Completed

Effect of the SGLT-2 Inhibitor Dapagliflozin on Impaired Awareness of Hypoglycemia in Type 1 Diabetes

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What is being tested

Dapagliflozin

+ Placebo oral capsule

Drug
Who is being recruted

Autoimmune Diseases+6

+ Diabetes Mellitus

+ Diabetes Mellitus, Type 1

From 18 to 75 Years
+25 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: November 2018
See protocol details

Summary

Principal SponsorRadboud University Medical Center
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 23, 2018

Actual date on which the first participant was enrolled.

Approximately 25% of patients with type 1 diabetes have lost the capacity to timely detect hypoglycaemia, a condition referred to as impaired awareness of hypoglycaemia (IAH) that causes a six-fold higher risk of severe, potentially hazardous, hypoglycaemia. IAH is usually the end-result of a process of habituation to recurrent hypoglycaemia that is potentially reversible. Treatment with sodium glucose cotransporter (SGLT)-2 inhibitors (SGLT-2i) in addition to insulin therapy may decrease the incidence of hypoglycaemia in patients with type 1 diabetes. This study will test the hypothesis that treatment with the SGLT-2 inhibitor, dapagliflozin, added to basal-bolus insulin therapy will improve awareness of hypoglycaemia in patients with type 1 diabetes and IAH. In a randomized doubleblind placebo-controlled cross-over trial, patients will be treated for 8 weeks with dapagliflozin (or placebo), after which hypoglycemic symptoms and counterregulatory hormone responses will be examined during a hyperinsulinemic hypoglycemic glucose clamp study.

Official TitleEffect of the SGLT-2 Inhibitor Dapagliflozin on Impaired Awareness of Hypoglycemia in Type 1 Diabetes
NCT03556033
Principal SponsorRadboud University Medical Center
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

15 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesDiabetes MellitusDiabetes Mellitus, Type 1Endocrine System DiseasesHypoglycemiaImmune System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

7 inclusion criteria required to participate
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)
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18 exclusion criteria prevent from participating
Treatment with SGLT-2 inhibitors
Known intolerance to SGLT-2 inhibitors
Treatment with loop diuretics or other anti-hypertensive agents
Treatment with glucose-modifying (other than insulin) or immune-modifying agents (e.g. prednisolon)
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Dapagliflozin 10 mg capsule once daily for 8 weeks

Group II

Placebo
Placebo matched to dapagliflozin 10 mg capsule once daily for 8 weeks

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Radboud university medical center

Nijmegen, NetherlandsOpen Radboud university medical center in Google Maps
CompletedOne Study Center