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

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00316758

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: GK Activator (2) Drug: Metformin	Phase II

MedlinePlus related topics: Diabetes

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official 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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

AEs, laboratory parameters, ECG. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean change from original baseline in HbA1c, FPG, lipid profile. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	259
Study Completion Date:	October 2007

Arms	Assigned Interventions
1: Experimental	Drug: GK Activator (2) Escalating doses bid Drug: Metformin As prescribed, in patients who were in study BM18249

Eligibility

Ages Eligible for Study:	30 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00316758

Show 59 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	NC19794
Study First Received:	April 20, 2006
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00316758
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009