Status:
COMPLETED
ACute and Chronic Effects of Saxagliptin
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Impaired Glucose Tolerance
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Glucose ACCES study will explore the acute and long term (12-week treatment) effects of saxagliptin in patients with impaired glucose tolerance during fasting and after a standardised breakfast. The i...
Detailed Description
The aim of this pilot study is to compare in patients with impaired glucose tolerance the effects of saxagliptin versus placebo: (i) on glucose metabolism (ii) on vago-sympathetic activity, arterial ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01521312
Start Date
September 1 2012
End Date
September 1 2014
Last Update
February 3 2015
Active Locations (1)
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1
Jean Verdier hospital, Department of Endocrinology-Diabetology-Nutrition
Bondy, France, 93140