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
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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 23, 2014