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

Hoffmann-La Roche0 sites55 target enrollmentStarted: May 2008Last updated: November 2, 2016

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 1
Status: Completed
Sponsor: Hoffmann-La Roche
Enrollment: 55
Primary Endpoint: AUC0-24h, Cmax

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Records & Identifiers Similar Trials

Study Overview

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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Eligibility Criteria

Ages: 18 Years to 65 Years (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

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.

Arms & Interventions

1

Experimental

Intervention: RO4998452 (Drug)