Status:
COMPLETED
Effects of Dapagliflozin on Hormonal Glucose Homeostasis in Type 1 Diabetes
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Inhibitors of sodium-dependent glucose-transporter 2 (including dapagliflozin) represent intensively investigated drugs in the field of diabetes. SGLT-2 inhibition limits glucose reabsorption in renal...
Eligibility Criteria
Inclusion
- Informed Consent as documented by signature
- Duration of T1DM \> 5 years
- Male or female sex
- Body mass index (BMI) between 20 and 29 kg/m2
- Adherence to safe contraception during the study and for 2 weeks after completion of the study protocol. Safe contraception comprises double barrier methods (hormonal contraception \[like: oral contraceptive pills or intrauterine contraceptive devices\] together with a mechanical barrier \[like: condom, diaphragm\]).
Exclusion
- Contraindications to SGLT-2 inhibitors
- Contraindications to lactose
- Diagnosis of renal and/or hepatic dysfunction
- History of malignancy of any kind
- Intake of drugs influencing glucose homeostasis during the last three months (steroids, metformin, sulfonylureas, thiazolidinedione)
- Known or suspected non-compliance, drug or alcohol abuse.
- Inadequate vein status on both forearms
- Active smoker (defined as ≥1 or more cigarettes or nicotine-containing equivalents per day)
- Known pregnancy, positive plasma beta-HCG test prior to study inclusion or intention to become pregnant during the study period.
- Women who are breast feeding
- Lack of safe contraception
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
Key Trial Info
Start Date :
January 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2020
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04035031
Start Date
January 9 2020
End Date
November 12 2020
Last Update
March 14 2023
Active Locations (1)
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1
Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
Bern, Switzerland, 3010