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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014