Trial information
A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus
Status: Completed
Protocol number: BM18248
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific 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
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. Target sample size is 250.
Study phase: II
Study type: Interventional; Treatment; Randomized; Double Blind; Active; Parallel; Safety/Efficacy study
Condition: Diabetes Mellitus, Type 2
Intervention type: Drug
Intervention name: GK Activator (2)
Primary outcome: 1. HbA1c mean change from baseline, compared to placebo. Time frame: Week 12
Key secondary outcomes: 1. Additional parameters of glycemic and lipid control. Time frame: Week 12
2. AEs, laboratory parameters. Time frame: Throughout study
3. Pharmacokinetic and exposure-response relationship Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 30 Years Max: 75 Years
Accepts healthy volunteers: No
Trial registration date: 12/09/2005
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
Bulgaria
- Dimitrovgrad
- Pleven
- Ruse
- Sofia
Croatia
Guatemala
Hungary
Mexico
- Chihuahua
- Cuernavaca
- Durango
- Mexico City
Poland
- Bialystok
- Gdansk
- Gorzow
- Wroclaw
United States
- Tucson , AZ
- Chula Vista, CA
- Spring Valley, CA
- West Hills, CA
- Hollywood, FL
- Atlanta, GA
- Binghamton, NY
- Fayetteville, NC
- Statesville, NC
- Springdale, OH
- Oklahoma City, OK
- Medford, OR
- Beaver, PA
- Tipton, PA
- Mount Pleasant, SC
- Renton, WA
