A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Plus Pioglitazone.
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00744367
First received: August 29, 2008
Last updated: February 5, 2015
Last verified: February 2015
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Purpose
This 3 arm study will assess the efficacy of taspoglutide on glycemic control (as assessed by HbA1c) in patients with type 2 diabetes mellitus inadequately controlled with metformin plus pioglitazone, compared to placebo after 24 weeks of treatment. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg once weekly, taspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) or placebo, in addition to their continued stable metformin plus pioglitazone treatment. After the first 24 weeks patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: metformin Drug: pioglitazone Drug: placebo Drug: taspoglutide |
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 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide on Glycemic Control Compared to Placebo in Patients With Type II Diabetes Mellitus Inadequately Controlled With Metformin Plus Pioglitazone |
Resource links provided by NLM:
MedlinePlus related topics:
Diabetes Type 2
Drug Information available for:
Metformin
Metformin hydrochloride
Pioglitazone
Pioglitazone hydrochloride
U.S. FDA Resources
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Absolute change from baseline in HbA1c [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline in fasting plasma glucose; change from baseline in body weight; responder rates for HbA1c (target <=7.0%, <=6.5%); responder rates for body weight; beta cell function. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Safety: adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies. [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
| Enrollment: | 326 |
| Study Start Date: | October 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: metformin
>1500 mg/day or MTD
Drug: pioglitazone
>= 30 mg/day
Drug: taspoglutide
10 mg sc once weekly;
|
| Experimental: 2 |
Drug: metformin
>1500 mg/day or MTD
Drug: pioglitazone
>= 30 mg/day
Drug: taspoglutide
20 mg sc once weekly (after 4 weeks of taspoglutide 10 mg sc once weekly)
|
| Placebo Comparator: 3 |
Drug: metformin
>1500 mg/day or MTD
Drug: pioglitazone
>= 30 mg/day
Drug: placebo
sc once weekly
|
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 age;
- type 2 diabetes receiving pioglitazone (>= 30 mg/day) and metformin (>= 1500 mg/day) for at least 12 weeks prior to screening;
- HbA1c >=7.0% and <=10.0% at screening;
- BMI >= 25 (>23 for Asians) and <=45 kg/m2 at screening;
- stable weight +/-5% for at least 12 weeks prior to screening.
Exclusion Criteria:
- history of type 1 diabetes mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months;
- evidence of clinically significant diabetic complications;
- clinically symptomatic gastrointestinal disease;
- myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months;
- known hemoglobinopathy or chronic anemia.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00744367
Show 113 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00744367
Show 113 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00744367 History of Changes |
| Other Study ID Numbers: | BC20963, 2008-001744-39 |
| Study First Received: | August 29, 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 |
Metformin Pioglitazone Hypoglycemic Agents Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on March 01, 2015