Status:
COMPLETED
Dapagliflozin in Type 1 Diabetes
Lead Sponsor:
Medical University Innsbruck
Collaborating Sponsors:
Medical University of Graz
University of Bern
Conditions:
Fasting Glucose
Glucose Excursion
Eligibility:
MALE
18-60 years
Phase:
PHASE4
Brief Summary
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...
Eligibility Criteria
Inclusion
- Type 1 diabetes mellitus (duration of disease at least 5 years)
- C-peptide concentration \< 0.2µg/l
- male sex
- aged 18 to 60 years
- Body Mass Index 20 - 25 kg/m2
- no measurable, clinically relevant ketonuria
Exclusion
- insufficient venous status on both forearms
- renal and/or hepatic insufficiency (including microalbuminuria and/or albumin/creatinin-ratio)
- history of cancer
- intake of medication and/or substances capable to influence insulin sensitivity within the last 3 months prior to study inclusion
- alcohol- and/or drug abuse, nicotine consumption \> 5 cigarettes / 24h
- brittle-diabetes
- history of severe hypoglycemia, defined as the need for foreign assistance independent of actual blood glucose concentration measured
- history or evidence of any other clinically significant disorder, condition or disease other than those outlined above that, in the opinion of the investigator may compromise the ability of the participant to give written informed consent, would pose a risk to subject safety, or interfere with the study evaluation, procedures or completion.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2017
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02211742
Start Date
August 1 2014
End Date
February 8 2017
Last Update
March 16 2023
Active Locations (1)
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1
Medical University Innsbruck, Department of Internal Medicine I
Innsbruck, Tyrol, Austria, 6020