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ACute and Chronic Effects of Saxagliptin (ACCES)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01521312
First Posted: January 30, 2012
Last Update Posted: February 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
    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 ]
    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 ]
    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 ]
    This is a pilot study. The vascular measurements will be performed before and during a standardized breakfast.


Enrollment: 24
Study Start Date: September 2012
Study Completion Date: September 2014
Primary Completion Date: September 2014 (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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01521312


Locations
France
Jean Verdier hospital, Department of Endocrinology-Diabetology-Nutrition
Bondy, France, 93140
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Paul Valensi, MD Jean Verdier Hospital - Department of Endocrinology-Diabetology-Nutrition
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01521312     History of Changes
Other Study ID Numbers: P101105
First Submitted: November 22, 2011
First Posted: January 30, 2012
Last Update Posted: February 3, 2015
Last Verified: January 2015

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
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents