A Study of the Effect of Taspoglutide on Gastric Emptying in Patients With Type 2 Diabetes
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00809705
First received: December 16, 2008
Last updated: December 5, 2011
Last verified: December 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: taspoglutide Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Investigate the Effect of Taspoglutide on Gastric Emptying Measured by a Paracetamol Test After Single Dose and After Multiple Doses in Patients With Type 2 Diabetes |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Tmax, log (AUC), log(Cmax)of paracetamol [ Time Frame: Days -1, 1, 5, 29, 33, 78 and 82 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Adverse events, laboratory parameters, vital signs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- renal function (creatinine clearance, urine volume and electrolytes) [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Multiple dose pharmacokinetics of Taspoglutide [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
| Enrollment: | 60 |
| Study Start Date: | December 2008 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: taspoglutide
10mg sc once weekly for 12 weeks
|
| Experimental: 2 |
Drug: taspoglutide
10mg sc once weekly for 4 weeks, followed by 20mg sc once weekly for 8 weeks
|
| Placebo Comparator: 3 |
Drug: Placebo
sc once weekly for 12 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- adult patients, 18-75 years of age;
- type 2 diabetes mellitus, treated with stable oral antidiabetic drug therapy for >=3 months prior to screening;
- stable weight +/-10% for >=3 months before screening.
Exclusion Criteria:
- type 1 diabetes mellitus;
- acute gastrointestinal symptoms at screening and/or day -1;
- clinically relevant cardiovascular, bronchopulmonary, gastrointestinal or neurological disease.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Disclosures Group, Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00809705 History of Changes |
| Other Study ID Numbers: | BP21572, 2008-003575-47 |
| Study First Received: | December 16, 2008 |
| Last Updated: | December 5, 2011 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013