A Study of Taspoglutide Versus Exenatide for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, Thiazolidinedione or a Combination of Both.

Lead Sponsor

Hoffmann-La Roche

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

No

•adult patients, 18-75 years of age;
•type 2 diabetes receiving metformin and/or pioglitazone or rosiglitazone for at least 12 weeks;
•HbA1c \>=7.0% and \<=10% at screening;
•BMI \>=25kg/m2 (\>23kg/m2 for Asians) and \<=45kg/m2 at screening;
•stable weight +/- 5% for at least 12 weeks prior to screening.

•history of type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes;
•history of acute metabolic diabetic complications within the previous 6 months;
•evidence of clinically significant diabetic complications;
•known proliferative diabetic retinopathy;
•myocardial infarction (MI), coronary artery bypass surgery, post-transplantation cardiomyopathy (PTCM) or stroke within the past 6 months;
•any abnormality in clinical laboratory test or ECG, which precludes safe involvement in the study as judged by the investigator;
•known hemoglobinopathy or chronic anemia;
•clinically significant gastrointestinal disease.