Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Subjects With T1DM

Zealand Pharma45 enrolled

Overview

A randomized, double-blind, parallel-group trial to confirm the clinical efficacy and safety of dasiglucagon in the rescue treatment of hypoglycemia in subjects with type 1 diabetes mellitus (T1DM) compared to placebo

Subjects were randomized in a ratio of 3:1 to receive a single subcutaneous dose of dasiglucagon (0.6 mg) or matching placebo. Randomization also determined whether the subject was to be injected in the buttock or deltoid. During the dosing visit (Visit 2), hypoglycemia was induced by a fast-acting insulin glulisine (Apidra®) infusion, and trial drug was administered when the subject's plasma glucose level was 45-60 mg/dL (2.5-3.3 mmol/L). During the insulin-induced hypoglycemia, pharmacokinetic and pharmacodynamic samples were drawn, and plasma glucose levels were monitored closely at site for safety reasons. A rescue glucose infusion could be administered to ameliorate persistent hypoglycemia. Subjects were followed for at least 28 days after dosing to perform an adequate immunogenicity evaluation of treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hypoglycemia Diabetes Mellitus, Type 1

Interventions

DasiglucagonDRUG

Glucagon analogue

PlaceboDRUG

Placebo for dasiglucagon

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female or male subjects with T1DM for at least 1 year; diagnostic criteria as defined by the American Diabetes Association (3). * Treated with insulin for T1DM for at least 1 year and with stable insulin treatment (defined as no more than a 10-unit daily variation in total daily insulin dose) 30 days prior to screening * Hemoglobin A1c \<10%. * Aged between 18 and 75 years, both inclusive. Exclusion Criteria: * Previous participation in a clinical trial within the dasiglucagon in the rescue treatment of hypoglycemia program. * Known or suspected allergy to trial drug(s) or related products. * History of anaphylaxis or symptoms of severe systemic allergy (such as angioedema). * Previous participation in this trial. Participation being defined by signing the informed consent document.

Locations (3)

ProSciento, Inc.

Chula Vista, California, United States

AMCR Institute

Escondido, California, United States

Rainier Clinical Research, Inc.

Renton, Washington, United States

Outcomes

Primary Outcomes

Time to Plasma Glucose Recovery.

Plasma glucose recovery was 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 (IV) glucose. Patients who received rescue IV glucose before 45 minutes and patients not recovering within 45 minutes after dosing were censored at 45 minutes.

Time frame: 0-45 minutes after dosing

Secondary Outcomes

Plasma Glucose Recovery After Trial Drug Injection

Plasma glucose recovery (patient has achieved increase in plasma glucose of ≥20 mg/dL (1.1 mmol/L)) within 30 minutes, within 20 minutes, within 15 minutes, and within 10 minutes after trial drug injection without administration of rescue intravenous (IV) glucose.

Time frame: 0-30 minutes after dosing

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

Time to Target Plasma Glucose Concentration

Time to first plasma glucose concentration ≥70 mg/dL (3.9 mmol/L) without administration of rescue intravenous glucose

Time frame: 0-45 minutes after dosing

Pharmacodynamics - Area Under the Effect Curve

Plasma glucose response as area under the effect curve (AUE) above baseline from time zero to 30 minutes, AUE0-30min.

Time frame: 0-30 minutes after dosing

Pharmacokinetics - Area Under the Plasma Concentration Curve

Area under the drug concentration curve (AUC) from time zero to 90 minutes, AUC0-90min

Data from ClinicalTrials.gov

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