Patients with type 1 diabetes mellitus MedDRA version: 19.0 Level: LLT Classification code 10012608 Term: Diabetes mellitus insulin-dependent System Organ Class: 100000004861
Conditions
Interventions
Trade Name: GlucaGen
Product Name: GlucaGen
Product Code: SUB02347MIG
Pharmaceutical Form: Powder and solution for solution for injection
Pharmaceutical form of the placebo: Concentrate and solvent fo
Sponsors
Hvidovre University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 18 - 70 years - T1D = 2 year - BMI 20-30 kg/m2 - Insulin pump = 1 year. - HbA1c =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Allergy or intolerance to lactose or GlucaGen® (Novo Nordisk, Bagsværd, DK) - Impaired renal function (eGFR 2.5 times the upper limit of the reference interval - Use of anti-diabetic medicine (other than insulin), per oral corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start - Known or suspected alcohol or drug abuse - Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation - Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods - Inability to understand the patient information and to give informed consent - Physical or mental incapacity to perform exercise -People with vigorous intensity aerobic physical activity such as swimming, jogging, aerobics, football, tennis, gym, workout etc, more than 3 hours or more per week. - Chronic use or unable to stop acetaminophen (paracetamol) use -Allergy to the patch of CGM sensors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To compare the increase in plasma glucose after 200µg glucagon given either after exercise or after resting for 45 minutes. ;Secondary Objective: 2. To determine whether a subcutaneous glucagon injection just before exercise has a greater impact on hepatic glucose production and thereby is superior to an injection after exercise in preventing hypoglycemia during and two hours after exercise. ;Primary end point(s): The primary endpoint is peak plasma glucose achieved within 2 hours after the 200 µg subcutaneous glucagon injection. In the primary analysis, we will compare the peak plasma glucose after exercise and after resting. ;Timepoint(s) of evaluation of this end point: 2 hours after injection of glucagon as mentioned in E.5.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) The time-to-peak value after glucagon injection. 2) Duration of the glucagon effect; equal to the time point from glucagon injection to when plasma glucose is below baseline. 3) The glycaemic effect, calculated as the total area under the curve (tAUC) after each glucagon injection. 4) Changes after each glucagon injection (ketone bodies, lactic acid glucagon, and FFA/TG). 5) Differences of continuously glucose monitoring placed at different sites on the patient during exercise compared to plasma glucose monitoring. 6) Number of events of hypoglycemia (plasma glucose =3.9 mmol/l) in the three study groups. 7) Number of re-events of hypoglycemia (plasma glucose =3.9 mmol/l) 30 minutes after first event in the three study groups. 8) Number of rebound hyperglycemia (plasma glucose =10.0 mmol/l). 9) To test the difference in mean absolute relative difference (MARD) during the study visits between the two sensor sites (CGMarm vs. CGMabdomen) with the YSI 2300 STAT PLUS as the reference value. 10) To test the difference in MARD between the two CGM sites (CGMarm vs. CGMabdomen) during the four days after the study day using the daily 8 prespecified plasma glucose measurements by Bayer Contour Link as the reference value. 11) To test the difference in MARD during the hypoglycemia range (=3.9 mmol/l) of the study visits between the two sensor sites (CGMarm vs. CGMabdomen) with the YSI 2300 STAT PLUS as the reference value. 12) To test the difference in MARD during the euglycemia range (>3.9 mmol/l and < 10.0 mmol/l) of the study visits between the two sensor sites (CGMarm vs. CGMabdomen) with the YSI 2300 STAT PLUS as the reference. 13) To test the difference in MARD during the hyperglycemia range (=10.0 mmol/l) of the study visits between the two Dexcom G4 sensor sites (CGMarm vs. CGMabdomen) with the YSI 2300 STAT PLUS as the reference value. 14) To test the difference in MARD between the two sensor sites (CGMarm vs. CGMabdomen | — |
Countries
Denmark
Contacts
Public ContactIsabelle
Hvidovre University Hospital
Outcome results
None listed