Clinical trial NCT00266253: A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin
Official 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 Treated With a Stable Dose of Metformin.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2005-12-16
Enrollment: 220
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of GK Activator (2) in combination with metformin, compared to that of placebo (metformin monotherapy), in patients with type 2 diabetes mellitus. Patients will continue on their stable dose of metformin and will be randomized to receive either GK Activator (2) or placebo. The anticipated time on study treatment is less than 3 months, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients 30-75 years of age;
* type 2 diabetes mellitus;
* individual maximal tolerated daily dose of metformin monotherapy for \>=3 months prior to screening.

Exclusion Criteria:

* type 1 diabetes mellitus;
* any oral anti-hyperglycemic medication, other than metformin monotherapy, during last 3 months

Primary outcomes:
measure: HbA1c mean change from baseline compared with placebo.
timeFrame: Week 12
Secondary outcomes:
measure: Additional parameters of glycemic and lipid control.
timeFrame: Week 12
measure: AEs, laboratory parameters.
timeFrame: Throughout study
measure: Pharmacokinetic and exposure-response relationship
timeFrame: Throughout study
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Chula Vista
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Kissimmee
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Lawrenceville
country: United States
state: Georgia
city: Arkansas City
country: United States
state: Kansas
city: Benzonia
country: United States
state: Michigan
city: Springfield
country: United States
state: Missouri
city: Butte
country: United States
state: Montana
city: Kettering
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Medford
country: United States
state: Oregon
city: Morrisville
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Memphis
country: United States
state: Tennessee
city: Bellevue
country: United States
state: Washington
city: Federal Way
country: United States
state: Washington
city: Adelaide
country: Australia
city: Heidelberg
country: Australia
city: Sydney
country: Australia
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: London
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: Bammental
country: Germany
city: Berlin
country: Germany
city: Essen
country: Germany
city: Giessen
country: Germany
city: Görlitz
country: Germany
city: Hamburg
country: Germany
city: Kuenzing
country: Germany
city: Mannheim
country: Germany
city: Nürnberg
country: Germany
city: Tann
country: Germany
city: Alzira
country: Spain
city: Bacarot Alicant
country: Spain
city: Baracaldo
country: Spain
city: Barcelona
country: Spain
city: Dundee
country: United Kingdom
city: Frome
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Liverpool
country: United Kingdom
city: Motherwell
country: United Kingdom
city: Northwood
country: United Kingdom
city: Plymouth
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: