Trial Information

Summary: A Dose-Titration Study of GK Activator (2) in Patients With Type 2 Diabetes.

Status: Completed

Protocol Number: BC19800

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: An open label study to determine the effect on fasting glucose levels, and safety, of increasing doses of GK Activator (2) in patients with Type 2 diabetes not optimally controlled with one previous oral antihyperglycemic agent.

Brief Summary: This study will assess the efficacy, safety and tolerability of increasing doses of GK Activator (2) in patients with type 2 diabetes whose condition has not been optimally controlled with one previous oral antihyperglycemic agent. After a 2 week washout from their previous antidiabetic therapy, patients will receive GK Activator (2) orally, twice a day for 12 weeks, at increasing doses of 25mg bid to 200mg bid; doses will be titrated to achieve a target fasting glucose level (FPG) of <100mg/dL. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals. Target sample size is 120.

Study Phase: II

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Non-Randomized
• Masking: Open Label
• Control: Uncontrolled
• Assignment: Single Group
• Endpoints: Safety/Efficacy

Study Type:

Condition: Diabetes Mellitus, Type 2

Intervention Type: Drug

Intervention Name: GK Activator (2)

Primary Outcome: 1. Percentage of patients at each dose who achieve FPG <100mg/dL. Time frame: Throughout study

Key Secondary Outcomes: 1. Mean change in HbA1c and FPG from baseline to endpoint; absolute/relative changes in lipid profile. Time frame: At intervals throughout study 2. AEs, laboratory parameters. Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years Max: 75 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 08/16/2006

Date Last Updated: 10/17/2008

Link To Trial Results

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Trial listings updated: November 17, 2008 at 2:36:09 PM