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A Dose-Finding Study of RO4998452 in Patients With Diabetes Mellitus

NCT00800176 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 394

Last updated 2020-11-18

Study results available
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Summary

This 6 arm study will evaluate the efficacy, safety and pharmacokinetics of 5 doses of RO4998452 compared to placebo in patients with type 2 diabetes mellitus. Patients will be randomized to one of 6 groups to receive RO4998452 at doses of 2.5mg, 5mg, 10mg, 20mg or 40mg po daily, or placebo daily. Patients pre-treated with stable metformin will continue to take their usual dose of metformin throughout the study.The anticipated time on study treatment is \<=3 months

Conditions

  • Diabetes Mellitus Type 2

Interventions

DRUG

Placebo

po daily for 12 weeks

DRUG

RO4998452

2.5mg po daily for 12 weeks

DRUG

RO4998452

5mg po daily for 12 weeks

DRUG

RO4998452

10mg po daily for 12 weeks

DRUG

RO4998452

20mg po daily for 12 weeks

DRUG

RO4998452

40mg po daily for 12 weeks

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-22
Primary Completion
2009-10-28
Completion
2009-10-28

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • Germany
  • Hong Kong
  • Japan
  • Latvia
  • Mexico
  • Romania
  • Russia
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00800176 on ClinicalTrials.gov