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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: |
NCT00699790 |
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Date of registration:
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17/06/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Proof of Confidence Study of CCR2 Antagonist (BMS-741672) in Insulin Resistance
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Scientific title:
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A 12-Week Randomized, Double-Blinded Study to Evaluate the Effects of Daily Oral Doses of BMS-741672 in Drug-Naive Type 2 Diabetic Patients |
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Date of first enrolment:
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February 2009 |
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Target sample size:
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58 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00699790 |
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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 2
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Countries of recruitment
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Russian Federation
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Contacts
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Name:
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Bristol-Myers Squibb |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bristol-Myers Squibb |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Drug-naive Type 2 diabetics with a screening HbA1c of = 7.5% and = 10%
- Screening FPG = 140 mg/dL and = 220 mg/dL
- BMI = 40 kg/m2
Exclusion Criteria:
- Active tuberculosis
- Symptoms of poorly controlled diabetes
- History of diabetic ketoacidosis
- Significant cardiovascular history or gastrointestinal disorders
- History of unstable or rapidly progressing renal disease
- Active liver disease and/or significant abnormal liver function
- Abnormal chest x-ray at screening indicative of tuberculosis or other infection
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus, Non-Insulin-Dependent
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Intervention(s)
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Drug: Placebo
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Drug: CCR2 Antagonist
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Primary Outcome(s)
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Change in HbA1c
[Time Frame: after 12 weeks of treatment]
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Secondary Outcome(s)
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Other glycemic, atherosclerosis, lipid and mechanism-based biomarkers will be measured
[Time Frame: throughout the 12 weeks of treatment]
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Secondary ID(s)
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MB114-005
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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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