A Study to Evaluate Safety and Efficacy of PHX1149T in Subjects With Type 2 Diabetes Mellitus
NCT ID: NCT00482950
Last Updated: 2009-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
400 participants
INTERVENTIONAL
2007-04-30
2008-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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PHX1149T
Eligibility Criteria
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Inclusion 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.
18 Years
75 Years
ALL
No
Sponsors
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Phenomix
INDUSTRY
Principal Investigators
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Hans-Peter Guler, MD
Role: STUDY_DIRECTOR
Phenomix Corp.
Locations
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Chula Vista, California, United States
Fullerton, California, United States
Long Beach, California, United States
Orange, California, United States
Kissimmee, Florida, United States
Melbourne, Florida, United States
Bloomington, Indiana, United States
Wichita, Kansas, United States
Kansas City, Missouri, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Trenton, New Jersey, United States
Charlotte, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Medford, Oregon, United States
Westminster, Pennsylvania, United States
Columbia, South Carolina, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Multiple Cities, , Argentina
Mutiple Cities, , Canada
Mutiple Cities, , India
Mutiple Cities, , Mexico
Countries
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Other Identifiers
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PHX1149-Prot202
Identifier Type: -
Identifier Source: org_study_id
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