A Study of the Effect of Taspoglutide on Gastric Emptying in Patients With Type 2 Diabetes
NCT00809705 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2016-11-02
Summary
This 3 arm, placebo-controlled study will investigate the effect of Taspoglutide on gastric emptying in patients with type 2 diabetes. Patients will be randomized into one of 3 groups to receive a)10mg Taspoglutide sc weekly for 12 weeks b)10mg Taspoglutide sc weekly for 4 weeks followed by 20mg Taspoglutide sc weekly for 8 weeks or c) placebo sc weekly for 12 weeks, with all injections administered in the abdomen.Gastric emptying will be assessed by a paracetamol test at intervals during the study. The anticipated time on study treatment is 3 months, and the target sample size is \<100 individuals.
Conditions
- Diabetes Mellitus Type 2
Interventions
- DRUG
-
sc once weekly for 12 weeks
- DRUG
-
taspoglutide
10mg sc once weekly for 4 weeks, followed by 20mg sc once weekly for 8 weeks
- DRUG
-
taspoglutide
10mg sc once weekly for 12 weeks
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-12-31
- Primary Completion
- 2009-10-31
- Completion
- 2009-10-31
Countries
- Germany
- United Kingdom
Study Locations
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