Overview

A Study to Evaluate the Long-Term Safety and Tolerability of GK Activator (2) in Patients With Type 2 Diabetes.

Status:
Completed

Trial end date:
2007-10-01

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Hoffmann-La Roche

Treatments:

Metformin

Criteria

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.