HypoglycemiaPhase 3NCT03688711
Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Subjects With T1DM
A Phase 3 study testing Dasiglucagon in people with Hypoglycemia and Diabetes Mellitus, Type 1, run by Zealand Pharma at 3 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypoglycemia, Diabetes Mellitus, Type 1
- What is being tested?
- Dasiglucagon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Nov 2018to 11 Mar 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
ProSciento, Inc.
Chula Vista, California, 91911
AMCR Institute
Escondido, California, 92025
Rainier Clinical Research, Inc.
Renton, Washington, 98057
About this study
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
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
Read the 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.
- Conditions
- Hypoglycemia, Diabetes Mellitus, Type 1
- Being tested
- Dasiglucagon, Placebo
- Keywords
- glucagon
- Medical subject headings
- Hypoglycemia, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasiglucagonDrug
Also called ZP4207
Glucagon analogue
PlaceboDrug
Also called Placebo for dasiglucagon
Placebo for dasiglucagon
| Study group | Role | What they receive |
|---|---|---|
| Dasiglucagon | Experimental | single fixed dose (subcutaneous injection) of dasiglucagon Receives: Drug: Dasiglucagon |
| Placebo | Placebo comparator | single fixed dose (subcutaneous injection) of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Plasma Glucose Recovery.
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.
Measured: 0-45 minutes after dosing
Secondary outcomes (11)
Plasma Glucose Recovery After Trial Drug Injection
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.
Measured: 0-30 minutes after dosing
Plasma Glucose Changes From Baseline
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).
Measured: 0-30 minutes after dosing
Time to Target Plasma Glucose Concentration
Time to first plasma glucose concentration ≥70 mg/dL (3.9 mmol/L) without administration of rescue intravenous glucose
Measured: 0-45 minutes after dosing
Pharmacodynamics - Area Under the Effect Curve
Plasma glucose response as area under the effect curve (AUE) above baseline from time zero to 30 minutes, AUE0-30min.
Measured: 0-30 minutes after dosing
Pharmacokinetics - Area Under the Plasma Concentration Curve
Area under the drug concentration curve (AUC) from time zero to 90 minutes, AUC0-90min
Measured: 0-90 minutes after dosing
Pharmacokinetics - Area Under the Plasma Concentration Curve
Area under the drug concentration curve (AUC) from time zero to 120 minutes, AUC0-120min
Measured: 0-120 minutes after dosing
Pharmacokinetics - Maximum Plasma Concentration
Maximum plasma dasiglucagon concentration (Cmax)
Measured: 0-120 minutes after dosing
Pharmacokinetics - Time to Maximum Plasma Concentration
Time to maximum plasma dasiglucagon concentration (tmax)
Measured: 0-120 minutes after dosing
Immunogenicity - Occurrence of Anti-drug Antibodies
Occurrence of antibodies against dasiglucagon. Presented as percentage of patients with antibodies.
Measured: 58 days
Rescue Infusions of IV Glucose After Trial Drug Administration
Presented as number of patients with rescue infusions of IV glucose after trial drug administration. This was a safety outcome measure. IV = intravenous
Measured: 0-45 minutes after dosing
Time to First Rescue Infusion of IV Glucose After Trial Drug Administration
Safety outcome measure: time to first rescue infusion of IV glucose after trial drug administration. IV = intravenous
Measured: 0-45 minutes after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start1 Nov 2018
- Primary completion11 Mar 2019
- Study completion11 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypoglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christina M Sylvest, MSc Pharm, Study director, Zealand Pharma A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688711
- Sponsor's protocol ID
- ZP4207-17145
- Status last verified
- Apr 2021
- First submitted
- 25 Sep 2018
- Last updated
- 19 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03688711
- Acronym / sponsor ID
- ZP4207-17145
- Conditions
- Hypoglycemia, Diabetes Mellitus, Type 1
- Keywords
- glucagon
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Zealand PharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 11 Mar 2019 (actual)
- Study completion
- 11 Mar 2019 (actual)
- First posted
- 28 Sep 2018 (actual)
- Results
- Posted 19 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dasiglucagon | Experimental | Drug: Dasiglucagonsingle fixed dose (subcutaneous injection) of dasiglucagon |
| Placebo | Placebo comparator | Drug: Placebosingle fixed dose (subcutaneous injection) of placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DasiglucagonAlso: ZP4207Glucagon analogue | Drug | Dasiglucagon |
| PlaceboAlso: Placebo for dasiglucagonPlacebo for dasiglucagon | Drug | Placebo |
Primary outcome
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.
11 secondary outcomes
Plasma Glucose Recovery After Trial Drug Injection
Time frame: 0-30 minutes after dosing
Plasma Glucose Changes From Baseline
Time frame: 0-30 minutes after dosing
Time to Target Plasma Glucose Concentration
Time frame: 0-45 minutes after dosing
Pharmacodynamics - Area Under the Effect Curve
Time frame: 0-30 minutes after dosing
Pharmacokinetics - Area Under the Plasma Concentration Curve
Time frame: 0-90 minutes after dosing
Pharmacokinetics - Area Under the Plasma Concentration Curve
Time frame: 0-120 minutes after dosing
Pharmacokinetics - Maximum Plasma Concentration
Time frame: 0-120 minutes after dosing
Pharmacokinetics - Time to Maximum Plasma Concentration
Time frame: 0-120 minutes after dosing
Immunogenicity - Occurrence of Anti-drug Antibodies
Time frame: 58 days
Rescue Infusions of IV Glucose After Trial Drug Administration
Time frame: 0-45 minutes after dosing
Time to First Rescue Infusion of IV Glucose After Trial Drug Administration
Time frame: 0-45 minutes after dosing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina M Sylvest, MSc Pharm study director
Zealand Pharma A/S
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dasiglucagon in people with Hypoglycemia and Diabetes Mellitus, Type 1, run by Zealand Pharma at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Plasma Glucose Recovery. (time frame: 0-45 minutes after dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.