Status:

COMPLETED

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

Lead Sponsor:

Hoffmann-La Roche

Conditions:

Diabetes Mellitus Type 2

Eligibility:

All Genders

30-75 years

Phase:

PHASE2

Brief 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...

Eligibility Criteria

Inclusion

  • 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

  • type 1 diabetes mellitus;
  • women who are pregnant, breast-feeding or not using adequate contraceptive methods.

Key Trial Info

Start Date :

February 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2007

Estimated Enrollment :

259 Patients enrolled

Trial Details

Trial ID

NCT00316758

Start Date

February 1 2006

End Date

October 1 2007

Last Update

November 2 2016

Active Locations (58)

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Page 1 of 15 (58 locations)

1

Chula Vista, California, United States, 91910

2

Chula Vista, California, United States, 91911

3

Los Angeles, California, United States, 90057

4

Spring Valley, California, United States, 91978