ACute and Chronic Effects of Saxagliptin (ACCES)
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|ClinicalTrials.gov Identifier: NCT01521312|
Recruitment Status : Completed
First Posted : January 30, 2012
Last Update Posted : February 3, 2015
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
|Condition or disease||Intervention/treatment||Phase|
|Impaired Glucose Tolerance||Drug: saxagliptin Other: placebo pill||Phase 2|
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®).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|