Logo 1 Logo 2

Clinical Trial Details

Trial ID: L7331
Source ID: NCT02916251
Associated Drug: Zp4207(Dasiglucagon) Glucagon Analogue
Title: ZP4207(Dasiglucagon) Administered to T1D Patients to Assess the PK and PD Compared to Marketed Glucagon
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus Type 1
Interventions: DRUG: ZP4207(dasiglucagon) glucagon analogue|DRUG: Glucagon (Native glucagon)
Outcome Measures: Primary: PK endpoint for ZP4207(dasiglucagon) and baseline adjusted glucagon: AUC 0-240 min, Area under the curve from 0-240 min, AUC 0-240 min during all treatment periods (V2-V5)|PK endpoint for ZP4207(dasiglucagon) and baseline adjusted glucagon: Cmax, max. concentration, Pre-dose, 5, 15, 30, 60, 90, 150 and 240 minutes post dosing. Peak of plasma concentration during all treatment periods (V2-V 5)|PK endpoint for ZP4207(dasiglucagon) and baseline adjusted glucagon: tmax, Time to peak plasma concentration, Pre-dose, 5, 15, 30, 60, 90, 150 and 240 minutes post dosing. Time to peak plasma concentration during all treatment periods (V2-V5)|PD endpoint: Plasma glucose profiles above baseline: AUE 0-240 min, Area under the effect curve from 0-240 min, Pre-dose, 10, 30, 50, 70, 90, 150, 240 minutes post dosing. AUE 0-240 min during all treatment periods (V2-V5)|PD endpoint: Plasma glucose profiles above baseline: CEmax, Max concentration effect, Pre-dose, 10, 30, 50, 70, 90, 150, 240 minutes post dosing. Peak of plasma glucose concentration during all treatment periods (V2-V5)|PD endpoint: Plasma glucose profiles above baseline: tmax, Time to peak plasma glucose concentration, Pre-dose, 10, 30, 50, 70, 90, 150, 240 minutes post dosing Time to plasma glucose concentration during all treatment periods (V2-V5) | Secondary: PK endpoints for ZP4207(dasiglucagon) and baseline adjusted glucagon: MRT, Mean residence time, Pre-dose, 5, 15, 30, 60, 90, 150 and 240 minutes post dosing. Mean residence time for ZP4207(dasiglucagon) and baseline adjusted glucagon during all treatment periods (V2-V5)|PK endpoints for ZP4207(dasiglucagon) and baseline adjusted glucagon: Vz/f,, Volume of distribution, Pre-dose, 5, 15, 30, 60, 90, 150 and 240 minutes post dosing. Volume of distribution of plasma ZP4207(dasiglucagon) or glucagon during all treatment periods (V2-V5)|PK endpoints for ZP4207(dasiglucagon) and baseline adjusted glucagon: λz, Terminal elimination rate constant, Pre-dose, 5, 15, 30, 60, 90, 150 and 240 minutes post dosing. Terminal elimination rate constant of ZP4207(dasiglucagon) and baseline adjusted glucagon during all treatment periods (V2-V5)|PK endpoints for ZP4207(dasiglucagon) and baseline adjusted glucagon: t½,, Terminal plasma elimination half-life, Pre-dose, 5, 15, 30, 60, 90, 150 and 240 minutes post dosing. Terminal plasma elimination half-life of ZP4207(dasiglucagon) or glucagon during all treatment periods (V2-V5)|PK endpoints for ZP4207(dasiglucagon) and baseline adjusted glucagon: CL/f, Total body clearance, Pre-dose, 5, 15, 30, 60, 90, 150 and 240 minutes post dosing. Total body clearance of plasma ZP4207(dasiglucagon) or glucagon during all treatment periods (V2-V5)|PK endpoints for ZP4207(dasiglucagon) and baseline adjusted glucagon: AUC 0-30min, Area under the curve from 0-30 min, AUC 0-30 min during all treatment periods (V2-V 5)|PK endpoints for ZP4207(dasiglucagon) and baseline adjusted glucagon: AUC 0-inf, Area under the curve from 0-inf, Pre-dose, 5, 15, 30, 60, 90, 150 and 240 minutes post dosing. AUC 0-inf during all treatment periods (V2-V 5)|Insulin concentrations before and after dosing with ZP4207(dasiglucagon) or glucagon:, Insulin concentrations, Pre-dose, 5, 15, 30, 60, 90, 150 and 240 minutes post dosing. Insulin concentrations during all treatment periods (V2-V 5)|PD endpoints for ZP4207(dasiglucagon) and baseline adjusted glucagon: AUE 0-30min, Area under the effect curve from 0-30 min, AUE 0-240 min during all treatment periods (V2-V5)|PD endpoints for ZP4207(dasiglucagon) and baseline adjusted glucagon: CE 30min, Concentration effect at 30 min, Concentration effect at 30 min during all treatment periods (V2-V5)|PD endpoints for ZP4207(dasiglucagon) and baseline adjusted glucagon: t50%CE, early, Time to half concentration effect, Pre-dose, 10, 30, 50, 70, 90, 150, 240 minutes post dosing. Time to half concentration effect (t50%CE, early) during all treatment periods (V2-V5)|PD endpoints for ZP4207(dasiglucagon) and baseline adjusted glucagon: t10%CE, late, Time to 90% decrease from CEmax, Pre-dose, 10, 30, 50, 70, 90, 150, 240 minutes post dosing. Time to 90% decrease from peak concentration effect during all