A Trial to Compare the Efficacy and Safety of 2 Different Batches of Subcutaneous Dasiglucagon in Patients With T1DM
- Registration Number
- NCT03895697
- Lead Sponsor
- Zealand Pharma
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 92
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Dasiglucagon batch A crossover to dasiglucagon batch B dasiglucagon V2: Single fixed dose (subcutaneous injection) of dasiglucagon batch A then at V3: Single fixed dose (subcutaneous injection) of dasiglucagon batch B Dasiglucagon batch B crossover to dasiglucagon batch A dasiglucagon V2: Single fixed dose (subcutaneous injection) of dasiglucagon batch B then at V3: Single fixed dose (subcutaneous injection) of dasiglucagon batch A
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Pharmacokinetics - Maximum plasma concentration 0-300 minutes after dosing Measured maximum plasma drug concentration after dosing, Cmax
Pharmacodynamics - Maximum plasma glucose concentration 0-90 minutes after dosing Change from baseline plasma glucose to maximum plasma glucose measure after dosing, CEmax
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 - 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)
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 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
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
Pharmacokinetics - Mean residence time 0-300 minutes after dosing Mean residence time, MRT
Safety - Number of rescue infusions 0-90 minutes after dosing Number of rescue infusions of IV glucose after trial drug administration
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 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
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
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
Trial Locations
- Locations (1)
LMC Diabetes & Manna Research
🇨🇦Toronto, Ontario, Canada