Type 1 Diabetes MellitusPhase 1NCT03176524
A Trial to Investigate the Safety and the Pharmacokinetic, Pharmacodynamic Characteristics of Two BioChaperone® Glucagon Formulations Compared to Marketed GlucaGen® in Subjects With T1DM
A Phase 1 study testing BioChaperone® glucagon formulation 1, BioChaperone® glucagon formulation 2 and GlucaGen® HypoKit® in people with Type 1 Diabetes Mellitus, run by Adocia at 1 site in Germany.
Trial summary
This is a single centre, double-blind, randomised, three-period crossover phase 1 trial in subjects with type 1 diabetes mellitus (T1DM). Each subject will be randomly allocated to a sequence of three treatments, i.e. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- BioChaperone® glucagon formulation 1, BioChaperone® glucagon formulation 2 and GlucaGen® HypoKit®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteGermany
- Study dates
- 6 Jun 2017to 4 Sep 2017
- Phase
- Phase 1
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female patients aged between 18 and 64 years (both inclusive)
- Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months prior to the screening visit
- Treated with daily insulin for T1DM ≥ 12 months prior to the screening visit
- Stable insulin treatment at least 3 months prior to the screening visit
- Stable disease with HbA1c <9.0 %
- C peptide <=0.30 nmol/L
- Body mass index (BMI) < 30.0 kg/m2
Who cannot join
- Type 2 Diabetes mellitus
- Previous participation in this trial. Participation is defined as being randomised
- Receipt of any medicinal product in clinical development within 60 days prior to this trial
- Clinically significant abnormal haematology, biochemistry, urinalysis, or coagulation screening tests, as judged by the Investigator considering the underlying disease
- Known or suspected hypersensitivity to the trial products or related products
- Severe hypoglycaemic events within one month prior to screening, as judged by the investigator
Show all 9Show fewer
- Recent administration of glucagon (within 3 months prior to Screening)
- Clinically relevant diabetic complications as judged by the investigator
- Women of child bearing potential not willing to use contraceptive methods
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Three-period Crossover Trial to Investigate the Safety and the Pharmacokinetic, Pharmacodynamic Characteristics of Two BioChaperone® Glucagon Formulations Compared to Marketed GlucaGen® in Subjects With Type 1 Diabetes
This is a single centre, double-blind, randomised, three-period crossover phase 1 trial in subjects with type 1 diabetes mellitus (T1DM). Each subject will be randomly allocated to a sequence of three treatments, i.e. two single subcutaneous doses of BioChaperone® Glucagon (BC Glucagon) formulation 1, BioChaperone® Glucagon formulation 2 and GlucaGen® HypoKit®, each at the fixed doses of 50 µg and 1 mg on 3 separate dosing visits.
Following trial drug administration, pharmacokinetics (PK) and pharmacodynamics (PD) assessments will be carried until 4 hours. Safety will be assessed during all the trial period.
The total trial maximum duration for the individual subject will be up to 10 weeks.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- BioChaperone® glucagon formulation 1, BioChaperone® glucagon formulation 2, GlucaGen® HypoKit®
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioChaperone® glucagon formulation 1Drug
Injection of BioChaperone® glucagon formulation 1 at Day 1: 50 µg and at Day 2: 1 mg
BioChaperone® glucagon formulation 2Drug
Injection of BioChaperone® glucagon formulation 2 at Day 1: 50 µg and at Day 2: 1 mg
GlucaGen® HypoKit®Drug
Injection of GlucaGen® HypoKit® at Day 1: 50 µg and at Day 2: 1 mg
| Study group | Role | What they receive |
|---|---|---|
| BioChaperone® glucagon formulation 1 | Experimental | Single subcutaneous fixed doses (50 µg and 1.0 mg) Receives: Drug: BioChaperone® glucagon formulation 1 |
| BioChaperone® glucagon formulation 2 | Experimental | Single subcutaneous fixed doses (50 µg and 1.0 mg) Receives: Drug: BioChaperone® glucagon formulation 2 |
| GlucaGen® HypoKit® | Active comparator | Single subcutaneous fixed doses (50 µg and 1.0 mg) Receives: Drug: GlucaGen® HypoKit® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical safety laboratory
Haematology, biochemistry and urinalysis: changes or findings from baseline in clinical safety laboratory parameters during the trial duration (screening visit, treatment visits and follow up visit)
Measured: Up to 10 weeks
Physical examination
Examination of the body systems
Measured: Up to 10 weeks
ECG parameters
Heart rate, PQ, QRS, QT, QTcB: changes or findings from baseline in ECG parameters during the trial duration (screening visit, treatment visits and follow up visit)
Measured: Up to 10 weeks
Vital signs
Diastolic and systolic blood pressure (mmHg), Pulse (beats/min), Body temperature (°C), Respiratory frequency (RF/min): changes or findings from baseline in vital signs during the trial duration (screening visit, treatment visits and follow up visit)
Measured: Up to 10 weeks
Adverse events and serious adverse events
Untoward medical occurrence
Measured: Up to 10 weeks
Assessments of local tolerability at injection site
Local reaction at injection site
Measured: Up to 10 weeks
Secondary outcomes (7)
AUCPK 0-30min
area under the baseline adjusted plasma glucagon concentration curve from 0 to 30 min
Measured: From 0 to 30 min
AUC PK 0-4h
area under the baseline adjusted plasma glucagon concentration curve from 0 to 4 h
Measured: From 0 to 4 hours
ΔAUCPG 0-30min
area under the baseline adjusted plasma glucose curve from 0 until 30 min
Measured: From 0 to 30 min
ΔAUCPG 0-4h
area under the baseline adjusted plasma glucose curve from 0 until 4h
Measured: From 0 to 4 hours
ΔPG 30min
baseline adjusted plasma glucose concentration at 30 min
Measured: From 0 to 30 min
Percentage of patients achieving a plasma glucose increase of ≥20 mg/dL from baseline within 30 minutes after treatment
only at day 2
Measured: 30 min after drug administration
Time to plasma glucose increase of ≥20 mg/dL from baseline
only at day 2
Measured: Up to 4 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start6 Jun 2017
- Primary completion4 Sep 2017
- Study completion4 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adocia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ulrike Hövelmann, MD, Principal investigator, Profil Institut für Stoffwechselforschung GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176524
- Sponsor's protocol ID
- BC13-CT028
- Status last verified
- Dec 2017
- First submitted
- 1 Jun 2017
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Three-period Crossover Trial to Investigate the Safety and the Pharmacokinetic, Pharmacodynamic Characteristics of Two BioChaperone® Glucagon Formulations Compared to Marketed GlucaGen® in Subjects With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03176524
- Acronym / sponsor ID
- BC13-CT028
- Conditions
- Type 1 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- AdociaIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 4 Sep 2017 (actual)
- Study completion
- 4 Sep 2017 (actual)
- First posted
- 5 Jun 2017 (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.
This is a single centre, double-blind, randomised, three-period crossover phase 1 trial in subjects with type 1 diabetes mellitus (T1DM). Each subject will be randomly allocated to a sequence of three treatments, i.e. two single subcutaneous doses of BioChaperone® Glucagon (BC Glucagon) formulation 1, BioChaperone® Glucagon formulation 2 and GlucaGen® HypoKit®, each at the fixed doses of 50 µg and 1 mg on 3 separate dosing visits.
Following trial drug administration, pharmacokinetics (PK) and pharmacodynamics (PD) assessments will be carried until 4 hours. Safety will be assessed during all the trial period.
