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.

Hoffmann-La Roche0 sites220 target enrollmentStarted: November 2005Last updated: November 2, 2016

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 2
Status: Completed
Sponsor: Hoffmann-La Roche
Enrollment: 220
Primary Endpoint: HbA1c mean change from baseline compared with placebo.

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Eligibility Criteria

Ages: 30 Years to 75 Years (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

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

Arms & Interventions

1

Experimental

Intervention: GK Activator (2) (Drug)