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

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ClinicalTrials.gov Identifier: NCT00690638
Recruitment Status : Completed
First Posted : June 4, 2008
Last Update Posted : April 13, 2010
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
Phenomix

Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: PHX1149T Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : July 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. To demonstrate changes in HbA1c [ Time Frame: Day 28 to Day 196 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00690638


  Show 62 Study Locations
Sponsors and Collaborators
Phenomix
Forest Laboratories

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
First Posted: June 4, 2008    Key Record Dates
Last Update Posted: April 13, 2010
Last Verified: January 2010

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