Status:
COMPLETED
Dapagliflozin in Physical Exercise 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 (SGLT-2 inhibitors, including dapagliflozin) inhibit glucose reabsorption in renal tubular cells, hereby increasing glycosuria in the hyperglycemic...
Eligibility Criteria
Inclusion
- Written informed consent
- Diagnosis of T1DM
- Duration of T1DM \> 5 years
- Male or female sex
- Insulin therapy via multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII)
- Body mass index (BMI) between 20 and 29 kg/m2
- Adherence to sufficient contraceptive measures (double barrier method combining hormonal with mechanical barriers).
- Ability to perform a 60 minutes exercise session at 50% VO2max.
Exclusion
- Diagnosis of renal and/or hepatic dysfunction
- History of malignancy of any kind
- Intake of drugs influencing glucose homeostasis during the last three months
- Alcohol or drug abuse
- Inadequate vein status on both forearms
- Active smoker
- Known pregnancy, positive plasma beta human choriogonadotropine test prior to study inclusion or intention to become pregnant during the study period.
Key Trial Info
Start Date :
August 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2023
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT04049110
Start Date
August 25 2020
End Date
May 10 2023
Last Update
August 31 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