ACute and Chronic Effects of Saxagliptin (ACCES)

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014