HypoglycemiaPhase 3NCT03895697
A Trial to Compare the Efficacy and Safety of 2 Different Batches of Subcutaneous Dasiglucagon in Patients With T1DM
A Phase 3 study testing dasiglucagon in people with Hypoglycemia and Diabetes Mellitus, Type 1, run by Zealand Pharma at 1 site in Canada.
Trial summary
A randomized, double-blind, crossover trial to compare the efficacy and safety of 2 different batches of subcutaneous dasiglucagon in patients with type 1 diabetes mellitus (T1DM) 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?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteCanada
- Study dates
- 26 Mar 2019to 30 Jul 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Type 1 diabetes mellitus for at least 1 year according to the diagnostic criteria as defined by the American Diabetes Association.
- Hemoglobin A1c <10.0% at screening
- Treated with stable insulin treatment (defined as no more than a 10-unit daily variation in total daily insulin dose) 30 days prior to screening
Who cannot join
- History of hypoglycemic events associated with seizures in the last year prior to screening
- History of severe hypoglycemia (an episode requiring assistance from another person) in the last month prior to screening
- Previous participation in a clinical trial within the dasiglucagon program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3b, Randomized, Double-blind, Crossover Trial to Compare the Efficacy and Safety of 2 Different Batches of Subcutaneous Dasiglucagon in Patients With Type 1 Diabetes Mellitus
A randomized, double-blind, crossover trial to compare the efficacy and safety of 2 different batches of subcutaneous dasiglucagon in patients with type 1 diabetes mellitus (T1DM)
Read the detailed description
This multicenter, double-blind, crossover, randomized clinical trial was designed to evaluate the efficacy and safety of 2 different batches of subcutaneous dasiglucagon in patients with T1DM. Patients were randomly assigned 1:1 to either dasiglucagon Batch A or dasiglucagon Batch B as their initial dose and the other as the second dose. To avoid bias in the evaluation of clinical assessments, the trial was conducted in a double-blinded manner.
- Conditions
- Hypoglycemia, Diabetes Mellitus, Type 1
- Being tested
- dasiglucagon
- 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
| Study group | Role | What they receive |
|---|---|---|
| Dasiglucagon batch A crossover to dasiglucagon batch B | Experimental | V2: Single fixed dose (subcutaneous injection) of dasiglucagon batch A then at V3: Single fixed dose (subcutaneous injection) of dasiglucagon batch B Receives: Drug: dasiglucagon |
| Dasiglucagon batch B crossover to dasiglucagon batch A | Experimental | V2: Single fixed dose (subcutaneous injection) of dasiglucagon batch B then at V3: Single fixed dose (subcutaneous injection) of dasiglucagon batch A Receives: Drug: dasiglucagon |
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 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 intravenous glucose
Measured: 0-45 minutes after dosing
Secondary outcomes (18)
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
Pharmacodynamics - Area under the effect curve 30 min
Area under the baseline-adjusted effect curve (AUE) from zero up to the concentration at 30 minutes, AUE 0-30min
Measured: 0-30 minutes after dosing
Pharmacodynamics - Area under the effect curve 90 min
Area under the baseline-adjusted effect curve (AUE) from zero up to the concentration at 90 minutes, AUE 0-90min
Measured: 0-90 minutes after dosing
Pharmacodynamics - Maximum plasma glucose concentration
Change from baseline plasma glucose to maximum plasma glucose measure after dosing, CEmax
Measured: 0-90 minutes after dosing
Pharmacodynamics - Time maximum plasma glucose concentration
Time to maximum change in plasma glucose measure from baseline, TEmax
Measured: 0-90 minutes after dosing
Pharmacokinetics - Area under the plasma concentration-time curve 30 min
Area under the concentration-time curve (AUC) from zero up to the concentration at 30 minutes, AUC0-30min
Measured: 0-30 minutes after dosing
Pharmacokinetics - Area under the plasma concentration-time curve 300 min
Area under the concentration-time curve (AUC) from zero up to the concentration at 300 minutes, AUC0-300min
Measured: 0-300 minutes after dosing
Pharmacokinetics - Area under the plasma concentration curve Infinitely
Area under the concentration-time curve from zero up to the concentration at infinitely after dosing, AUC0-inf
Measured: 0-300 minutes after dosing
Pharmacokinetics - Maximum plasma concentration
Measured maximum plasma drug concentration after dosing, Cmax
Measured: 0-300 minutes after dosing
Pharmacokinetics - Time to maximum plasma concentration
Sampling time until reaching Cmax, Tmax
Measured: 0-300 minutes after dosing
Pharmacokinetics - Half-life
Half-life dasiglucagon, t½
Measured: 0-300 minutes after dosing
Pharmacokinetics - Volume of distribution
Apparent volume of distribution of dasiglucagon, Vz/f
Measured: 0-300 minutes after dosing
Pharmacokinetics - Mean residence time
Mean residence time, MRT
Measured: 0-300 minutes after dosing
Pharmacokinetics - Body clearance
Total body clearance, CL/f
Measured: 0-300 minutes after dosing
Safety - Adverse events
The incidence, type and severity of adverse events (AEs)
Measured: 90 days
Safety - Number of rescue infusions
Number of rescue infusions of IV glucose after trial drug administration
Measured: 0-90 minutes after dosing
Safety - Time to first rescue infusion
Time to first rescue infusion of IV glucose after trial drug administration
Measured: 0-90 minutes after dosing
Immunogenicity - Occurrence of anti-drug antibodies
Occurrence of antibodies against dasiglucagon
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start26 Mar 2019
- Primary completion30 Jul 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stine J Maarbjerg, PHD, Study director, Zealand Pharma A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895697
- Sponsor's protocol ID
- ZP4207-17084
- Status last verified
- Feb 2023
- First submitted
- 27 Mar 2019
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b, Randomized, Double-blind, Crossover Trial to Compare the Efficacy and Safety of 2 Different Batches of Subcutaneous Dasiglucagon in Patients With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03895697
- Acronym / sponsor ID
- ZP4207-17084
- Conditions
- Hypoglycemia, Diabetes Mellitus, Type 1
- Keywords
- glucagon
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Zealand PharmaIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 29 Mar 2019 (actual)
- Results
- Not posted in the source record
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, crossover trial to compare the efficacy and safety of 2 different batches of subcutaneous dasiglucagon in patients with type 1 diabetes mellitus (T1DM)
Detailed description
This multicenter, double-blind, crossover, randomized clinical trial was designed to evaluate the efficacy and safety of 2 different batches of subcutaneous dasiglucagon in patients with T1DM. Patients were randomly assigned 1:1 to either dasiglucagon Batch A or dasiglucagon Batch B as their initial dose and the other as the second dose. To avoid bias in the evaluation of clinical assessments, the trial was conducted in a double-blinded manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dasiglucagon batch A crossover to dasiglucagon batch B | Experimental | Drug: dasiglucagonV2: Single fixed dose (subcutaneous injection) of dasiglucagon batch A then at V3: Single fixed dose (subcutaneous injection) of dasiglucagon batch B |
| Dasiglucagon batch B crossover to dasiglucagon batch A | Experimental | Drug: dasiglucagonV2: Single fixed dose (subcutaneous injection) of dasiglucagon batch B then at V3: Single fixed dose (subcutaneous injection) of dasiglucagon batch A |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 1 diabetes mellitus for at least 1 year according to the diagnostic criteria as defined by the American Diabetes Association.
- Hemoglobin A1c <10.0% at screening
- Treated with stable insulin treatment (defined as no more than a 10-unit daily variation in total daily insulin dose) 30 days prior to screening
Key exclusion criteria (3 listed)
- History of hypoglycemic events associated with seizures in the last year prior to screening
- History of severe hypoglycemia (an episode requiring assistance from another person) in the last month prior to screening
- Previous participation in a clinical trial within the dasiglucagon program
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 batch A crossover to dasiglucagon batch B, Dasiglucagon batch B crossover to dasiglucagon batch A |
Primary outcome
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 intravenous glucose
18 secondary outcomes
Plasma glucose changes from baseline
Time frame: 0-30 minutes after dosing
Pharmacodynamics - Area under the effect curve 30 min
Time frame: 0-30 minutes after dosing
Pharmacodynamics - Area under the effect curve 90 min
Time frame: 0-90 minutes after dosing
Pharmacodynamics - Maximum plasma glucose concentration
Time frame: 0-90 minutes after dosing
Pharmacodynamics - Time maximum plasma glucose concentration
Time frame: 0-90 minutes after dosing
Pharmacokinetics - Area under the plasma concentration-time curve 30 min
Time frame: 0-30 minutes after dosing
Pharmacokinetics - Area under the plasma concentration-time curve 300 min
Time frame: 0-300 minutes after dosing
Pharmacokinetics - Area under the plasma concentration curve Infinitely
Time frame: 0-300 minutes after dosing
Pharmacokinetics - Maximum plasma concentration
Time frame: 0-300 minutes after dosing
Pharmacokinetics - Time to maximum plasma concentration
Time frame: 0-300 minutes after dosing
Pharmacokinetics - Half-life
Time frame: 0-300 minutes after dosing
Pharmacokinetics - Volume of distribution
Time frame: 0-300 minutes after dosing
Pharmacokinetics - Mean residence time
Time frame: 0-300 minutes after dosing
Pharmacokinetics - Body clearance
Time frame: 0-300 minutes after dosing
Safety - Adverse events
Time frame: 90 days
Safety - Number of rescue infusions
Time frame: 0-90 minutes after dosing
Safety - Time to first rescue infusion
Time frame: 0-90 minutes after dosing
Immunogenicity - Occurrence of anti-drug antibodies
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
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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.
Stine J Maarbjerg, PHD study director
Zealand Pharma A/S
1 site 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 1 site in Canada.
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 3 inclusion and 3 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 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 21 Feb 2023.