Short-term effects of the substance dapagliflozin on the increase of blood sugar concentrations after meal and insulinsensitivity in type 1 diabetic patients.

Phase 1

• Conditions: effects of Dapagliflozin on postprandial glucose excursion and fasting glucose homeostasis; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2014-001441-24-AT
• Lead Sponsor: Medical University Innsbruck

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-04
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

-Typ 1 Diabetes Mellitus (duration at least 5 years)
-C-Peptid < 0.2µg/l
-male sex
-aged 18 to 60 years
-Body Mass Index 20 – 25 kg/m2
-absence of clinically relevant ketonuria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-insufficient venous conditions on both forearms and cubita
-renal or hepatic insuffiency (including presence of mikroalbuminuria and determination of albumin/creatinin-ratio)
-History of malignant disease
-concomitant medicaion/ substances that may influence postprandial glucose excursion and/or fasting glucose-homeostasis within 3 months prior to study entry
-alcoholabuse and/or drugabuse, nikotinconsumption > 5 cigarettes per day
-brittle-diabetes
-history of severe hypoglycemia, defined as hypoglycemia the need for forein assistance independent of the effectively measured blood glucose concentration within 12 months prior to study entry
-any medical/individual condition that may jeopardize patients safety while participating in the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Changes in postprandial glucose excursion and fasting glucose homeostasis;Secondary Objective: not applicable;Primary end point(s): Changes in postprandial glucose excursion and fasting glucose homeostasis;Timepoint(s) of evaluation of this end point: 48 hours after the first intake of either dapagliflozin or placebo

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable