ACute and Chronic Effects of Saxagliptin (ACCES)

February 2, 2015 updated by: Assistance Publique - Hôpitaux de Paris

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bondy, France, 93140
        • Jean Verdier hospital, Department of Endocrinology-Diabetology-Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Saxagliptin
Saxagliptin 5 mg (tablet) at BREAKFEAST
Drug: saxagliptin
5mg a day for 11-14 weeks
Other Names:
  • Onglyza
Placebo Comparator: placebo pill
at BREAKFEAST
Other: placebo pill
one tablet a day for 11-14 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
First day (inclusion) and after 11-14 weeks of treatment
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.
First day (inclusion) and after 11-14 weeks of treatment
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.
First day (inclusion) and after 11-14 weeks of treatment
oral glucose tolerance test.
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.
First day (inclusion) and after 11-14 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Paul Valensi, MD, Jean Verdier Hospital - Department of Endocrinology-Diabetology-Nutrition

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

November 22, 2011

First Submitted That Met QC Criteria

January 25, 2012

First Posted (Estimate)

January 30, 2012

Study Record Updates

Last Update Posted (Estimate)

February 3, 2015

Last Update Submitted That Met QC Criteria

February 2, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P101105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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