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

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ClinicalTrials.gov Identifier: NCT00530881
Recruitment Status : Completed
First Posted : September 18, 2007
Last Update Posted : September 18, 2007
Sponsor:
Information provided by:
Phenomix

Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: PHX1149 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
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
Study Start Date : April 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 4 Drug: PHX1149
Placebo Comparator: 3 active, 1 placebo Drug: PHX1149



Primary Outcome Measures :
  1. postprandial blood glucose

Secondary Outcome Measures :
  1. fasting blood glucose, HbA1c, safety


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

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.

ClinicalTrials.gov Identifier: NCT00530881     History of Changes
Other Study ID Numbers: PHX1149-Prot201
First Posted: September 18, 2007    Key Record Dates
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