Trial Information

Summary: A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus

Status: Completed

Protocol Number: BM18248

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific 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

Brief Summary: 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. Target sample size is 250.

Study Phase: II

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double Blind
  • Control: Active
  • Assignment: Parallel
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Diabetes Mellitus, Type 2

Intervention Type: Drug

Intervention Name: GK Activator (2)

Primary Outcome: 1. HbA1c mean change from baseline, compared to placebo. Time frame: Week 12

Key Secondary Outcomes: 1. Additional parameters of glycemic and lipid control. Time frame: Week 12 2. AEs, laboratory parameters. Time frame: Throughout study 3. Pharmacokinetic and exposure-response relationship Time frame: Throughout study

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.

Gender: Males or Females

Age Limits: Min: 30 Years Max: 75 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 12/09/2005

Date Last Updated: 06/17/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Ruse, Bulgaria, 7002
Telephone: 973-235-5000 or 800-526-6367

  

This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.

Trial listings updated: July 7, 2008 at 2:40:58 PM


Back to Centerwatch Trial Listing by Location


Additional resources
in this illness area

Copyright © 1995 - 2008, CenterWatch
All Rights Reserved

This site was developed in association with Illumina Interactive, Boston, MA