Diabetes
Conditions
Interventions
8 weeks treatment with dapagliflozin or placebo 10 mg capsules once daily
orally
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Type 1 diabetes, disease duration >1 year * Age >18 years,
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom score in response to the hyperinsulinemic hypoglycemic glucose clamp experiment | — |
Secondary
| Measure | Time frame |
|---|---|
| - Responses of counterregulatory hormones (adrenaline, glucagon, cortisol, growth hormone) to the hyperinsulinemic hypoglycemic glucose clamp - Time until glycemic recovery from hypoglycemia after the hyperinsulinemic glucose clamp - Maximal glucose excursion post-hypoglycemia after the hyperinsulinemic glucose clamp - Time until glucose peak post-hypoglycemia after the hyperinsulinemic glucose clamp - Area under the glucose concentration curve post-hypoglycemia after the hyperinsulinemic glucose clamp - Amount of carbohydrates and total amount of calories consumed after hypoglycemia - Number of severe hypoglycemic events during 8 weeks of treatment with dapagliflozin or placebo - Number of nocturnal hypoglycemic events during 8 weeks of treatment with dapagliflozin or placebo - Number of any hypoglycamic events during 8 weeks of treatment with dapagliflozin or placebo - Number of hypoglycemic events and time spent under hypoglycemic conditions as measured by continuous glucose sensor monitoring - Glucose variability as measured by continuous glucose sensor monitoring - Vital signs during the hyperinsulinemic hypoglycemic glucose clamp - HbA1c-levels - The inflammatory/atherogenic phenotype of circulating monocytes from the participating patients | — |
Countries
Netherlands
Outcome results
None listed