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Randomized, Double-Blind, Placebo-Controlled, With PHX1149 in Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00530881
First Posted: September 18, 2007
Last Update Posted: September 18, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Phenomix
  Purpose
This will be a 4-week, multicenter, randomized, double-blind, parallel group, placebo-controlled, safety, tolerability, and efficacy study. Patients will be screened and be on one of three doses of PHX1149 (a new drug candidate for the treatment of Type 2 diabetes ) or placebo. The drug is a "DPP4 inhibitor"

Condition Intervention Phase
Type 2 Diabetes Mellitus Drug: PHX1149 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Examine Safety and Establish Proof of Concept With PHX1149 in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Phenomix:

Primary Outcome Measures:
  • postprandial blood glucose

Secondary Outcome Measures:
  • fasting blood glucose, HbA1c, safety

Enrollment: 180
Study Start Date: April 2006
Study Completion Date: October 2006
Arms Assigned Interventions
Placebo Comparator: 4 Drug: PHX1149
Placebo Comparator: 3 active, 1 placebo Drug: PHX1149

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus treatment with metformin +/- TZD

Exclusion Criteria:

  • Type 1 diabetes mellitus
  Contacts and Locations
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): NCT00530881


Locations
United States, California
Multiple Sites
san Diego, California, United States, 92121
Sponsors and Collaborators
Phenomix
Investigators
Study Director: Hans-Peter Guler, MD Phenomix Corp.
  More Information

ClinicalTrials.gov Identifier: NCT00530881     History of Changes
Other Study ID Numbers: PHX1149-Prot201
First Submitted: September 14, 2007
First Posted: September 18, 2007
Last Update Posted: September 18, 2007
Last Verified: September 2007

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