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

NCT ID: NCT03688711

Last Updated: 2021-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2019-03-11

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.

Conditions

Hypoglycemia; Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dasiglucagon

single fixed dose (subcutaneous injection) of dasiglucagon

Group Type: EXPERIMENTAL

Dasiglucagon

Intervention Type: DRUG

Glucagon analogue

Placebo

single fixed dose (subcutaneous injection) of placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo for dasiglucagon

Interventions

Dasiglucagon

Glucagon analogue

Intervention Type: DRUG

Placebo

Placebo for dasiglucagon

Intervention Type: DRUG

Other Intervention Names

ZP4207; Placebo for dasiglucagon

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zealand Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christina M Sylvest, MSc Pharm

Role: STUDY_DIRECTOR

Zealand Pharma A/S

Locations

ProSciento, Inc.

Chula Vista, California, United States

AMCR Institute

Escondido, California, United States

Rainier Clinical Research, Inc.

Renton, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ZP4207-17145

Identifier Type: -

Identifier Source: org_study_id