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



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 75
Updated:8/3/2016
Start Date:July 2006
End Date:June 2007

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An Open Label Study to Determine the Effect on Fasting Glucose Levels, and Safety, of Increasing Doses of GK Activator (2) in Patients With Type 2 Diabetes Not Optimally Controlled With One Previous Oral Antihyperglycemic Agent.

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.


Inclusion Criteria:

- adult patients, 18-75 years of age;

- type 2 diabetes mellitus treated with one oral antihyperglycemic agent for >=3 months
prior to screening.

Exclusion Criteria:

- 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.
We found this trial at
11
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Evansville, IN
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Butte, MT
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Canton, OH
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Chandler, AZ
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Greer, SC
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Midland, TX
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Nampa, ID
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Oviedo, FL
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Portland, OR
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Richmond, VA
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Tallinn,
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