effects of Dapagliflozin on postprandial glucose excursion and fasting glucose homeostasis
Conditions
Interventions
Trade Name: Forxiga
Product Name: Dapagliflozin, Forxiga (trade name)
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Dapagliflozin
Sponsors
Medical University Innsbruck
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Typ 1 Diabetes Mellitus (duration at least 5 years) - C-Peptid =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - insufficient venous conditions on both forearms and cubita - renal or hepatic insuffiency (including presence of mikroalbuminuria and determination of albumin/creatinin-ratio) - History of malignant disease - concomitant medicaion/ substances that may influence postprandial glucose excursion and/or fasting glucose-homeostasis within 3 months prior to study entry - alcoholabuse and/or drugabuse, nikotinconsumption > 5 cigarettes per day - brittle-diabetes - history of severe hypoglycemia, defined as hypoglycemia the need for forein assistance independent of the effectively measured blood glucose concentration within 12 months prior to study entry - any medical/individual condition that may jeopardize patients safety while participating in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Changes in postprandial glucose excursion and fasting glucose homeostasis;Secondary Objective: not applicable;Primary end point(s): Changes in postprandial glucose excursion and fasting glucose homeostasis;Timepoint(s) of evaluation of this end point: 48 hours after the first intake of either dapagliflozin or placebo | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Austria
Contacts
Public ContactClinical Trial Center (OE CTC)
Medical University Innsbruck
Outcome results
None listed