Diabetes mellitus type 1 MedDRA version: 17.1 Level: LLT Classification code 10012608 Term: Diabetes mellitus insulin-dependent System Organ Class: 100000004861
Conditions
Sponsors
Medizinische Universität Graz; Universitätsklinik für Innere Medizin; Abteilung für Endokrinologie und Stoffwechsel
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): ?HGPMAX, percentage reduction in the maximum hepatic glucose production rate ?AUCPG, percentage reduction in the area under the plasma glucose concentration curve ?PGMAX, percentage reduction in the maximum plasma glucose concentration 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 Observed for 120 minutes following the second glucagon administration compared to that observed for 120 minutes following the first glucagon administration Observed for 120 minutes following each glucagon administration | — |
Countries
Austria
Contacts
Public ContactZentrum f. Med. Grundlagenforschung
Medizinische Universität Graz
Outcome results
None listed