A Study to Evaluate the Long-Term Safety and Tolerability of GK Activator (2) in Patients With Type 2 Diabetes.
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 30 - 75 |
| Updated: | 8/3/2016 |
| Start Date: | February 2006 |
| End Date: | October 2007 |
A Multi-center, Open Label, Extension Study to Evaluate the Long-term Safety and Tolerability of GK Activator (2) in Type 2 Diabetic Patients From Studies BM18248 or BM18249
This study will evaluate the long-term safety and tolerability of GK Activator (2) at doses
ranging from 25mg - 100mg po bid, administered alone or in combination with metformin, in
patients with type 2 diabetes. Eligible patients will be those who have completed study
BM18248 (GK Activator (2) monotherapy) or BM18249 (GK Activator (2) and metformin); they
will continue on the same treatment regimen (mono or combination therapy) as they received
in the initial study. The anticipated time on study treatment is 3-12 months, and the target
sample size is 100-500 individuals.
ranging from 25mg - 100mg po bid, administered alone or in combination with metformin, in
patients with type 2 diabetes. Eligible patients will be those who have completed study
BM18248 (GK Activator (2) monotherapy) or BM18249 (GK Activator (2) and metformin); they
will continue on the same treatment regimen (mono or combination therapy) as they received
in the initial study. The anticipated time on study treatment is 3-12 months, and the target
sample size is 100-500 individuals.
Inclusion Criteria:
- type 2 diabetic patients who have completed studies BM18248 or BM18249;
- patients considered by the investigator to be suitable for long term treatment with
GK Activator (2).
Exclusion Criteria:
- type 1 diabetes mellitus;
- women who are pregnant, breast-feeding or not using adequate contraceptive methods.
We found this trial at
22
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials