ACute and Chronic Effects of Saxagliptin (ACCES)
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
|Impaired Glucose Tolerance||Drug: saxagliptin Other: placebo pill||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||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|
- Vago-sympathetic activity. [ Time Frame: First day (inclusion) and after 11-14 weeks of treatment ]This is a pilot study. The vascular measurements will be performed before and during a standardized breakfast.
- arterial stiffness [ Time Frame: First day (inclusion) and after 11-14 weeks of treatment ]This is a pilot study. The vascular measurements will be performed before and during a standardized breakfast.
- endothelial function [ Time Frame: First day (inclusion) and after 11-14 weeks of treatment ]This is a pilot study. The vascular measurements will be performed before and during a standardized breakfast.
- oral glucose tolerance test. [ Time Frame: First day (inclusion) and after 11-14 weeks of treatment ]
|Study Start Date:||September 2012|
|Study Completion Date:||September 2014|
|Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Saxagliptin 5 mg (tablet) at BREAKFEAST
5mg a day for 11-14 weeks
Other Name: Onglyza
Placebo Comparator: placebo pill
Other: placebo pill
one tablet a day for 11-14 weeks
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®).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01521312
|Jean Verdier hospital, Department of Endocrinology-Diabetology-Nutrition|
|Bondy, France, 93140|
|Principal Investigator:||Paul Valensi, MD||Jean Verdier Hospital - Department of Endocrinology-Diabetology-Nutrition|