Type 2 diabetes mellitus MedDRA version: 16.1 Level: LLT Classification code 10012613 Term: Diabetes mellitus non-insulin-dependent System Organ Class: 100000004861
Conditions
Interventions
Trade Name: Forxiga
Product Name: Forxiga
Pharmaceutical Form: Coated tablet
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use
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 (WOCBP) are only eligible if pregnancy test at the screening visit is negative and they use adequate contraceptive precautions during the trial. 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
Exclusion criteria: • age over 75 years • Any other form of diabetes mellitus than type 2 diabetes mellitus • History of diabetic ketoacidosis or hyperosmolar nonketotic coma • Patients with more than one oral blood glucose lowering medication or on insulin therapy • Any medication with loop diuretics • Last measured HbA1c = 10% • Blood pressure levels =180/110 mmHg • Estimated glomerular filtration rate (eGFR 40 kg/m² • Triglyceride levels >1000 mg/dl • HDL-cholesterol levels 300 mg/g • Known liver function test >3 times upper limit of normal • Pregnant or breast-feeding patients • Any patient currently receiving chronic (>30 consecutive days) treatment with an oral corticosteroid • Subjects with a history of any serious hypersensitivity reaction to Dapagliflozin or SGLT-2 inhibitor • Presence of significant renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, immunological, haematological or oncological, neurological and psychiatric diseases or dysfunction • Diabetic retinopathy • History of epilepsia or history of seizures • Patients suffering from cataract or glaucoma • History of drug medication abuse. • Patients being treated for severe auto immune disease e.g. lupus • Involvement in the planning and/or conduct of the study (applies to BMS or representative staff and/or staff at the study site) • 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 • Prisoners or subjects who are involuntarily incarcerated. • Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: the effect of dapagliflozin on endothelial and microvascular function of the retinal circulation using Scanning-laser-Doppler-Flowmetry by assessing retinal capillary flow. ;Secondary Objective: the effect of dapagliflozin on central (aortic) systolic pressure, central (aortic) pulse pressure and augmentation pressure, parameters that all are determined by pulse wave reflection (i.e. arterial wall properties) in the arterial tree. the effect of retinal capillary flow after flicker light exposure (repeated flashes that cause vasodilatation by an in part NO dependent mechanism). the effect of dapagliflozin on total body sodium content by 24 hour urinary sodium analysis and by using new MRI technology (at ISI of the University of Erlangen) the effect of dapagliflozin on cardiovascular parameters, i.e. office blood pressure, fasting plasma glucose, postprandial glucose concentration and HbA1c ;Primary end point(s): The effect of dapagliflozin on endothelial and microvascular function of the retinal circulation using Scanning-laser-Doppler-Flowmetry by assessing the retinal capillary flow ;Timepoint(s) of evaluation of this end point: after second phase of crossoverdesign | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): on central (aortic) systolic pressure, central (aortic) pulse pressure and augmentation pressure, parameters that all are determined by pulse wave reflection (i.e. arterial wall properties) in the arterial tree. on retinal capillary flow after flicker light exposure (repeated flashes that cause vasodilatation by an in part NO dependent mechanism). on total body sodium content by 24 hour urinary sodium analysis and by using new MRI technology (at imaging science institute of the University of Erlangen) on cardiovascular parameters, i.e. office blood pressure, fasting plasma glucose, postprandial glucose concentration and HbA1c ;Timepoint(s) of evaluation of this end point: after second phase of crossoverdesign | — |
Countries
Germany
Outcome results
None listed