Effect of Dapagliflozin on IAH in T1DM

Sponsor
Radboud University Medical Center
Study ID
NCT03556033
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    8 weeks treatment with dapagliflozin on top of insulin treatment
  • Placebo oral capsule — DRUG
    8 weeks treatment with placebo capsules on top of insulin treatment

Study Details

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.

Key Dates

Start date
Nov 23, 2018
Status verified
Sep 2019
Primary completion
Dec 20, 2019
Completion
Dec 20, 2019

Study Design

Enrollment
15 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Dapagliflozin
    Dapagliflozin 10 mg capsule once daily for 8 weeks
  • Placebo Comparator: Placebo oral capsule
    Placebo matched to dapagliflozin 10 mg capsule once daily for 8 weeks

Primary Outcome Measure

Symptom score in response to insulin-induced hypoglycaemia [ Time Frame: 45 minutes ]

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