ACute and Chronic Effects of Saxagliptin (ACCES)

This study is currently recruiting participants.
Verified February 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01521312
First received: November 22, 2011
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
Impaired Glucose Tolerance
Drug: saxagliptin
Other: placebo pill
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Vago-sympathetic activity. [ Time Frame: First day (inclusion) and after 11-14 weeks of treatment ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    This is a pilot study. The vascular measurements will be performed before and during a standardized breakfast.


Estimated Enrollment: 36
Study Start Date: September 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Saxagliptin
Saxagliptin 5 mg (tablet) at BREAKFEAST
Drug: saxagliptin
5mg a day for 11-14 weeks
Other Name: Onglyza
Placebo Comparator: placebo pill
at BREAKFEAST
Other: placebo pill
one tablet a day for 11-14 weeks
Other Name: placebo pill

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®).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01521312

Contacts
Contact: Paul Valensi, MD +33 (0)1 48 02 65 96 paul.valensi@jvr.aphp.fr
Contact: Emmanuel Cosson, MD, PhD +33 (0)1 48 02 65 80 emmanuel.cosson@jvr.aphp.fr

Locations
France
Jean Verdier hospital, Department of Endocrinology-Diabetology-Nutrition Recruiting
Bondy, France, 93140
Contact: Paul Valensi, MD    +33 (0)1 48 02 65 96    paul.valensi@jvr.aphp.fr   
Contact: Emmanuel Cossson, MD, PhD    +33 (0) 1 48 02 65 80    emmanuel.cosson@jvr.aphp.fr   
Sub-Investigator: Emmanuel Cosson, MD,PHD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Paul Valensi, MD Jean Verdier Hospital - Department of Endocrinology-Diabetology-Nutrition
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01521312     History of Changes
Other Study ID Numbers: P101105
Study First Received: November 22, 2011
Last Updated: February 20, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Impaired glucose tolerance
Saxagliptin
Cardiovascular risk integrators
Vago-sympathetic activity
Arterial stiffness
Endothelial function

Additional relevant MeSH terms:
Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Saxagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014