A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 30 - 75 |
| Updated: | 8/3/2016 |
| Start Date: | November 2005 |
| End Date: | May 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
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.
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.
Inclusion Criteria:
- 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).
Exclusion Criteria:
- type 1 diabetes mellitus;
- women who are pregnant, breast-feeding or not using adequate contraceptive methods.
We found this trial at
20
sites
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