DelfaGLP-1 Atlas

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CompletedPhase 3Results posted

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

A Randomized, Open-Label, Active-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Albiglutide Administered in Combination With Insulin Glargine as Compared With the Combination of Insulin Glargine and Preprandial Lispro Insulin in Subjects With Type 2 Diabetes Mellitus

Lead sponsor

GlaxoSmithKline

Asset

Albiglutide

Subcutaneous · GLP-1 agonist

Listed sites

209

Recruiting sites

—

Enrollment

586

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c ≤7%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00976391
Org study ID108486

Timeline

Milestones

Study first posted2009-09-14estimated
Results first posted2014-07-16estimated
Last update posted2017-01-11estimated
Study start2009-09 (month precision)
Primary completion2011-10actual (month precision)
Study completion2012-05actual (month precision)

Assets

Investigational agents

Albiglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

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

•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

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
6
Weight & body composition
2

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Change From Baseline in Body Weight at Week 26

Time frame:Baseline and Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Kilograms95% CI
Albiglutide 30 mg With Insulin Glargine-0.73—
Preprandial Lispro Insulin With Insulin Glargine0.81—
Secondary/protocol endpoint

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

Time frame:Baseline and Weeks 36, 48 and 52

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), Kilograms95% CI
Albiglutide 30 mg With Insulin GlargineWeek 36, n=172, 182-0.42—
Week 48, n=142, 153-0.60—
Week 52, n=122, 141-0.70—
Preprandial Lispro Insulin With Insulin GlargineWeek 36, n=172, 1821.31—
Week 48, n=142, 1531.56—
Week 52, n=122, 1411.44—

Glycemic / diabetes

6 endpoints
Primary/protocol endpoint

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

Time frame:Baseline and Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (least_squares_mean), Percentage of HbA1c in the blood95% CI
Albiglutide 30 mg With Insulin Glargine-0.82—
Preprandial Lispro Insulin With Insulin Glargine-0.66—
Mean Difference (Net)-0.1695% CI-0.32 – 0.00p<0.0001t-test, 1 sided
Secondary/protocol endpoint

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

Time frame:Baseline and Weeks 36, 48 and 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (mean), Percentage of HbA1c in the blood95% CI
Albiglutide 30 mg With Insulin GlargineWeek 36, n=173, 182-1.04—
Week 48, n=140, 153-0.97—
Week 52, n=121, 141-1.01—
Preprandial Lispro Insulin With Insulin GlargineWeek 36, n=173, 182-0.88—
Week 48, n=140, 153-0.81—
Week 52, n=121, 141-0.84—
Secondary/protocol endpoint

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

Time frame:Baseline and Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (least_squares_mean), Millimoles per liter (mmol/L)95% CI
Albiglutide 30 mg With Insulin Glargine-0.99—
Preprandial Lispro Insulin With Insulin Glargine-0.71—
Secondary/protocol endpoint

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

Time frame:Baseline and Weeks 36, 48 and 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (mean), Millimoles per liter (mmol/L)95% CI
Albiglutide 30 mg With Insulin GlargineWeek 36, n=171, 182-1.41—
Week 48, n=131, 151-1.13—
Week 52, n=121, 139-1.36—
Preprandial Lispro Insulin With Insulin GlargineWeek 36, n=171, 182-0.91—
Week 48, n=131, 151-1.07—
Week 52, n=121, 139-0.97—
Secondary/protocol endpoint

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

Time frame:Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), Participants95% CI
Albiglutide 30 mg With Insulin GlargineHbA1c <6.5 %31—
HbA1c <7.0 %83—
Preprandial Lispro Insulin With Insulin GlargineHbA1c <6.5 %23—
HbA1c <7.0 %70—
Secondary/protocol endpoint

Time to Hyperglycemia Rescue

Time frame:From the start of study medication until the end of the treatment (up to Week 52)

time to event, event

Posted result

GroupValue (median), Weeks95% CI
Albiglutide 30 mg With Insulin GlargineNANA – NA
Preprandial Lispro Insulin With Insulin GlargineNANA – NA

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.