A Study to Compare Taspoglutide and Insulin Glargine in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin and Sulfonylurea Combination Therapy

A Multi-center, Randomized, Open-label, Active-controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin-naive Type 2 Diabetic Patients Inadequately Controlled With Metformin and Sulphonylurea Combination Therapy.

This randomized, open-label, parallel arm study will compare the safety, tolerability and effect on glycemic control of taspoglutide versus insulin glargine in insulin-naïve patients with type 2 diabetes mellitus inadequately controlled on merformin and sulfonylurea combination therapy. Patients will be randomized to receive either taspoglutide 10mg subcutaneously (sc) weekly, or taspoglutide 10mg sc weekly for 4 weeks followed by 20mg sc weekly, or insulin glargine at an initial dose of 10 international units sc daily. Metformin treatment will be continued in all patients throughout the study, whereas sulfonylurea will be discontinued before starting study treatment. Anticipated time on study treatment is 24 weeks, with an option to continue the assigned treatment for another 28 weeks. Target sample size is 500-600 patients.

Inclusion Criteria:

• adult patients, 18-75 years of age
• type 2 diabetes mellitus, treated with stable dose of metformin and sulfonylurea for >/= 12 weeks prior to screening
• HbA1c 7-10% at screening
• body weight stable (+/-5%) for >/= 12 weeks prior to screening
• fasting C-peptide >/=1ng/ml
• treatment-naïve for insulin

Exclusion Criteria:

• diagnosis or history of type 1 diabetes mellitus or secondary forms of diabetes
• acute metabolic diabetic complications or evidence of clinically significant diabetic complications
• clinically symptomatic gastrointestinal disease
• history of chronic pancreatitis or acute idiopathic pancreatitis
• >3 episodes of severe hypoglycemia within 6 months prior to screening
• miocardial infarcion, unstable angina pectoris, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within 6 months prior to screening
• any treatment with exenatide, exendin analogues, GLP-1 or its analogues