A monotherapy study to evaluate the efficacy and safety of 2 dose levels of albiglutide in Japanese subjects with type 2 diabetes mellitus (T2DM)
Trial overview
Model-adjusted change from Baseline in glycosylated hemoglobin (HbA1c) at Week 24
Timeframe: Baseline and Week 24
Mean HbA1c at Baseline, Week 24, and change from Baseline at Week 24
Timeframe: Baseline and Week 24
Change from Baseline in HbA1c at Week 52
Timeframe: Baseline and Week 52
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
Timeframe: Week 24
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
Timeframe: Week 52
Change from Baseline in Fasting Plasma Glucose (FPG) at Week 24
Timeframe: Baseline and Week 24
Change from Baseline in Fasting Plasma Glucose (FPG) at Week 52
Timeframe: Baseline and Week 52
Change from Baseline in body weight at Week 24
Timeframe: Baseline and Week 24
Change from Baseline in body weight at Week 52
Timeframe: Baseline and Week 52
Time to study withdrawal due to hyperglycemia
Timeframe: Baseline through Week 52
Time to study withdrawal for any reason
Timeframe: Baseline through Week 52
Participation 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
- History of type 1 diabetes mellitus
- Female subject is pregnant, lactating, or <6 weeks postpartum•
•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)
- •Clinically significant cardiovascular and/or cerebrovascular disease •Current ongoing symptomatic biliary disease, clinical signs or symptoms of pancreatitis, or a history of chronic or acute pancreatitis, as determined by the investigator •Serum amylase >=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
•History of type 1 diabetes mellitus •Female subject is pregnant, lactating, or <6 weeks postpartum
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.