A Trial to Compare the Efficacy and Safety of 2 Different Batches of Subcutaneous Dasiglucagon in Patients With T1DM
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sequence 1 V2: Single fixed dose (sc injection) of dasiglucagon batch B then at V3: Single fixed dose (sc injection) of dasiglucagon batch A |
Drug: dasiglucagon
Glucagon analogue
Other Names:
|
| Experimental: Sequence 2 V2: Single fixed dose (sc injection) of dasiglucagon batch A then at V3: Single fixed dose (sc injection) of dasiglucagon batch B |
Drug: dasiglucagon
Glucagon analogue
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
- 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
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | LMC Diabetes & Manna Research | Toronto | Ontario | Canada | M4G 3E8 |
Sponsors and Collaborators
- Zealand Pharma
Investigators
- Study Director: Stine J Maarbjerg, Zealand Pharma A/S
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ZP4207-17084