Diabetes Mellitus type 1 MedDRA version: 14.1 Level: LLT Classification code 10012608 Term: Diabetes mellitus insulin-dependent System Organ Class: 100000004861
Conditions
Sponsors
Medizinische Universität Graz
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 0
Exclusion criteria
Exclusion criteria: Pregnancy, breast-feeding, intention of becoming pregnant, or not usingadequate 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 deseases 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 ot topical steroids, except in the case of a stable state with a minimum duration of at least 3 months preceeding the study as well asunder 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 assess the effect of repeated subcutaneous glucagon administration on the hepatic glucose production in type 1 diabetic patients under fed and fasted conditions.;Secondary Objective: To assess the effect of repeated subcutaneous glucagon administration on the blood glucose concentration in type 1 diabetic patients under fed and fasted conditions.;Primary end point(s): AUChgp: area under the hepatic glucose production rate curve ;Timepoint(s) of evaluation of this end point: during the glucagon administrations on the first study day under fed conditions and on the second study day under fasted conditions | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): HGPmax: maximum hepatic glucose production rate AUCpg: area under the plasma glucose concentration curve PGmax: maximum plasma glucose concentration AUCpgl: area under the plasma glucagon concentration curve ;Timepoint(s) of evaluation of this end point: during the glucagon administrations on the first study day under fed conditions and on the second study day under fasted conditions | — |
Countries
Austria
Contacts
Public ContactZentrum f. Med. Grundlagenforschung
Medizinische Universität Graz
Outcome results
None listed