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

Primary Purpose

Hypoglycemia, Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Dasiglucagon
Placebo
Sponsored by
Zealand Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoglycemia focused on measuring glucagon

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • ProSciento, Inc.
  • AMCR Institute
  • Rainier Clinical Research, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dasiglucagon

Placebo

Arm Description

single fixed dose (subcutaneous injection) of dasiglucagon

single fixed dose (subcutaneous injection) of placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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 to Target Plasma Glucose Concentration
Time to first plasma glucose concentration ≥70 mg/dL (3.9 mmol/L) without administration of rescue intravenous glucose
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.
Pharmacokinetics - Area Under the Plasma Concentration Curve
Area under the drug concentration curve (AUC) from time zero to 90 minutes, AUC0-90min
Pharmacokinetics - Area Under the Plasma Concentration Curve
Area under the drug concentration curve (AUC) from time zero to 120 minutes, AUC0-120min
Pharmacokinetics - Maximum Plasma Concentration
Maximum plasma dasiglucagon concentration (Cmax)
Pharmacokinetics - Time to Maximum Plasma Concentration
Time to maximum plasma dasiglucagon concentration (tmax)
Immunogenicity - Occurrence of Anti-drug Antibodies
Occurrence of antibodies against dasiglucagon. Presented as percentage of patients with antibodies.
Rescue Infusions of IV Glucose After Trial Drug Administration
Presented as number of patients with rescue infusions of IV glucose after trial drug administration. This was a safety outcome measure. IV = intravenous
Time to First Rescue Infusion of IV Glucose After Trial Drug Administration
Safety outcome measure: time to first rescue infusion of IV glucose after trial drug administration. IV = intravenous

Full Information

First Posted
September 25, 2018
Last Updated
April 28, 2021
Sponsor
Zealand Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT03688711
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
March 11, 2019 (Actual)
Study Completion Date
March 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zealand Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoglycemia, Diabetes Mellitus, Type 1
Keywords
glucagon

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dasiglucagon
Arm Type
Experimental
Arm Description
single fixed dose (subcutaneous injection) of dasiglucagon
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
single fixed dose (subcutaneous injection) of placebo
Intervention Type
Drug
Intervention Name(s)
Dasiglucagon
Other Intervention Name(s)
ZP4207
Intervention Description
Glucagon analogue
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo for dasiglucagon
Intervention Description
Placebo for dasiglucagon
Primary Outcome Measure Information:
Title
Time to Plasma Glucose Recovery.
Description
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 Outcome Measure Information:
Title
Plasma Glucose Recovery After Trial Drug Injection
Description
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
Title
Plasma Glucose Changes From Baseline
Description
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
Title
Time to Target Plasma Glucose Concentration
Description
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
Title
Pharmacodynamics - Area Under the Effect Curve
Description
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
Title
Pharmacokinetics - Area Under the Plasma Concentration Curve
Description
Area under the drug concentration curve (AUC) from time zero to 90 minutes, AUC0-90min
Time Frame
0-90 minutes after dosing
Title
Pharmacokinetics - Area Under the Plasma Concentration Curve
Description
Area under the drug concentration curve (AUC) from time zero to 120 minutes, AUC0-120min
Time Frame
0-120 minutes after dosing
Title
Pharmacokinetics - Maximum Plasma Concentration
Description
Maximum plasma dasiglucagon concentration (Cmax)
Time Frame
0-120 minutes after dosing
Title
Pharmacokinetics - Time to Maximum Plasma Concentration
Description
Time to maximum plasma dasiglucagon concentration (tmax)
Time Frame
0-120 minutes after dosing
Title
Immunogenicity - Occurrence of Anti-drug Antibodies
Description
Occurrence of antibodies against dasiglucagon. Presented as percentage of patients with antibodies.
Time Frame
58 days
Title
Rescue Infusions of IV Glucose After Trial Drug Administration
Description
Presented as number of patients with rescue infusions of IV glucose after trial drug administration. This was a safety outcome measure. IV = intravenous
Time Frame
0-45 minutes after dosing
Title
Time to First Rescue Infusion of IV Glucose After Trial Drug Administration
Description
Safety outcome measure: time to first rescue infusion of IV glucose after trial drug administration. IV = intravenous
Time Frame
0-45 minutes after dosing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina M Sylvest, MSc Pharm
Organizational Affiliation
Zealand Pharma A/S
Official's Role
Study Director
Facility Information:
Facility Name
ProSciento, Inc.
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
AMCR Institute
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Rainier Clinical Research, Inc.
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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