Trial information
A Multiple Ascending Dose Study of RO4998452 in Patients With Type 2 Diabetes Mellitus.
Status: Recruiting
Protocol number: BP21549
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A Randomized, Double-Blind, Multiple-Ascending-Dose, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO4998452 Following Oral Administrations in Patients with Type 2 Diabetes Mellitus
Brief summary: This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of RO4998452 compared to placebo in patients with type 2 diabetes mellitus. Successive cohorts of patients will be randomized to receive either active drug, at escalating doses, or placebo. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals. Target sample size is 77.
Study phase: I
Study type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Safety study
Condition: Diabetes Mellitus, Type 2
Intervention type: Drug
Intervention name: RO4998452
Primary outcome: 1. AEs, laboratory parameters, vital signs. Time frame: Throughout study
2. AUC0-24h, Cmax Time frame: Days 1 and 14
Key secondary outcomes: 1. Parameters of glucose metabolism Time frame: Throughout study
Inclusion criteria:
- adult patients, 18-65 years of age;
- type 2 diabetes;
- either treated by diet and exercise alone or with metformin.
Exclusion criteria:
- type 1 diabetes mellitus;
- uncontrolled hypertension;
- clinically severe diabetic complications.
Gender: Males or Females
Age limits: Min: 18 Years Max: 65 Years
Accepts healthy volunteers: No
Anticipated start date: May, 2008
Trial registration date: 05/20/2008
Date last updated: 9/29/2008
Link to trial result
This trial is being conducted at the following locations:
Germany
United States
- Chula Vista, CA
- San Antonio, TX
