NCT01521312

ACute and Chronic Effects of Saxagliptin

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 investigations will be performed on: * glycemic parameters * on cardiovascular parameters

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 stiffness and endothelial function. A total of 36 patients will be recruited in the department of Endocrinology-Diabetology-Nutrition of Jean VERDIER hospital, AP-HP, Bondy, France. The measurements will be performed in the morning 1) at the time of randomisation (Acute ACCES study) and 2) 11-14 weeks after the beginning of saxagliptin or placebo (Chronic ACCES study). We will evaluate at fasting and each hour after a standardized breakfast: (i) biological and metabolic parameters. Furthermore, an oral glucose tolerance test will be performed at the end of the study. (ii) by non-invasive devices arterial stiffness (Sphygmocor®), endothelial function (ENDOPAT 2000® ), cutaneous microcirculation (laser doppler Perimed ®.PF 5010) and cardiac autonomic function(task force monitor®).

Conditions

• Impaired Glucose Tolerance

Interventions

Type	Name	Description
DRUG	saxagliptin	5mg a day for 11-14 weeks
OTHER	placebo pill	one tablet a day for 11-14 weeks

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2012-01-30
• Last updated: 2015-02-03

Locations

1 site across 1 country: France