Dapagliflozin in Type 1 Diabetes

Phase 4

Completed

• Conditions: Glycemic Control; Fasting Glucose; Glucose Excursion
• Interventions: Drug: Dapagliflozin

• Registration Number: NCT02211742
• Lead Sponsor: Medical University Innsbruck

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 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-06
• Study First Submitted QC: 2014-08-06
• Study First Posted: 2014-08-07
• Primary Completion: 2016-07-29
• Study Completion: 2017-02-08
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-14
• Last Update Posted: 2023-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
dapagliflozin	Dapagliflozin	10mg dapagliflozin per 24h for 3 days per cross-over phase (equals 2 x 30mg)
placebo sugar pills	Dapagliflozin	placebo tablet, 1 per 24h for 3 days in total per cross-over phase (equals 2 x 3 tablets)

Primary Outcome Measures

Name	Time	Method
postprandial glucose homeostasis	study visit, immediatly	During euglycemic oral glucose tolerance clamp tests, postprandial glucose excursion will be determined and compared between dapagliflozin and placebo.
fasting glucose homeostasis	study visit, immediatly	During hyperinsulinemic, euglycemic clamp studies, fasting glucose homeostasis will be determined for both, dapagliflozin and placebo.

Trial Locations

Locations (1)

Medical University Innsbruck, Department of Internal Medicine I; 🇦🇹 Innsbruck, Tirol, Austria