A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 30 - 75 |
| Updated: | 8/3/2016 |
| Start Date: | November 2005 |
| End Date: | March 2007 |
A Randomized Double-blind Study to Determine the Effect of GK Activator (2) on Efficacy (HbA1c), Safety, Tolerability and Pharmacokinetics in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.
This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of GK
Activator (2) in combination with metformin, compared to that of placebo (metformin
monotherapy), in patients with type 2 diabetes mellitus. Patients will continue on their
stable dose of metformin and will be randomized to receive either GK Activator (2) or
placebo. The anticipated time on study treatment is less than 3 months, and the target
sample size is 100-500 individuals.
Activator (2) in combination with metformin, compared to that of placebo (metformin
monotherapy), in patients with type 2 diabetes mellitus. Patients will continue on their
stable dose of metformin and will be randomized to receive either GK Activator (2) or
placebo. The anticipated time on study treatment is less than 3 months, and the target
sample size is 100-500 individuals.
Inclusion Criteria:
- adult patients 30-75 years of age;
- type 2 diabetes mellitus;
- individual maximal tolerated daily dose of metformin monotherapy for >=3 months prior
to screening.
Exclusion Criteria:
- type 1 diabetes mellitus;
- any oral anti-hyperglycemic medication, other than metformin monotherapy, during last
3 months
We found this trial at
19
sites
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