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A Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Type 1 Diabetes Subjects

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ClinicalTrials.gov Identifier: NCT03378635
Recruitment Status : Completed
First Posted : December 20, 2017
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Zealand Pharma

Brief Summary:
The objective of the trial is to demonstrate superiority of dasiglucagon compared to placebo following a single subcutaneous dose administered to subjects with type 1 diabetes mellitus with insulin-induced hypoglycemia. Additionaly to compare the glycemic response observed after administration dasiglucagon with that of GlucaGen®.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Parallel Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in Rescue Treatment of Hypoglycemia in Subjects With Type 1 Diabetes Mellitus Compared to Placebo and With Reference to GlucaGen
Actual Study Start Date : December 7, 2017
Actual Primary Completion Date : April 27, 2018
Actual Study Completion Date : May 25, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Glucagon

Arm Intervention/treatment
Experimental: Dasiglucagon
Single fixed dose (s.c.injection) of dasiglucagon
Drug: Dasiglucagon
Glucagon analog
Other Name: ZP4207

Placebo Comparator: Placebo
Single fixed dose (s.c.injection) of placebo
Drug: Placebo
Placebo for dasiglucagon
Other Name: Placebo for dasiglucagon

Active Comparator: GlucaGen®
Single fixed dose (s.c.injection) of GlucaGen®
Drug: GlucaGen
Native glucagon
Other Name: GlucaGen HypoKit




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 [ Time Frame: 0-30 minutes after dosing ]
    Plasma glucose recovery within 30 minutes, within 20 minutes, within 15 minutes, and within 10 minutes after study drug injection without administration of rescue IV glucose

  2. Plasma glucose changes drom baseline [ Time Frame: 0-30 minutes after dosing ]
    Plasma glucose recovery within 30 minutes, within 20 minutes, within 15 minutes, and within 10 minutes after study drug injection without administration of rescue IV glucose

  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 curve (AUC) above baseline from time zero to 30 minutes, AUC0-30min.

  5. Pharmacokinetics - Area under the plasma concentration curve [ Time Frame: 0-90 minutes after dosing ]
    Area under the drug concentration curve 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: 28 days ]
    The incidence, type and severity of adverse events (AEs)

  9. Safety - Biochemistry laboratory parameters [ Time Frame: 28 days ]
    Changes from baseline in biochemistry laboratory parameters

  10. Safety - Hematology laboratory parameters [ Time Frame: 28 days ]
    Changes from baseline in hematology laboratory parameters

  11. Safety - Blood pressure [ Time Frame: 28 days ]
    Changes from baseline in blood pressure (mmHg)

  12. Safety - Pulse [ Time Frame: 28 days ]
    Changes from baseline in pulse (beats pr. min)

  13. Safety - Physical Examination [ Time Frame: 28 days ]
    Clinically meaningful changes from baseline of the following body systems: head, ears, eyes, nose, throat, including the thyroid gland; heart, lung, chest; abdomen; skin and mucosae; musculoskeletal system; nervous system; lymph node

  14. Safety - Electrocardiogram [ Time Frame: 28 days ]
    Clinically meaningful changes from baseline in electrocardiogram (ECG)

  15. Safety - Injection site reactions [ Time Frame: 28 days ]
    The incidence, type and severity of injection site reactions

  16. Safety - Glucose for rescue [ Time Frame: 0-45 minutes after dosing ]
    Administration of rescue infusion of IV glucose during the hypoglycemic clamp procedure

  17. Immunogenicity - Occurence of anti-drug antibodies [ Time Frame: 28 days ]
    Occurence of antibodies against dasiglucagon/GlucaGen



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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
  • 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%

Exclusion Criteria:

  • Previously treated with dasiglucagon (previously referred to as ZP4207)
  • Known or suspected allergy to trial product(s) or related products
  • Females who are pregnant according to a positive pregnancy test, are actively attempting to get pregnant, or are lactating.
  • History of hypoglycemic events associated with seizures in the last year prior to screening
  • History of severe hypoglycemia in the last month prior to screening
  • Active malignancy within the last 5 years
  • Current bleeding disorder, including anti-coagulant treatment
  • Known presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma (i.e. insulin secreting pancreas tumor)
  • Use of a daily systemic beta-blocker drug, indomethacin, warfarin or anticholinergic drugs in the previous 28 days before Day 1 of this trial
  • Clinically significant abnormal ECG at screening as judged by the investigator
  • Donation of blood or plasma in the past month, or in excess of 500 mL within 12 weeks prior to screening
  • Surgery or trauma with significant blood loss within the last 2 months prior to screening
  • A positive result in the alcohol and/or urine drug screen at the screening visit. Significant history of alcoholism or drug abuse as judged by the investigator or consuming more than 24 g alcohol per day for men, or more than 12 g alcohol per day for women

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): NCT03378635


Locations
United States, California
ProSciento
Chula Vista, California, United States, 91911
Austria
Clinical Research Center, Medizinische Universität Graz
Graz, Austria
Canada
LMC Diabetes & Manna Research
Toronto, Canada
Germany
Profil
Mainz, Germany
Profil
Neuss, Germany
Sponsors and Collaborators
Zealand Pharma
Investigators
Study Director: Benedikte Bandak, MS Zealand Pharma

Responsible Party: Zealand Pharma
ClinicalTrials.gov Identifier: NCT03378635     History of Changes
Other Study ID Numbers: ZP4207-16137
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: June 2018

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:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Glucagon
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs