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
Conditions
Interventions
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)/mi
Sponsors
Steno Diabetes Center Copenhagen
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: • Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start • History of allergy or intolerance to glucagon or glucagon-like products • Patients with pheochromocytoma • Clinically significant ECG abnormalities • Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (sterilization, intrauterine device, contraceptive pill, patch or injection) • Inability to understand the individual information and to give informed consent • Current participation in another clinical trial that, in the judgment of the principle investigator, will compromise the results of the study or the safety of the subject • Other concomitant medical or psychological condition that, according to the investigator's assessment, makes the individual unsuitable for study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;Secondary Objective: Not applicable;Primary end point(s): • Time (min) in hypoglycemia (P-glucose (PG) < 3.9 mmol/l) from 0-180 minutes post-intervention;Timepoint(s) of evaluation of this end point: From 0-180 minutes post-intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: From 0-180 minutes post-intervention (unless specified otherwise in the "Secondary end points" section;Secondary end point(s): • Incidence rate of hypoglycemia (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-in | — |
Countries
Denmark
Contacts
Public ContactChristian Laugesen
Steno Diabetes Center Copenhagen
Outcome results
None listed