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.
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| ClinicalTrials.gov Identifier: NCT00717457 |
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Recruitment Status
:
Completed
First Posted
: July 17, 2008
Last Update Posted
: November 2, 2016
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetes Mellitus Type 2 | Drug: exenatide Drug: taspoglutide | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1189 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Study Start Date : | July 2008 |
| Actual Primary Completion Date : | March 2011 |
| Actual Study Completion Date : | March 2011 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Type 2 diabetes
Drug Information available for:
Exenatide
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: exenatide |
Drug: exenatide
5mg twice daily for 4 weeks followed by 10mg twice daily
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| Experimental: taspoglutide 10mg |
Drug: taspoglutide
10mg once weekly
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| Experimental: taspoglutide 10mg/20mg |
Drug: taspoglutide
10mg once weekly for 4 weeks followed by 20mg once weekly
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Primary Outcome Measures
:
- Change in HbA1c [ Time Frame: 24 weeks ]
Secondary Outcome Measures
:
- Fasting body weight [ Time Frame: 24 weeks ]
- Proportion of patients reaching target HbA1c <=7.0%, <=6.5% [ Time Frame: 24 weeks ]
- Relative change in glucose, insulin, C-peptide and glucagon values during a meal tolerance test in a subset of patients. [ Time Frame: 24 weeks ]
- Beta cell function (proinsulin/insulin ratio) [ Time Frame: 24 weeks ]
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00717457
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
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 |
| First Posted: | July 17, 2008 Key Record Dates |
| Last Update Posted: | November 2, 2016 |
| Last Verified: | November 2016 |
Additional relevant MeSH terms:
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Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Exenatide 2,4-thiazolidinedione |
Metformin Glucagon-Like Peptide 1 Hypoglycemic Agents Physiological Effects of Drugs Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |