Phase 3
Completed N=812
A Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide.
Source: ClinicalTrials.gov NCT01128894 ↗Enrolled (actual)
812
Serious AEs
5.3%
Results posted
May 2014
Primary outcomePrimary: Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 32 — -0.78; -0.99 Percentage of HbA1c in the blood — p=0.0846
Summary
This open-label study examines the efficacy and safety of albiglutide as compared with liraglutide in subjects with type 2 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 32 |
-0.78; -0.99 | 0.0846 |
| SECONDARY Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26 |
-0.52; -0.73; -0.66; -0.94; -0.88; -1.18 | — |
| SECONDARY Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32 |
-1.22; -1.68 | — |
| SECONDARY Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26 |
-0.98; -1.62; -1.33; -2.25; -1.61; -2.43 | — |
| SECONDARY Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 32 |
78; 113; 168; 208 | — |
| SECONDARY Time to Hyperglycemia Rescue at Week 32 |
NA; NA | — |
| SECONDARY Mean Change From Baseline in Body Weight at Week 32 |
-0.62; -2.21 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of type 2 diabetes mellitus and experiencing inadequate glycemic control on their current regimen of metformin, TZD, SU, or any combination of these oral antidiabetic medications
- BMI >/=20kg/m2 and /=0.8 ng/mL (>/=0.26 nmol/L)
- HbA1c between 7.0% and 10.0%, inclusive
- Female subjects of childbearing potential must be practicing adequate contraception.
Exclusion Criteria
- History of cancer
- History of treated diabetic gastroparesis
- Current biliary disease or history of pancreatitis
- History of significant GI surgery
- Recent clinically significant cardiovascular and/or cerebrovascular disease
- Hypertension
- History of human immunodeficiency virus infection
- History of or current liver disease or acute symptomatic infection with hepatitis B or hepatitis C
- History of alcohol or substance abuse
- Female subject is pregnant, lactating, or <6 weeks postpartum
- Known allergy to any GLP 1 analogue, liraglutide, other study medications' excipients, excipients of albiglutide, or Baker's yeast
- History of type 1 diabetes mellitus
- Contraindications (as per the prescribing information) for the use of either background or potential randomized study medications (e.g., liraglutide)
- Receipt of any investigational drug or liraglutide 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
- History or family history of thyroid disease
Data sourced from ClinicalTrials.gov (NCT01128894). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.