Clinical trial NCT03895697: A Trial to Compare the Efficacy and Safety of 2 Different Batches of Subcutaneous Dasiglucagon in Patients With T1DM
Official title: A Phase 3b, 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypoglycemia
Diabetes Mellitus, Type 1
Keywords: glucagon
Lead sponsor: Zealand Pharma
Sponsor class: INDUSTRY
First posted: 2019-03-29
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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)

Detailed description: This multicenter, double-blind, crossover, randomized clinical trial was designed to evaluate the efficacy and safety of 2 different batches of subcutaneous dasiglucagon in patients with T1DM. Patients were randomly assigned 1:1 to either dasiglucagon Batch A or dasiglucagon Batch B as their initial dose and the other as the second dose. To avoid bias in the evaluation of clinical assessments, the trial was conducted in a double-blinded manner.

Eligibility criteria: 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

Primary outcomes:
measure: Time to plasma glucose recovery
timeFrame: 0-45 minutes after dosing
Secondary outcomes:
measure: Plasma glucose changes from baseline
timeFrame: 0-30 minutes after dosing
measure: Pharmacodynamics - Area under the effect curve 30 min
timeFrame: 0-30 minutes after dosing
measure: Pharmacodynamics - Area under the effect curve 90 min
timeFrame: 0-90 minutes after dosing
measure: Pharmacodynamics - Maximum plasma glucose concentration
timeFrame: 0-90 minutes after dosing
measure: Pharmacodynamics - Time maximum plasma glucose concentration
timeFrame: 0-90 minutes after dosing
measure: Pharmacokinetics - Area under the plasma concentration-time curve 30 min
timeFrame: 0-30 minutes after dosing
measure: Pharmacokinetics - Area under the plasma concentration-time curve 300 min
timeFrame: 0-300 minutes after dosing
measure: Pharmacokinetics - Area under the plasma concentration curve Infinitely
timeFrame: 0-300 minutes after dosing
measure: Pharmacokinetics - Maximum plasma concentration
timeFrame: 0-300 minutes after dosing
measure: Pharmacokinetics - Time to maximum plasma concentration
timeFrame: 0-300 minutes after dosing
measure: Pharmacokinetics - Half-life
timeFrame: 0-300 minutes after dosing
measure: Pharmacokinetics - Volume of distribution
timeFrame: 0-300 minutes after dosing
measure: Pharmacokinetics - Mean residence time
timeFrame: 0-300 minutes after dosing
measure: Pharmacokinetics - Body clearance
timeFrame: 0-300 minutes after dosing
measure: Safety - Adverse events
timeFrame: 90 days
measure: Safety - Number of rescue infusions
timeFrame: 0-90 minutes after dosing
measure: Safety - Time to first rescue infusion
timeFrame: 0-90 minutes after dosing
measure: Immunogenicity - Occurrence of anti-drug antibodies
timeFrame: 60 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: LMC Diabetes & Manna Research
state: Ontario
Study officials:
affiliation: Zealand Pharma A/S
name: Stine J Maarbjerg, PHD
role: STUDY_DIRECTOR
References: