ACute and Chronic Effects of Saxagliptin

Phase 2

Completed

• Conditions: Impaired Glucose Tolerance
• Interventions: Other: placebo pill; Drug: saxagliptin

• Registration Number: NCT01521312
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 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®).

Study Timeline

• Study First Submitted: 2011-11-22
• Study First Submitted QC: 2012-01-25
• Study First Posted: 2012-01-30
• Study Start: 2012-09
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-01
• Last Update Submitted: 2015-02-02
• Last Update Posted: 2015-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo pill	placebo pill	at BREAKFEAST
Saxagliptin	saxagliptin	Saxagliptin 5 mg (tablet) at BREAKFEAST

Primary Outcome Measures

Name	Time	Method
oral glucose tolerance test.	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.
Vago-sympathetic activity.	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	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	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.

Trial Locations

Locations (1)

Jean Verdier hospital, Department of Endocrinology-Diabetology-Nutrition; 🇫🇷 Bondy, France