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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: |
NCT01429818 |
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Date of registration:
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05/09/2011 |
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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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Endothelial Disfunction Treatment With Glimepiride/Metformin Combination (Glimetal) in Type 2 Diabetes Patients
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Scientific title:
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Endothelial Disfunction Treatment With Glimepiride/Metformin Combination (Glimetal) in Type 2 Diabetes Patients. Positron Emission Tomography Assessment(PET) |
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Date of first enrolment:
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July 2007 |
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Target sample size:
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16 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01429818 |
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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: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Mexico
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Contacts
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Name:
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Jorge González, 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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Laboratorios Silanes S.A. de C.V. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Both genders
- At least 18 years old
- Type 2 diabetes mellitus diagnosis
- Signed Informed Consent
Exclusion Criteria:
- History of smoking, hypertension, dyslipidemia, ischemic heart disease or autoimmune
rheumatic diseases
- Pregnancy or lactation
- History of abuse and/or substance dependence within 6 months preceding the survey.
- History of glimepiride or metformin allergy
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus
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Endothelial Dysfunction
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Intervention(s)
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Drug: Glimepiride/metformin
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Drug: Metformin
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Primary Outcome(s)
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EDVI
[Time Frame: 8 weeks]
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%?MBF
[Time Frame: 8 weeks]
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MFR
[Time Frame: 8 weeks]
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Secondary Outcome(s)
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Adverse effects
[Time Frame: 8 weeks]
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Fasting glucose
[Time Frame: 8 weeks]
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Glycated hemoglobin
[Time Frame: 8 weeks]
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Secondary ID(s)
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PET-GLI01
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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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