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Safety and Efficacy Study of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin

NCT00850239 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2010-08-11

No results posted yet for this study

Summary

The purpose of this study is to demonstrate the efficacy of dutogliptin over 26 weeks (as evidenced by placebo-corrected changes in HbA1c relative to baseline), to demonstrate safety and tolerability of dutogliptin, and to demonstrate changes in fasting plasma glucose over 26 weeks.

Conditions

Interventions

DRUG

dutogliptin

400 mg

DRUG

placebo

Sponsors & Collaborators

  • Forest Laboratories

    collaborator INDUSTRY

  • Phenomix

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2010-10-31
Completion
2010-12-31

Countries

  • United States
  • Argentina
  • Chile
  • Czechia
  • India
  • Peru
  • Poland

Study Locations

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Entities

Drugs
Diseases

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 NCT00850239 on ClinicalTrials.gov