Trial information
A Multiple Ascending Dose Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With Glimepiride.
Status: Completed
Protocol number: BM18250
Sponsor: F. Hoffmann-La Roche Ltd
Company division: Pharmaceutical
Official Scientific Title: An open label study to investigate the safety and tolerability of GK Activator (2) in patients with type 2 diabetes mellitus not adequately controlled with glimepiride as a standard prescribed therapy.
Brief summary: This study will evaluate the safety and tolerability of multiple ascending doses of GK Activator (2), in patients with type 2 diabetes mellitus inadequately controlled by glimepiride as a standard prescribed therapy. Patients will receive GK Activator (2) in combination with glimepiride throughout the study. The starting dose of GK Activator (2) will be 25mg po bid; this dose will be escalated in subsequent groups of patients to a potential maximum of 100mg po bid after a satisfactory assessment of safety and tolerability of the previous dose. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals. Target sample size is
24.
Study phase: I
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety study
Condition: Diabetes Mellitus, Type 2
Intervention type: Drug
Intervention name: GK Activator (2)
Primary outcome: 1. Safety: AEs, laboratory parameters, vital signs.
Key secondary outcomes: 1. Comparison of 3 different viral kinetic phases
Inclusion criteria:
- adult patients, 18-75 years of age;
- type 2 diabetic patients receiving maximal tolerated dose of glimepiride monotherapy for >=3 months.
Exclusion criteria:
- type 1 diabetes mellitus;
- treatment with antidiabetic agents other than glimepiride monotherapy in past 3 months;
- clinically significant cardiovascular disease.
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: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Germany
Spain
