Clinical trial NCT00316758: A Study to Evaluate the Long-Term Safety and Tolerability of GK Activator (2) in Patients With Type 2 Diabetes.
Official title: A Multi-center, Open Label, Extension Study to Evaluate the Long-term Safety and Tolerability of GK Activator (2) in Type 2 Diabetic Patients From Studies BM18248 or BM18249
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-04-21
Enrollment: 259
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 long-term safety and tolerability of GK Activator (2) at doses ranging from 25mg - 100mg po bid, administered alone or in combination with metformin, in patients with type 2 diabetes. Eligible patients will be those who have completed study BM18248 (GK Activator (2) monotherapy) or BM18249 (GK Activator (2) and metformin); they will continue on the same treatment regimen (mono or combination therapy) as they received in the initial study. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* type 2 diabetic patients who have completed studies BM18248 or BM18249;
* patients considered by the investigator to be suitable for long term treatment with GK Activator (2).

Exclusion Criteria:

* type 1 diabetes mellitus;
* women who are pregnant, breast-feeding or not using adequate contraceptive methods.

Primary outcomes:
measure: AEs, laboratory parameters, ECG.
timeFrame: Throughout study
Secondary outcomes:
measure: Mean change from original baseline in HbA1c, FPG, lipid profile.
timeFrame: Throughout study
Other outcomes:
Locations:
city: Chula Vista
country: United States
state: California
city: Chula Vista
country: United States
state: California
city: Los Angeles
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: Kissimmee
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Arkansas City
country: United States
state: Kansas
city: Butte
country: United States
state: Montana
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: Mount Pleasant
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Federal Way
country: United States
state: Washington
city: Renton
country: United States
state: Washington
city: Camperdown
country: Australia
city: Heidelberg
country: Australia
city: Dimitrovgrad
country: Bulgaria
city: Pleven
country: Bulgaria
city: Ruse
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Vancouver
country: Canada
state: British Columbia
city: London
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Zagreb
country: Croatia
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: Nürnberg
country: Germany
city: Tann
country: Germany
city: Guatemala City
country: Guatemala
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: