Dapagliflozin in Type 1 Diabetes (DapaT1DM)

Medical University Innsbruck

Status and phase

Completed

Phase 4

Conditions

Glycemic Control

Glucose Excursion

Fasting Glucose

Treatments

Drug: Dapagliflozin

Study type

Interventional

Funder types

Other

Identifiers

NCT02211742

CUI_001

Details and patient eligibility

About

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).

Enrollment

12 patients

Sex

Male

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.