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Therapeutic Areas: Endocrinology
Disease Category: Diabetes Mellitus, Type 2
Trial Information
A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Plus Pioglitazone.
Status: Recruiting
Protocol Number: BC20963
Sponsor: Hoffmann-La Roche
Company Division: Pharmaceutical
Official Scientific 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
Brief Summary: 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. Target sample size is 330.
Study Phase: III
Study Design / Study Details:
- Purpose: Treatment
- Allocation: Randomized
- Masking: Double Blind
- Control: Placebo
- Assignment: Parallel
- Endpoints: Safety/Efficacy
Study Type:
Interventional
Condition: Diabetes Mellitus, Type 2
Intervention Type: Drug
Intervention Name: taspoglutide
Primary Outcome: 1. Absolute change from baseline in HbA1c Time frame: 24 weeks
Key Secondary Outcomes: 1. 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
2. Safety: adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies. Time frame: Throughout the study
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.
Gender: Males or Females
Age Limits: Min: 18 Years Max: 75 Years
Accepts Healthy Volunteers: No
Anticipated Start Date: October, 2008
Trial Registration Date: 08/29/2008
Date Last Updated: 12/08/2008
Link To Trial Results
Research Site:
Located In:
Phoenix AZ 85015
Phone: 973-235-5000 or 800-526-6367
View Google Map
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