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 in cartridge
INN or Proposed INN: Dasiglucagon
CAS Number: 1544300-84-6
Current Sponsor code: ZP4207
Concentration unit: mg/ml mi
Sponsors
Steno Diabetes Center Copenhagen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age = 18 years • T1D = 2 years • Use of insulin pump therapy (without sensor-augmented insulin suspension/adjustment functionality) = 6 months • Use of CGM (real-time or intermittently scanned) = 3 months and = 70% during the previous 14 days • HbA1c = 70 mmol/l (8.5%) • Performs aerobic exercise on a regular basis (= 2 times per week; self-reported) and desires to exercise per American Diabetes Association guidelines (150 minutes per week) during the study. • Use of carbohydrate counting and bolus calculator (self-reported) • Sensor glucose level (SGL) =65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: • Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period and within 30 days prior to study start • Know or suspected allergies to glucagon or related products • History of hypersensitivity or allergic reaction to dasiglucagon or any of the excipients (refer to Table 1 in the Investigators brochure) • Patients with pheochromocytoma or insulinoma • Hypoglycemia unawareness • Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (methods are considered adequate for study enrollment for females: an intrauterine device, hormonal contraception (birth control pills, implant, patch, vaginal ring or injection), a single partner who is sterile or infertile, or sexual abstinence. Contraception is required throughout the study duration. Sterilized or postmenopausal women (>12 months since last period) are not required to use contraception) • Inability to understand the individual information and to give informed consent • Current participation in another clinical trial that, in the judgment of the investigator, will compromise the results of the study or the safety of the subject • Concomitant medical or psychological conditions identified through review of medical history, physical examination and clinical laboratory analysis that, according to the investigator's assessment, makes the individual unsuitable for study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the efficacy, safety and feasibility of outpatient-utilization of low-dose (80 µg) dasiglucagon administered via an investigational trial device (a multi-dose reusable pen injector) in preventing and treating mild hypoglycemia in insulin pump-treated people type 1 diabetes;Secondary Objective: Not applicable;Primary end point(s): • Percentage of time in target glucose range [SGL = 3.9 mmol/l and = 10.0 mmol/l];Timepoint(s) of evaluation of this end point: From start (day 1) to end (day 14) of each intervention period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Percentage of time in hypoglycemia [SGL 10 mmol/l] • Coefficient of variation (%) • Successful cases (%) of hypoglycemia treatment* [initial SGL = 2.2 mmol/l and = 3.9 mmol/l AND SGL > 3.9 mmol/l 30 minutes post-treatment] • Successful cases (%) of hypoglycemia treatment* [initial SGL = 2.2 mmol/l and = 3.9 mmol/l AND SGL > 3.9 mmol/l 30 minutes post-treatment] without subsequent hyperglycemia [SGL > 10 mmol/l during the first two hours post-treatment] • Successful cases (%) of hypoglycemia prevention* [initial SGL > 3.9 mmol/l AND SGL < 3.9 for = 15 consecutive minutes during the first two hours post-treatment] • Time (min) from hypoglycemia treatment [initial SGL = 2.2 mmol/l and = 3.9 mmol/l] to euglycemia [SGL = 3.9 mmol/l] • Incidence rate of supplement carbohydrate administration during the first hour following dasiglucagon administration • Average daily carbohydrate intake registered on the insulin pump • Average total daily insulin dose (basal and bolus) • Number and intensity (mild/moderate/severe) of episodes with nausea, headache, stomach-ache, palpitations and injection site pain [assessed by questionnaire each day during the two intervention periods (appendix 3)] • Percentage of participants scoring a favorable outcome [likely OR very likely] on the patient-reported outcome questionnaire [measured on a four-point Likert scale**] *Cases where the assigned intervention (carbohydrate consumption or dasiglucagon) was used to treat/prevent the hypoglycemic event **How likely is it that you, given the option, would use dasiglucagon as part of your diabetes management? (Very unlikely, unlikely, likely, very likely) Safety evaluation endpoints: • Percentage of participants with treatment-induced or treatment-boosted anti-dasiglucagon antibodies Device endpoint: • Device failures/malfunctions occurring during the trial. ;Timepoint(s) of evaluation of this end point: From start (day 1) to end (day 14) of each intervention period. | — |
Countries
Denmark
Contacts
Public ContactChristian Laugesen
Steno Diabetes Center Copenhagen
Outcome results
None listed