Dapagliflozin in Type 1 Diabetes

Sponsor
Medical University Innsbruck
Study ID
NCT02211742
Phase
PHASE4
Status
Completed

Conditions

  • Fasting Glucose
  • Glucose Excursion
  • Glycemic Control

Eligibility Criteria

Sex
MALE
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    euglycemic hyperinsulinemic clamp tests and euglycemic oral glucose tolerance clamp tests after the short-term (i.e.: 3 days, equals 10mg / 24h) intake of dapagliflozin

Study Details

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).

Key Dates

Start date
Aug 31, 2014
Status verified
Mar 2023
Primary completion
Jul 29, 2016
Completion
Feb 8, 2017

Study Design

Enrollment
12 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: dapagliflozin
    10mg dapagliflozin per 24h for 3 days per cross-over phase (equals 2 x 30mg)
  • Placebo Comparator: placebo sugar pills
    placebo tablet, 1 per 24h for 3 days in total per cross-over phase (equals 2 x 3 tablets)

Primary Outcome Measure

fasting glucose homeostasis [ Time Frame: study visit, immediatly ]

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