A Study of Taspoglutide Versus Sitagliptin for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin.
Diabetes Mellitus Type 2
About this trial
This is an interventional treatment trial for Diabetes Mellitus Type 2
Eligibility Criteria
Inclusion Criteria:
- adult patients, 18-75 years of age;
- type 2 diabetes receiving metformin (>=1500mg/day) for at least 12 weeks;
- HbA1c >=7.0% and <=10.0% at screening;
- BMI >=25 (>23 for Asians) and <=45kg/m2 at screening;
- stable weight +/- 5% for at least 12 weeks prior to screening.
Exclusion Criteria:
- history of type 1 diabetes mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months;
- evidence of clinically significant diabetic complications;
- clinically symptomatic gastrointestinal disease;
- myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months;
- known hemoglobinopathy or chronic anemia.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Active Comparator
Experimental
Experimental
Placebo
Sitagliptin
Taspoglutide 10 mg
Taspoglutide up-titrated to 20 mg
Once daily oral administration of placebo (matching sitagliptin). Once weekly sc injection of placebo (matching taspoglutide). Continued treatment with metformin at prescribed doses.
Once daily oral administration of 100 mg of sitagliptin. Once weekly sc injection of placebo (matching taspoglutide). Continued treatment with metformin at prescribed doses.
Once weekly subcutaneous (sc) injection of 10 mg of taspoglutide. Once daily oral administration of placebo (matching sitagliptin). Continued treatment with metformin at prescribed doses.
Once weekly sc injection of 10 mg of taspoglutide for the first 4 weeks, then up-titrated to once weekly sc injection of 20 mg of taspoglutide from week 5 onwards. Once daily oral administration of placebo (matching sitagliptin). Continued treatment with metformin at prescribed doses.