Impaired Glucose TolerancePhase 2ACCESNCT01521312
ACute and Chronic Effects of Saxagliptin
A Phase 2 study testing saxagliptin in people with Impaired Glucose Tolerance, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Impaired Glucose Tolerance
- What is being tested?
- saxagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2012to Sep 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnancy
- Breast feeding
- Diabetes
- No contraception
- Body Mass Index > 45 kg/m²
- Arterial blood pressure > 160/110 mmHg
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- Creatinine clearance < 60 ml/min
- Severe hepatocellular insufficiency
- Chronic respiratory disease
- Anaemia (Hemoglobin < 10 g/dl)
- Peripheral arterial occlusive disease
- Heart failure
- Cardiac arrhythmia
Trial locations and contacts
1 site in 1 country.
France1 site
Jean Verdier hospital, Department of Endocrinology-Diabetology-Nutrition
Bondy, 93140
About this study
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
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
Read the 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®).
- Conditions
- Impaired Glucose Tolerance
- Being tested
- saxagliptin, placebo pill
- Keywords
- Impaired glucose tolerance, Saxagliptin, Cardiovascular risk integrators, Vago-sympathetic activity, Arterial stiffness, Endothelial function
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saxagliptinDrug
Also called Onglyza
5mg a day for 11-14 weeks
placebo pillOther
one tablet a day for 11-14 weeks
| Study group | Role | What they receive |
|---|---|---|
| Saxagliptin | Experimental | Saxagliptin 5 mg (tablet) at BREAKFEAST Receives: Drug: saxagliptin |
| placebo pill | Placebo comparator | at BREAKFEAST Receives: Other: placebo pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vago-sympathetic activity.
This is a pilot study. The vascular measurements will be performed before and during a standardized breakfast.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: First day (inclusion) and after 11-14 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Impaired Glucose ToleranceStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Valensi, MD, Principal investigator, Jean Verdier Hospital - Department of Endocrinology-Diabetology-Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521312
- Sponsor's protocol ID
- P101105
- Acronym
- ACCES
- Status last verified
- Jan 2015
- First submitted
- 22 Nov 2011
- Last updated
- 3 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34420816Rezki 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.
PubMed 33618922
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01521312
- Acronym / sponsor ID
- ACCES / P101105
- Conditions
- Impaired Glucose Tolerance
- Keywords
- Impaired glucose tolerance, Saxagliptin, Cardiovascular risk integrators, Vago-sympathetic activity, Arterial stiffness, Endothelial function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 30 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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®).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saxagliptin | Experimental | Drug: saxagliptinSaxagliptin 5 mg (tablet) at BREAKFEAST |
| placebo pill | Placebo comparator | Other: placebo pillat BREAKFEAST |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- Pregnancy
- Breast feeding
- Diabetes
- No contraception
- Body Mass Index > 45 kg/m²
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| saxagliptinAlso: Onglyza5mg a day for 11-14 weeks | Drug | Saxagliptin |
| placebo pillone tablet a day for 11-14 weeks | Other | placebo pill |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2015.
- Derived from this study: PubMed 34420816Rezki 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.
- Derived from this study: PubMed 33618922Rezki 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Valensi, MD principal investigator
Jean Verdier Hospital - Department of Endocrinology-Diabetology-Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing saxagliptin in people with Impaired Glucose Tolerance, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vago-sympathetic activity. (time frame: First day (inclusion) and after 11-14 weeks of treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01521312, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2015.