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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: |
NCT00924534 |
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Date of registration:
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18/06/2009 |
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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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A Safety PK/PD Study of SLV337 in Patients With Type 2 Diabetes
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Scientific title:
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A Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SLV337 in Patients With Type 2 Diabetes on Metformin Monotherapy |
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Date of first enrolment:
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December 2009 |
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Target sample size:
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61 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00924534 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, 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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Bulgaria
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Poland
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South Africa
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Contacts
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Name:
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Francis Roy, MS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Abbott Products |
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Key inclusion & exclusion criteria
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Inclusion Criteria Type 2 diabetes ,stable dose of Metformin,HbA1c >= 7%, but < 9%
Exclusion Criteria Type 1 diabetes mellitus, Body Mass Index (BMI) >40.0 kg/m2, evidence
of unstable cardiovascular diseases, NYHA class I to IV, ALT > 1.5 times UNL, creatinine
clearance <60 mL/min
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
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Intervention(s)
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Drug: SLV337
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Drug: Placebo
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Primary Outcome(s)
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Change from baseline in the count of Red blood cells to Day 35
[Time Frame: 35 days]
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Change from Baseline in alanine amino transferase level to Day 35
[Time Frame: 35 days]
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Change from baseline in White blood cells count to Day 35
[Time Frame: 35 days]
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Change from baseline in Creatinine kinase level to Day 35
[Time Frame: 35 days]
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Change from baseline in Creatinine level to Day 35
[Time Frame: 35 days]
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Secondary Outcome(s)
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Change from baseline in Triglycerides level to Day 28
[Time Frame: 28 days]
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Change from baseline in Adiponectin level to Day 28
[Time Frame: 28 days]
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Change from baseline in Fasting plasma glucose level to Day 28
[Time Frame: 28 days]
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Change from baseline in High density lipoprotein cholesterol level to Day 28
[Time Frame: 28 days]
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Secondary ID(s)
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S337.2.001
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2009-011589-27
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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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