ACute and Chronic Effects of Saxagliptin (ACCES)

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 2

Conditions: Impaired Glucose Tolerance

Treatments: Other: placebo pill; Drug: saxagliptin

Study type: Interventional

Funder types: Other

Identifiers

NCT01521312

P101105

Details and patient eligibility

About

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

Full 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®).

Enrollment: 24 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

24 participants in 2 patient groups, including a placebo group

Saxagliptin

Experimental group

Description:

Saxagliptin 5 mg (tablet) at BREAKFEAST

Treatment:

Drug: saxagliptin

placebo pill

Placebo Comparator group

Description:

at BREAKFEAST

Treatment:

Other: placebo pill