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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00482950 |
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Date of registration:
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04/06/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study to Evaluate Safety and Efficacy of PHX1149T in Subjects With Type 2 Diabetes Mellitus
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Scientific title:
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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 |
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Date of first enrolment:
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April 2007 |
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Target sample size:
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400 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00482950 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Argentina
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Canada
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India
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Mexico
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United States
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Contacts
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Name:
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Hans-Peter Guler, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Phenomix Corp. |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes Mellitus
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Intervention(s)
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Drug: PHX1149T
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Primary Outcome(s)
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HbA1c
[Time Frame: 12 weeks]
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Secondary ID(s)
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PHX1149-Prot202
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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