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: ZP4207
Pharmaceutical Form: Solution for injection
INN or Proposed INN: dasiglucagon
CAS Number: 1544300-84-6
Current Sponsor code: ZP4207
Other descriptive name: ZP4207
Concentration un
Sponsors
Zealand Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female patients with T1DM for at least 1 year. Diagnostic criteria as defined by the American Diabetes Association - Hemoglobin A1c (HbA1c) =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 3. History of anaphylaxis or symptoms of severe systemic allergy (such as angioedema) 6. Patients on a closed loop artificial pancreas 8. Active malignancy within the last 5 years 9. Congestive heart failure, New York Heart Association class II-IV 10. Inadequately treated blood pressure as defined as systolic blood pressure =160 mmHg or diastolic blood pressure =90 mmHg at screening 11. Current bleeding disorder, including use of anticoagulant treatment 12. Known presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma (i.e. insulin-secreting pancreas tumor) 13. Known or suspected HIV infection 14. Use of a systemic beta-blocker drug, indomethacin, warfarin or anticholinergic drugs in the previous 28 days before Day 1 of this trial 15. Use of systemic corticosteroids, anti-inflammatory biological agents, kinase inhibitors or other immune modulating agents within the last 3 months prior to screening 16. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 X the upper limit of normal (ULN), bilirubin >1.5 X ULN, estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 according to the Modification of Diet in Renal Disease (MDRD) Study definition. Altered electrolytes values of clinical relevance for cardiac conduction, as judged by the investigator. 17. Clinically significant abnormal ECG at screening as evaluated by Investigator 19. A positive result in the alcohol and/or urine drug screen at the screening visit. Significant history of alcoholism or drug abuse as judged by the investigator or consuming more than 24 g alcohol per day for men, or more than 12 g alcohol per day for women. 23. 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 evaluate the immunogenicity of repeated single doses of dasiglucagon and GlucaGen following subcutaneous (s.c.) administration compared with s.c. GlucaGen in T1DM patients.;Secondary Objective: The secondary objective is to evaluate the safety, tolerability and pharmacodynamic response of repeated single doses of dasiglucagon following s.c. administration compared with s.c. GlucaGen in T1DM patients.;Primary end point(s): Overall ADA incidence This will be calculated as a percentage of the combined results of treatment-induced ADA-positive patients and treatment-boosted ADA-positive patients and the total number of evaluable patients, excluding baseline-positive patients without any samples available after drug administration. ;Timepoint(s) of evaluation of this end point: Visit 7(Day 104 of the follow-up period; EoT visit) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Treatment-induced ADA Incidence calculated as a percentage of the total number of evaluable patients that were ADA negative at baseline and ADA positive after drug administration and the total number of evaluable patients, excluding baseline positive patients without any samples available after drug administration. • Treatment-boosted ADA Incidence calculated as percentage of baseline ADA-positive patients with significant increases (=5-fold) in ADA titer after drug administration and the total number of evaluable patients, excluding baseline-positive patients without any samples available after drug administration. ;Timepoint(s) of evaluation of this end point: Visit 7 (Day 104 of the follow-up period; EoT visit) | — |
Countries
Austria, Canada, Germany, United States
Contacts
Public ContactDorte Skydsgaard
Zealand Pharma A/S
Outcome results
None listed