Safety and Efficacy Study of Dutogliptin/PHX1149T to Treat Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
Phenomix
ClinicalTrials.gov Identifier:
NCT00690638
First received: June 2, 2008
Last updated: April 12, 2010
Last verified: January 2010
  Purpose

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of PHX1149T as Monotherapy in Subjects with Type 2 Diabetes Mellitus


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: PHX1149T
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of PHX1149T as Monotherapy in Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Phenomix:

Primary Outcome Measures:
  • To demonstrate changes in HbA1c [ Time Frame: Day 28 to Day 196 ] [ Designated as safety issue: No ]

Estimated Enrollment: 480
Study Start Date: July 2008
Study Completion Date: April 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
Drug: Placebo
Placebo
Experimental: 2
PHX1149T 200 mg
Drug: PHX1149T
200 mg
Other Name: dutogliptin
Experimental: 3
PHX1149T 400 mg
Drug: PHX1149T
400 mg
Other Name: dutogliptin

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus, drug naïve or willing to wash-out from existing oral therapy
  • BMI 25 to 48 kg/m2, inclusive
  • HbA1c 7.0% - 10.0%, inclusive
  • Age 18 to 75 years, inclusive

Exclusion Criteria:

  • Currently on 3 or more oral antidiabetic drugs or insulin.
  • Type 1 diabetes mellitus
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00690638

  Show 62 Study Locations
Sponsors and Collaborators
Phenomix
Forest Laboratories
  More Information

No publications provided

Responsible Party: Hans-Peter Guler, MD / Chief Medical Officer, Phenomix Corporation
ClinicalTrials.gov Identifier: NCT00690638     History of Changes
Other Study ID Numbers: PHX1149-PROT301, EudraCT 2008-002614-22
Study First Received: June 2, 2008
Last Updated: April 12, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Phenomix:
dutogliptin
PHX1149
DPP4 inhibitor

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 29, 2014