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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

2014-08-27 03:16:34 | BioPortfolio

Summary

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Diabetes Mellitus, Type 2

Intervention

taspoglutide, taspoglutide, insulin glargine, metformin

Location

Beijing
China
100029

Status

Recruiting

Source

Hoffmann-La Roche

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:34-0400

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