CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 394 enrolled
Drug / intervention
Placebo +5 moredrug
Likely dose
RO4998452 2.5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00800176
NCT00800176Phase 2Completed
CompareCT.gov

A Multi-center, Double-blind, Randomized, Parallel Group, Placebo-controlled 12-week Study to Investigate Glycemic Parameters of Efficacy, Safety/ Tolerability and Pharmacokinetics of Five Dose Levels of RO4998452 in Patients With Type 2 Diabetes Mellitus

Hoffmann-La Roche·interventional·Posted Dec 2, 2008·Updated Nov 18, 2020

In Brief

A Phase 2 clinical trial evaluating Placebo and RO4998452 for Diabetes Mellitus Type 2. Completed, enrolled 394 participants across 67 sites in 12 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus Type 2
CountriesAustralia, Brazil, Canada, Germany, Hong Kong, Japan, Latvia, Mexico, Romania, Russia, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2, 2008
Enrollment StartJan 22, 2009
Primary CompletionOct 28, 2009
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 17.6 years ago

Interventions

Placebodrug

po daily for 12 weeks

RO4998452drug

2.5mg po daily for 12 weeks

RO4998452drug

5mg po daily for 12 weeks

RO4998452drug

10mg po daily for 12 weeks

RO4998452drug

20mg po daily for 12 weeks

RO4998452drug

40mg po daily for 12 weeks