A Trial to Compare the Efficacy and Safety of 2 Different Batches of Subcutaneous Dasiglucagon in Patients With T1DM

Diabetes Mellitus, Type 1 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03895697
• Other study ID #: ZP4207-17084
• Status: Completed
• Phase: Phase 3
• Start date: March 26, 2019
• Est. completion date: July 30, 2019

Study information

• Verified date: February 2023
• Source: Zealand Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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 information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: July 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypoglycemia

Intervention

Drug:
• dasiglucagon
Glucagon analogue

Locations

Country	Name	City	State
Canada	LMC Diabetes & Manna Research	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Zealand Pharma

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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	0-30 minutes after dosing
Secondary	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
Secondary	Pharmacodynamics - Maximum plasma glucose concentration	Change from baseline plasma glucose to maximum plasma glucose measure after dosing, CEmax	0-90 minutes after dosing
Secondary	Pharmacodynamics - Time maximum plasma glucose concentration	Time to maximum change in plasma glucose measure from baseline, TEmax	0-90 minutes after dosing
Secondary	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
Secondary	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
Secondary	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
Secondary	Pharmacokinetics - Maximum plasma concentration	Measured maximum plasma drug concentration after dosing, Cmax	0-300 minutes after dosing
Secondary	Pharmacokinetics - Time to maximum plasma concentration	Sampling time until reaching Cmax, Tmax	0-300 minutes after dosing
Secondary	Pharmacokinetics - Half-life	Half-life dasiglucagon, t½	0-300 minutes after dosing
Secondary	Pharmacokinetics - Volume of distribution	Apparent volume of distribution of dasiglucagon, Vz/f	0-300 minutes after dosing
Secondary	Pharmacokinetics - Mean residence time	Mean residence time, MRT	0-300 minutes after dosing
Secondary	Pharmacokinetics - Body clearance	Total body clearance, CL/f	0-300 minutes after dosing
Secondary	Safety - Adverse events	The incidence, type and severity of adverse events (AEs)	90 days
Secondary	Safety - Number of rescue infusions	Number of rescue infusions of IV glucose after trial drug administration	0-90 minutes after dosing
Secondary	Safety - Time to first rescue infusion	Time to first rescue infusion of IV glucose after trial drug administration	0-90 minutes after dosing
Secondary	Immunogenicity - Occurrence of anti-drug antibodies	Occurrence of antibodies against dasiglucagon	60 days