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Completed

NCT Number: NCT02211742

Dapagliflozin in Type 1 Diabetes

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).

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Key information

Conditions

Fasting Glucose Glucose Excursion Glycemic Control

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Medical University Innsbruck, Department of Internal Medicine I

Innsbruck, Tyrol, 6020, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. fasting glucose homeostasis

    Time frame: study visit, immediatly

    During hyperinsulinemic, euglycemic clamp studies, fasting glucose homeostasis will be determined for both, dapagliflozin and placebo.

  2. postprandial glucose homeostasis

    Time frame: study visit, immediatly

    During euglycemic oral glucose tolerance clamp tests, postprandial glucose excursion will be determined and compared between dapagliflozin and placebo.

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Collaborators

  • Medical University of Graz
  • University of Bern

Registry information

Official study title

Short-term Effects of Dapagliflozin on Fasting and Postprandial Glucose Homeostasis in Male Type 1 Diabetes Patients.

Acronym: DapaT1DM

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Aug 7, 2014
Registry last updated
Mar 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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