A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin

Completed · Phase 2

Conditions studied: Diabetes Mellitus Type 2

In brief

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.

Key facts

Study ID

NCT00266253

Run by

Hoffmann-La Roche

People needed

220

Starts

2005-11-01

Expected to finish

2007-03-01

Last updated by the study team

2016-11-02

Who can join

Age: 30 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• type 1 diabetes mellitus;
• any oral anti-hyperglycemic medication, other than metformin monotherapy, during last 3 months

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Chula Vista, California, United States
• Study site — Los Angeles, California, United States
• Study site — Kissimmee, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Lawrenceville, Georgia, United States
• Study site — Arkansas City, Kansas, United States
• Study site — Benzonia, Michigan, United States
• Study site — Springfield, Missouri, United States
• Study site — Butte, Montana, United States
• Study site — Kettering, Ohio, United States
• Study site — Tulsa, Oklahoma, United States
• Study site — Medford, Oregon, United States
• Study site — Morrisville, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Memphis, Tennessee, United States
• Study site — Bellevue, Washington, United States
• Study site — Federal Way, Washington, United States
• Study site — Adelaide, Australia
• Study site — Heidelberg, Australia
• Study site — Sydney, Australia
• Study site — Edmonton, Alberta, Canada
• Study site — Vancouver, British Columbia, Canada
• Study site — London, Ontario, Canada
• Study site — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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