Type 1 Diabetes mellitus MedDRA version: 20.0 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: Dasiglucagon A
Product Code: ZP4207
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Dasiglucagon
CAS Number: 1544300-84-6
Current Sponsor code: ZP4207
Other descriptive
Sponsors
Zealand Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be eligible to be included in the trial only if all of the following criteria apply: 1. Informed consent obtained before any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the patient) 2. Female or male patients with T1DM for at least 1 year, diagnostic criteria as defined by the American Diabetes Association (American Diabetes Association, 2017) 3. Treated with insulin for T1DM for at least 1 year and with stable insulin treatment (defined as no more than a 10-unit daily variation in total daily insulin dose) 30 days prior to screening 4. Hemoglobin A1c =65 years) yes F.1.3.1 Number of subjects for this age range 11
Exclusion criteria
Exclusion criteria: Patients are excluded from the trial if any of the following criteria apply: 1. Previous participation in a clinical trial within the dasiglucagon program 2. Known or suspected allergy to trial medication(s) or related products 3. History of anaphylaxis or symptoms of severe systemic allergy (such as angioedema) 4. Previous participation in this trial. Participation is defined as having been randomized 5. Females who are pregnant according to a positive pregnancy test, are actively attempting to get pregnant, or are lactating 6. History of hypoglycemic events associated with seizures or hypoglycemia unawareness in the last year prior to screening 7. Current daily basal insulin treatment > 1.0 U/kg/day 8. History of epilepsy or seizure disorder 9. History of severe hypoglycemia (an episode requiring assistance from another person) in the last month prior to screening 10. Receipt of any investigational medicinal product within 3 months prior to screening 11. Active malignancy within the last 5 years 12. Congestive heart failure, New York Heart Association class II-IV 13. Inadequately treated blood pressure as defined as systolic blood pressure =160 mmHg or diastolic blood pressure =90 mmHg at screening (The Task Force for the management of arterial hypertension, 2013) 14. Current bleeding disorder, including use of anticoagulant treatment 15. Known presence or history of pheochromocytoma (i.e., adrenal gland tumor) or insulinoma (i.e., insulin-secreting pancreas tumor) 16. Use of a systemic beta-blocker drug, indomethacin, warfarin or anticholinergic drugs at screening 17. Any of the following abnormal laboratory parameters at screening: ? Aspartate aminotransferase >2.5 × the upper limit of normal ? Alanine aminotransferase >2.5 × the upper limit of normal ? Bilirubin >1.5 × the upper limit of normal ? Estimated glomerular filtration rate <30 mL/min/1.73m2 according to the Modification of Diet in Renal Disease Study definition (Levey et al, 2006) ? Altered electrolyte values of clinical relevance for cardiac conduction, as judged by the investigator 18. Clinically significant abnormal electrocardiogram (ECG) at screening as evaluated by investigator 19. Clinically significant illness within 4 weeks before screening, as judged by the investigator 20. Any donation of blood or plasma in the past month, or donation in excess of 500 mL within 12 weeks before screening 21. Surgery or trauma with significant blood loss within the last 2 months before screening 22. A positive result in the alcohol and/or urine drug screen at the screening visit 23. Significant history of alcoholism or non-prescribed opioid misuse as judged by the investigator 24. Patients with mental incapacity or language barriers that preclude adequate understanding or cooperation, who are unwilling to participate in the trial, or who in the opinion of the investigator should not participate in the trial 25. Any condition interfering with trial participation or evaluation or that could be hazardous to the patient 26. The use of prescription or non-prescription medications known to cause QT prolongation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to show non-inferiority of the efficacy of a single subcutaneous dose of dasiglucagon batch B relative to that of dasiglucagon batch A for treatment of hypoglycemia in patients with type 1 diabetes mellitus;Secondary Objective: The secondary objective is to evaluate the safety, immunogenicity and PK of 2 different batches of dasiglucagon following a single SC dose administered to patients with T1DM with insulin-induced hypoglycemia;Primary end point(s): Time to plasma glucose recovery. ;Timepoint(s) of evaluation of this end point: Plasma glucose recovery is defined as first increase in plasma glucose of =20 mg/dL (1.1 mmol/L) from baseline during the hypoglycemic clamp procedure without administration of rescue intravenous (IV) glucose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Plasma glucose change from baseline at 30 minutes, at 20 minutes, at 15 minutes, and at 10 minutes after trial product injection or at the time of rescue;Timepoint(s) of evaluation of this end point: From baseline at 30 minutes, at 20 minutes, at 15 minutes, and at 10 minutes after trial product injection or at the time of rescue. | — |
Countries
Austria, Canada, Germany
Contacts
Public ContactStine Just Maarbjerg
Zealand Pharma A/S
Outcome results
None listed