The total trial maximum duration for the individual subject will be up to 10 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BioChaperone® glucagon formulation 1 | Experimental | Drug: BioChaperone® glucagon formulation 1Single subcutaneous fixed doses (50 µg and 1.0 mg) |
| BioChaperone® glucagon formulation 2 | Experimental | Drug: BioChaperone® glucagon formulation 2Single subcutaneous fixed doses (50 µg and 1.0 mg) |
| GlucaGen® HypoKit® | Active comparator | Drug: GlucaGen® HypoKit®Single subcutaneous fixed doses (50 µg and 1.0 mg) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female patients aged between 18 and 64 years (both inclusive)
- Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months prior to the screening visit
- Treated with daily insulin for T1DM ≥ 12 months prior to the screening visit
- Stable insulin treatment at least 3 months prior to the screening visit
- Stable disease with HbA1c <9.0 %
Key exclusion criteria (9 listed)
- Type 2 Diabetes mellitus
- Previous participation in this trial. Participation is defined as being randomised
- Receipt of any medicinal product in clinical development within 60 days prior to this trial
- Clinically significant abnormal haematology, biochemistry, urinalysis, or coagulation screening tests, as judged by the Investigator considering the underlying disease
- Known or suspected hypersensitivity to the trial products or related products
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 |
|---|---|---|
| BioChaperone® glucagon formulation 1Injection of BioChaperone® glucagon formulation 1 at Day 1: 50 µg and at Day 2: 1 mg | Drug | BioChaperone® glucagon formulation 1 |
| BioChaperone® glucagon formulation 2Injection of BioChaperone® glucagon formulation 2 at Day 1: 50 µg and at Day 2: 1 mg | Drug | BioChaperone® glucagon formulation 2 |
| GlucaGen® HypoKit®Injection of GlucaGen® HypoKit® at Day 1: 50 µg and at Day 2: 1 mg | Drug | GlucaGen® HypoKit® |
Primary outcome
Clinical safety laboratory
Time frame: Up to 10 weeks
Haematology, biochemistry and urinalysis: changes or findings from baseline in clinical safety laboratory parameters during the trial duration (screening visit, treatment visits and follow up visit)
Physical examination
Time frame: Up to 10 weeks
Examination of the body systems
ECG parameters
Time frame: Up to 10 weeks
Heart rate, PQ, QRS, QT, QTcB: changes or findings from baseline in ECG parameters during the trial duration (screening visit, treatment visits and follow up visit)
Vital signs
Time frame: Up to 10 weeks
Diastolic and systolic blood pressure (mmHg), Pulse (beats/min), Body temperature (°C), Respiratory frequency (RF/min): changes or findings from baseline in vital signs during the trial duration (screening visit, treatment visits and follow up visit)
Adverse events and serious adverse events
Time frame: Up to 10 weeks
Untoward medical occurrence
Assessments of local tolerability at injection site
Time frame: Up to 10 weeks
Local reaction at injection site
7 secondary outcomes
AUCPK 0-30min
Time frame: From 0 to 30 min
AUC PK 0-4h
Time frame: From 0 to 4 hours
ΔAUCPG 0-30min
Time frame: From 0 to 30 min
ΔAUCPG 0-4h
Time frame: From 0 to 4 hours
ΔPG 30min
Time frame: From 0 to 30 min
Percentage of patients achieving a plasma glucose increase of ≥20 mg/dL from baseline within 30 minutes after treatment
Time frame: 30 min after drug administration
Time to plasma glucose increase of ≥20 mg/dL from baseline
Time frame: Up to 4 hours after drug administration
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 12 Dec 2017.
- 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.
Ulrike Hövelmann, MD principal investigator
Profil Institut für Stoffwechselforschung GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BioChaperone® glucagon formulation 1, BioChaperone® glucagon formulation 2 and GlucaGen® HypoKit® in people with Type 1 Diabetes Mellitus, run by Adocia at 1 site in Germany.
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 7 inclusion and 9 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 12 Dec 2017. 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 Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Clinical safety laboratory (time frame: Up to 10 weeks). The study lists 6 primary outcomes in all. 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 12 Dec 2017.