Trial · Interventional
CompletedPhase 2Registry dataZP4207(Dasiglucagon) Administered to T1D Patients to Assess the PK and PD Compared to Marketed Glucagon
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 38 participants (actual)
- Sponsor
- Zealand Pharma · Industry
- Design
- Randomized · Double masking
- Countries
1 country
Germany
- Start
- 1 Dec 2016
- Primary completion
- 5 Apr 2017
- Completion
- 5 Apr 2017
- First posted
- 27 Sept 2016 (estimated)
- Last update posted
- 21 Apr 2017
- Conditions
- Diabetes Mellitus Type 1
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 2
ZP4207(Dasiglucagon) Administered to T1D Patients to Assess the PK and PD Compared to Marketed Glucagon
NCT029162511 Dec 2016 to 5 Apr 2017
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The trial is a single-centre, randomised, sequential, cross-over trial assessing pharmacokinetic and pharmacodynamic responses after micro-doses of ZP4207 (dasiglucagon\*) administered subcutaneously to patients with type 1 diabetes mellitus under euglycaemic and hypoglycaemic conditions and compared to marketed glucagon. \*dasiglucagon is the proposed International Nonproprietary Name (pINN) for ZP4207
Interventions
- ZP4207(dasiglucagon) glucagon analogueDrug
- Glucagon (Native glucagon)Drug
Arms2
Experimental
ZP4207(dasiglucagon)
Intervention: ZP4207(dasiglucagon) glucagon analogue (4 mg/mL) planned doses: 0.03, 0.08, 0.2 and 0.6 mg at euglycemic and hypoglycemic conditions.
Active comparator
Glucagon (Native glucagon)
Intervention: Glucagon (Native glucagon) 1 mg/mL as active comparator planned doses: 0.03, 0.08 and 0.2 mg at euglycemic conditions.
Primary outcomes6
Outcomes the sponsor listed as primary.
PK endpoint for ZP4207(dasiglucagon) and baseline adjusted glucagon: AUC 0-240 min
Time frame · AUC 0-240 min during all treatment periods (V2-V5)
Registry description
Area under the curve from 0-240 min
PK endpoint for ZP4207(dasiglucagon) and baseline adjusted glucagon: Cmax
Time frame · Pre-dose, 5, 15, 30, 60, 90, 150 and 240 minutes post dosing. Peak of plasma concentration during all treatment periods (V2-V 5)
Registry description
max. concentration
PK endpoint for ZP4207(dasiglucagon) and baseline adjusted glucagon: tmax
Time frame · Pre-dose, 5, 15, 30, 60, 90, 150 and 240 minutes post dosing. Time to peak plasma concentration during all treatment periods (V2-V5)
Registry description
Time to peak plasma concentration
PD endpoint: Plasma glucose profiles above baseline: AUE 0-240 min
Time frame · Pre-dose, 10, 30, 50, 70, 90, 150, 240 minutes post dosing. AUE 0-240 min during all treatment periods (V2-V5)
Registry description
Area under the effect curve from 0-240 min
PD endpoint: Plasma glucose profiles above baseline: CEmax
Time frame · Pre-dose, 10, 30, 50, 70, 90, 150, 240 minutes post dosing. Peak of plasma glucose concentration during all treatment periods (V2-V5)
Registry description
Max concentration effect
PD endpoint: Plasma glucose profiles above baseline: tmax
Time frame · Pre-dose, 10, 30, 50, 70, 90, 150, 240 minutes post dosing Time to plasma glucose concentration during all treatment periods (V2-V5)
Registry description
Time to peak plasma glucose concentration
Secondary outcomes(20)
PK endpoints for ZP4207(dasiglucagon) and baseline adjusted glucagon: MRT
Time frame · 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)
Registry description
Mean residence time
PK endpoints for ZP4207(dasiglucagon) and baseline adjusted glucagon: Vz/f,
Time frame · 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)
Registry description
Volume of distribution
PK endpoints for ZP4207(dasiglucagon) and baseline adjusted glucagon: λz
Time frame · 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)
Registry description
Terminal elimination rate constant
PK endpoints for ZP4207(dasiglucagon) and baseline adjusted glucagon: t½,
Time frame · 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)
Registry description
Terminal plasma elimination half-life
PK endpoints for ZP4207(dasiglucagon) and baseline adjusted glucagon: CL/f
Time frame · 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)
Registry description
Total body clearance
PK endpoints for ZP4207(dasiglucagon) and baseline adjusted glucagon: AUC 0-30min
Time frame · AUC 0-30 min during all treatment periods (V2-V 5)
Registry description
Area under the curve from 0-30 min
PK endpoints for ZP4207(dasiglucagon) and baseline adjusted glucagon: AUC 0-inf
Time frame · Pre-dose, 5, 15, 30, 60, 90, 150 and 240 minutes post dosing. AUC 0-inf during all treatment periods (V2-V 5)
Registry description
Area under the curve from 0-inf
Insulin concentrations before and after dosing with ZP4207(dasiglucagon) or glucagon:
Time frame · Pre-dose, 5, 15, 30, 60, 90, 150 and 240 minutes post dosing. Insulin concentrations during all treatment periods (V2-V 5)
Registry description
Insulin concentrations
PD endpoints for ZP4207(dasiglucagon) and baseline adjusted glucagon: AUE 0-30min
Time frame · AUE 0-240 min during all treatment periods (V2-V5)
Registry description
Area under the effect curve from 0-30 min
PD endpoints for ZP4207(dasiglucagon) and baseline adjusted glucagon: CE 30min
Time frame · Concentration effect at 30 min during all treatment periods (V2-V5)
Registry description
Concentration effect at 30 min
PD endpoints for ZP4207(dasiglucagon) and baseline adjusted glucagon: t50%CE, early
Time frame · 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)
Registry description
Time to half concentration effect
PD endpoints for ZP4207(dasiglucagon) and baseline adjusted glucagon: t10%CE, late
Time frame · 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)
Registry description
Time to 90% decrease from CEmax
PD endpoints: Percentage of patients achieving a plasma glucose increase of ≥20 mg/dL within 30 minutes after treatment
Time frame · During all treatment periods (V2-V5) within 30 min after dosing
PD endpoints: Time to plasma glucose increase of ≥20 mg/dL
Time frame · 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)
Time frame · 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)
Time frame · 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
Time frame · Through study completion. The total trial duration for a patient will be about 5.5 to 12 weeks.
Registry description
Includes events from the first trial related activity after the patient has signed the informed consent until Follow up visit.
Safety endpoints: Local tolerability of injection site
Time frame · 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).
Registry description
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)
Safety endpoints: Laboratory safety parameters
Time frame · Through study completion. The total trial duration for a patient will be about 5.5 to 12 weeks.
Registry description
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).
Safety endpoints: Physical examination
Time frame · Through study completion. The total trial duration for a patient will be about 5.5 to 12 weeks.
Registry description
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
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 64 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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