A Study of Taspoglutide Versus Exenatide for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, Thiazolidinedione or a Combination of Both.
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00717457
First received: July 16, 2008
Last updated: February 5, 2015
Last verified: February 2015
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Purpose
This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared with exenatide in patients with type 2 diabetes mellitus inadequately controlled with metformin, thiazolidinedione or a combination of both. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly) or exenatide (5 micrograms twice daily for 4 weeks followed by 10 micrograms twice daily) in a ratio of 1:1:1 in addition to continued prestudy metformin and thiazolidinedione either alone or in combination. The anticipated time on study treatment is 3+ years, and the target sample size is >500 individuals.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: exenatide Drug: taspoglutide |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized, Active Controlled, Open Label Study to Compare Taspoglutide vs Exenatide as add-on Treatment to Metformin and/or Thiazolidinediones in Patients With Type 2 Diabetes Mellitus |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Change in HbA1c [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Fasting body weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Proportion of patients reaching target HbA1c <=7.0%, <=6.5% [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Relative change in glucose, insulin, C-peptide and glucagon values during a meal tolerance test in a subset of patients. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Beta cell function (proinsulin/insulin ratio) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 1189 |
| Study Start Date: | July 2008 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: taspoglutide
10mg once weekly
|
| Experimental: 2 |
Drug: taspoglutide
10mg once weekly for 4 weeks followed by 20mg once weekly
|
| Active Comparator: 3 |
Drug: exenatide
5mg twice daily for 4 weeks followed by 10mg twice daily
|
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 receiving metformin and/or pioglitazone or rosiglitazone for at least 12 weeks;
- HbA1c >=7.0% and <=10% at screening;
- BMI >=25kg/m2 (>23kg/m2 for Asians) and <=45kg/m2 at screening;
- stable weight +/- 5% for at least 12 weeks prior to screening.
Exclusion Criteria:
- history of type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes;
- history of acute metabolic diabetic complications within the previous 6 months;
- evidence of clinically significant diabetic complications;
- known proliferative diabetic retinopathy;
- myocardial infarction (MI), coronary artery bypass surgery, post-transplantation cardiomyopathy (PTCM) or stroke within the past 6 months;
- any abnormality in clinical laboratory test or ECG, which precludes safe involvement in the study as judged by the investigator;
- known hemoglobinopathy or chronic anemia;
- clinically significant gastrointestinal disease.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00717457
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00717457
Show 216 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided by Hoffmann-La Roche
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00717457 History of Changes |
| Other Study ID Numbers: | BC21625, 2008-001856-36 |
| Study First Received: | July 16, 2008 |
| Last Updated: | February 5, 2015 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Exenatide |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Hypoglycemic Agents Incretins Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on March 01, 2015