Trial information
A Study to Evaluate the Long-Term Safety and Tolerability of GK Activator (2) in Patients With Type 2 Diabetes.
Status: Completed
Protocol number: NC19794
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: 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
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 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. Target sample size is 259.
Study phase: II
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Diabetes Mellitus, Type 2
Intervention type: Drug
Intervention name: GK Activator (2)
Primary outcome: 1. AEs, laboratory parameters, ECG. Time frame: Throughout study
Key secondary outcomes: 1. Mean change from original baseline in HbA1c, FPG, lipid profile. Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 30 Years Max: 75 Years
Accepts healthy volunteers: No
Trial registration date: 05/04/2006
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Australia
Germany
- Berlin
- Giessen
- Görlitz
- Nürnberg
Mexico
- Chihuahua
- Cuernavaca
- Mexico City
United States
- Los Angeles, CA
- Butte, MT
- Statesville, NC
- Oklahoma City, OK
- Medford, OR
- Mount Pleasant, SC
- Federal Way, WA
