A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00266240

Purpose

This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of oral GK Activator (2), compared to placebo, in patients with type 2 diabetes mellitus. 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: Placebo	Phase II

MedlinePlus related topics: Diabetes

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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

HbA1c mean change from baseline, compared to 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:	267
Study Completion Date:	May 2007

Arms	Assigned Interventions
1: Experimental	Drug: GK Activator (2) Escalating doses po bid
2: Experimental	Drug: GK Activator (2) Escalating doses po bid
3: Experimental	Drug: GK Activator (2) Escalating doses po bid
4: Experimental	Drug: GK Activator (2) Escalating doses po bid
5: Placebo Comparator	Drug: Placebo po bid

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 for >3 months before screening;
treatment-naive, inadequately controlled diabetes despite diet and exercise, or inadequately controlled diabetes in patients on monotherapy or combination therapy (maximum of 2 oral anti-hyperglycemic medications).

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: NCT00266240

Show 45 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:	BM18248
Study First Received:	December 15, 2005
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00266240
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009