Investigation of the duration of the effect of the hormone glucagon on the glucose production of the liver in patients with diabetes

• Conditions: Diabetes mellitus type 1; MedDRA version: 17.1Level: LLTClassification code 10012608Term: Diabetes mellitus insulin-dependentSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2015-000322-11-AT
• Lead Sponsor: Medizinische Universität Graz; Universitätsklinik für Innere Medizin; Abteilung für Endokrinologie und Stoffwechsel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-17
• Last Update Posted: 14 December 2015

Recruitment & Eligibility

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

Inclusion Criteria

Type 1 diabetes treated with multiple daily insulin injections or continuous subcutaneous insulin infusion for 12 months

Male or female aged 18-65 years (both inclusive)

HbA1c < 10%

Informed consent obtained after being advised of the nature of the study
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 5
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnancy, breast-feeding, intention of becoming pregnant, or not using adequate contraception

Any disease or condition which would interfere with the subject's safety

Skin pathology or condition prohibiting needle insertion/glucagon administration as judged by the investigator

Severe acute diseases

Current participation in another clinical study

Uncontrolled hypertension

Clinically overt diabetic complications

Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation

Taking any vasoactive substances or anticoagulatory medication

Use of a medication that significantly impacts glucose metabolism, i.e. oral or topical steroids, except in the case of a stable state with a minimum duration of at least 3 months preceeding the study as well as under the condition that the state remain stable for the duration of the study

Symptomatic coronary artery disease

Blood donation within 3 months preceeding the study

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To asses the duration of glucagon’s waning effect on the hepatic glucose production in type 1 diabetes patients;Secondary Objective: To asses the duration of glucagon’s waning effect on the blood glucose concentration in type 1 diabetes patients;Primary end point(s): ?AUCHGP, percentage reduction in the area under the hepatic glucose production rate curve ;Timepoint(s) of evaluation of this end point: Observed for 120 minutes following the second glucagon administration compared to that observed for 120 minutes following the first glucagon administration

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): ?HGPMAX, percentage reduction in the maximum hepatic glucose production rate <br><br>?AUCPG, percentage reduction in the area under the plasma glucose concentration curve <br><br>?PGMAX, percentage reduction in the maximum plasma glucose concentration <br> <br>AUCPGL, area under the plasma glucagon concentration curve ;Timepoint(s) of evaluation of this end point: Observed following the second glucagon administration compared to that observed following the first glucagon administration<br><br>Observed for 120 minutes following the second glucagon administration compared to that observed for 120 minutes following the first glucagon administration<br><br>Observed for 120 minutes following each glucagon administration