Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Phenomix
ClinicalTrials.gov Identifier:
NCT00530881
First received: September 14, 2007
Last updated: September 17, 2007
Last verified: September 2007
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Type 1 diabetes mellitus
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00530881     History of Changes
Other Study ID Numbers: PHX1149-Prot201
Study First Received: September 14, 2007
Last Updated: September 17, 2007
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013