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

November 22, 2011
February 20, 2013
September 2012
October 2013   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01521312 on ClinicalTrials.gov Archive Site
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ACute and Chronic Effects of Saxagliptin
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

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®).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Impaired Glucose Tolerance
  • Drug: saxagliptin
    5mg a day for 11-14 weeks
    Other Name: Onglyza
  • Other: placebo pill
    one tablet a day for 11-14 weeks
    Other Name: placebo pill
  • Experimental: Saxagliptin
    Saxagliptin 5 mg (tablet) at BREAKFEAST
    Intervention: Drug: saxagliptin
  • Placebo Comparator: placebo pill
    at BREAKFEAST
    Intervention: Other: placebo pill
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
36
February 2014
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
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
France
 
NCT01521312
P101105
Yes
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Paul Valensi, MD Jean Verdier Hospital - Department of Endocrinology-Diabetology-Nutrition
Assistance Publique - Hôpitaux de Paris
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP