Trial information
A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin
Status: Completed
Protocol number: BM18249
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized double-blind study to determine the effect of GK Activator (2) on efficacy (HbA1c), safety, tolerability and pharmacokinetics in patients with type 2 diabetes mellitus treated with a stable dose of metformin.
Brief summary: This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of GK Activator (2) in combination with metformin, compared to that of placebo (metformin monotherapy), in patients with type 2 diabetes mellitus. Patients will continue on their stable dose of metformin and will be randomized to receive either GK Activator (2) or placebo. The anticipated time on study treatment is less than 3 months, and the target sample size is 100-500 individuals. Target sample size is 210.
Study phase: II
Study type: Interventional; Treatment; Randomized; Double Blind; Active; Parallel; Safety/Efficacy study
Condition: Diabetes Mellitus, Type 2
Intervention type: Drug
Intervention name: GK Activator (2)
Primary outcome: 1. HbA1c mean change from baseline compared with placebo. Time frame: Week 12
Key secondary outcomes: 1. Additional parameters of glycemic and lipid control. Time frame: Week 12
2. AEs, laboratory parameters. Time frame: Throughout study
3. Pharmacokinetic and exposure-response relationship Time frame: Throughout study
Inclusion criteria:
- adult patients 30-75 years of age;
- type 2 diabetes mellitus;
- individual maximal tolerated daily dose of metformin monotherapy for >=3 months prior to screening.
Exclusion criteria:
- type 1 diabetes mellitus;
- any oral anti-hyperglycemic medication, other than metformin monotherapy, during last 3 months
Gender: Males or Females
Age limits: Min: 30 Years Max: 75 Years
Accepts healthy volunteers: No
Trial registration date: 12/12/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Australia
- Adelaide
- Heidelberg
- Sydney
Canada
- Vancouver, BC
- London, ON
- Montreal, QC
Germany
- Bammental
- Berlin
- Essen
- Giessen
- Görlitz
- Hamburg
- Kuenzing
- Mannheim
- Nürnberg
- Tann
Spain
- Alzira
- Bacarot Alicant
- Baracaldo
- Barcelona
United Kingdom
- Frome
- Glasgow
- Lanarkshire
- Liverpool
- Northwood
- Plymouth
United States
- Phoenix, AZ
- Chula Vista, CA
- Los Angeles, CA
- Kissimmee, FL
- Arkansas City, KS
- Butte, MT
- Kettering , OH
- Medford, OR
- Morrisville, PA
- Philadelphia, PA
- Memphis , TN
- Federal Way, WA
