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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
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Zealand Pharma

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

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: dasiglucagon
single fixed dose (sc injection) of dasiglucagon
Drug: dasiglucagon
Glucagon analogue
Other Name: ZP4207

Placebo Comparator: Placebo
single fixed dose (sc injection) of placebo
Drug: Placebo
Placebo for dasiglucagon
Other Name: Placebo for dasiglucagon




Primary Outcome Measures :
  1. Time to plasma glucose recovery. [ Time Frame: 0-45 minutes after dosing ]
    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 glucose


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 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 [ Time Frame: 0-45 minutes after dosing ]
    Time to first plasma glucose concentration ≥70 mg/dL (3.9 mmol/L) without administration of rescue IV 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 - Maximum plasma concentration [ Time Frame: 0-120 minutes after dosing ]
    Maximum plasma drug concentration (Cmax)

  7. Pharmacokinetics - Time to maximum plasma concentration [ Time Frame: 0-120 minutes after dosing ]
    Time to maximum plasma drug concentration (tmax)

  8. Safety - Adverse events [ Time Frame: 58 days ]
    The incidence, type and severity of adverse events (AEs)

  9. Safety - Biochemistry laboratory parameter sodium [ Time Frame: 28 days ]
    Changes from baseline sodium

  10. Safety - Biochemistry laboratory parameter potassium [ Time Frame: 28 days ]
    Changes from baseline potassium

  11. Safety - Biochemistry laboratory parameter calcium [ Time Frame: 28 days ]
    Changes from baseline calcium

  12. Safety - Biochemistry laboratory parameter glucose [ Time Frame: 28 days ]
    Changes from baseline glucose

  13. Safety - Biochemistry laboratory parameter urea [ Time Frame: 28 days ]
    Changes from baseline urea

  14. Safety - Biochemistry laboratory parameter creatinine [ Time Frame: 28 days ]
    Changes from baseline creatinine

  15. Safety - Biochemistry laboratory parameter total bilirubin [ Time Frame: 28 days ]
    Changes from baseline total bilirubin

  16. Safety - Biochemistry laboratory parameter AST [ Time Frame: 28 days ]
    Changes from baseline AST

  17. Safety - Biochemistry laboratory parameter ALT [ Time Frame: 28 days ]
    Changes from baseline ALT

  18. Safety - Biochemistry laboratory parameter gamma-glutamyl transferase [ Time Frame: 28 days ]
    Changes from baseline gamma-glutamyl transferase

  19. Safety - Biochemistry laboratory parameter alkaline phosphatase [ Time Frame: 28 days ]
    Changes from baseline alkaline phosphatase

  20. Safety - Biochemistry laboratory parameter total protein [ Time Frame: 28 days ]
    Changes from baseline total protein

  21. Safety - Biochemistry laboratory parameter C-reactive protein [ Time Frame: 28 days ]
    Changes from baseline C-reactive protein

  22. Safety - Biochemistry laboratory parameter C-peptide [ Time Frame: 28 days ]
    Changes from baseline C-peptide

  23. Safety - Biochemistry laboratory parameter HbA1c [ Time Frame: 28 days ]
    Changes from baseline HbA1c

  24. Safety - Hematology laboratory parameter hemoglobin [ Time Frame: 28 days ]
    Changes from baseline hemglobin

  25. Safety - Hematology laboratory parameter red blood cell count (erythrocytes) [ Time Frame: 28 days ]
    Changes from baseline red blood cell count (erythrocytes)

  26. Safety - Hematology laboratory parameter total white blood cell count (leukocytes) [ Time Frame: 28 days ]
    Changes from baseline total white blood cell count (leukocytes)

  27. Safety - Hematology laboratory parameter hematocrit [ Time Frame: 28 days ]
    Changes from baseline hematocrit

  28. Safety - Hematology laboratory parameter platelet count (thrombocytes) [ Time Frame: 28 days ]
    Changes from baseline platelet count (thrombocytes)

  29. Safety - Urinalysis laboratory parameter pH [ Time Frame: 28 days ]
    Changes from baseline pH

  30. Safety - Urinalysis laboratory parameter blood [ Time Frame: 28 days ]
    Changes from baseline blood

  31. Safety - Urinalysis laboratory parameter protein [ Time Frame: 28 days ]
    Changes from baseline protein

  32. Safety - Urinalysis laboratory parameter glucose [ Time Frame: 28 days ]
    Changes from baseline

  33. Safety - Urinalysis laboratory parameter ketones [ Time Frame: 28 days ]
    Changes from baseline ketones

  34. Safety - Urinalysis laboratory parameter nitrite [ Time Frame: 28 days ]
    Changes from baseline nitrite

  35. Safety - Summary of Local tolerability - Occurrence of incidents of injection site reactions [ Time Frame: 28 days ]
    Occurrence of incidents of injection site reactions

  36. Safety - Summary of Local tolerability - Summary of type of injection site reactions [ Time Frame: 28 days ]
    Summary of type of injection site reactions

  37. Safety - Summary of Local tolerability - Summary of severity of injection site reactions [ Time Frame: 28 days ]
    Summary of severity of injection site reactions

  38. Safety - Number of rescue infusions [ Time Frame: 0-90 minutes after dosing ]
    Number of rescue infusions of IV glucose after trial drug administration.

  39. Safety - Time to first rescue infusion [ Time Frame: 0-90 minutes after dosing ]
    Time to first rescue infusion of IV glucose after trial drug administration

  40. Immunogenicity - Occurrence of anti-drug antibodies [ Time Frame: 28 days ]
    Occurrence of antibodies against dasiglucagon



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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.

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: Lena S List Zealand Pharma

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Responsible Party: Zealand Pharma
ClinicalTrials.gov Identifier: NCT03688711     History of Changes
Other Study ID Numbers: ZP4207-17145
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019

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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