Type 1 Diabetes mellitus MedDRA version: 19.0 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: ZP4207
Product Code: ZP4207
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Dasiglucagon
CAS Number: 1544300-84-6
Other descriptive name: ZP4207
Concentration unit: mg/m
Sponsors
Zealand Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female patients with T1D for at least one year, as defined by the American Diabetes Association 1 - Age between 18 and 64 years, both inclusive - Diabetes managed using an insulin infusion pump for at least 1 week prior to screening - Stable disease with HbA1c less than 8.5% 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 17 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Previous exposure to ZP4207 or previously randomized to this trial • Known or suspected allergy to trial product(s) or related products • Receipt of any investigational drug within 3 months prior to Screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize the PK and PD properties of ZP4207 4 mg/mL following s.c. administration at euglycemic and hypoglycemic conditions in adult patients with T1DM.;Secondary Objective: • To compare the PK and PD of ZP4207 4 mg/mL to Lilly Glucagon 1 mg/mL after s.c. administration of micro-doses in adult patients with T1DM. • To evaluate the safety and local tolerability of ZP4207 following s.c. injection in patients with T1DM compared to Lilly Glucagon. ;Primary end point(s): PK endpoint: ? Plasma ZP4207 and baseline adjusted Lilly Glucagon profiles 0-240 min: AUC0-240min, Cmax, tmax PD endpoint: ? Plasma glucose profiles 0-240 min above baseline: AUE0-240min, CEmax, tmax;Timepoint(s) of evaluation of this end point: PK endpoint: 0-240 min after administration of study drug , Cmax, tmax PD endpoint: 0-240 min above baseline, tmax, CEmax | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PK endpoint: a) Additional PK endpoints for ZP4207 and baseline adjusted Lilly Glucagon; AUC0-t, MRT, Vz/f, ?z, t½, and CL/f b) Insulin concentrations PD endpoint: - AUE0-30min - CE30min - Time to half CEmax(t50%CE, early) - Time to 90% decrease from CEmax(t10%CE, late) - Percentage of patients achieving a plasma glucose increase of =20 mg/dL within 30 minutes after treatment - Time to plasma glucose increase of =20 mg/dL - Percentage of patients achieving a plasma glucose concentration =70 mg/dL within 30 minutes after treatment (insulin-induced hypoglycaemia) - Time to plasma glucose concentration of =70 mg/dL (insulin-induced hypoglycaemia) Safety and Tolerability: - Adverse events, clinical laboratory assessments (hematology, biochemistry, urinalysis), vital signs, physical examination, electrocardiogram, local tolerability, antidrug antibodies incidences ;Timepoint(s) of evaluation of this end point: a) 0-t b) before and after dosing with ZP4207 or Lilly Glucagon c) ongoing | — |
Countries
Germany
Contacts
Public ContactSr. Clinical Pharmacology Specialis
Zealand Pharma A/S
Outcome results
None listed