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 13, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypoglycemia Diabetes Mellitus, Type 1 | Drug: dasiglucagon Drug: Placebo | Phase 3 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: dasiglucagon
single fixed dose (sc injection) of dasiglucagon
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Drug: dasiglucagon
Glucagon analogue
Other Name: ZP4207 |
Placebo Comparator: Placebo
single fixed dose (sc injection) of placebo
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Drug: Placebo
Placebo for dasiglucagon
Other Name: Placebo for dasiglucagon |
- 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
- 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).
- 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
- 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 - Maximum plasma concentration [ Time Frame: 0-120 minutes after dosing ]Maximum plasma drug concentration (Cmax)
- Pharmacokinetics - Time to maximum plasma concentration [ Time Frame: 0-120 minutes after dosing ]Time to maximum plasma drug concentration (tmax)
- Safety - Adverse events [ Time Frame: 58 days ]The incidence, type and severity of adverse events (AEs)
- Safety - Biochemistry laboratory parameter sodium [ Time Frame: 28 days ]Changes from baseline sodium
- Safety - Biochemistry laboratory parameter potassium [ Time Frame: 28 days ]Changes from baseline potassium
- Safety - Biochemistry laboratory parameter calcium [ Time Frame: 28 days ]Changes from baseline calcium
- Safety - Biochemistry laboratory parameter glucose [ Time Frame: 28 days ]Changes from baseline glucose
- Safety - Biochemistry laboratory parameter urea [ Time Frame: 28 days ]Changes from baseline urea
- Safety - Biochemistry laboratory parameter creatinine [ Time Frame: 28 days ]Changes from baseline creatinine
- Safety - Biochemistry laboratory parameter total bilirubin [ Time Frame: 28 days ]Changes from baseline total bilirubin
- Safety - Biochemistry laboratory parameter AST [ Time Frame: 28 days ]Changes from baseline AST
- Safety - Biochemistry laboratory parameter ALT [ Time Frame: 28 days ]Changes from baseline ALT
- Safety - Biochemistry laboratory parameter gamma-glutamyl transferase [ Time Frame: 28 days ]Changes from baseline gamma-glutamyl transferase
- Safety - Biochemistry laboratory parameter alkaline phosphatase [ Time Frame: 28 days ]Changes from baseline alkaline phosphatase
- Safety - Biochemistry laboratory parameter total protein [ Time Frame: 28 days ]Changes from baseline total protein
- Safety - Biochemistry laboratory parameter C-reactive protein [ Time Frame: 28 days ]Changes from baseline C-reactive protein
- Safety - Biochemistry laboratory parameter C-peptide [ Time Frame: 28 days ]Changes from baseline C-peptide
- Safety - Biochemistry laboratory parameter HbA1c [ Time Frame: 28 days ]Changes from baseline HbA1c
- Safety - Hematology laboratory parameter hemoglobin [ Time Frame: 28 days ]Changes from baseline hemglobin
- Safety - Hematology laboratory parameter red blood cell count (erythrocytes) [ Time Frame: 28 days ]Changes from baseline red blood cell count (erythrocytes)
- Safety - Hematology laboratory parameter total white blood cell count (leukocytes) [ Time Frame: 28 days ]Changes from baseline total white blood cell count (leukocytes)
- Safety - Hematology laboratory parameter hematocrit [ Time Frame: 28 days ]Changes from baseline hematocrit
- Safety - Hematology laboratory parameter platelet count (thrombocytes) [ Time Frame: 28 days ]Changes from baseline platelet count (thrombocytes)
- Safety - Urinalysis laboratory parameter pH [ Time Frame: 28 days ]Changes from baseline pH
- Safety - Urinalysis laboratory parameter blood [ Time Frame: 28 days ]Changes from baseline blood
- Safety - Urinalysis laboratory parameter protein [ Time Frame: 28 days ]Changes from baseline protein
- Safety - Urinalysis laboratory parameter glucose [ Time Frame: 28 days ]Changes from baseline
- Safety - Urinalysis laboratory parameter ketones [ Time Frame: 28 days ]Changes from baseline ketones
- Safety - Urinalysis laboratory parameter nitrite [ Time Frame: 28 days ]Changes from baseline nitrite
- Safety - Summary of Local tolerability - Occurrence of incidents of injection site reactions [ Time Frame: 28 days ]Occurrence of incidents of injection site reactions
- Safety - Summary of Local tolerability - Summary of type of injection site reactions [ Time Frame: 28 days ]Summary of type of injection site reactions
- Safety - Summary of Local tolerability - Summary of severity of injection site reactions [ Time Frame: 28 days ]Summary of severity of injection site reactions
- Safety - Number of rescue infusions [ Time Frame: 0-90 minutes after dosing ]Number of rescue infusions of IV glucose after trial drug administration.
- 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
- Immunogenicity - Occurrence of anti-drug antibodies [ Time Frame: 28 days ]Occurrence of antibodies against dasiglucagon

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
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 |
Study Director: | Lena S List | Zealand Pharma |
Responsible Party: | Zealand Pharma |
ClinicalTrials.gov Identifier: | NCT03688711 |
Other Study ID Numbers: |
ZP4207-17145 |
First Posted: | September 28, 2018 Key Record Dates |
Last Update Posted: | March 13, 2020 |
Last Verified: | March 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
glucagon |
Diabetes Mellitus Hypoglycemia Diabetes Mellitus, Type 1 Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |