Type 2 DiabetesPhase 1NCT05373212
A Trial Investigating the Dose Linearity and Safety of BC Combo THDB0207 in Subjects With Type 2 Diabetes
A Phase 1 study testing Euglycemic clamp with BC Combo THDB0207 and Euglycemic clamp with Humalog® Mix25 in people with Type 2 Diabetes, run by Adocia at 1 site in Germany.
Trial summary
This is a randomised, double-blind, four-period crossover euglycaemic clamp trial in subjects with type 2 diabetes. Each subject will be randomly allocated to one of four treatment sequences. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Euglycemic clamp with BC Combo THDB0207 and Euglycemic clamp with Humalog® Mix25
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 12 May 2022to 2 Jan 2023
- 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
- Type 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months
- HbA1c ≤9.0%
- Total insulin dose of < 1.2 U/kg/day
- Body mass index between 20.0 and 35.0 kg/m2 (both inclusive)
- Treated with a stable insulin regimen for ≥ 3 months prior to screening
Who cannot join
- Known or suspected hypersensitivity to the IMPs or any of the excipients or to any component of the IMP formulation
- Receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomisation in this trial
- Clinically significant abnormal screening laboratory tests, as judged by the Investigator considering the underlying disease
- Clinically relevant comorbidity, capable of constituting a risk for the subject when participating in the trial or of interfering with the interpretation of data
- Systolic blood pressure < 90 mmHg or >160 mmHg and/or diastolic blood pressure < 50 mmHg or > 95 mmHg (one repeat test will be acceptable in case of suspected white-coat hypertension)
- Heart rate at rest outside the range of 50-90 beats per minute
- Use of GLP-1 receptor agonists or oral antidiabetic drugs (OADs) other than stable intake of metformin within 4 weeks prior to screening
- Women of childbearing potential who are not using a highly effective contraceptive method
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomised, double-blind, four-period crossover euglycaemic clamp trial in subjects with type 2 diabetes.
Each subject will be randomly allocated to one of four treatment sequences. Each sequence will comprise 3 different single doses of BC Combo THDB0207 (Low dose, Medium dose, and High dose) and one single dose of Humalog® Mix25.
Subjects will come to the clinical trial centre in a fasted state in the morning of each dosing day and stay at the clinical trial centre until the 30-hour clamp procedures have been terminated.
Read the detailed description
Subjects will attend the study site in the morning in a fasted state and will be connected to an automated glucose clamp device. Prior to dose administration plasma glucose will be stabilised at a target level of 100 mg/dL by means of an intravenous infusion of glucose or insulin. IMP administration will be done by an unblinded person by means of subcutaneous injections in the abdominal wall.
Following each dosing a euglycaemic glucose clamp procedure will be carried out for up to 30 hours.
The pharmacodynamic assessment will be based on the time course of glucose infusion rate (GIR) and plasma glucose.
Plasma insulin concentrations will be measured using a specific validated bioanalytical method differentiating concentrations of insulin glargine, of its main metabolites insulin-glargine-M1 and insulin-glargine-M2, and of insulin lispro. Pharmacokinetic assessments will be based on total insulin concentration (insulin glargine + insulin glargine-M1 + insulin glargine-M2 + insulin lispro), on insulin glargine concentration (insulin glargine + insulin glargine-M1 + insulin glargine-M2), or on insulin lispro concentration.
- Conditions
- Type 2 Diabetes
- Being tested
- Euglycemic clamp with BC Combo THDB0207, Euglycemic clamp with Humalog® Mix25
- 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.
Euglycemic clamp with BC Combo THDB0207Drug
Administration of a single dose of BC Combo THDB0207 during an euglycemic clamp procedure.
