Phase 3
Completed N=490
A Monotherapy Study to Evaluate the Efficacy and Safety of 2 Dose Levels of Albiglutide in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)
Source: ClinicalTrials.gov NCT01733758 ↗Enrolled (actual)
490
Serious AEs
2.0%
Results posted
May 2015
Primary outcomePrimary: Model-adjusted Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 — 0.25; -1.10; -1.30 Percentage of HbA1c in the blood — p=<0.0001
Summary
This study is designed to examine the efficacy and safety of 2 dose levels of weekly subcutaneously injected albiglutide compared with placebo and an open label reference arm of daily subcutaneous injections of liraglutide, in Japanese subjects with Type 2 diabetes mellitus.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Model-adjusted Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 |
0.25; -1.10; -1.30 | <0.0001 sig |
| PRIMARY Mean HbA1c at Baseline, Week 24, and Change From Baseline at Week 24 |
8.16; 8.06; 8.15; 8.07; 8.39; 6.98 | — |
| SECONDARY Change From Baseline in HbA1c at Week 52 |
-1.07; -1.07; -1.34; -1.17 | — |
| SECONDARY Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0%) at Week 24 |
1; 31; 47; 29; 4; 92 | — |
| SECONDARY Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0%) at Week 52 |
14; 44; 53; 27; 33; 82 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 |
159.3; 157.1; 158.7; 157.2; 167.0; 132.2 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 |
154.5; 154.7; 159.8; 157.4; 131.7; 131.9 | — |
| SECONDARY Change From Baseline in Body Weight at Week 24 |
68.65; 69.46; 71.54; 72.65; 68.15; 69.78 | — |
| SECONDARY Change From Baseline in Body Weight at Week 52 |
68.07; 70.07; 71.27; 72.43; 68.00; 70.15 | — |
| SECONDARY Time to Study Withdrawal Due to Hyperglycemia |
NA; NA; NA; NA | — |
| SECONDARY Time to Study Withdrawal for Any Reason |
NA; NA; NA; NA | — |
Eligibility Criteria
Inclusion Criteria
- Subjects with diagnosis of Type 2 Diabetes Mellitus, treated with diet and exercise or a stable dose of 1 OAD at screening
- Body mass index (BMI) 17 to 40 kg/ m^2 inclusive
- Subjects who are OAD naïve, HbA1c between 7.0% and 10.0% at Screening and at Visit 2; for subjects who enter the study with 1 OAD, HbA1c between 6.5% and 9.5% at Screening and HbA1c between 7.0% and 10.0% at Visit 2
- Creatinine clearance >30 mL/min (calculated using the Cockcroft-Gault formula)
Exclusion Criteria
- History of type 1 diabetes mellitus •Female subject is pregnant, lactating, or =3 ×ULN and/or serum lipase >=2 × ULN and/or subject is experiencing any symptoms possibly related to pancreatitis
- Prior use of a TZD or GLP-1R agonist within 4 months before Screening
Data sourced from ClinicalTrials.gov (NCT01733758). 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.