Trial information
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 type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Safety/Efficacy study
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 Percentage of patients withdrawn because of gastrointestinal effects Time frame: Week 9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: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Australia
France
- Besancon
- Corbeil-Essonnes
- Narbonne
- Paris
- Poitiers
Germany
Mexico
- Chihuahua
- Culiacan
- Monterrey
- Tampico
Peru
United States
- Harrisburg, AR
- Hot Springs, AR
- Jonesboro, AR
- National City, CA
- Jacksonville, FL
- Madisonville, KY
- Winston-Salem, NC
- Dallas, TX
- Richmond, VA
