Type 1 diabetes
Conditions
Interventions
Trade Name: Tresiba
Product Name: Insulin degludec
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: INSULIN DEGLUDEC
CAS Number: 844439-96-9
Concentration unit: U/ml
Sponsors
Medizinische Universität Graz/Endokrinologie und Stoffwechsel
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Subjects must give their signed and dated informed consent before any trial-related activities. Trial-related activities are any procedure that would not have been performed during normal management of the subject • Male subjects with type 1 diabetes with duration =12 month • Age = 18 to = 35 years, both inclusive • HbA1c = 64 mmol/mol • Fasting C-peptide negative (= 0.3 nmol/l) • Treatment with intensified insulin therapy or insulin pump therapy • No diabetic long term complications • No other physical and/or mental disease 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 7 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Previous participation (randomisation) in this trial • History of any illness or disease that, in the opinion of the Investigator might confound the results of the trial • Use of drugs, which may interfere with the interpretation of trial results or are known to cause clinically relevant interference with insulin action, glucose utilisation, or recovery from hypoglycemia • Current addiction to alcohol or substances of abuse as determined by the investigator • Known or suspected allergy to trial products or related products • Any condition that the investigator feels would interfere with the trial participation or evaluation of data Testing day inclusion criteria: • 48h before testing no hypoglycemia • 24h before testing no alcohol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the present study is to aoid hypoglycemia during and after testing and therefor to calculate a critical time by a pre exercise standardized insulin regimen during standardized cycle ergometer exercises dependent on different modes, intensity, duration and energy expenditure as well as counter regulatory hormones. ;Secondary Objective: Not applicable;Primary end point(s): As a hypothesis we expect no hypoglycemia during the cycle ergometer exercises dependent on an standardized pre exercise standardized insulin regimen in relation to the intensity, duration and the energy expenditure of the exercise and no post exercise hypoglycemia.;Timepoint(s) of evaluation of this end point: End of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Austria
Contacts
Public ContactGerd Köhler, attending physician
Medizinische Universität Graz/Endokrinologie und Stoffwechsel
Outcome results
None listed