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

Zealand Pharma92 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hypoglycemia Diabetes Mellitus, Type 1

Interventions

dasiglucagonDRUG

Glucagon analogue

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

LMC Diabetes & Manna Research

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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

Time frame: 0-45 minutes after dosing

Secondary Outcomes

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).

Time frame: 0-30 minutes after dosing

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

Time frame: 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

Time frame: 0-90 minutes after dosing

Pharmacodynamics - Maximum plasma glucose concentration

Change from baseline plasma glucose to maximum plasma glucose measure after dosing, CEmax

Time frame: 0-90 minutes after dosing

Pharmacodynamics - Time maximum plasma glucose concentration

Time to maximum change in plasma glucose measure from baseline, TEmax

Time frame: 0-90 minutes after dosing

Pharmacokinetics - Area under the plasma concentration-time curve 30 min

Data from ClinicalTrials.gov

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