ACute and Chronic Effects of Saxagliptin

Impaired Glucose Tolerance Clinical Trial

— ACCES  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01521312
• Other study ID #: P101105
• Status: Completed
• Phase: Phase 2
• First received: November 22, 2011
• Last updated: February 2, 2015
• Start date: September 2012
• Est. completion date: September 2014

Study information

• Verified date: January 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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®).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glucose Intolerance
• Impaired Glucose Tolerance

Intervention

Drug:
• saxagliptin
5mg a day for 11-14 weeks

Other:
• placebo pill
one tablet a day for 11-14 weeks

Locations

Country	Name	City	State
France	Jean Verdier hospital, Department of Endocrinology-Diabetology-Nutrition	Bondy

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vago-sympathetic activity.	This is a pilot study. The vascular measurements will be performed before and during a standardized breakfast.	First day (inclusion) and after 11-14 weeks of treatment	Yes
Primary	arterial stiffness	This is a pilot study. The vascular measurements will be performed before and during a standardized breakfast.	First day (inclusion) and after 11-14 weeks of treatment	Yes
Primary	endothelial function	This is a pilot study. The vascular measurements will be performed before and during a standardized breakfast.	First day (inclusion) and after 11-14 weeks of treatment	Yes
Primary	oral glucose tolerance test.	This is a pilot study. The vascular measurements will be performed before and during a standardized breakfast.	First day (inclusion) and after 11-14 weeks of treatment	Yes