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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: |
NCT01521312 |
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Date of registration:
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22/11/2011 |
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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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ACute and Chronic Effects of Saxagliptin
ACCES |
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Scientific title:
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A Randomized, Double Blind, Placebo Controlled, Pilot Study to Evaluate ACute and Chronic Effects of Saxagliptin on Impaired Glucose Tolerance and micro-and Macro-vascular Integrators |
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Date of first enrolment:
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September 2012 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01521312 |
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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 2
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Countries of recruitment
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France
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Contacts
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Name:
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Paul Valensi, 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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Jean Verdier Hospital - Department of Endocrinology-Diabetology-Nutrition |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Social security affiliation
- Persons without TUTORSHIP that can freely agree to participate to the study
- Age between 18 to 70 years
- Impaired glucose tolerance diagnosed during the previous month.
Exclusion criteria:
- Pregnancy
- Breast feeding
- Diabetes
- No contraception
- Body Mass Index > 45 kg/m²
- Arterial blood pressure > 160/110 mmHg
- Creatinine clearance < 60 ml/min
- Severe hepatocellular insufficiency
- Chronic respiratory disease
- Anaemia (Hemoglobin < 10 g/dl)
- Peripheral arterial occlusive disease
- Heart failure
- Cardiac arrhythmia
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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Impaired Glucose Tolerance
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Intervention(s)
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Drug: saxagliptin
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Other: placebo pill
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Primary Outcome(s)
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Vago-sympathetic activity.
[Time Frame: First day (inclusion) and after 11-14 weeks of treatment]
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oral glucose tolerance test.
[Time Frame: First day (inclusion) and after 11-14 weeks of treatment]
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arterial stiffness
[Time Frame: First day (inclusion) and after 11-14 weeks of treatment]
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endothelial function
[Time Frame: First day (inclusion) and after 11-14 weeks of treatment]
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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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