Diabetes Mellitus type 1 MedDRA version: 17.0 Level: LLT Classification code 10012608 Term: Diabetes mellitus insulin-dependent System Organ Class: 100000004861
Conditions
Interventions
Trade Name: GlucaGen
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: GLUCAGON HYDROCHLORIDE
CAS Number: 9007-92-5
Concentration unit: mg/ml milligram(s)/millili
Sponsors
Medizinische Universität Graz; Universitätsklinik für InnereMedizin; Abteilung für Endokrinologie und Stoffwechsel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 18 to 64 years of age, both inclusive - Type 1 diabetes treated with CSII or MDI - HbA1C =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: - Severe acute diseases - Clinically overt diabetic complications - Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation - Taking of any vasoactive substances or anticoagulation medication - Diseases of the skin which could interfere with application of catheters as judged by the investigator - Uncontrolled hypertension - Use of a medication that significantly impacts glucose metabolism (e.g. oral or topical steroids) except in the case of a stable state with a minimum duration of at least three months preceding the study as well as under the condition that the state remain stable for the duration of the study - No superficial veins for catheter insertion as judged by the investigator - Pregnancy, breastfeeding, intention of becoming pregnant or not using adequate contraception. - Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject - Concurrent participation in another study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to ascertain in humans whether commercially available glucagon solutions affect the glucose concentration in the interstitial fluid (ISF) at the subcutaneous infusion site.;Secondary Objective: A secondary objective of the study is to assess in humans whether the arterial-to-ISF glucose concentration gradient in adipose tissue surrounding a catheter is affected by the level of local tissue oxygenation.;Primary end point(s): - Mean ISF-to-plasma glucose ratios before and during exposure of the tissue surrounding the microperfusion catheters to glucagon solutions;Timepoint(s) of evaluation of this end point: over the duration of the study day (23 hours) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Mean ISF-to-plasma glucose ratios before and after changes in the oxygenation of the tissue surrounding the microperfusion catheters - Mean ISF-to-plasma glucose ratios before and during exposure of the tissue surrounding the microperfusion catheters to insulin - Mean ionic recovery in the effluents of the four subcutaneous microperfusion catheters - Mean ISF lactate concentration in the tissue surrounding the four microperfusion catheters ;Timepoint(s) of evaluation of this end point: over the duration of the study day (23 hours) | — |
Countries
Austria
Contacts
Public ContactZentrum f. Med. Grundlagenforschung
Medizinische Universität Graz; Universitätsklinik für Innere Medizin; Abteilung für Endokrinologie und Stoffwechsel
Outcome results
None listed