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A Study of RO5095932 in Patients With Type 2 Diabetes Mellitus

NCT00961909 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2016-11-02

No results posted yet for this study

Summary

This randomized, double-blind, placebo-controlled study will assess the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in patients with type 2 diabetes mellitus. Patients will be randomized to receive either RO5095932 subcutaneously once weekly or placebo for 4 weeks (part 1) or 6 weeks (part 2), in addition to their current stable doses of metformin.

Conditions

  • Diabetes Mellitus Type 2

Interventions

DRUG

RO5095932

cohorts receiving multiple ascending doses, sc once weekly for 4 weeks

DRUG

RO5095932

dose titration to target dose, sc once weekly for 6 weeks

DRUG

metformin

stable dose

DRUG

placebo

sc once weekly for 4 weeks

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United States

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 NCT00961909 on ClinicalTrials.gov