompliance	4	4
Withdrew: Lost to follow-up	10	8
Withdrew: Withdrawal by subject	9	19
Withdrew: Physician decision	1	1
Withdrew: Termination of study/site by gsk	0	4
Withdrew: Pregnancy	1	0

Follow-up Period (8 Weeks)

Participant flow — Follow-up Period (8 Weeks)
Milestone	Albiglutide 30 mg With Insulin Glargine	Preprandial Lispro Insulin With Insulin Glargine
Started	285	281
Completed	256	247
Not completed	29	34
Withdrew: Adverse event	3	1
Withdrew: Noncompliance	2	2
Withdrew: Lost to follow-up	14	12
Withdrew: Did not entered follow-up	6	8
Withdrew: Withdrawal by subject	4	7
Withdrew: Termination of study/site by gsk	0	4

Outcome measures

PrimaryChange From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 26

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 BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 26 minus the value at BL. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (\<65 years versus ≥65 years) as factors and Baseline HbA1c as a continuous covariate.The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values.

Time frame:: Baseline and Week 26
Reported as:: Least squares mean · Percentage of HbA1c in the blood

Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 26
Percentage of HbA1c in the blood	Albiglutide 30 mg With Insulin Glargine	Preprandial Lispro Insulin With Insulin Glargine
Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 26	-0.82 ± 0.058	-0.66 ± 0.058

Statistical analysis

Albiglutide 30 mg With Insulin Glargine vs Preprandial Lispro Insulin With Insulin Glargine · t-test, 1 sided · p = <0.0001 · Mean difference (net): -0.16 · 95% CI -0.32 to 0.00

SecondaryChange From Baseline in HbA1c at Weeks 36, 48 and 52

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline is defined as the last available assessment on or prior to the first dose of study drug. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.

Time frame:: Baseline and Weeks 36, 48 and 52
Reported as:: Mean · Percentage of HbA1c in the blood

Change From Baseline in HbA1c at Weeks 36, 48 and 52
Percentage of HbA1c in the blood	Albiglutide 30 mg With Insulin Glargine	Preprandial Lispro Insulin With Insulin Glargine
Week 36, n=173, 182	-1.04 ± 0.990	-0.88 ± 0.924
Week 48, n=140, 153	-0.97 ± 1.070	-0.81 ± 0.961
Week 52, n=121, 141	-1.01 ± 1.024	-0.84 ± 0.925

SecondaryChange From Baseline in Fasting Plasma Glucose (FPG) at Week 26

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. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + region

Time frame:: Baseline and Week 26
Reported as:: Least squares mean · Millimoles per liter (mmol/L)

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Millimoles per liter (mmol/L)	Albiglutide 30 mg With Insulin Glargine	Preprandial Lispro Insulin With Insulin Glargine
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26	-0.99 ± 0.164	-0.71 ± 0.164

SecondaryChange From Baseline in Fasting Plasma Glucose (FPG) at Weeks 36, 48 and 52

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. Change from Baseline was calculated as the post-Baseline FPG minus the Baseline FPG. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.

Time frame:: Baseline and Weeks 36, 48 and 52
Reported as:: Mean · Millimoles per liter (mmol/L)

Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 36, 48 and 52
Millimoles per liter (mmol/L)	Albiglutide 30 mg With Insulin Glargine	Preprandial Lispro Insulin With Insulin Glargine
Week 36, n=171, 182	-1.41 ± 2.905	-0.91 ± 3.039
Week 48, n=131, 151	-1.13 ± 3.078	-1.07 ± 2.965
Week 52, n=121, 139	-1.36 ± 3.054	-0.97 ± 3.305

SecondaryNumber of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 26

The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of \<6.5% and \<7.0% at Week 26) were assessed.

Time frame:: Week 26
Reported as:: Number · Participants

Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 26
Participants	Albiglutide 30 mg With Insulin Glargine	Preprandial Lispro Insulin With Insulin Glargine
HbA1c <6.5 %	31	23
HbA1c <7.0 %	83	70

SecondaryTime to Hyperglycemia Rescue

Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: HbA1c \>9.0% and \<0.5% decrease from Baseline between \>=Week 4 and \<Week 8; HbA1c \>9.0% and \<0.5% decrease from Baseline between \>=Week 8 and \<Week 12; HbA1c \>8.5% and \>=4 weeks since uptitration between \>=Week 12 and \<Week 16; HbA1c \>8.0% and \>=4 weeks since uptitration; HbA1c \>7.5% and \>=4 weeks between \>Week 26 and \>=Week 48 since uptitration. Participants could have been rescued at any time after Week 4. Time to hyperglycemia rescue is the time between the date of first dose and the date of hyperglycemia rescue plus 1 day, or the time between the date of first dose and the date of last visit during active treatment period plus 1 day for participants not requiring rescue. This time is divided by 7 to express the result in weeks.

