Acute Effects of SGLT2 Inhibition on Renal Oxygenation and Autonomic Function in Type 1 Diabetes

PHASE4CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

February 1, 2020

Primary Completion Date

September 1, 2020

Study Completion Date

January 1, 2021

Conditions
NephropathyHypoxiaMitochondrial AlterationType 1 DiabetesAutonomic Neuropathy, Diabetic
Interventions
DRUG

Forxiga

"Forxiga®, dapagliflozin 10 mg film-coated tablet.~For further information please refer to:~https://www.ema.europa.eu/en/documents/product-information/forxiga-epar-product-information\_en.pdf.~Common side effects include hypoglycemia, hypotension, elevated hematocrite, dyslipidemia, back pain, dizziness, skin rash, urinary tract infection, vulvovaginitis and dehydration. Very rare incidents of ketoacidosis have been observed. Side effects have only been observed after use in longer periods and not in single-dose usage, as planned in the present study. A dose of 50 mg has been chosen to achieve optimal efficacy. Once-per-day doses of dapagliflozin for 12 weeks of 2.5 mg, 5 mg, 10 mg, 20 mg and 50 mg have been demonstrated to be relatively safe across the mentioned doses (20) and no apparent risk is expected from instituting two single-doses of 50 mg dapagliflozin."

Trial Locations (1)

2820

Steno Diabetes Center Copenhagen, Gentofte Municipality

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Glostrup University Hospital, Copenhagen

OTHER

collaborator

Novo Nordisk A/S

INDUSTRY

lead

Steno Diabetes Center Copenhagen

OTHER

NCT04193566 - Acute Effects of SGLT2 Inhibition on Renal Oxygenation and Autonomic Function in Type 1 Diabetes | Biotech Hunter | Biotech Hunter