A Trial to Compare the Efficacy and Safety of 2 Different Batches of Subcutaneous Dasiglucagon in Patients With T1DM

NCTNCT03895697Other idZP4207-17084

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Overview

Status: Completed
Phase: Phase 3
Enrollment: 92 participants (actual)
Sponsor: Zealand Pharma · Industry
Design: Randomized · Quadruple masking
Countries: 1 country
Canada
Start: 26 Mar 2019
Primary completion: 30 Jul 2019
Completion: 30 Jul 2019
First posted: 29 Mar 2019
Last update posted: 21 Feb 2023
Conditions: Hypoglycemia · Diabetes Mellitus, Type 1

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20192020

Ph 3
A Trial to Compare the Efficacy and Safety of 2 Different Batches of Subcutaneous Dasiglucagon in Patients With T1DM
NCT03895697
26 Mar 2019 to 30 Jul 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

A randomized, double-blind, crossover trial to compare the efficacy and safety of 2 different batches of subcutaneous dasiglucagon in patients with type 1 diabetes mellitus (T1DM)

Interventions

dasiglucagonDrug

Arms2

Experimental
Dasiglucagon batch A crossover to dasiglucagon batch B
V2: Single fixed dose (subcutaneous injection) of dasiglucagon batch A then at V3: Single fixed dose (subcutaneous injection) of dasiglucagon batch B
Experimental
Dasiglucagon batch B crossover to dasiglucagon batch A
V2: Single fixed dose (subcutaneous injection) of dasiglucagon batch B then at V3: Single fixed dose (subcutaneous injection) of dasiglucagon batch A

Primary outcomes1

Outcomes the sponsor listed as primary.

Time to plasma glucose recovery
Time frame · 0-45 minutes after dosing
Registry description
Plasma glucose recovery is defined as first increase in plasma glucose of ≥20 mg/dL (1.1 mmol/L) from baseline during the hypoglycemic clamp procedure without administration of rescue intravenous glucose

Secondary outcomes(18)

Plasma glucose changes from baseline
Time frame · 0-30 minutes after dosing
Registry description
Plasma glucose changes from baseline at 30 minutes, at 20 minutes, at 15 minutes, and at 10 minutes after trial drug injection or at the time of rescue patient level).
Pharmacodynamics - Area under the effect curve 30 min
Time frame · 0-30 minutes after dosing
Registry description
Area under the baseline-adjusted effect curve (AUE) from zero up to the concentration at 30 minutes, AUE 0-30min
Pharmacodynamics - Area under the effect curve 90 min
Time frame · 0-90 minutes after dosing
Registry description
Area under the baseline-adjusted effect curve (AUE) from zero up to the concentration at 90 minutes, AUE 0-90min
Pharmacodynamics - Maximum plasma glucose concentration
Time frame · 0-90 minutes after dosing
Registry description
Change from baseline plasma glucose to maximum plasma glucose measure after dosing, CEmax
Pharmacodynamics - Time maximum plasma glucose concentration
Time frame · 0-90 minutes after dosing
Registry description
Time to maximum change in plasma glucose measure from baseline, TEmax
Pharmacokinetics - Area under the plasma concentration-time curve 30 min
Time frame · 0-30 minutes after dosing
Registry description
Area under the concentration-time curve (AUC) from zero up to the concentration at 30 minutes, AUC0-30min
Pharmacokinetics - Area under the plasma concentration-time curve 300 min
Time frame · 0-300 minutes after dosing
Registry description
Area under the concentration-time curve (AUC) from zero up to the concentration at 300 minutes, AUC0-300min
Pharmacokinetics - Area under the plasma concentration curve Infinitely
Time frame · 0-300 minutes after dosing
Registry description
Area under the concentration-time curve from zero up to the concentration at infinitely after dosing, AUC0-inf
Pharmacokinetics - Maximum plasma concentration
Time frame · 0-300 minutes after dosing
Registry description
Measured maximum plasma drug concentration after dosing, Cmax
Pharmacokinetics - Time to maximum plasma concentration
Time frame · 0-300 minutes after dosing
Registry description
Sampling time until reaching Cmax, Tmax
Pharmacokinetics - Half-life
Time frame · 0-300 minutes after dosing
Registry description
Half-life dasiglucagon, t½
Pharmacokinetics - Volume of distribution
Time frame · 0-300 minutes after dosing
Registry description
Apparent volume of distribution of dasiglucagon, Vz/f
Pharmacokinetics - Mean residence time
Time frame · 0-300 minutes after dosing
Registry description
Mean residence time, MRT
Pharmacokinetics - Body clearance
Time frame · 0-300 minutes after dosing
Registry description
Total body clearance, CL/f
Safety - Adverse events
Time frame · 90 days
Registry description
The incidence, type and severity of adverse events (AEs)
Safety - Number of rescue infusions
Time frame · 0-90 minutes after dosing
Registry description
Number of rescue infusions of IV glucose after trial drug administration
Safety - Time to first rescue infusion
Time frame · 0-90 minutes after dosing
Registry description
Time to first rescue infusion of IV glucose after trial drug administration
Immunogenicity - Occurrence of anti-drug antibodies
Time frame · 60 days
Registry description
Occurrence of antibodies against dasiglucagon

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 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Type 1 diabetes mellitus for at least 1 year according to the diagnostic criteria as defined by the American Diabetes Association. * Hemoglobin A1c \<10.0% at screening * Treated with stable insulin treatment (defined as no more than a 10-unit daily variation in total daily insulin dose) 30 days prior to screening Exclusion Criteria: * History of hypoglycemic events associated with seizures in the last year prior to screening * History of severe hypoglycemia (an episode requiring assistance from another person) in the last month prior to screening * Previous participation in a clinical trial within the dasiglucagon program

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