Time frame:: From the start of study medication until the end of the treatment (up to Week 52)
Reported as:: Median · Weeks

Time to Hyperglycemia Rescue
Weeks	Albiglutide 30 mg With Insulin Glargine	Preprandial Lispro Insulin With Insulin Glargine
Time to Hyperglycemia Rescue	NA (NA to NA)	NA (NA to NA)

SecondaryChange From Baseline in Body Weight at Week 26

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. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region + current oral antidiabetic therapy.

Time frame:: Baseline and Week 26
Reported as:: Least squares mean · Kilograms

Change From Baseline in Body Weight at Week 26
Kilograms	Albiglutide 30 mg With Insulin Glargine	Preprandial Lispro Insulin With Insulin Glargine
Change From Baseline in Body Weight at Week 26	-0.73 ± 0.194	0.81 ± 0.195

SecondaryChange From Baseline in Body Weight at Weeks 36, 48 and 52

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. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.

Time frame:: Baseline and Weeks 36, 48 and 52
Reported as:: Mean · Kilograms

Change From Baseline in Body Weight at Weeks 36, 48 and 52
Kilograms	Albiglutide 30 mg With Insulin Glargine	Preprandial Lispro Insulin With Insulin Glargine
Week 36, n=172, 182	-0.42 ± 3.656	1.31 ± 4.005
Week 48, n=142, 153	-0.60 ± 3.928	1.56 ± 3.846
Week 52, n=122, 141	-0.70 ± 4.023	1.44 ± 4.053

Adverse events

Collected over On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring while participants were on treatment up until 56 days after the last dose (up to Week 60), are reported.. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Albiglutide 30 mg With Insulin Glargine	—	38/285 (13.3%)	188/285 (66%)
Preprandial Lispro Insulin With Insulin Glargine	—	29/281 (10.3%)	178/281 (63.3%)

Most frequent serious events

Showing 10 of 60

Most frequent serious events
Event	Albiglutide 30 mg With Insulin Glargine	Preprandial Lispro Insulin With Insulin Glargine
Coronary artery diseaseCardiac disorders	0/285	4/281
Angina unstableCardiac disorders	1/285	2/281
Incisional herniaInjury, poisoning and procedural complications	1/285	2/281
CellulitisInfections and infestations	1/285	2/281
Chest painGeneral disorders	1/285	2/281
Acute myocardial infarctionCardiac disorders	2/285	1/281
Atrial fibrillationCardiac disorders	2/285	0/281
Road traffic accidentInjury, poisoning and procedural complications	2/285	0/281
AsthmaRespiratory, thoracic and mediastinal disorders	2/285	0/281
Ventricular tachycardiaCardiac disorders	1/285	1/281

Most frequent other events

Showing 10 of 37

Most frequent other events
Event	Albiglutide 30 mg With Insulin Glargine	Preprandial Lispro Insulin With Insulin Glargine
DiarrhoeaGastrointestinal disorders	41/285	16/281
NauseaGastrointestinal disorders	37/285	6/281
NasopharyngitisInfections and infestations	30/285	29/281
Urinary Tract InfectionInfections and infestations	29/285	27/281
Upper Repiratory Tract InfectionInfections and infestations	27/285	20/281
Oedema PeripheralGeneral disorders	11/285	24/281
Diabetic RetinopathyEye disorders	18/285	23/281
HeadacheNervous system disorders	21/285	12/281
Back PainMusculoskeletal and connective tissue disorders	13/285	20/281
VomitingGastrointestinal disorders	20/285	4/281

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	Albiglutide 30 mg With Insulin Glargine	Preprandial Lispro Insulin With Insulin Glargine	Total
Mean	54.8 ± 9.10	56.3 ± 8.87	55.6 ± 9.01