Euglycemic clamp with Humalog® Mix25Drug
Administration of a single dose of Humalog® Mix25 during an euglycemic clamp procedure.
| Study group | Role | What they receive |
|---|---|---|
| BC Combo THDB0207 Low dose | Experimental | Single administration of BC Combo THDB0207 (Low dose) Receives: Drug: Euglycemic clamp with BC Combo THDB0207 |
| BC Combo THDB0207 Medium dose | Experimental | Single administration of BC Combo THDB0207 (Medium dose) Receives: Drug: Euglycemic clamp with BC Combo THDB0207 |
| BC Combo THDB0207 High dose | Experimental | Single administration of BC Combo THDB0207 (High dose) Receives: Drug: Euglycemic clamp with BC Combo THDB0207 |
| Humalog® Mix25 | Active comparator | Single administration of Humalog® Mix25 Receives: Drug: Euglycemic clamp with Humalog® Mix25 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCTOTAL0-last
Area under the total insulin concentration-time curve from t=0 to the last measured insulin concentration above LLOQ
Measured: From t=0 to t=30 hours after IMP administration
CmaxTOTAL
Maximum total insulin concentration
Measured: From t=0 to t=30 hours after IMP administration
Secondary outcomes (41)
AUCGIR 0-last
Area under the glucose infusion rate curve from 0 hours until the end of clamp
Measured: From t=0 to t=30 hours after IMP administration
GIRmax
Maximum glucose infusion rate
Measured: From t=0 to t=30 hours after IMP administration
tGIRmax
Time to maximum glucose infusion rate
Measured: From t=0 to t=30 hours after IMP administration
Tonset of action
Time until Plasma Glucose (PG) has decreased by at least 5 mg/dL from the baseline PG value.
Measured: From t=0 to t=30 hours after IMP administration
AUCGIR 0-6h
Area under the glucose infusion rate curve from t=0 hours to t=6 hours
Measured: From t=0 to t=6 hours
AUCTOTALlast
Area under the insulin concentration-time curve from t=0 to the last measured insulin concentration above LLOQ
Measured: From t=0 to t=30 hours after IMP administration
AUCTOTAL 0-1h
Area under the total insulin concentration-time curve from t=0 to t=1 hour
Measured: From t=0 to t=1 hour
AUCTOTAL 0-2h
Area under the total insulin concentration-time curve from t=0 to t=2 hours
Measured: From t=0 to t=2 hours
AUCTOTAL 0-6h
Area under the total insulin concentration-time curve from t=0 to t=6 hours
Measured: From t=0 to t=6 hours
AUCTOTAL 2-6h
Area under the total insulin concentration-time curve from t=2 to t=6 hours
Measured: From t=2 to t=6 hours
AUCTOTAL 6-12h
Area under the total insulin concentration-time curve from t=6 to t=12 hours
Measured: From t=6 to t=12 hours
AUCTOTAL 6-24h
Area under the total insulin concentration-time curve from t=6 to t=24 hours
Measured: From t=6 to t=24 hours
AUCTOTAL 12-24h
Area under the total insulin concentration-time curve from t=12 to t=24 hours
Measured: From t=12 to t=24 hours
AUCTOTAL 12-30h
Area under the total insulin concentration-time curve from t=12 to t=30 hours
Measured: From t=12 to t=30 hours
AUCTOTAL 0-30h
Area under the total insulin concentration-time curve from t=0 to t=30 hours
Measured: From t=0 to t=30 hours
CTOTALmax
Maximum insulin concentration
Measured: From t=0 to t=30 hours after IMP administration
tmaxTOTAL
Time to maximum total insulin concentration
Measured: From t=0 to t=30 hours after IMP administration
AUCGLA 0-last
Area under the insulin glargine concentration-time curve from t=0 to the last measured insulin concentration above LLOQ
Measured: From t=0 to t=30 hours after IMP administration
AUCGLA 0-1h
Area under the insulin glargine concentration-time curve from t=0 to t=1 hour
Measured: From t=0 to t=1 hour after IMP administration
AUCGLA 0-2h
Area under the insulin glargine concentration-time curve from t=0 to t=2 hours
Measured: From t=0 to t=2 hours after IMP administration
AUCGLA 0-6h
Area under the insulin glargine concentration-time curve from t=0 to t=6 hours
Measured: From t=0 to t=6 hours after IMP administration
AUCGLA 2-6h
Area under the insulin glargine concentration-time curve from t=2 to t=6 hours
Measured: From t=2 to t=6 hours after IMP administration
AUCGLA 6-12h
