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Clinical Trials/NL-OMON48616
NL-OMON48616
Completed
Phase 2

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 sites15 target enrollmentTBD
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ConditionsDiabetesImpaired Awareness of Hypoglycemiahypoglycemia unawareness10018424

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Diabetes
Sponsor
Radboud Universitair Medisch Centrum
Enrollment
15
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

Similar Trials

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