Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 25, 2018
First Posted Date  ICMJE September 28, 2018
Results First Submitted Date  ICMJE March 26, 2021
Results First Posted Date  ICMJE May 19, 2021
Last Update Posted Date May 19, 2021
Actual Study Start Date  ICMJE November 1, 2018
Actual Primary Completion Date March 11, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2021)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 27, 2018)
Time to Plasma Glucose Recovery. [ Time Frame: 0-45 minutes after dosing ]
Time to plasma glucose recovery. Plasma glucose recovery is 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 IV
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2021)
  • 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.
  • 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).
  • 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
  • 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.
  • 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
  • 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
  • Pharmacokinetics - Maximum Plasma Concentration [ Time Frame: 0-120 minutes after dosing ]
    Maximum plasma dasiglucagon concentration (Cmax)
  • Pharmacokinetics - Time to Maximum Plasma Concentration [ Time Frame: 0-120 minutes after dosing ]
    Time to maximum plasma dasiglucagon concentration (tmax)
  • Immunogenicity - Occurrence of Anti-drug Antibodies [ Time Frame: 58 days ]
    Occurrence of antibodies against dasiglucagon. Presented as percentage of patients with antibodies.
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2018)
  • 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 IV glucose.
  • 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Subjects With T1DM
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypoglycemia
  • Diabetes Mellitus, Type 1
Intervention  ICMJE
  • Drug: Dasiglucagon
    Glucagon analogue
    Other Name: ZP4207
  • Drug: Placebo
    Placebo for dasiglucagon
    Other Name: Placebo for dasiglucagon
Study Arms  ICMJE
  • Experimental: Dasiglucagon
    single fixed dose (subcutaneous injection) of dasiglucagon
    Intervention: Drug: Dasiglucagon
  • Placebo Comparator: Placebo
    single fixed dose (subcutaneous injection) of placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 13, 2019)
45
Original Estimated Enrollment  ICMJE
 (submitted: September 27, 2018)
46
Actual Study Completion Date  ICMJE March 11, 2019
Actual Primary Completion Date March 11, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03688711
Other Study ID Numbers  ICMJE ZP4207-17145
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zealand Pharma
Study Sponsor  ICMJE Zealand Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Christina M Sylvest, MSc Pharm Zealand Pharma A/S
PRS Account Zealand Pharma
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP