Trial information
A Dose-Titration Study of GK Activator (2) in Patients With Type 2 Diabetes.
Status: Completed
Protocol number: BC19800
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open label study to determine the effect on fasting glucose levels, and safety, of increasing doses of GK Activator (2) in patients with Type 2 diabetes not optimally controlled with one previous oral antihyperglycemic agent.
Brief summary: This study will assess the efficacy, safety and tolerability of increasing doses of GK Activator (2) in patients with type 2 diabetes whose condition has not been optimally controlled with one previous oral antihyperglycemic agent. After a 2 week washout from their previous antidiabetic therapy, patients will receive GK Activator (2) orally, twice a day for 12 weeks, at increasing doses of 25mg bid to 200mg bid; doses will be titrated to achieve a target fasting glucose level (FPG) of <100mg/dL. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals. Target sample size is 120.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Diabetes Mellitus, Type 2
Intervention type: Drug
Intervention name: GK Activator (2)
Primary outcome: 1. Percentage of patients at each dose who achieve FPG <100mg/dL. Time frame: Throughout study
Key secondary outcomes: 1. Mean change in HbA1c and FPG from baseline to endpoint; absolute/relative changes in lipid profile. Time frame: At intervals throughout study
2. AEs, laboratory parameters. Time frame: Throughout study
Inclusion criteria:
- adult patients, 18-75 years of age;
- type 2 diabetes mellitus treated with one oral antihyperglycemic agent for >=3 months prior to screening.
Exclusion criteria:
- type 1 diabetes mellitus;
- treatment with insulin, PPAR agonists or systemic corticosteroids during the 3 months prior to screening;
- women who are pregnant, breast-feeding or not using adequate contraceptive methods.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Trial registration date: 08/16/2006
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
Latvia
Mexico
- Chihuahua
- Guadalajara
- Pachuca
United States
- Chandler, AZ
- Oviedo, FL
- Nampa, ID
- Canton, OH
- Portland, OR
- Greer, SC
- Midland, TX
- Richmond, VA
