Type 1 Diabetes mellitus MedDRA version: 18.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Product Name: ZP4207
Product Code: ZP4207
Pharmaceutical Form: Solution for injection
INN or Proposed INN: GLUCAGON
CAS Number: 1544300-84-6
Concentration unit: mg/ml milligram(s)/millilitre
Concentra
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 • Having been treated with insulin for T1D for at least 1 year. • Age between 18 and 50 years, both inclusive. • Body weight between 60 and 90 kg, both inclusive 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 56 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Previously treated with ZP4207. • Known or suspected allergy to trial product(s) or related products. • Previous participation (randomization) in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize the pharmacokinetic (PK) and pharmacodynamic (PD) properties of ZP4207 in the final formulation following a single s.c. dose administered to hypoglycaemic Type 1 diabetic (T1D) patients;Secondary Objective: • To evaluate the safety and tolerability of ZP4207 in the final formulation following a single s.c. dose administered to hypoglycaemic T1D patients as compared to marketed glucagon • To compare PK and PD of ZP4207 to marketed glucagon following a single s.c. dose administered to hypoglycaemic T1D patients • To compare PK and PD of a proposed pediatric dose of ZP4207 to the approved marketed glucagon pediatric dose following a single s.c. dose administered to hypoglycaemic T1D patients ;Primary end point(s): PD endpoint: • Plasma glucose profiles 0-360 min above baseline: AUE0-30min, AUE, CE30min, CE, tmax PK endpoint: • Plasma ZP4207 and glucagon profiles 0-360 min: AUC0-30min, AUC0-360min, Cmax, tmax, ?z, t½, CL/f, Vz/f, MRT;Timepoint(s) of evaluation of this end point: 0-360 min after trial drug administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PD endpoints: • Percentage of patients achieving a plasma glucose concentration =70 mg/dL within 30 minutes after treatment • Time to plasma glucose concentration of =70 mg/dL • 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 PK endpoints: • Baseline adjusted glucagon profiles 0-360 min: AUC0-30min,BL AUC0-360min,BL Cmax,BL, AUC0-inf,BL • AUC0-inf for plasma ZP4207 concentration Exploratory Endpoint: • Insulin concentrations • Changes in hypoglycaemic symptom scores from 0-30 minutes – eVAS questionnaire 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: as given in the list above; for safety and tolerability: ongoing | — |
Countries
Germany
Contacts
Public ContactBritta Bysted
Zealand Pharma A/S
Outcome results
None listed