A Dose-Titration Study of GK Activator (2) in Patients With Type 2 Diabetes.

Completed · Phase 2

Conditions studied: Diabetes Mellitus Type 2

In brief

This study will assess the efficacy, safety and tolerability of increasing doses of GK Activator (2) in patients with type 2 diabetes whose condition has not been optimally controlled with one previous oral antihyperglycemic agent. After a 2 week washout from their previous antidiabetic therapy, patients will receive GK Activator (2) orally, twice a day for 12 weeks, at increasing doses of 25mg bid to 200mg bid; doses will be titrated to achieve a target fasting glucose level (FPG) of \<100mg/dL. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.

Key facts

Study ID

NCT00366379

Run by

Hoffmann-La Roche

People needed

127

Starts

2006-07-01

Expected to finish

2007-06-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• adult patients, 18-75 years of age;
• type 2 diabetes mellitus treated with one oral antihyperglycemic agent for >=3 months prior to screening.

You may not qualify if…

• type 1 diabetes mellitus;
• treatment with insulin, PPAR agonists or systemic corticosteroids during the 3 months prior to screening;
• women who are pregnant, breast-feeding or not using adequate contraceptive methods.

Where it is running

• Study site — Chandler, Arizona, United States
• Study site — Oviedo, Florida, United States
• Study site — Nampa, Idaho, United States
• Study site — Evansville, Indiana, United States
• Study site — Butte, Montana, United States
• Study site — Canton, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Greer, South Carolina, United States
• Study site — Midland, Texas, United States
• Study site — Richmond, Virginia, United States
• Study site — Tallinn, Estonia
• Study site — Tartu, Estonia
• Study site — Tartu, Estonia
• Study site — Tartu, Estonia
• Study site — Jelgava, Latvia
• Study site — Riga, Latvia
• Study site — Riga, Latvia
• Study site — Chihuahua City, Mexico
• Study site — Guadalajara, Mexico
• Study site — Guadalajara, Mexico
• Study site — Pachuca, Mexico

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.