Type 2 Diabetes MellitusPhase 1NCT03180710
A Trial to Investigate the Dose-linearity of BioChaperone® Combo 75/25 and the Safety at Three Different Doses in Subjects With Type 2 Diabetes
A Phase 1 study testing BioChaperone® Combo 75/25 at 0.6 U/kg, BioChaperone® Combo 75/25 at 0.8 U/kg and BioChaperone® Combo 75/25 at 1.0 U/kg in people with Type 2 Diabetes Mellitus, run by Adocia at 2 sites in Germany.
Trial summary
This is a bicentric, double-blinded, randomised, four-period crossover phase 1 trial, using automated 30-hour euglycemic clamp in subjects with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- BioChaperone® Combo 75/25 at 0.6 U/kg, BioChaperone® Combo 75/25 at 0.8 U/kg and BioChaperone® Combo 75/25 at 1.0 U/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesGermany
- Study dates
- 6 Jun 2017to 21 Dec 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subject aged 18-70 years (both inclusive)
- Type 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months
- HbA1c level between 6.5% and 9.0 % (both inclusive)
- Body mass index between 20.0 and 40.0 kg/m2 (both inclusive)
- Body weight <= 125.0 kg at the screening visit
- Insulin-treated subjects. Total insulin dose of <= 1.2 (I)U/kg/day
Who cannot join
- Type 1 diabetes mellitus
- Known or suspected hypersensitivity to IMP(s) or related products
- Previous participation in this trial. Participation is defined as randomised.
- Receipt of any medicinal product in clinical development within 60 days before randomisation in this trial.
- Clinically significant abnormal values for haematology, biochemistry, coagulation, or urinalysis as judged by the Investigator considering the underlying disease.
- Supine blood pressure at screening (after resting for at least 5 min in supine position) outside the range of 90-160 mmHg systolically or 50-95 mmHg diastolically (excluding white-coat hypertension; therefore, if a repeated measurement shows values within the range, the subject can be included in the trial); symptoms of arterial hypotension and/or a heart rate at rest outside the range of 50-90 beats per minute. This exclusion criterion also pertains to subjects being on anti-hypertensives.
- Women of child bearing potential not willing to use contraceptive methods.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Profil Mainz GmbH & Co. KG
Mainz
Profil Institut für Stoffwechselforschung GmbH
Neuss
About this study
Official title: A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-linearity of BioChaperone® Combo 75/25 and the Safety at Three Different Doses in Subjects With Type 2 Diabetes
This is a bicentric, double-blinded, randomised, four-period crossover phase 1 trial, using automated 30-hour euglycemic clamp in subjects with type 2 diabetes mellitus.
Read the detailed description
This is a bicentric, double-blinded, randomised, four-period crossover phase 1 trial, using automated 30-hour euglycemic clamp in subjects with type 2 diabetes mellitus.
Each subject will be randomly allocated to a sequence of four treatments, three single doses of BioChaperone® Combo 75/25 (0.6 U/kg, 0.8 U/kg or 1.0 U/kg) and one single dose of Humalog® Mix25 at 0.8 U/kg on four separate dosing visits.
Subjects will come in a fasted state to the clinical trial centre in the morning of each dosing day and stay at the clinical trial centre until the 30-hour clamp procedures have been terminated.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- BioChaperone® Combo 75/25 at 0.6 U/kg, BioChaperone® Combo 75/25 at 0.8 U/kg, BioChaperone® Combo 75/25 at 1.0 U/kg, Humalog® Mix25 at 0.8 U/kg
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioChaperone® Combo 75/25 at 0.6 U/kgDrug
Injection of BioChaperone® Combo 75/25 at 0.6 U/kg
BioChaperone® Combo 75/25 at 0.8 U/kgDrug
Injection of BioChaperone® Combo 75/25 at 0.8 U/kg
BioChaperone® Combo 75/25 at 1.0 U/kgDrug
Injection of BioChaperone® Combo 75/25 at 1.0 U/kg
Humalog® Mix25 at 0.8 U/kgDrug
Injection of Humalog® Mix25 at 0.8 U/kg
| Study group | Role | What they receive |
|---|---|---|
| BioChaperone® Combo 75/25 at 0.6 U/kg | Experimental | Single subcutaneous injection of 0.6 U/kg Receives: Drug: BioChaperone® Combo 75/25 at 0.6 U/kg |
| BioChaperone® Combo 75/25 at 0.8 U/kg | Experimental | Single subcutaneous dose of 0.8 U/kg Receives: Drug: BioChaperone® Combo 75/25 at 0.8 U/kg |
| BioChaperone® Combo 75/25 at 1.0 U/kg | Experimental | Single subcutaneous dose of 1.0 U/kg Receives: Drug: BioChaperone® Combo 75/25 at 1.0 U/kg |
| Humalog® Mix25 at 0.8 U/kg | Active comparator | Single subcutaneous dose of 0.8 U/kg Receives: Drug: Humalog® Mix25 at 0.8 U/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC last_total
Area under the plasma insulin concentration-time curve from t=0 to the last measured total insulin plasma concentration above LLOQ. The total insulin concentration is the sum of lispro and basal concentrations.
Measured: From 0 to 30 hours
Cmax_total
Maximum observed plasma insulin total concentration
Measured: From 0 to 30 hours
Secondary outcomes (6)
AUCGIR 0-last (mg/kg)
Area under the glucose infusion rate curve from 0 hours until the end of clamp
Measured: From 0 to 30 hours
GIRmax (mg/kg/min)
Maximum glucose infusion rate
Measured: From 0 to 30 hours
tGIRmax
Time to maximum glucose infusion rate
Measured: From 0 to 30 hours
Adverse Events
Measured: Up to 102 days (maximum duration of subject's participation)
Local tolerability: number of injection site reaction
Frequency of injection site reaction in each arm.
