Clinical trial NCT03688711: Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Subjects With T1DM
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypoglycemia
Diabetes Mellitus, Type 1
Keywords: glucagon
Lead sponsor: Zealand Pharma
Sponsor class: INDUSTRY
First posted: 2018-09-28
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to Plasma Glucose Recovery.
timeFrame: 0-45 minutes after dosing
Secondary outcomes:
measure: Plasma Glucose Recovery After Trial Drug Injection
timeFrame: 0-30 minutes after dosing
measure: Plasma Glucose Changes From Baseline
timeFrame: 0-30 minutes after dosing
measure: Time to Target Plasma Glucose Concentration
timeFrame: 0-45 minutes after dosing
measure: Pharmacodynamics - Area Under the Effect Curve
timeFrame: 0-30 minutes after dosing
measure: Pharmacokinetics - Area Under the Plasma Concentration Curve
timeFrame: 0-90 minutes after dosing
measure: Pharmacokinetics - Area Under the Plasma Concentration Curve
timeFrame: 0-120 minutes after dosing
measure: Pharmacokinetics - Maximum Plasma Concentration
timeFrame: 0-120 minutes after dosing
measure: Pharmacokinetics - Time to Maximum Plasma Concentration
timeFrame: 0-120 minutes after dosing
measure: Immunogenicity - Occurrence of Anti-drug Antibodies
timeFrame: 58 days
measure: Rescue Infusions of IV Glucose After Trial Drug Administration
timeFrame: 0-45 minutes after dosing
measure: Time to First Rescue Infusion of IV Glucose After Trial Drug Administration
timeFrame: 0-45 minutes after dosing
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: ProSciento, Inc.
state: California
city: Escondido
country: United States
facility: AMCR Institute
state: California
city: Renton
country: United States
facility: Rainier Clinical Research, Inc.
state: Washington
Study officials:
affiliation: Zealand Pharma A/S
name: Christina M Sylvest, MSc Pharm
role: STUDY_DIRECTOR
References: