A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00266253

Purpose

This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of GK Activator (2) in combination with metformin, compared to that of placebo (metformin monotherapy), in patients with type 2 diabetes mellitus. Patients will continue on their stable dose of metformin and will be randomized to receive either GK Activator (2) or placebo. The anticipated time on study treatment is less than 3 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, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Double-Blind Study to Determine the Effect of GK Activator (2) on Efficacy (HbA1c), Safety, Tolerability and Pharmacokinetics in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

HbA1c mean change from baseline compared with placebo. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Additional parameters of glycemic and lipid control. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Pharmacokinetic and exposure-response relationship [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	220
Study Completion Date:	March 2007

Arms	Assigned Interventions
1: Experimental	Drug: GK Activator (2) Escalating doses, po bid or qd for 12 weeks. Drug: Metformin As prescribed, for 12 weeks
2: Experimental	Drug: GK Activator (2) Escalating doses, po bid or qd for 12 weeks. Drug: Metformin As prescribed, for 12 weeks
3: Experimental	Drug: GK Activator (2) Escalating doses, po bid or qd for 12 weeks. Drug: Metformin As prescribed, for 12 weeks
4: Experimental	Drug: GK Activator (2) Escalating doses, po bid or qd for 12 weeks. Drug: Metformin As prescribed, for 12 weeks
5: Experimental	Drug: GK Activator (2) Escalating doses, po bid or qd for 12 weeks. Drug: Metformin As prescribed, for 12 weeks
6: Active Comparator	Drug: Metformin As prescribed, for 12 weeks

Eligibility

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

Criteria

Inclusion Criteria:

adult patients 30-75 years of age;
type 2 diabetes mellitus;
individual maximal tolerated daily dose of metformin monotherapy for >=3 months prior to screening.

Exclusion Criteria:

type 1 diabetes mellitus;
any oral anti-hyperglycemic medication, other than metformin monotherapy, during last 3 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00266253

Show 47 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	BM18249
Study First Received:	December 15, 2005
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00266253 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Metformin
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009