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

June 4, 2007
June 4, 2009
April 2007
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HbA1c [ Time Frame: 12 weeks ]
Same as current
Complete list of historical versions of study NCT00482950 on ClinicalTrials.gov Archive Site
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A Study to Evaluate Safety and Efficacy of PHX1149T in Subjects With Type 2 Diabetes Mellitus
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
Drug: PHX1149T
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
400
February 2008
Not Provided

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Mexico,   Argentina,   Canada,   India
 
NCT00482950
PHX1149-Prot202
No
Not Provided
Phenomix
Not Provided
Study Director: Hans-Peter Guler, MD Phenomix Corp.
Phenomix
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP