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

Phase 2

Completed

• Conditions: Diabetes; Impaired Awareness of Hypoglycemia; hypoglycemia unawareness; 10018424

• Registration Number: NL-OMON48616
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2020-11-25
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

* 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

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 <20 units unless on pump treatment
- Pregnancy or unwillingness to undertake measures for birth control

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Symptom score in response to the hyperinsulinemic hypoglycemic glucose clamp<br /><br>experiment</p><br>