EFFECTS OF SAXAGLITPIN ON ENDOTHELIAL FUNCTION IN PATIENTS WITH TYPE 2 DIABETES - ESENDI

• Register: EUCTR
• Last refreshed on: 27 October 2014
• Main ID: EUCTR2010-018979-16-DE
• Date of registration: 03/05/2010
• Prospective Registration: Yes
• Primary sponsor: University Hospital Erlangen
• Public title: EFFECTS OF SAXAGLITPIN ON ENDOTHELIAL FUNCTION IN PATIENTS WITH TYPE 2 DIABETES - ESENDI
• Scientific title: EFFECTS OF SAXAGLITPIN ON ENDOTHELIAL FUNCTION IN PATIENTS WITH TYPE 2 DIABETES - ESENDI
• Date of first enrolment: 23/08/2010
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-018979-16
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion criteria:
Type 2 diabetes mellitus defined by fasting glucose =126 mg/dl or HbA1c =6.5% or on blood glucose lowering medication

Age of 18 -75 years

Male and Female patients are eligible. Females of child bearing potential or within two years of the menopause are only eligible if pregnancy test at the screening visit is negative and they use adequate contraceptive precautions during the trial. Adequate contraceptive precautions include precaution with a Pearl-Index <1 (oral contraceptive pill, subdermal contraceptive rod - Implanon®, intra-uterine spiral, tubular sterilization).

The patient must demonstrate that she/he is able and willing to perform blood glucose measurements as necessary for Home Blood Glucose Monitoring by herself/himself after it was demonstrated to her/him.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Any other form of diabetes mellitus than type 2 diabetes mellitus

Patients with more than on one blood glucose lowering medication or on insulin therapy

Last measured HbA1c = 10%

Fasting plasma glucose > 240 mg/dl

Blood pressure levels =180/110 mmHg

Body mass index >50 kg/m²

Triglyceride levels > 500 mg/dl

HDL-cholesterol levels <25 mg/dl

Estimated creatinine clearance < 50 ml/min/1.73m²

Macroalbuminuria defined by urinary albumine-to-creatinine ratio > 300 mg/g

Known liver function test >3 times upper limit of normal

Pregnant or breast-feeding patients

Current or previous (within 6 months) treatment with an incretin-based therapy such as DPP 4 inhibitors and/or GLP-1 mimetics

Patients with a history of a hypersensitivity reaction or anaphylaxia in response to a previous treatment to a DPP 4 inhibitor and/or GLP-1 mimetics

Any patient currently receiving chronic (>30 consecutive days) treatment with an oral steroid)

Acute cardiovascular event (including myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, heart failure, stroke, TIA. PRIND, intracerebral bleeding) <6 months prior to screening visit (visit 1)

Diabetic retinopathy

History of epilepsia or history of seizures

Patients being treated for severe auto immune disease such as lupus

Involvement in the planning and/or conduct of the study (applies to both AstraZeneca and BMS or representative staff and/or staff at the study site)

Previous randomisation in the present study

Participation in another clinical study within 30 days prior to visit 1

Individuals at risk for poor protocol or medication compliance

Subject who do not give written consent, that pseudonymous data will be transferred in line with the duty of documentation and the duty of notification according to § 12 and § 13 GCP-V



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

diabetes mellitus
MedDRA version: 12.1 Level: LLT Classification code 10012613 Term: Diabetes mellitus non-insulin-dependent

Intervention(s)

Trade Name: Onglyza
Product Name: Onglyza
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: SAXAGLIPTIN
CAS Number: 361442-04-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): Primary parameter is the change of retinal capillary flow in reponse to L-NMMA.

Secondary Objective: To evaluate the effect of saxagliptin on metabolic parameters (HbA1c, glucose levels, [fasting, postprandial] adiponectin, lipids, insulin, insulin sensitivity [HOMA-index]and lipids)

To evaluate the effect of saxagliptin on other biomarkers (oxidative stress [e.g isoprostanes, GSH/GSSG ratio] and/or inflammatory markers [e.g IL-6, hsCRP]

To evaluate the effect of saxagliptin on carotid-to-femoral pulse wave velocity and aortic pulse wave contour [aortic augmentation index]

To evaluate the effect of saxagliptin on urinary albumine-to-creatinine ratio (UACR)

Main Objective: To investigate the beneficial effect of saxagliptin compared to placebo on endothelial and vascular function of the retinal circulation. By applying Scanning-Laser-Doppler-Flowmetry, the retinal capillary flow will be measured at baseline and its change to 1) Flicker light (repeated flashes that cause vasodilation) and 2) after i.v. L-NMMA application (known to block NO synthase thereby analysing the basal NO activity in the retinal circulation).

Secondary ID(s)

SAXA24011980GLIPTIN