Trial information
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 type: Interventional; Treatment; Randomized; Double Blind; Active; Crossover; Safety study
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:
- adult patients, 18-70 years of age;
- type 2 diabetes, taken off current therapy for >=2 weeks before first dosing period.
Exclusion criteria:
- type 1 diabetes;
- treatment with insulin or PPAR gamma agonist within 6 months of screening;
- clinically significant cardiovascular disease.
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: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Belgium
Germany
United Kingdom