Area under the insulin glargine concentration-time curve from t=6 to t=12 hours
Measured: From t=6 to t=12 hours after IMP administration
AUCGLA 12-24h
Area under the insulin glargine concentration-time curve from t=12 to t=24 hours
Measured: From t=12 to t=24 hours after IMP administration
AUCGLA 12-30h
Area under the insulin glargine concentration-time curve from t=12 to t=30 hours
Measured: From t=12 to t=30 hours after IMP administration
AUCGLA 0-30h
Area under the insulin glargine concentration-time curve from t=0 to t=30 hours
Measured: From t=0 to t=30 hours after IMP administration
CmaxGLA
Maximum concentration of insulin glargine
Measured: From t=0 to t=30 hours after IMP administration
tmaxGLA
Time to maximum insulin glargine concentration
Measured: From t=0 to t=30 hours after IMP administration
AUCLIS0-last
Area under the insulin lispro concentration-time curve from t=0 to the last measured insulin concentration above LLOQ
Measured: From t=0 to t=30 hours after IMP administration
AUCLIS 0-1h
Area under the insulin lispro concentration-time curve from t=0 to t=1 hour
Measured: From t=0 to t=1 hour after IMP administration
AUCLIS 0-2h
Area under the insulin lispro concentration-time curve from t=0 to t=2 hours
Measured: From t=0 to t=2 hours after IMP administration
AUCLIS 0-6h
Area under the insulin lispro concentration-time curve from t=0 to t=6 hours
Measured: From t=0 to t=6 hours after IMP administration
AUCLIS 2-6h
Area under the insulin lispro concentration-time curve from t=2 to t=6 hours
Measured: From t=2 to t=6 hours after IMP administration
AUCLIS 6-12h
Area under the insulin lispro concentration-time curve from t=6 to t=12 hours
Measured: From t=6 to t=12 hours after IMP administration
AUCLIS 12-24h
Area under the insulin lispro concentration-time curve from t=12 to t=24 hours
Measured: From t=12 to t=24 hours after IMP administration
AUCLIS 12-30h
Area under the insulin lispro concentration-time curve from t=12 to t=30 hours
Measured: From t=12 to t=30 hours after IMP administration
AUCLIS 0-30h
Area under the insulin lispro concentration-time curve from t=0 to t=30 hours
Measured: From t=0 to t=30 hours after IMP administration
CmaxLIS
Maximum concentration of insulin lispro
Measured: From t=0 to t=30 hours after IMP administration
tmaxLIS
Time to maximum insulin lispro concentration
Measured: From t=0 to t=30 hours after IMP administration
Adverse Events
Incidence of Adverse Events
Measured: From the first IMP administration to the follow-up visit (i.e. up to 14 weeks)
Local tolerability
Incidence of Injection Site Reactions
Measured: From the first IMP administration to the follow-up visit (i.e. up to 14 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start12 May 2022
- Primary completion2 Jan 2023
- Study completion2 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Model description
- Four-period crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adocia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tonghua Dongbao Pharmaceutical Co.,Ltd
- Responsible party
- Sponsor
- Investigators
- Oliver Klein, MD, Principal investigator, Profil Institut für Stoffwechselforschung GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373212
- Sponsor's protocol ID
- CT048-ADO05
- Status last verified
- Sep 2023
- First submitted
- 4 May 2022
- Last updated
- 15 Sep 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 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Investigating the Dose Linearity and Safety of BC Combo THDB0207 in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05373212
- Acronym / sponsor ID
- CT048-ADO05
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AdociaIndustry (pharma, biotech, devices)
- Collaborators
- Tonghua Dongbao Pharmaceutical Co.,Ltd
- Study start
- 12 May 2022 (actual)
- Primary completion
- 2 Jan 2023 (actual)
- Study completion
- 2 Jan 2023 (actual)
- First posted
- 13 May 2022 (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 randomised, double-blind, four-period crossover euglycaemic clamp trial in subjects with type 2 diabetes.
