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

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ClinicalTrials.gov Identifier: NCT03688711
Recruitment Status : Completed
First Posted : September 28, 2018
Results First Posted : May 19, 2021
Last Update Posted : May 19, 2021
Sponsor:
Information provided by (Responsible Party):
Zealand Pharma

Study Description
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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

Condition or disease Intervention/treatment Phase
Hypoglycemia Diabetes Mellitus, Type 1 Drug: Dasiglucagon Drug: Placebo Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : March 11, 2019
Actual Study Completion Date : March 11, 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Dasiglucagon
single fixed dose (subcutaneous injection) of dasiglucagon
 Drug: Dasiglucagon
Glucagon analogue
Other Name: ZP4207
Placebo Comparator: Placebo
single fixed dose (subcutaneous injection) of placebo
 Drug: Placebo
Placebo for dasiglucagon
Other Name: Placebo for dasiglucagon


Outcome Measures
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Primary Outcome Measures :
  1. Time to Plasma Glucose Recovery. [ Time Frame: 0-45 minutes after dosing ]
    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 :
  1. Plasma Glucose Recovery After Trial Drug Injection [ Time Frame: 0-30 minutes after dosing ]
    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.

  2. Plasma Glucose Changes From Baseline [ Time Frame: 0-30 minutes after dosing ]
    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).

  3. Time to Target Plasma Glucose Concentration [ Time Frame: 0-45 minutes after dosing ]
    Time to first plasma glucose concentration ≥70 mg/dL (3.9 mmol/L) without administration of rescue intravenous glucose

  4. Pharmacodynamics - Area Under the Effect Curve [ Time Frame: 0-30 minutes after dosing ]
    Plasma glucose response as area under the effect curve (AUE) above baseline from time zero to 30 minutes, AUE0-30min.

  5. Pharmacokinetics - Area Under the Plasma Concentration Curve [ Time Frame: 0-90 minutes after dosing ]
    Area under the drug concentration curve (AUC) from time zero to 90 minutes, AUC0-90min

  6. Pharmacokinetics - Area Under the Plasma Concentration Curve [ Time Frame: 0-120 minutes after dosing ]
    Area under the drug concentration curve (AUC) from time zero to 120 minutes, AUC0-120min

  7. Pharmacokinetics - Maximum Plasma Concentration [ Time Frame: 0-120 minutes after dosing ]
    Maximum plasma dasiglucagon concentration (Cmax)

  8. Pharmacokinetics - Time to Maximum Plasma Concentration [ Time Frame: 0-120 minutes after dosing ]
    Time to maximum plasma dasiglucagon concentration (tmax)

  9. Immunogenicity - Occurrence of Anti-drug Antibodies [ Time Frame: 58 days ]
    Occurrence of antibodies against dasiglucagon. Presented as percentage of patients with antibodies.

  10. Rescue Infusions of IV Glucose After Trial Drug Administration [ Time Frame: 0-45 minutes after dosing ]
    Presented as number of patients with rescue infusions of IV glucose after trial drug administration. This was a safety outcome measure. IV = intravenous

  11. Time to First Rescue Infusion of IV Glucose After Trial Drug Administration [ Time Frame: 0-45 minutes after dosing ]
    Safety outcome measure: time to first rescue infusion of IV glucose after trial drug administration. IV = intravenous


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688711


Locations
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United States, California
ProSciento, Inc.
Chula Vista, California, United States, 91911
AMCR Institute
Escondido, California, United States, 92025
United States, Washington
Rainier Clinical Research, Inc.
Renton, Washington, United States, 98057
Sponsors and Collaborators
Zealand Pharma
Investigators
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Study Director: Christina M Sylvest, MSc Pharm Zealand Pharma A/S
  Study Documents (Full-Text)

Documents provided by Zealand Pharma:
Study Protocol  [PDF] July 4, 2018
Statistical Analysis Plan  [PDF] April 24, 2019

More Information
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Responsible Party: Zealand Pharma
ClinicalTrials.gov Identifier: NCT03688711    
Other Study ID Numbers: ZP4207-17145
First Posted: September 28, 2018    Key Record Dates
Results First Posted: May 19, 2021
Last Update Posted: May 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zealand Pharma:
glucagon
Additional relevant MeSH terms:
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Diabetes Mellitus
Hypoglycemia
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases