This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared to insulin glargine in patients with insulin-naive type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea combination therapy. Patients will be randomized to receive taspoglutide (10 mg once weekly, or 10mg once weekly for 4 weeks followed by 20mg once weekly) or insulin glargine (starting dose 10 IU/day) in a ratio of 1:1:1 in addition to continued prestudy metformin treatment. The anticipated time on study treatment is 2+ years, and the target sample size if 500+ individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,072
starting dose 10 IU daily
As prescribed
10 mg once weekly
20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly)
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Phoenix, Arizona, United States
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Searcy, Arkansas, United States
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Concord, California, United States
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Huntington Beach, California, United States
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Los Angeles, California, United States
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Absolute change from baseline in HbA1c
Time frame: 24 weeks
Change from baseline in fasting plasma glucose; change from baseline in body weight; responder rates for HbA1c (target <=7.0%, <=6.5%); incidence of hypoglycemia; change from baseline in lipid profile.
Time frame: 24 weeks
Relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test.
Time frame: 24 weeks
Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies
Time frame: Throughout study
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Los Angeles, California, United States
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Los Gatos, California, United States
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Roseville, California, United States
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San Diego, California, United States
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Santa Ana, California, United States
...and 200 more locations