NCT03556033

Effect of Dapagliflozin on IAH in T1DM

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Diabetes Mellitus, Type 1
• Hypoglycemia
• Hypoglycemia Unawareness

Interventions

Type	Name	Description
DRUG	Dapagliflozin	8 weeks treatment with dapagliflozin on top of insulin treatment
DRUG	Placebo oral capsule	8 weeks treatment with placebo capsules on top of insulin treatment

Timeline

• Start date: 2018-11-23
• Primary completion: 2019-12-20
• Completion: 2019-12-20
• First posted: 2018-06-14
• Last updated: 2020-03-23

Locations

1 site across 1 country: Netherlands