A Study to Evaluate the Long-Term Safety and Tolerability of GK Activator (2) in Patients With Type 2 Diabetes.

Completed · Phase 2

Conditions studied: Diabetes Mellitus Type 2

In brief

This study will evaluate the long-term safety and tolerability of GK Activator (2) at doses ranging from 25mg - 100mg po bid, administered alone or in combination with metformin, in patients with type 2 diabetes. Eligible patients will be those who have completed study BM18248 (GK Activator (2) monotherapy) or BM18249 (GK Activator (2) and metformin); they will continue on the same treatment regimen (mono or combination therapy) as they received in the initial study. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Key facts

Study ID

NCT00316758

Run by

Hoffmann-La Roche

People needed

259

Starts

2006-02-01

Expected to finish

2007-10-01

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…

• type 2 diabetic patients who have completed studies BM18248 or BM18249;
• patients considered by the investigator to be suitable for long term treatment with GK Activator (2).

You may not qualify if…

• type 1 diabetes mellitus;
• women who are pregnant, breast-feeding or not using adequate contraceptive methods.

Where it is running

• Study site — Chula Vista, California, United States
• Study site — Los Angeles, California, United States
• Study site — Spring Valley, California, United States
• Study site — West Hills, California, United States
• Study site — Hollywood, Florida, United States
• Study site — Kissimmee, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Arkansas City, Kansas, United States
• Study site — Butte, Montana, United States
• Study site — Binghamton, New York, United States
• Study site — Fayetteville, North Carolina, United States
• Study site — Statesville, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Springdale, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Medford, Oregon, United States
• Study site — Beaver, Pennsylvania, United States
• Study site — Mt. Pleasant, South Carolina, United States
• Study site — Memphis, Tennessee, United States
• Study site — Federal Way, Washington, United States
• Study site — Renton, Washington, United States
• Study site — Camperdown, Australia
• Study site — Heidelberg, Australia
• Study site — Dimitrovgrad, Bulgaria
• Study site — Chula Vista, California, United States

Full record on ClinicalTrials.gov

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