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Clinical Trials/EUCTR2014-001441-24-AT
EUCTR2014-001441-24-AT
Active, Not Recruiting
Phase 1

Short-term effect of SGLT 2-inhibitor dapagliflozin on postprandial glucose excursion and insulin sensitivity in type 1 diabetic patients.

Medical University Innsbruck0 sites12 target enrollmentAugust 4, 2014

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
effects of Dapagliflozin on postprandial glucose excursion and fasting glucose homeostasis
Sponsor
Medical University Innsbruck
Enrollment
12
Status
Active, Not Recruiting
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 4, 2014
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Medical University Innsbruck

Eligibility Criteria

Inclusion Criteria

  • \-Typ 1 Diabetes Mellitus (duration at least 5 years)
  • \-C\-Peptid \< 0\.2µg/l
  • \-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

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

Outcomes

Primary Outcomes

Not specified

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