Trial Information

Summary: A Titration Study of a GLP-1 Analogue in Patients With Type 2 Diabetes Treated With Metformin.

Status: Completed

Protocol Number: BC20728

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A double-blind, placebo-controlled titration study to investigate the tolerability, safety and pharmacodynamic profile of a GLP-1 analogue in patients with type 2 diabetes mellitus treated with a stable dose of metformin.

Brief Summary: This 4 arm study will evaluate the tolerability, efficacy and pharmacodynamics of different doses of a GLP-1 analogue in patients with type 2 diabetes who are treated with a stable dose of metformin. Patients will be randomized to receive either subcutaneous placebo, or subcutaneous GLP-1 analogue (at a dose of 20mg, or a starting dose of 20mg escalating to either 30mg or 40mg), weekly. All patients will continue on their existing metformin treatment regimen throughout the study. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals. Target sample size is 120.

Study Phase: II

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: GLP-1 analogue

Primary Outcome: 1. Percentage of patients withdrawn because of gastrointestinal effects Time frame: Week 9

Key Secondary Outcomes: 1. Mean changes in 24h blood glucose AUC, FPG, fructosamine, HbAlc, body weight, AEs, laboratory parameters. Time frame: Week 9

Inclusion Criteria:

  • male,and post-menopausal or surgically sterilized female, patients, 18-75 years of age;
  • type 2 diabetes mellitus, with stable metformin treatment for >=3 months;
  • HbA1c >=7.0% and <=9.5% at screening;
  • stable weight +/-10% for >=3 months before screening.

Exclusion Criteria:

  • type 1 diabetes mellitus;
  • clinically significant gastrointestinal disease;
  • treatment with any anti-hyperglycemic medication other than metformin monotherapy during last 3 months;
  • use of weight-lowering medications in the last 3 months;
  • uncontrolled hypertension;
  • previous exposure to GLP-1 or GLP-1 analogues.

Gender: Males or Females

Age Limits: Min: 18 Years Max: 75 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 04/17/2007

Date Last Updated: 06/17/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Sydney, Australia, 2060
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: June 30, 2008 at 3:10:30 PM


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