Each subject will be randomly allocated to one of four treatment sequences. Each sequence will comprise 3 different single doses of BC Combo THDB0207 (Low dose, Medium dose, and High dose) and one single dose of Humalog® Mix25.
Subjects will come to the clinical trial centre in a fasted state in the morning of each dosing day and stay at the clinical trial centre until the 30-hour clamp procedures have been terminated.
Detailed description
Subjects will attend the study site in the morning in a fasted state and will be connected to an automated glucose clamp device. Prior to dose administration plasma glucose will be stabilised at a target level of 100 mg/dL by means of an intravenous infusion of glucose or insulin. IMP administration will be done by an unblinded person by means of subcutaneous injections in the abdominal wall.
Following each dosing a euglycaemic glucose clamp procedure will be carried out for up to 30 hours.
The pharmacodynamic assessment will be based on the time course of glucose infusion rate (GIR) and plasma glucose.
Plasma insulin concentrations will be measured using a specific validated bioanalytical method differentiating concentrations of insulin glargine, of its main metabolites insulin-glargine-M1 and insulin-glargine-M2, and of insulin lispro. Pharmacokinetic assessments will be based on total insulin concentration (insulin glargine + insulin glargine-M1 + insulin glargine-M2 + insulin lispro), on insulin glargine concentration (insulin glargine + insulin glargine-M1 + insulin glargine-M2), or on insulin lispro concentration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Four-period crossover
| Arm | Type | Receives |
|---|---|---|
| BC Combo THDB0207 Low dose | Experimental | Drug: Euglycemic clamp with BC Combo THDB0207Single administration of BC Combo THDB0207 (Low dose) |
| BC Combo THDB0207 Medium dose | Experimental | Drug: Euglycemic clamp with BC Combo THDB0207Single administration of BC Combo THDB0207 (Medium dose) |
| BC Combo THDB0207 High dose | Experimental | Drug: Euglycemic clamp with BC Combo THDB0207Single administration of BC Combo THDB0207 (High dose) |
| Humalog® Mix25 | Active comparator | Drug: Euglycemic clamp with Humalog® Mix25Single administration of Humalog® Mix25 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Type 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months
- HbA1c ≤9.0%
- Total insulin dose of < 1.2 U/kg/day
- Body mass index between 20.0 and 35.0 kg/m2 (both inclusive)
- Treated with a stable insulin regimen for ≥ 3 months prior to screening
Key exclusion criteria (8 listed)
- Known or suspected hypersensitivity to the IMPs or any of the excipients or to any component of the IMP formulation
- Receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomisation in this trial
- Clinically significant abnormal screening laboratory tests, as judged by the Investigator considering the underlying disease
- Clinically relevant comorbidity, capable of constituting a risk for the subject when participating in the trial or of interfering with the interpretation of data
- Systolic blood pressure < 90 mmHg or >160 mmHg and/or diastolic blood pressure < 50 mmHg or > 95 mmHg (one repeat test will be acceptable in case of suspected white-coat hypertension)
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 |
|---|---|---|
| Euglycemic clamp with BC Combo THDB0207Administration of a single dose of BC Combo THDB0207 during an euglycemic clamp procedure. | Drug | BC Combo THDB0207 High dose, BC Combo THDB0207 Low dose, BC Combo THDB0207 Medium dose |
| Euglycemic clamp with Humalog® Mix25Administration of a single dose of Humalog® Mix25 during an euglycemic clamp procedure. | Drug | Humalog® Mix25 |
