Low-Dose Dasiglucagon for Prevention of Insulin-Induced Hypoglycemia in People with Type 1 Diabetes

INTERVENTION: Product Name: Dasiglucagon Pharmaceutical Form: Solution for injection INN or Proposed INN: DASIGLUCAGON CAS Number: 1544300‐84‐6 Current Sponsor code: ZP4207 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 4‐ CONDITION: Therapeutic area: Diseases [C] ‐ Hormonal diseases [C19] Type 1 diabetes ; MedDRA version: 21.1 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 ‐ Metabolism and nutrition disorders PRIMARY OUTCOME: Main Objective: The main objective of the study is to compare the efficacy of low‐dose (80 and 120 µg) dasiglucagon to oral carbohydrate (15 g) consumption for prevention of s.c. insulin‐induced hypoglycemia in people with type 1 diabetes. Primary end point(s): • Time (min) in hypoglycemia (P‐glucose (PG) < 3.9 mmol/l) from 0‐180 minutes post‐intervention Secondary Objective: Not applicable Timepoint(s) of evaluation of this end point: From 0‐180 minutes post‐intervention SECONDARY OUTCOME: Secondary end point(s): • Incidence rate of hypoglycemia (PG < 3.9 mmol/l) from 0‐180 minutes post‐intervention ; • Incidence rate of level 2 hypoglycemia (PG < 3.0 mmol/l) from 0‐180 minutes post‐intervention ; • Incidence rate of rebound hyperglycemia (PG > 10 mmol/l) from 0‐180 minutes post‐intervention ; • Nadir plasma glucose concentration from 0‐180 minutes post‐intervention ; • Peak plasma glucose concentration from 0‐180 minutes post‐intervention ; • Incremental peak in plasma glucose concentration from 0‐180 minutes post‐intervention ; • Mean plasma glucose concentration from 0‐180 minutes post‐intervention ; • Time (min) from intervention to first increase in plasma glucose concentration of 1.1 mmol/l ; • Plasma glucose Area Under the Curve (AUC) from 0 to 180 min post‐intervention ; • Time to peak plasma glucose concentration from 0‐180 minutes post‐intervention ; • Time (min) in range (PG = 3.9 mmol/l and ? 10.0 mmol/l) from 0‐180 minutes post‐intervention ; • Time (min) in hyperglycemia (PG > 10 mmol/l) from 0‐180 minutes post‐intervention ; • Time (%) in hypoglycemia (PG < 3.9 mmol/l) from 0‐180 minutes post‐intervention (per protocol) ; • Incidence rate of rescue carbohydrate administration from 0‐180 minutes post‐intervention ; • Time (min) to rescue carbohydrate administration from 0‐180 minutes post‐intervention ; • Plasma dasiglucagon Area Under the Curve (AUC) from 0‐180 minutes post‐intervention ; • Peak plasma dasiglucagon concentration from 0‐180 minutes post‐intervention ; • Time to peak plasma dasiglucagon concentration from 0‐180 minutes post‐intervention ; • Serum insulin concentration at t = 0 and tintervention = 0 ; • Serum insulin AUC from 0‐180 minutes post‐intervention ; • Dose (units) of insulin bolus at t = 0 ; • Change in Edinburgh Hypoglycemia Symptoms Scale (EHSS) from intervention (t‐intervention = 0) to 180 min post‐intervention (tintervention = 180) ; • Change in visual analogue scale (VAS) for nausea, headache, stomach ache, injection site pain, palpitations and hunger from intervention (t‐intervention = 0) to 180 min post‐intervention (t‐intervention = 180) ; • Incidence rate of vomiting 0‐180 minutes post‐intervention ; Timepoint(s) of evaluation of this end point: From 0‐180 minutes post‐intervention (unless specified otherwise in the "Secondary end points" section INCLUSION CRITERIA: • Age 18‐64 years • Type 1 diabetes = 3 years • Use of continuous subcutaneous insulin infusion or multiple daily injection therapy for = 6 months • HbA1c = 8.0% 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 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range