To investigate whether treatment with the SGLT-2 inhibitor dapagliflozin improves the perception of hypoglycemia in people with type 1 diabetes with impaired awareness of hypoglycemia

Phase 1

• Conditions: Type 1 diabetes; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2018-001569-17-NL
• Lead Sponsor: Radboud university medical center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-15
• Last Update Posted: 29 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

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
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 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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
• History of laser coagulation for proliferative
retinopathy (past 6 months)
• Proliferative retinopathy
• Symptomatic diabetic neuropathy
• Diabetic nephropathy as reflected by albumin-creatinin ratio >30
mmol/mg or MDRD <60 ml/min/1.73 m2
• 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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the effect of treatment with the SGLT-2 inhibitor dapagliflozin on the<br>awareness of and counterregulatory hormone responses to<br>hypoglycemia in people with type 1 diabetes and impaired<br>hypoglycemic awareness;Secondary Objective: To investigate the effect of treatment with the SGLT-2 inhibitor dapagliflozin on the<br>glycemic recovery from hypoglycemia and the post-hypoglycemic<br>glucose excursion in people with type 1 diabetes and impaired awareness of hypoglycemia;Primary end point(s): Maximal symptom score in response to hypoglycemia during the hyperinsulinemic<br>hypoglycemic glucose clamp experiment;Timepoint(s) of evaluation of this end point: During hypoglycemic glucose clamp after 8 weeks of treatment