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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: |
NCT00970424 |
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Date of registration:
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01/09/2009 |
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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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Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus (T2DM) on Background Therapy With Pioglitazone
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Scientific title:
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A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus on Background Treatment With Pioglitazone |
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Date of first enrolment:
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August 2009 |
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Target sample size:
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252 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00970424 |
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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 (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Belarus
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Germany
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India
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Lithuania
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Romania
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United States
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Contacts
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Name:
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Kaity Posada, PharmD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Forest Research Institute, a subsidiary of Forest Laboratories, Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Type 2 diabetes mellitus, diagnosed at least 3 months prior to Screening (Visit 1)
- BMI 20 to 48 kg/m2, inclusive
- HbA1c 7.0% - 10.0%, inclusive
- Age 18 to 85 years, inclusive
Exclusion Criteria:
- Currently taking more than one oral hypoglycemic agent
- 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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Diabetes Mellitus, Type II
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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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Hemoglobin A1c Level (HbA1c)
[Time Frame: HbA1c is drawn at Visit 1 (Week -16 to -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18) and Week 8 (Week 26)]
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Secondary Outcome(s)
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Fasting Plasma Glucose Level (FPG)
[Time Frame: FPG is drawn at Visit 1 (Week -16 to -4), Visit 2 (Week -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18) and Visit 8 (Week 26).]
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Secondary ID(s)
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DUT-MD-304
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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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