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

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

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.

Conditions

Diabetes Mellitus, Type 2

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• Efficacy: HbA1c mean change from baseline at end of treatment period compared with placebo.
• Safety and tolerability.

Secondary Outcome Measures:

• Measurement of additional parameters of glycemic and lipid control.
• Pharmacokinetics and exposure-response relationships.

Study Start

November 2005

Eligibility & Criteria

• Ages Eligible for Study: 30 Years – 75 Years
• Genders Eligible for Study: Both

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

Total Enrolment

Contact Details

Australian Locations:

• SYDNEY, 2050, Australia
• ADELAIDE, 5000, Australia
• HEIDELBERG, 3081, Australia

For more information refer to Hoffmann-La Roche Clinical Trials