Primary outcome
AUCTOTAL0-last
Time frame: From t=0 to t=30 hours after IMP administration
Area under the total insulin concentration-time curve from t=0 to the last measured insulin concentration above LLOQ
CmaxTOTAL
Time frame: From t=0 to t=30 hours after IMP administration
Maximum total insulin concentration
41 secondary outcomes
AUCGIR 0-last
Time frame: From t=0 to t=30 hours after IMP administration
GIRmax
Time frame: From t=0 to t=30 hours after IMP administration
tGIRmax
Time frame: From t=0 to t=30 hours after IMP administration
Tonset of action
Time frame: From t=0 to t=30 hours after IMP administration
AUCGIR 0-6h
Time frame: From t=0 to t=6 hours
AUCTOTALlast
Time frame: From t=0 to t=30 hours after IMP administration
AUCTOTAL 0-1h
Time frame: From t=0 to t=1 hour
AUCTOTAL 0-2h
Time frame: From t=0 to t=2 hours
AUCTOTAL 0-6h
Time frame: From t=0 to t=6 hours
AUCTOTAL 2-6h
Time frame: From t=2 to t=6 hours
AUCTOTAL 6-12h
Time frame: From t=6 to t=12 hours
AUCTOTAL 6-24h
Time frame: From t=6 to t=24 hours
AUCTOTAL 12-24h
Time frame: From t=12 to t=24 hours
AUCTOTAL 12-30h
Time frame: From t=12 to t=30 hours
AUCTOTAL 0-30h
Time frame: From t=0 to t=30 hours
CTOTALmax
Time frame: From t=0 to t=30 hours after IMP administration
tmaxTOTAL
Time frame: From t=0 to t=30 hours after IMP administration
AUCGLA 0-last
Time frame: From t=0 to t=30 hours after IMP administration
AUCGLA 0-1h
Time frame: From t=0 to t=1 hour after IMP administration
AUCGLA 0-2h
Time frame: From t=0 to t=2 hours after IMP administration
AUCGLA 0-6h
Time frame: From t=0 to t=6 hours after IMP administration
AUCGLA 2-6h
Time frame: From t=2 to t=6 hours after IMP administration
AUCGLA 6-12h
Time frame: From t=6 to t=12 hours after IMP administration
AUCGLA 12-24h
Time frame: From t=12 to t=24 hours after IMP administration
AUCGLA 12-30h
Time frame: From t=12 to t=30 hours after IMP administration
AUCGLA 0-30h
Time frame: From t=0 to t=30 hours after IMP administration
CmaxGLA
Time frame: From t=0 to t=30 hours after IMP administration
tmaxGLA
Time frame: From t=0 to t=30 hours after IMP administration
AUCLIS0-last
Time frame: From t=0 to t=30 hours after IMP administration
AUCLIS 0-1h
Time frame: From t=0 to t=1 hour after IMP administration
AUCLIS 0-2h
Time frame: From t=0 to t=2 hours after IMP administration
AUCLIS 0-6h
Time frame: From t=0 to t=6 hours after IMP administration
AUCLIS 2-6h
Time frame: From t=2 to t=6 hours after IMP administration
AUCLIS 6-12h
Time frame: From t=6 to t=12 hours after IMP administration
AUCLIS 12-24h
Time frame: From t=12 to t=24 hours after IMP administration
AUCLIS 12-30h
Time frame: From t=12 to t=30 hours after IMP administration
AUCLIS 0-30h
Time frame: From t=0 to t=30 hours after IMP administration
CmaxLIS
Time frame: From t=0 to t=30 hours after IMP administration
tmaxLIS
Time frame: From t=0 to t=30 hours after IMP administration
Adverse Events
Time frame: From the first IMP administration to the follow-up visit (i.e. up to 14 weeks)
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 15 Sep 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.
Oliver Klein, 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 Euglycemic clamp with BC Combo THDB0207 and Euglycemic clamp with Humalog® Mix25 in people with Type 2 Diabetes, 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 5 inclusion and 8 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 15 Sep 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 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?
AUCTOTAL0-last (time frame: From t=0 to t=30 hours after IMP administration). 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 15 Sep 2023.