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 |
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.
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
sites
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