diabetes mellitus MedDRA version: 12.1 Level: LLT Classification code 10012613 Term: Diabetes mellitus non-insulin-dependent
Conditions
Interventions
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
Sponsors
University Hospital Erlangen
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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) ;Primary end point(s): Primary parameter is the change of retinal capillary flow in reponse to L-NMMA. | — |
Countries
Germany
Outcome results
None listed