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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00850239 |
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Date of registration:
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20/02/2009 |
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Primary sponsor: |
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Public title:
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Safety and Efficacy Study of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin
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Scientific title:
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin |
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Date of first enrolment:
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May 2009 |
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Target sample size:
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700 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00850239 |
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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: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Argentina
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Chile
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Czech Republic
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India
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Peru
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Poland
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Type 2 diabetes mellitus, diagnosed at least 4 months prior to Screening (Visit 1)
- Age 18 to 85 years, inclusive.
- Male and non-pregnant, non-lactating (and not planning to become pregnant during the
study) female subjects with a BMI of 20 to 48 kg/m2, inclusive
- Current treatment of Type 2 diabetes mellitus with a stable dose of metformin of =
2000 mg (or the highest tolerated dose) used in accordance with product labeling for
at least 6 weeks prior to screening (Visit 1)
- HbA1c 7.0% - 10.0%, inclusive; and fasting plasma C peptide greater than 0.26 nmol/L
(> 0.8 ng/mL; > 281 pmol/L) at screening (Visit 1)
Exclusion Criteria:
- Type 1 diabetes mellitus
Age minimum:
18 Years
Age maximum:
85 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: dutogliptin
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Drug: placebo
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Primary Outcome(s)
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Primary objective is to demonstrate the efficacy of dutogliptin, as evidenced by placebo-corrected changes in HbA1c relative to baseline.
[Time Frame: 26 weeks]
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Secondary Outcome(s)
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• Demonstrate changes in fasting plasma glucose
[Time Frame: 26 weeks]
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Demonstrate safety and tolerability of dutogliptin
[Time Frame: 26 weeks]
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Secondary ID(s)
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PHX1149-PROT302
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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