Gender
Gender(Participants)	Albiglutide 30 mg With Insulin Glargine	Preprandial Lispro Insulin With Insulin Glargine	Total
Female	153	145	298
Male	132	136	268

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Albiglutide 30 mg With Insulin Glargine	Preprandial Lispro Insulin With Insulin Glargine	Total
African American/African Heritage	39	34	73
American Indian or Alaskan Native	29	20	49
Asian - Central/South Asian Heritage	17	17	34
Asian - East Asian Heritage	15	17	32
Asian - South East Asian Heritage	16	16	32
Native Hawaiian or Other Pacific Islander	1	3	4
White - Arabic/North African Heritage	2	3	5
White - White/Caucasian/European Heritage	174	171	345
Other-Black	1	0	1
Other-Native American	0	1	1

Study locations

210 sites

GSK Investigational Site
Birmingham, Alabama 35205, United States
GSK Investigational Site
Dothan, Alabama 36301, United States
GSK Investigational Site
Gilbert, Arizona 85295, United States
GSK Investigational Site
Phoenix, Arizona 85028, United States
GSK Investigational Site
Phoenix, Arizona 85050, United States
GSK Investigational Site
Jonesboro, Arkansas 72401, United States
GSK Investigational Site
Searcy, Arkansas 72143, United States
GSK Investigational Site
Chino, California 91710, United States
GSK Investigational Site
Commerce, California 90040, United States
GSK Investigational Site
Fresno, California 93720, United States
GSK Investigational Site
Fullerton, California 92835, United States
GSK Investigational Site
Huntington Beach, California 92646, United States
GSK Investigational Site
La Jolla, California 92037, United States
GSK Investigational Site
LaJolla, California 92037, United States
GSK Investigational Site
Long Beach, California 90806, United States
GSK Investigational Site
Los Alamitos, California 90720, United States
GSK Investigational Site
Los Angeles, California 90073, United States
GSK Investigational Site
Mission Viejo, California 92691, United States
GSK Investigational Site
Sacramento, California 95821, United States
GSK Investigational Site
San Diego, California 92117, United States
GSK Investigational Site
San Diego, California 92128, United States
GSK Investigational Site
San Diego, California 92161, United States
GSK Investigational Site
Satna Monica, California 90404, United States
GSK Investigational Site
Spring Valley, California 91978, United States
GSK Investigational Site
Tustin, California 92780, United States
GSK Investigational Site
Walnut Creek, California 94598, United States
GSK Investigational Site
West Hills, California 91307, United States
GSK Investigational Site
Denver, Colorado 80220, United States
GSK Investigational Site
New Britain, Connecticut 06050, United States
GSK Investigational Site
Trumbull, Connecticut 06611, United States
GSK Investigational Site
Waterbury, Connecticut 06708, United States
GSK Investigational Site
Boynton Beach, Florida 33437, United States
GSK Investigational Site
Clearwater, Florida 33756, United States
GSK Investigational Site
Cutler Bay, Florida 33189, United States
GSK Investigational Site
Hallandale Beach, Florida 33009, United States
GSK Investigational Site
Jacksonville, Florida 32205, United States
GSK Investigational Site
Lauderdale Lakes, Florida 33319, United States
GSK Investigational Site
Miami, Florida 33156, United States
GSK Investigational Site
Orlando, Florida 32822, United States
GSK Investigational Site
Plantation, Florida 33317, United States
GSK Investigational Site
West Palm Beach, Florida 33401, United States
GSK Investigational Site
Atlanta, Georgia 30308, United States
GSK Investigational Site
Atlanta, Georgia 30338, United States
GSK Investigational Site
Blue Ridge, Georgia 30513, United States
GSK Investigational Site
Columbus, Georgia 31904, United States
GSK Investigational Site
Savannah, Georgia 31419, United States
GSK Investigational Site
Snellville, Georgia 30078, United States
GSK Investigational Site
Honolulu, Hawaii 96813, United States
GSK Investigational Site
Honolulu, Hawaii 96814, United States
GSK Investigational Site
Idaho Falls, Idaho 83404, United States
GSK Investigational Site
La Grange, Illinois 60525, United States
GSK Investigational Site
Avon, Indiana 46123, United States
GSK Investigational Site
