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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
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: 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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 24, 2014