Trial Information

Summary: A Multiple Ascending Dose Study of RO4998452 in Patients With Type 2 Diabetes Mellitus.

Status: No longer 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 Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Double Blind
• Control: Placebo
• Assignment: Parallel
• Endpoints: Safety

Study Type:

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:

Exclusion Criteria:

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: 10/17/2008

Link To Trial Results

This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.

Trial listings updated: November 17, 2008 at 2:53:53 PM