A Study to Evaluate Safety and Efficacy of PHX1149T in Subjects With Type 2 Diabetes Mellitus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Phenomix.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Phenomix
ClinicalTrials.gov Identifier:
NCT00482950
First received: June 4, 2007
Last updated: June 4, 2009
Last verified: June 2009
  Purpose

This study is to test the efficacy and safety of PHX1149T in combination with metformin, a glitazone, or metformin and a glitazone in subjects with Type 2 diabetes for 12 weeks. After completing the 12 week double blind part of the study, subjects can enter an open label extension study


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: PHX1149T
Phase 2

Phenomix has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of PHX1149T in Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Phenomix:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 12 weeks ]

Estimated Enrollment: 400
Study Start Date: April 2007
Estimated Study Completion Date: February 2008
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Entry Criteria:

  • Type 2 diabetes mellitus, diagnosed at least 4 months but not more than 12 years prior to screening.
  • Male and non-pregnant, non-lactating (and not planning to become pregnant during the study) female subjects with a BMI of 25 to 48 kg/m2, inclusive. For India the BMI is 23 to 48 kg/m2, inclusive.
  • Current treatment of Type 2 diabetes mellitus with a stable dose of metformin of 1500 mg or more (or the highest tolerated dose), or TZD (any labeled dose), or metformin + TZD at doses used in accordance with product labeling for at least 4 weeks (metformin) or 10 weeks (TZD) prior to screening (Visit 1).
  • Fasting plasma glucose of 118 - 220 mg/dL (6.6 - 12.2 mmol/L), inclusive; HbA1c 7.3% - 11.0%, inclusive; and a fasting plasma C peptide greater than 0.26 nmol/L at screening. For Argentina the allowed upper limit of HbA1c is ≤ 10.5%. For Canada the upper limit will be 10.0%
  • No Type 1 diabetes mellitus or marked diabetic long-term complications.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00482950

  Show 26 Study Locations
Sponsors and Collaborators
Phenomix
Investigators
Study Director: Hans-Peter Guler, MD Phenomix Corp.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00482950     History of Changes
Other Study ID Numbers: PHX1149-Prot202
Study First Received: June 4, 2007
Last Updated: June 4, 2009
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
India: Ministry of Health
Mexico: Minstry of Health
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

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

ClinicalTrials.gov processed this record on April 17, 2014