Phase 3
Completed N=374
A Study to Determine the Long Term Safety and Efficacy of Albiglutide in Combination With Oral Monotherapy Antihyperglycemic Medications in Japanese Patients With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01777282 ↗Enrolled (actual)
374
Serious AEs
2.1%
Results posted
Oct 2015
Primary outcomePrimary: Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) — 97; 47; 58; 49 Participants
Summary
This study is designed to examine the long term safety and efficacy of weekly subcutaneously injected albiglutide in combination with a single oral antidiabetic drug for 52 weeks in Japanese subjects with type 2 diabetes mellitus.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) |
97; 47; 58; 49; 43; 2 | — |
| PRIMARY Number of Participants With Any Hypoglycemic Event |
17; 1; 4; 2; 0 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52 |
-1.04; -0.94; -0.95; -1.42; -1.39 | — |
| 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) |
20.0; 26.9; 24.6; 45.9; 26.2; 54.2 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 |
-16.4; -24.3; -16.4; -32.1; -33.2 | — |
| SECONDARY Change From Baseline in Body Weight at Week 52 |
0.25; -0.33; -0.04; 0.52; -0.13 | — |
| SECONDARY Time to Study Withdrawal Due to Hyperglycemia |
13.0; 16.5 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects with diagnosis of Type 2 Diabetes Mellitus, who are experiencing inadequate glycemic control and receiving treatment with a stable dose of a single oral antidiabetic medication
- Body mass index (BMI) 17 to 40 kg/ m2 inclusive
- Subjects with an HbA1c between 7.0% and 10.0% at Screening
- 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 GLP-1R agonist or DPP-IV inhibitor within 6 months before Screening
Data sourced from ClinicalTrials.gov (NCT01777282). 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.