ACute and Chronic Effects of Saxagliptin (ACCES)
This study is currently recruiting participants.
Verified February 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Assistance Publique - Hôpitaux de Paris
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
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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 May 23, 2013