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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dasiglucagon batch A crossover to dasiglucagon batch B | Experimental | V2: Single fixed dose (subcutaneous injection) of dasiglucagon batch A then at V3: Single fixed dose (subcutaneous injection) of dasiglucagon batch B |
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| Dasiglucagon batch B crossover to dasiglucagon batch A | Experimental | V2: Single fixed dose (subcutaneous injection) of dasiglucagon batch B then at V3: Single fixed dose (subcutaneous injection) of dasiglucagon batch A |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dasiglucagon | Drug | Glucagon analogue |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to plasma glucose recovery | 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 | 0-45 minutes after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma glucose changes from baseline | 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). | 0-30 minutes after dosing |
| Pharmacodynamics - Area under the effect curve 30 min |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stine J Maarbjerg, PHD | Zealand Pharma A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LMC Diabetes & Manna Research | Toronto | Ontario | M4G 3E8 | Canada |
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| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| C000710373 | dasiglucagon |
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Area under the baseline-adjusted effect curve (AUE) from zero up to the concentration at 30 minutes, AUE 0-30min |
| 0-30 minutes after dosing |
| Pharmacodynamics - Area under the effect curve 90 min | Area under the baseline-adjusted effect curve (AUE) from zero up to the concentration at 90 minutes, AUE 0-90min | 0-90 minutes after dosing |
| Pharmacodynamics - Maximum plasma glucose concentration | Change from baseline plasma glucose to maximum plasma glucose measure after dosing, CEmax | 0-90 minutes after dosing |
| Pharmacodynamics - Time maximum plasma glucose concentration | Time to maximum change in plasma glucose measure from baseline, TEmax | 0-90 minutes after dosing |
| Pharmacokinetics - Area under the plasma concentration-time curve 30 min | Area under the concentration-time curve (AUC) from zero up to the concentration at 30 minutes, AUC0-30min | 0-30 minutes after dosing |
| Pharmacokinetics - Area under the plasma concentration-time curve 300 min | Area under the concentration-time curve (AUC) from zero up to the concentration at 300 minutes, AUC0-300min | 0-300 minutes after dosing |
| Pharmacokinetics - Area under the plasma concentration curve Infinitely | Area under the concentration-time curve from zero up to the concentration at infinitely after dosing, AUC0-inf | 0-300 minutes after dosing |
| Pharmacokinetics - Maximum plasma concentration | Measured maximum plasma drug concentration after dosing, Cmax | 0-300 minutes after dosing |
| Pharmacokinetics - Time to maximum plasma concentration | Sampling time until reaching Cmax, Tmax | 0-300 minutes after dosing |
| Pharmacokinetics - Half-life | Half-life dasiglucagon, t½ | 0-300 minutes after dosing |
| Pharmacokinetics - Volume of distribution | Apparent volume of distribution of dasiglucagon, Vz/f | 0-300 minutes after dosing |
| Pharmacokinetics - Mean residence time | Mean residence time, MRT | 0-300 minutes after dosing |
| Pharmacokinetics - Body clearance | Total body clearance, CL/f | 0-300 minutes after dosing |
| Safety - Adverse events | The incidence, type and severity of adverse events (AEs) | 90 days |
| Safety - Number of rescue infusions | Number of rescue infusions of IV glucose after trial drug administration | 0-90 minutes after dosing |
| Safety - Time to first rescue infusion | Time to first rescue infusion of IV glucose after trial drug administration | 0-90 minutes after dosing |
| Immunogenicity - Occurrence of anti-drug antibodies | Occurrence of antibodies against dasiglucagon | 60 days |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |