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
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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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
single fixed dose (subcutaneous injection) of dasiglucagon
Other Name: ZP4207
Placebo Comparator: Placebo
single fixed dose (subcutaneous injection) of placebo
Placebo for dasiglucagon
Other Name: Placebo for dasiglucagon
- 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.
- 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
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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|
- 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.
- 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|
|Chula Vista, California, United States, 91911|
|Escondido, California, United States, 92025|
|United States, Washington|
|Rainier Clinical Research, Inc.|
|Renton, Washington, United States, 98057|
|Study Director:||Christina M Sylvest, MSc Pharm||Zealand Pharma A/S|
Documents provided by Zealand Pharma:
|Responsible Party:||Zealand Pharma|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Endocrine System Diseases
Immune System Diseases