Back to resultsA Trial to Compare the Efficacy and Safety of 2 Different Batches of Subcutaneous Dasiglucagon in Patients With T1DM
Primary Purpose
Hypoglycemia, Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
dasiglucagon
Sponsored by
About this trial
This is an interventional treatment trial for Hypoglycemia focused on measuring glucagon
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
Sites / Locations
- LMC Diabetes & Manna Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dasiglucagon batch A crossover to dasiglucagon batch B
Dasiglucagon batch B crossover to dasiglucagon batch A
Arm Description
V2: Single fixed dose (subcutaneous injection) of dasiglucagon batch A then at V3: Single fixed dose (subcutaneous injection) of dasiglucagon batch B
V2: Single fixed dose (subcutaneous injection) of dasiglucagon batch B then at V3: Single fixed dose (subcutaneous injection) of dasiglucagon batch A
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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).
Pharmacodynamics - Area under the effect curve 30 min
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
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
Change from baseline plasma glucose to maximum plasma glucose measure after dosing, CEmax
Pharmacodynamics - Time maximum plasma glucose concentration
Time to maximum change in plasma glucose measure from baseline, TEmax
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
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
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
Pharmacokinetics - Maximum plasma concentration
Measured maximum plasma drug concentration after dosing, Cmax
Pharmacokinetics - Time to maximum plasma concentration
Sampling time until reaching Cmax, Tmax
Pharmacokinetics - Half-life
Half-life dasiglucagon, t½
Pharmacokinetics - Volume of distribution
Apparent volume of distribution of dasiglucagon, Vz/f
Pharmacokinetics - Mean residence time
Mean residence time, MRT
Pharmacokinetics - Body clearance
Total body clearance, CL/f
Safety - Adverse events
The incidence, type and severity of adverse events (AEs)
Safety - Number of rescue infusions
Number of rescue infusions of IV glucose after trial drug administration
Safety - Time to first rescue infusion
Time to first rescue infusion of IV glucose after trial drug administration
Immunogenicity - Occurrence of anti-drug antibodies
Occurrence of antibodies against dasiglucagon
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03895697
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 26, 2019 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
July 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zealand Pharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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 (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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoglycemia, Diabetes Mellitus, Type 1
Keywords
glucagon
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dasiglucagon batch A crossover to dasiglucagon batch B
Arm Type
Experimental
Arm Description
V2: Single fixed dose (subcutaneous injection) of dasiglucagon batch A then at V3: Single fixed dose (subcutaneous injection) of dasiglucagon batch B
Arm Title
Dasiglucagon batch B crossover to dasiglucagon batch A
Arm Type
Experimental
Arm Description
V2: Single fixed dose (subcutaneous injection) of dasiglucagon batch B then at V3: Single fixed dose (subcutaneous injection) of dasiglucagon batch A
Intervention Type
Drug
Intervention Name(s)
dasiglucagon
Other Intervention Name(s)
ZP4207
Intervention Description
Glucagon analogue
Primary Outcome Measure Information:
Title
Time to plasma glucose recovery
Description
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
Time Frame
0-45 minutes after dosing
Secondary Outcome Measure Information:
Title
Plasma glucose changes from baseline
Description
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).
Time Frame
0-30 minutes after dosing
Title
Pharmacodynamics - Area under the effect curve 30 min
Description
Area under the baseline-adjusted effect curve (AUE) from zero up to the concentration at 30 minutes, AUE 0-30min
Time Frame
0-30 minutes after dosing
Title
Pharmacodynamics - Area under the effect curve 90 min
Description
Area under the baseline-adjusted effect curve (AUE) from zero up to the concentration at 90 minutes, AUE 0-90min
Time Frame
0-90 minutes after dosing
Title
Pharmacodynamics - Maximum plasma glucose concentration
Description
Change from baseline plasma glucose to maximum plasma glucose measure after dosing, CEmax
Time Frame
0-90 minutes after dosing
Title
Pharmacodynamics - Time maximum plasma glucose concentration
Description
Time to maximum change in plasma glucose measure from baseline, TEmax
Time Frame
0-90 minutes after dosing
Title
Pharmacokinetics - Area under the plasma concentration-time curve 30 min
Description
Area under the concentration-time curve (AUC) from zero up to the concentration at 30 minutes, AUC0-30min
Time Frame
0-30 minutes after dosing
Title
Pharmacokinetics - Area under the plasma concentration-time curve 300 min
Description
Area under the concentration-time curve (AUC) from zero up to the concentration at 300 minutes, AUC0-300min
Time Frame
0-300 minutes after dosing
Title
Pharmacokinetics - Area under the plasma concentration curve Infinitely
Description
Area under the concentration-time curve from zero up to the concentration at infinitely after dosing, AUC0-inf
Time Frame
0-300 minutes after dosing
Title
Pharmacokinetics - Maximum plasma concentration
Description
Measured maximum plasma drug concentration after dosing, Cmax
Time Frame
0-300 minutes after dosing
Title
Pharmacokinetics - Time to maximum plasma concentration
Description
Sampling time until reaching Cmax, Tmax
Time Frame
0-300 minutes after dosing
Title
Pharmacokinetics - Half-life
Description
Half-life dasiglucagon, t½
Time Frame
0-300 minutes after dosing
Title
Pharmacokinetics - Volume of distribution
Description
Apparent volume of distribution of dasiglucagon, Vz/f
Time Frame
0-300 minutes after dosing
Title
Pharmacokinetics - Mean residence time
Description
Mean residence time, MRT
Time Frame
0-300 minutes after dosing
Title
Pharmacokinetics - Body clearance
Description
Total body clearance, CL/f
Time Frame
0-300 minutes after dosing
Title
Safety - Adverse events
Description
The incidence, type and severity of adverse events (AEs)
Time Frame
90 days
Title
Safety - Number of rescue infusions
Description
Number of rescue infusions of IV glucose after trial drug administration
Time Frame
0-90 minutes after dosing
Title
Safety - Time to first rescue infusion
Description
Time to first rescue infusion of IV glucose after trial drug administration
Time Frame
0-90 minutes after dosing
Title
Immunogenicity - Occurrence of anti-drug antibodies
Description
Occurrence of antibodies against dasiglucagon
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stine J Maarbjerg, PHD
Organizational Affiliation
Zealand Pharma A/S
Official's Role
Study Director
Facility Information:
Facility Name
LMC Diabetes & Manna Research
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3E8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Trial to Compare the Efficacy and Safety of 2 Different Batches of Subcutaneous Dasiglucagon in Patients With T1DM
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