treatment periods (V2-V5)|PD endpoints: Percentage of patients achieving a plasma glucose increase of ≥20 mg/dL within 30 minutes after treatment, During all treatment periods (V2-V5) within 30 min after dosing|PD endpoints: Time to plasma glucose increase of ≥20 mg/dL, Pre-dose, 10, 30, 50, 70, 90, 150, 240 minutes post dosing. During all treatment periods (V2-V5) - time plasma glucose increase of ≥20 mg/dL after dosing|PD endpoints: Percentage of patients achieving a plasma glucose concentration ≥70 mg/dL within 30 minutes after treatment (insulin-induced hypoglycemia), During all treatment periods (V2-V5) within 30 min after dosing (insulin-induced hypoglycemia)|PD endpoints: Time to plasma glucose concentration of ≥70 mg/dL (insulin-induced hypoglycemia), Pre-dose, 10, 30, 50, 70, 90, 150, 240 minutes post dosing. During all treatment periods (V2-V5) - time plasma glucose increase of ≥70 mg/dL after dosing (insulin-induced hypoglycemia)|Safety endpoints: Number of participants with adverse events, Includes events from the first trial related activity after the patient has signed the informed consent until Follow up visit., Through study completion. The total trial duration for a patient will be about 5.5 to 12 weeks.|Safety endpoints: 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 these assessments will be reported on a scale of 0 (none), 1 (mild), 2 (moderate) and 3 (severe), Local tolerability assessed pre-dose (within 30 min) and at 0.5, 2, and 4 hours post-dose (each treatment visit and at Follow up visit).|Safety endpoints: Laboratory safety parameters, Haematology, biochemistry and urinalysis: Changes or findings from baseline (normal ranges) in clinical safety laboratory parameters during the study duration (from Screening, at treatment visits and at Follow up visit)., Through study completion. The total trial duration for a patient will be about 5.5 to 12 weeks.|Safety endpoints: Physical examination, Physical examination: Changes or findings from baseline (normal ranges) in physical examination during the study duration (at Screening and Follow up visit). 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, Through study completion. The total trial duration for a patient will be about 5.5 to 12 weeks.|Safety endpoints: Vital signs, Diastolic and systolic blood pressure (mmHg) are measured after at least 5 min rest in a supine position. At the screening visit blood pressure is measured in both arms. The blood pressure from the arm with the higher systolic value is transcribed into the CRF and this arm is used for all subsequent measurements of the patient's blood pressure in this trial. Pulse (beats per min) measured after at least 5 min rest in a supine position. Body temperature, tympanic (in Celsius). Respiratory frequency (RF/min). Changes or findings from baseline (normal ranges) in vital signs during the study duration (at Screening, at each treatment visit and at Follow up)., Through study completion. The total trial duration for a patient will be about 5.5 to 12 weeks.|Safety endpoints: ECGs, A standard 12-lead electrocardiogram (ECG) will be performed. ECG parameters (Heart rate, PQ, QRS, QT, QTcB) and any abnormality will be recorded and described in the CRF including the Investigator's assessment of clinical significance ('abnormal, not clinically significant' or 'abnormal, clinically significant'). Clinically significant findings at the screening visit should be recorded as concomitant illness. At subsequent visits, any clinically significant deterioration of a pre-existing condition as well as any new clinically significant findings will be recorded as AEs. Changes or findings from baseline (normal ranges) (Screening visit and at Follow up) in ECGs during the study duration., Through study completion. The total trial duration for a patient will be about 5.5 to 12 weeks.|Safety endpoints: Antidrug antibodies incidences, Antidrug antibodies analyses will be performed. Changes or findings from baseline (normal ranges) in Antidrug antibodies incidences during the study duration (before first dosing, at last treatment visit and at Follow up)., Through study completion. The total trial duration for a patient will be about 5.5 to 12 weeks.
Sponsor/Collaborators: Sponsor: Zealand Pharma
Gender: ALL
Age: ADULT
Phases: PHASE2
Enrollment: 38
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2016-12-01
Completion Date: 2017-04-05
Results First Posted:
Last Update Posted: 2017-04-21
Locations: Profil Institut für Stoffwechselforschung GmbH, Neuss, North Rhine-Westphalia, 41460, Germany
URL: https://clinicaltrials.gov/show/NCT02916251