A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus Type 2

In brief

This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of oral GK Activator (2), compared to placebo, in patients with type 2 diabetes mellitus. The anticipated time on study treatment is less than 3 months, and the target sample size is 100-500 individuals.

Key facts

Study ID

NCT00266240

Run by

Hoffmann-La Roche

People needed

267

Starts

2005-11-01

Expected to finish

2007-05-01

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 for >3 months before screening;
• treatment-naive, inadequately controlled diabetes despite diet and exercise, or inadequately controlled diabetes in patients on monotherapy or combination therapy (maximum of 2 oral anti-hyperglycemic medications).

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 — Tucson, Arizona, United States
• Study site — Pine Bluff, Arkansas, United States
• Study site — Chula Vista, 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 — Atlanta, Georgia, 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 — Tipton, Pennsylvania, United States
• Study site — Mt. Pleasant, South Carolina, United States
• Study site — Plano, Texas, United States
• Study site — Renton, Washington, United States
• Study site — Dimitrovgrad, Bulgaria
• Study site — Pleven, Bulgaria
• Study site — Rousse, Bulgaria
• Study site — Sofia, Bulgaria
• Study site — Sofia, Bulgaria
• Study site — Sofia, Bulgaria

Full record on ClinicalTrials.gov

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