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Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus (T2DM) on Background Therapy With Glimepiride With or Without Metformin

NCT00947557 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 677

Last updated 2011-09-21

No results posted yet for this study

Summary

This study will evaluate the safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM) who are receiving background therapy of glimepiride with or without metformin.

Conditions

  • Diabetes Mellitus, Type II

Interventions

DRUG

Dutogliptin

Dutogliptin oral administration once daily on background of glimepiride with or without metformin

DRUG

Placebo

Placebo, oral administration once daily on background of glimepiride with or without metformin

Sponsors & Collaborators

  • Phenomix

    collaborator INDUSTRY

  • Forest Laboratories

    lead INDUSTRY

Principal Investigators

  • Kaity Posada, PharmD · Forest Research Institute, a subsidiary of Forest Laboratories Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-07-31

Countries

  • United States
  • Belarus
  • Colombia
  • Hungary
  • India
  • Lithuania
  • Peru
  • Romania

Study Locations

More Related Trials

Entities

Drugs

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 NCT00947557 on ClinicalTrials.gov