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A Study of Dipeptidyl-peptidase IV (DPP-IV) RO4876904 in Patients With Type 2 Diabetes.

NCT00502710 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 289

Last updated 2016-08-05

No results posted yet for this study

Summary

This 5 arm study will assess the efficacy, pharmacokinetics, safety and tolerability of a DPP-IV inhibitor compared to placebo in patients with type 2 diabetes. Patients will be randomized to receive DPP-IV(3) at one of 4 doses (of 12.5mg and above), or placebo p.o. Patients receiving metformin before the study will continue on the same dose of metformin. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Conditions

  • Diabetes Mellitus Type 2

Interventions

DRUG

Placebo

Placebo po daily.

DRUG

RO4876904

Escalating doses, at a starting dose of 12.5mg po daily.

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
2007-07-31
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • United States
  • Australia
  • Brazil
  • Guatemala
  • Hong Kong
  • Mexico
  • Russia
  • Spain
  • United Kingdom

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 NCT00502710 on ClinicalTrials.gov