Hypoglycemia, Diabetes Mellitus, Type 1
Conditions
Keywords
glucagon
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.
Interventions
DRUGdasiglucagon
Glucagon analogue
Sponsors
Zealand Pharma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to plasma glucose recovery | 0-45 minutes after dosing | 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
| Measure | Time frame | Description |
|---|---|---|
| Plasma glucose changes from baseline | 0-30 minutes after dosing | 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 90 min | 0-90 minutes after dosing | 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 | 0-90 minutes after dosing | Change from baseline plasma glucose to maximum plasma glucose measure after dosing, CEmax |
| Pharmacodynamics - Time maximum plasma glucose concentration | 0-90 minutes after dosing | Time to maximum change in plasma glucose measure from baseline, TEmax |
| Pharmacokinetics - Area under the plasma concentration-time curve 30 min | 0-30 minutes after dosing | 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 | 0-300 minutes after dosing | 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 | 0-300 minutes after dosing | Area under the concentration-time curve from zero up to the concentration at infinitely after dosing, AUC0-inf |
| Pharmacokinetics - Maximum plasma concentration | 0-300 minutes after dosing | Measured maximum plasma drug concentration after dosing, Cmax |
| Pharmacodynamics - Area under the effect curve 30 min | 0-30 minutes after dosing | Area under the baseline-adjusted effect curve (AUE) from zero up to the concentration at 30 minutes, AUE 0-30min |
| Pharmacokinetics - Half-life | 0-300 minutes after dosing | Half-life dasiglucagon, t½ |
| Pharmacokinetics - Volume of distribution | 0-300 minutes after dosing | Apparent volume of distribution of dasiglucagon, Vz/f |
| Pharmacokinetics - Mean residence time | 0-300 minutes after dosing | Mean residence time, MRT |
| Pharmacokinetics - Body clearance | 0-300 minutes after dosing | Total body clearance, CL/f |
| Safety - Adverse events | 90 days | The incidence, type and severity of adverse events (AEs) |
| Safety - Number of rescue infusions | 0-90 minutes after dosing | Number of rescue infusions of IV glucose after trial drug administration |
| Safety - Time to first rescue infusion | 0-90 minutes after dosing | Time to first rescue infusion of IV glucose after trial drug administration |
| Immunogenicity - Occurrence of anti-drug antibodies | 60 days | Occurrence of antibodies against dasiglucagon |
| Pharmacokinetics - Time to maximum plasma concentration | 0-300 minutes after dosing | Sampling time until reaching Cmax, Tmax |
Countries
Canada
Outcome results
None listed