EUCTR2018-001569-17-NL
Active, Not Recruiting
Phase 1
Effect of the SGLT-2 inhibitor dapagliflozin on impaired awareness of hypoglycemia in type 1 diabetes - Dapagliflozin and impaired awareness of hypoglycemia in T1DM
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Type 1 diabetes
- Sponsor
- Radboud university medical center
- Enrollment
- 15
- Status
- Active, Not Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Type 1 diabetes, disease duration \>1 year
- •Age \>18 years, \<75 years
- •BMI 19\-30 kg/m^2
- •Insulin treatment according to basal\-bolus insulin regimen (injections
- •or insulin pump)
- •Impaired awarenessof hypoglycemia as assessed by a score of 3 or
- •more on the modified Dutch translation of the Clarke questionnaire
- •Glycated haemoglobin (HbA1c) \=42 mmol/mol (6%) and \=75
- •mmol/mol (9\.0%)
- •Ability to provide informed consent
Exclusion Criteria
- •Known intolerance to SGLT\-2 inhibitors (including allergy)
- •Treatment with glucose\-modefying or immune\-modefying agents, e.g.
- •prednisolon
- •Treatment with pioglitazone
- •History of cardiovascular disease (e.g. myocardial infarction, stroke, heart failure, symptomatic peripheral arterial disease) or hypotension
- •Conditions that can lead to volume depletion (acute gastro\-intestinal diseases)
- •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 hyper\- or hypoglycemia \<1 month before screening
- •Frequent episodes of severe hypoglycemia \<1 month before screening
Outcomes
Primary Outcomes
Not specified
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