A Phase 4 interventional study of Dapagliflozin in Fasting Glucose, Glucose Excursion and Glycemic Control, sponsored by Medical University Innsbruck. Completed at 1 site in Austria. Open to male participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-03-16.
Sponsored by Medical University Innsbruck · Phase 4, Interventional, and Treatment
Dapagliflozin is a highly selective, reversible and potent inhibitor of the sodium-glucose-linked Transporter 2 (SGLT2), which was successfully investigated for its use as a treatment option in type 2 diabetes mellitus. The effect of dapagliflozin is an increased glucosuria, and it was shown that mean blood glucose concentrations and postprandial glucose excursion in special were significantly reduced in type 2 diabetic patients. Due to its mechanism-of action it seems likely that also type 1 diabetic patients will benefit from dapagliflozin. The present study is focused on the effects of dapagliflozin on fasting glucose homeostasis and postprandial glucose excursion in male type 1diabetic patients. Participants will subsequently receive 10 milligrams of dapagliflozin and placebo for 3 days (equals 2 x 30mg per cross-over period) in a double-blind, randomised, cross-over design. The effects will be measured via euglycemic hyperinsulinemic clamp studies (fasting glucose homeostasis) and euglycemic oral glucose tolerance clamp tests (postprandial glucose excursions).
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 12 is below the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Medical University Innsbruck is the lead sponsor of 182 studies on the registry; 49 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
10mg dapagliflozin per 24h for 3 days per cross-over phase (equals 2 x 30mg)
Drug: Dapagliflozin
placebo tablet, 1 per 24h for 3 days in total per cross-over phase (equals 2 x 3 tablets)
Drug: Dapagliflozin
euglycemic hyperinsulinemic clamp tests and euglycemic oral glucose tolerance clamp tests after the short-term (i.e.: 3 days, equals 10mg / 24h) intake of dapagliflozin
fasting glucose homeostasis
During hyperinsulinemic, euglycemic clamp studies, fasting glucose homeostasis will be determined for both, dapagliflozin and placebo.
Time frame: study visit, immediatly
postprandial glucose homeostasis
During euglycemic oral glucose tolerance clamp tests, postprandial glucose excursion will be determined and compared between dapagliflozin and placebo.
Time frame: study visit, immediatly
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Medical University Innsbruck