Evansville, Indiana 47714, United States
GSK Investigational Site
Lafayette, Indiana 47904, United States
GSK Investigational Site
Council Bluffs, Iowa 51501, United States
GSK Investigational Site
Des Moines, Iowa 50314, United States
GSK Investigational Site
Iowa City, Iowa 52243, United States
GSK Investigational Site
Newton, Kansas 67114, United States
GSK Investigational Site
Topeka, Kansas 66606, United States
GSK Investigational Site
Lexington, Kentucky 40503, United States
GSK Investigational Site
Lexington, Kentucky 40504, United States
GSK Investigational Site
Shreveport, Louisiana 71101, United States
GSK Investigational Site
Hyattsville, Maryland 20782, United States
GSK Investigational Site
Haverhill, Massachusetts 01830, United States
GSK Investigational Site
Ann Arbor, Michigan 48106, United States
GSK Investigational Site
Benzonia, Michigan 49616, United States
GSK Investigational Site
Bloomfield Hills, Michigan 48302, United States
GSK Investigational Site
Dearborn, Michigan 48124, United States
GSK Investigational Site
Kalamazoo, Michigan 49009, United States
GSK Investigational Site
Kalamazoo, Michigan 49048, United States
GSK Investigational Site
Picayune, Mississippi 39466, United States
GSK Investigational Site
Chesterfield, Missouri 63017, United States
GSK Investigational Site
Jefferson City, Missouri 65109, United States
GSK Investigational Site
Kansas City, Missouri, United States
GSK Investigational Site
Springfield, Missouri 65807, United States
GSK Investigational Site
St. Louis, Missouri 63110, United States
GSK Investigational Site
St. Louis, Missouri 63141, United States
GSK Investigational Site
Great Falls, Montana 59405, United States
GSK Investigational Site
Omaha, Nebraska 68124, United States
GSK Investigational Site
Omaha, Nebraska 68131, United States
GSK Investigational Site
Haddon Heights, New Jersey 08035, United States
GSK Investigational Site
New York, New York 10025, United States
GSK Investigational Site
North Massapequa, New York 11758, United States
GSK Investigational Site
Asheville, North Carolina 28803, United States
GSK Investigational Site
Burlington, North Carolina 27215, United States
GSK Investigational Site
Durham, North Carolina 27710, United States
GSK Investigational Site
Hickory, North Carolina 28601, United States
GSK Investigational Site
Morehead City, North Carolina 28557, United States
GSK Investigational Site
Tabor City, North Carolina 28463, United States
GSK Investigational Site
Akron, Ohio 44320, United States
GSK Investigational Site
Canal Fulton, Ohio 44614, United States
GSK Investigational Site
Cincinnati, Ohio 45245, United States
GSK Investigational Site
Cleveland, Ohio 44122, United States
GSK Investigational Site
Columbus, Ohio 43213, United States
GSK Investigational Site
Dayton, Ohio 45439, United States
GSK Investigational Site
Oklahoma City, Oklahoma 73103, United States
GSK Investigational Site
Oklahoma City, Oklahoma 73104, United States
GSK Investigational Site
Tulsa, Oklahoma 74104, United States
GSK Investigational Site
Tulsa, Oklahoma 74136, United States
GSK Investigational Site
Bensalem, Pennsylvania 19020, United States

Showing the first 100 of 210 sites across 14 countries.

References and documents

Publications

Rosenstock J, Fonseca VA, Gross JL, Ratner RE, Ahren B, Chow FC, Yang F, Miller D, Johnson SL, Stewart MW, Leiter LA; Harmony 6 Study Group. Advancing basal insulin replacement in type 2 diabetes inadequately controlled with insulin glargine plus oral agents: a comparison of adding albiglutide, a weekly GLP-1 receptor agonist, versus thrice-daily prandial insulin lispro. Diabetes Care. 2014 Aug;37(8):2317-25. doi: 10.2337/dc14-0001. Epub 2014 Jun 4. PubMed 24898300 ↗

Individual participant data

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.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00976391
Lead sponsor: GlaxoSmithKline
Responsible party: Sponsor
First posted: Sep 14, 2009
Start date: Sep 2009
Primary completion: Oct 2011
Completion: May 2012
Results posted: Jul 16, 2014
Last update: Jan 11, 2017

Study contacts

GSK Clinical Trials

study director · GlaxoSmithKline

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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