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

This study is ongoing, but not recruiting participants.

Sponsored by:	Phenomix
Information provided by:	Phenomix
ClinicalTrials.gov Identifier:	NCT00482950

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 II

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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

Study ID Numbers:	PHX1149-Prot202
Study First Received:	June 4, 2007
Last Updated:	December 18, 2007
ClinicalTrials.gov Identifier:	NCT00482950
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

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 14, 2009