A Study of Taspoglutide in Type 2 Diabetic Patients
- Registration Number
- NCT00811460
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This crossover study will assess the effect of 2 doses of Taspoglutide on first- and second-phase insulin secretion in patients with type 2 diabetes. Patients will receive a continuous subcutaneous infusion of a)the Immediate Release Formulation (IRF)of Taspoglutide 300 micrograms/day for 2 days followed by Taspoglutide 800 micrograms/day for 2 days or b)saline placebo for 2+2 days. After a washout period of 10-15 days, patients will be crossed-over for further treatment;those receiving Taspoglutide in period 1 will receive placebo in period 2, and vice versa. On days 2 and 4 of each period, insulin secretion patterns will be assessed. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- adult patients, 18-65 years of age;
- type 2 diabetes mellitus;
- treated with diet and exercise alone, or in combination with stable metformin for at least 3 months prior to screening.
- type 1 diabetes mellitus;
- type 2 diabetes duration of <3 months;
- treatment with any oral anti-hyperglycemic medication other than metformin monotherapy during last 3 months;
- treatment with insulin for >7 days within 6 months prior to screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 Placebo - 1 taspoglutide -
- Primary Outcome Measures
Name Time Method Incremental area under insulin concentration time curve relative to basal insulin concentration First 10 minutes after glucose bolus
- Secondary Outcome Measures
Name Time Method Incremental area under insulin concentration time curve relative to basal insulin concentration 10-120 minutes after glucose bolus Adverse events, laboratory parameters Throughout study