Measured: Up to 102 days (maximum duration of subject's participation)
Number of hypoglycaemic events in each treatment arm
Measured: Up to 102 days (maximum duration of subject's participation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start6 Jun 2017
- Primary completion28 Aug 2017
- Study completion21 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adocia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oliver Klein, MD, Principal investigator, Profil Institut für Stoffwechselforschung GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180710
- Sponsor's protocol ID
- BC3-CT025
- Status last verified
- Jan 2018
- First submitted
- 6 Jun 2017
- Last updated
- 10 Jan 2018
- 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 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-linearity of BioChaperone® Combo 75/25 and the Safety at Three Different Doses in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03180710
- Acronym / sponsor ID
- BC3-CT025
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- AdociaIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 28 Aug 2017 (actual)
- Study completion
- 21 Dec 2017 (actual)
- First posted
- 8 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 bicentric, double-blinded, randomised, four-period crossover phase 1 trial, using automated 30-hour euglycemic clamp in subjects with type 2 diabetes mellitus.
Detailed description
This is a bicentric, double-blinded, randomised, four-period crossover phase 1 trial, using automated 30-hour euglycemic clamp in subjects with type 2 diabetes mellitus.
Each subject will be randomly allocated to a sequence of four treatments, three single doses of BioChaperone® Combo 75/25 (0.6 U/kg, 0.8 U/kg or 1.0 U/kg) and one single dose of Humalog® Mix25 at 0.8 U/kg on four separate dosing visits.
Subjects will come in a fasted state to the clinical trial centre in the morning of each dosing day and stay at the clinical trial centre until the 30-hour clamp procedures have been terminated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BioChaperone® Combo 75/25 at 0.6 U/kg | Experimental | Drug: BioChaperone® Combo 75/25 at 0.6 U/kgSingle subcutaneous injection of 0.6 U/kg |
| BioChaperone® Combo 75/25 at 0.8 U/kg | Experimental | Drug: BioChaperone® Combo 75/25 at 0.8 U/kgSingle subcutaneous dose of 0.8 U/kg |
| BioChaperone® Combo 75/25 at 1.0 U/kg | Experimental | Drug: BioChaperone® Combo 75/25 at 1.0 U/kgSingle subcutaneous dose of 1.0 U/kg |
| Humalog® Mix25 at 0.8 U/kg | Active comparator | Drug: Humalog® Mix25 at 0.8 U/kgSingle subcutaneous dose of 0.8 U/kg |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subject aged 18-70 years (both inclusive)
- Type 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months
- HbA1c level between 6.5% and 9.0 % (both inclusive)
- Body mass index between 20.0 and 40.0 kg/m2 (both inclusive)
- Body weight <= 125.0 kg at the screening visit
Key exclusion criteria (7 listed)
- Type 1 diabetes mellitus
- Known or suspected hypersensitivity to IMP(s) or related products
- Previous participation in this trial. Participation is defined as randomised.
- Receipt of any medicinal product in clinical development within 60 days before randomisation in this trial.
- Clinically significant abnormal values for haematology, biochemistry, coagulation, or urinalysis as judged by the Investigator considering the underlying disease.
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® Combo 75/25 at 0.6 U/kgInjection of BioChaperone® Combo 75/25 at 0.6 U/kg | Drug | BioChaperone® Combo 75/25 at 0.6 U/kg |
| BioChaperone® Combo 75/25 at 0.8 U/kgInjection of BioChaperone® Combo 75/25 at 0.8 U/kg | Drug | BioChaperone® Combo 75/25 at 0.8 U/kg |
| BioChaperone® Combo 75/25 at 1.0 U/kgInjection of BioChaperone® Combo 75/25 at 1.0 U/kg | Drug | BioChaperone® Combo 75/25 at 1.0 U/kg |
| Humalog® Mix25 at 0.8 U/kgInjection of Humalog® Mix25 at 0.8 U/kg | Drug | Humalog® Mix25 at 0.8 U/kg |
Primary outcome
AUC last_total
Time frame: From 0 to 30 hours
Area under the plasma insulin concentration-time curve from t=0 to the last measured total insulin plasma concentration above LLOQ. The total insulin concentration is the sum of lispro and basal concentrations.
Cmax_total
Time frame: From 0 to 30 hours
Maximum observed plasma insulin total concentration
6 secondary outcomes
AUCGIR 0-last (mg/kg)
Time frame: From 0 to 30 hours
GIRmax (mg/kg/min)
Time frame: From 0 to 30 hours
tGIRmax
Time frame: From 0 to 30 hours
Adverse Events
Time frame: Up to 102 days (maximum duration of subject's participation)
Local tolerability: number of injection site reaction
Time frame: Up to 102 days (maximum duration of subject's participation)
Number of hypoglycaemic events in each treatment arm
Time frame: Up to 102 days (maximum duration of subject's participation)
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 10 Jan 2018.
- 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.
Oliver Klein, MD principal investigator
Profil Institut für Stoffwechselforschung GmbH
2 sites 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® Combo 75/25 at 0.6 U/kg, BioChaperone® Combo 75/25 at 0.8 U/kg and BioChaperone® Combo 75/25 at 1.0 U/kg in people with Type 2 Diabetes Mellitus, run by Adocia at 2 sites 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 6 inclusion and 7 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 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
AUC last_total (time frame: From 0 to 30 hours). The study lists 2 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 10 Jan 2018.