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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

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

History of Changes

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 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

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 (Adult, Senior)
Sexes Eligible for Study:	All
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


ClinicalTrials.gov Identifier:	NCT00482950 History of Changes
Other Study ID Numbers:	PHX1149-Prot202
Study First Received:	June 4, 2007
Last Updated:	June 4, 2009

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases

ClinicalTrials.gov processed this record on June 23, 2017

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