Trial information
A Study of a GLP-1 Analogue in Patients With Type 2 Diabetes Treated With Metformin.
Status: Completed
Protocol number: BC20688
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A double blind, placebo-controlled, dose-ranging study to investigate the effect on glycemic control, safety, pharmacokinetics and pharmacodynamics of GLP-1 in patients with type 2 diabetes mellitus treated with a stable dose of metformin.
Brief summary: This 6 arm study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of multiple doses and regimens 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, 5mg, 10mg or 20mg weekly, or 10mg or 20mg every 2 weeks. 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 264.
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
Primary outcome: 1. Absolute change from baseline in HbAlc Time frame: Week 8
Key secondary outcomes: 1. Absolute change from baseline in FPG, fructosamine, body weight, fasting insulin, C-peptide, glucagon. Time frame: Week 8
2. Changes in lipid profile Time frame: Week 8
3. AEs, laboratory parameters, primary pharmacokinetic parameters Time frame: Throughout study
Inclusion criteria:
- adult patients, 18-75 years of age;
- type 2 diabetes mellitus, with stable metformin treatment for >=3 months;
- stable weight +/-10% for >=3 months before screening.
Exclusion criteria:
- type 1 diabetes mellitus;
- 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.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Trial registration date: 01/17/2007
Date last updated: 10/15/2008
Link to trial result
This trial was conducted at the following locations:
Australia
Bulgaria
- Dimitrovgrad
- Pleven
- Ruse
- Sofia
- Varna
China
Germany
- Bad Lauterberg
- Berlin
- Görlitz
- Hannover
- Mainz
- Neuss
- Nürnberg
Guatemala
Latvia
Lithuania
Mexico
- Guadalajara
- Mexico City
- Monterrey
- Pachuca
Romania
- Brasov
- Bucharest
- Cluj-Napoca
- Jud Covasna
- Mures
- Ploiesti
- Satu Mare
- Sibiu
United States
- Washington, DC
- Chicago, IL
- Springfield, IL
- Rochester, NY
- Portland, OR
- Midland, TX
- Richmond, VA
