Clinical trial NCT00266240: A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus
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
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: 267
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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: HbA1c mean change from baseline, compared to 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: Tucson
country: United States
state: Arizona
city: Pine Bluff
country: United States
state: Arkansas
city: Chula Vista
country: United States
state: California
city: Spring Valley
country: United States
state: California
city: West Hills
country: United States
state: California
city: Hollywood
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Binghamton
country: United States
state: New York
city: Fayetteville
country: United States
state: North Carolina
city: Statesville
country: United States
state: North Carolina
city: Winston-salem
country: United States
state: North Carolina
city: Springdale
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Medford
country: United States
state: Oregon
city: Beaver
country: United States
state: Pennsylvania
city: Tipton
country: United States
state: Pennsylvania
city: Mount Pleasant
country: United States
state: South Carolina
city: Plano
country: United States
state: Texas
city: Renton
country: United States
state: Washington
city: Dimitrovgrad
country: Bulgaria
city: Pleven
country: Bulgaria
city: Ruse
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Zagreb
country: Croatia
city: Guatemala City
country: Guatemala
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Gyor
country: Hungary
city: Kecskemet
country: Hungary
city: Chihuahua
country: Mexico
city: Cuernavaca
country: Mexico
city: Durango
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Mexico-city
country: Mexico
city: Bialystok
country: Poland
city: Gdansk
country: Poland
city: Gorzow
country: Poland
city: Krakow
country: Poland
city: Wroclaw
country: Poland
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: