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Sponsored by: |
Hoffmann-La Roche |
Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00744926 |
This 3 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to placebo in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg sc once weekly, taspoglutide 20mg sc once weekly (after 4 weeks of taspoglutide 10mg sc once weekly) or placebo. After the first 24 weeks patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly). The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.
Condition | Intervention | Phase |
Diabetes Mellitus, Type 2 |
Drug: taspoglutide Drug: placebo |
Phase III |
MedlinePlus related topics: | Diabetes Exercise and Physical Fitness |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide Compared to Placebo, in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise |
Estimated Enrollment: | 330 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | September 2010 |
Arms | Assigned Interventions |
1: Experimental |
Drug: taspoglutide
10mg sc, once weekly
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2: Experimental |
Drug: taspoglutide
20mg sc, once weekly (after 4 weeks of taspoglutide 10mg sc once weekly)
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3: Placebo Comparator |
Drug: placebo
sc, once weekly
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Please reference Study ID Number: PDO_BC20750 | 973-235-5000 | |
Contact: or | 800-526-6367 (FOR US ONLY) |
Show 88 Study Locations |
Hoffmann-La Roche |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | BC20750, 2008-001765-28 |
First Received: | August 29, 2008 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00744926 |
Health Authority: | United States: Food and Drug Administration |
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