NCT01521312

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 30, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

February 3, 2015

Status Verified

January 1, 2015

Enrollment Period

2 years

First QC Date

November 22, 2011

Last Update Submit

February 2, 2015

Conditions

Impaired Glucose Tolerance

Keywords

Impaired glucose toleranceSaxagliptinCardiovascular risk integratorsVago-sympathetic activityArterial stiffnessEndothelial function

Outcome Measures

Primary Outcomes (4)

  • Vago-sympathetic activity.

    This is a pilot study. The vascular measurements will be performed before and during a standardized breakfast.

    First day (inclusion) and after 11-14 weeks of treatment

  • arterial stiffness

    This is a pilot study. The vascular measurements will be performed before and during a standardized breakfast.

    First day (inclusion) and after 11-14 weeks of treatment

  • endothelial function

    This is a pilot study. The vascular measurements will be performed before and during a standardized breakfast.

    First day (inclusion) and after 11-14 weeks of treatment

  • oral glucose tolerance test.

    This is a pilot study. The vascular measurements will be performed before and during a standardized breakfast.

    First day (inclusion) and after 11-14 weeks of treatment

Study Arms (2)

Saxagliptin

EXPERIMENTAL

Saxagliptin 5 mg (tablet) at BREAKFEAST

Drug: saxagliptin

placebo pill

PLACEBO COMPARATOR

at BREAKFEAST

Other: placebo pill

Interventions

saxagliptinDRUG

5mg a day for 11-14 weeks

Also known as: Onglyza
Saxagliptin
placebo pillOTHER

one tablet a day for 11-14 weeks

placebo pill

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jean Verdier hospital, Department of Endocrinology-Diabetology-Nutrition

Bondy, 93140, France

Location

Related Publications (2)

  • Rezki A, Cosson E, Fysekidis M, Chiheb S, Vicaut E, Valensi P. Acute and long-term effects of saxagliptin on a set of cardiovascular targets measured at fasting and post-prandially in obese patients with impaired glucose tolerance: A placebo-controlled study. Nutr Metab Cardiovasc Dis. 2021 Sep 22;31(10):2945-2958. doi: 10.1016/j.numecd.2021.06.017. Epub 2021 Jul 1.

    PMID: 34420816DERIVED

  • Rezki A, Fysekidis M, Chiheb S, Vicaut E, Cosson E, Valensi P. Acute and long-term effects of saxagliptin on post-prandial glycemic response in obese patients with impaired glucose tolerance. Nutr Metab Cardiovasc Dis. 2021 Apr 9;31(4):1257-1266. doi: 10.1016/j.numecd.2020.12.025. Epub 2020 Dec 31.

    PMID: 33618922DERIVED

MeSH Terms

Conditions

Glucose Intolerance

Interventions

saxagliptin

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Paul Valensi, MD

    Jean Verdier Hospital - Department of Endocrinology-Diabetology-Nutrition

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2011

First Posted

January 30, 2012

Study Start

September 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

February 3, 2015

Record last verified: 2015-01

Locations

FR(1)