Trial Information

Summary: 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.

Status: Recruiting

Protocol Number: BC21625

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific 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

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 3-12 months, and the target sample size is >500 individuals. Target sample size is 990.

Study Phase: III

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Randomized
  • Masking: Open Label
  • Control: Active
  • Assignment: Parallel
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Diabetes Mellitus, Type 2

Intervention Type: Drug

Intervention Name: taspoglutide

Primary Outcome: 1. Change in HbA1c Time frame: 24 weeks

Key Secondary Outcomes: 1. Fasting body weight Time frame: 24 weeks 2. Proportion of patients reaching target HbA1c <=7.0%, <=6.5% Time frame: 24 weeks 3. Relative change in glucose, insulin, C-peptide and glucagon values during a meal tolerance test in a subset of patients. Time frame: 24 weeks 4. Beta cell function (proinsulin/insulin ratio) Time frame: 24 weeks

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.

Gender: Males or Females

Age Limits: Min: 18 Years Max: 75 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: July, 2008

Trial Registration Date: 07/15/2008

Date Last Updated: 10/17/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Little Rock, AR 72202
Telephone: 973-235-5000 or 800-526-6367

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Trial listings updated: November 17, 2008 at 2:55:16 PM


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