Trial Information

Summary: A Study to Evaluate the Effect of GK Activator (2) on QT Interval in Patients With Type 2 Diabetes Mellitus.

Status: Completed

Protocol Number: NP18422

Sponsor: Roche Global Development

Company Division: Pharmaceutical

Official Scientific Title: A randomized, double-blind study to investigate the effect of GK Activator (2) on QT interval following short-term multiple doses in patients with type 2 diabetes mellitus

Brief Summary: This study will determine the effect of oral GK Activator (2) on QTcS (QT corrected study specific) interval following a single dose and at steady state in type 2 diabetes patients. Patients will be randomized to one of 4 treatment sequence groups involving 4 treatments (placebo, 100mg GK Activator (2), 200mg GK Activator (2) and 400mg moxifloxacin). ECGs will be recorded for 3h after dosing. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals. Target sample size is 42.

Study Phase: I

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Double Blind
• Control: Active
• Assignment: Crossover
• Endpoints: Safety

Study Type:

Condition: Diabetes Mellitus, Type 2

Intervention Type: Drug

Intervention Name: GK Activator (2)

Primary Outcome: 1. Time-matched, placebo-subtracted effect of GK Activator (2) on QT interval (maximum QTcS mean difference).

Key Secondary Outcomes: 1. Safety: AEs, laboratory tests. Pharmacokinetic: Day 1 and Day 5 plasma profile of GK Activator (2) and moxifloxacin. Pharmacodynamics: Plasma glucose levels.

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years Max: 70 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 08/16/2006

Date Last Updated: 06/17/2008

Link To Trial Results

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Trial listings updated: July 7, 2008 at 2:40:51 PM