Effect of the SGLT-2 inhibitor dapagliflozine on impaired awareness of hypoglycemia in type 1 diabetes - Dapagliflozin and impaired awareness of hypoglycemia in T1DM

Radboud Universitair Medisch Centrum0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年4月15日

适应症

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•* Type 1 diabetes, disease duration >1 year
•* Age >18 years, <75 years
•* BMI 19-40 kg/m^2
•* Insulin treatment according to basal-bolus insulin regimen (injections or insulin pump)
•* Impaired awareness of hypoglycemia as assessed by a score of 3 or more on the modified Dutch translation of the Clarke questionnaire
•* Glycated haemoglobin (HbA1c) *75 mmol/mol (9.0%)
•* Ability to provide informed consent

•- Treatment with SGLT-2 inhibitors
•- Known intolerance to SGLT-2 inhibitors
•- Treatment with glucose-modifying (other than insulin) or immune-modifying agents (e.g. prednisolon)
•- Treatment with pioglitazone
•- Use of statins
•- A history of cardiovascular disease (e.g. myocardial infarction, stroke, heart failure) or hypotension
•- Conditions that can lead to volume depletion (e.g. acute gastro-intestinal diseases)
•- A history of galactose-intolerance, lactase deficiency, glucose-galactose malabsorption
•- History of diabetic ketoacidosis requiring medical intervention within 1 month before screening
•- Admission to the hospital for hyperglycemia or hypoglycemia within 1 month before screening
•- Frequent episodes of severe hypoglycemia within 1 month before screening
•- Laser coagulation for proliferative retinopathy (past 6 months)
•- Proliferative retinopathy
•- Diabetic nephropathy as reflected by an albumin-creatinin ratio * 30 mmol/mg or an estimated glomerular filtration rate (by MDRD) *60ml/min/1.73m2
•- Symptomatic diabetic neuropathy
•- History of pancreatitis (acute or chronic) or pancreatic cancer
•- Use of premixed insulin or of long-acting insulin alone
•- Total daily insulin dose requirements <20 units unless on pump treatment
•- Pregnancy or unwillingness to undertake measures for birth control

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