Dapagliflozin in Type 1 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-02-08

Brief Summary

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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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Detailed Description

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Conditions

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Fasting Glucose Glucose Excursion Glycemic Control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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dapagliflozin

10mg dapagliflozin per 24h for 3 days per cross-over phase (equals 2 x 30mg)

Group Type ACTIVE_COMPARATOR

Dapagliflozin

Intervention Type 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

placebo sugar pills

placebo tablet, 1 per 24h for 3 days in total per cross-over phase (equals 2 x 3 tablets)

Group Type PLACEBO_COMPARATOR

Dapagliflozin

Intervention Type 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

Interventions

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Dapagliflozin

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No