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: 10/17/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Tucson , AZ 85704
Telephone: 973-235-5000 or 800-526-6367

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Trial listings updated: November 17, 2008 at 2:35:48 PM


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