The trial is a single-centre, randomized, double-blind, parallel trial in Group 1 and cross-over trial in Groups 2-4 with single doses of ZP4207 administered s.c. to hypoglycemic Type 1 diabetic patients to evaluate the pharmacokinetics and pharmacodynamics of ZP4207 as compared to marketed glucagon.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
81
Parallel trial in Group 1 and cross-over trial in Groups 2-4 with single doses of ZP4207 administered s.c. to hypoglycemic Type 1 diabetic patients
Parallel trial in Group 1 and cross-over trial in Groups 2-4 with single doses of GlucaGen administered s.c. to hypoglycemic Type 1 diabetic patients
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany
PD endpoint: Plasma glucose profiles 0-360 min above baseline (Area under the effect curve 0-360 min)
At visit 2 and 3
Time frame: During visit 2 and 3 (0-360min)
PD endpoint: Time to peak plasma glucose concentration (tmax)
At visit 2 and 3
Time frame: During visit 2 and 3 (0-360min)
PK endpoint: Plasma ZP4207 and glucagon profiles 0-360 min
At visit 2 and 3
Time frame: During visit 2 and 3 (0-360min)
PK endpoint: Peak plasma concentration (Cmax)
At visit 2 and 3
Time frame: During visit 2 and 3 (0-360min)
PK endpoint: Time to peak plasma concentration (tCmax)
At visit 2 and 3
Time frame: During visit 2 and 3 (0-360min)
PD endpoints: Percentage of patients achieving a plasma glucose concentration ≥70 mg/dL within 30 minutes after treatment
At visit 2 and 3
Time frame: During visit 2 and 3 (0-30min)
PD endpoints: Time to plasma glucose concentration of ≥70 mg/dL
At visit 2 and 3
Time frame: During visit 2 and 3 (0-360min)
PD endpoints: Percentage of patients achieving a plasma glucose increase of ≥20 mg/dL within 30 minutes after treatment
At visit 2 and 3,
Time frame: During visit 2 and 3 (0-30min)
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PD endpoints: Time to plasma glucose increase of ≥20 mg/dL
At visit 2 and 3,
Time frame: During visit 2 and 3 (0-360min)
PK endpoints: Baseline adjusted glucagon profiles 0-360 min
At visit 2 and 3,
Time frame: During visit 2 and 3 (0-360min)
PK endpoints: AUC0-inf for plasma ZP4207 concentration
At visit 2 and 3, Area under the plasma curve from 0 to infinity
Time frame: During visit 2 and 3 (0-360min)
Exploratory endpoint: Insulin concentrations
At visit 2 and 3, insulin concentrations in serum
Time frame: During visit 2 and 3 (0-360min)
Exploratory endpoint: Changes in hypoglycaemic symptom scores from 0-30 minutes
At visit 2 and 3
Time frame: During visit 2 and 3 (0-30min)
Safety and Tolerability: Number of participants with adverse events
Number of participants with adverse events
Time frame: Through study completion (up to 63 days)
Safety and Tolerability: Changes or findings from baseline in physical examination
An examination of the following body systems will be performed: * Head, ears, eyes, nose, throat (HEENT), incl. thyroid gland * Heart, lung, chest * Abdomen * Skin and mucosae * Musculoskeletal system * Nervous system * Lymph node * Other findings
Time frame: Through study completion (up to 63 days)
Safety and Tolerability: Changes or findings from baseline (normal ranges) in clinical safety laboratory parameters
Haematology biochemistry, and urinalysis
Time frame: Through study completion (up to 63 days)
Safety and Tolerability: Changes or findings from baseline in vital signs
systolic/diastolic blood pressure (mmHg) and heart rate (beats per minute), body temperature (°C), respiratory frequency (RF/min)
Time frame: Through study completion (up to 63 days)
Safety and Tolerability: Changes or findings from baseline in ECG
Heart rate, PQ, QRS, QT, QTcB
Time frame: Through study completion (up to 63 days)
Safety and Tolerability: Local tolerability of injection site
Findings in local tolerability by means of the following assessments. * spontaneous pain * pain on palpation * itching * redness * oedema * induration/infiltration * other
Time frame: Through study completion (up to 63 days)
Safety and Tolerability: Immunogenicity (Ant-Drug Antibody sampling)
Antidrug antibodies incidences
Time frame: Through study completion (up to 63 days)