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Type 1 DiabetesPhase 1NCT05373199

A Trial Comparing the Pharmacodynamics and Pharmacokinetics of BC Combo THDB0207 and Lantus® and Humalog® in Subjects With Type 1 Diabetes

A Phase 1 study testing Euglycemic clamp with BC Combo THDB0207, Euglycemic clamp with Lantus® and Euglycemic clamp with Humalog® in people with Type 1 Diabetes, run by Adocia at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomised, double-blind, three-period crossover euglycaemic clamp trial comparing pharmacokinetics and pharmacodynamics of BC Combo THDB0207 and Lantus® and Humalog® in subjects with type 1 diabetes. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
Euglycemic clamp with BC Combo THDB0207, Euglycemic clamp with Lantus® and Euglycemic clamp with Humalog®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteGermany
Study dates
12 May 2022to 28 Oct 2022
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 1 diabetes mellitus (as diagnosed clinically) for ≥ 12 months
  • HbA1c ≤8.5%
  • Total insulin dose of < 1.2 U/kg/day
  • BMI between 20.0 and 29.9 kg/m2 (both inclusive)
  • Treated with insulin regimen for ≥ 12 months prior to screening
  • Using multiple dosing insulin therapy (MDI) with basal and bolus insulin or insulin pump therapy (continuous subcutaneous insulin infusion, CSII)
  • Fasting C-peptide <= 0.30 nmol/L

Who cannot join

  • Known or suspected hypersensitivity to the IMPs or any of the excipients or to any component of the IMP formulation.
  • Type 2 diabetes mellitus
  • Use of oral antidiabetic drugs (OADs) and/or GLP-1 receptor agonists (e.g. exenatide, liraglutide)
  • 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
Show all 10Show fewer
  • Systolic blood pressure < 90 mmHg or >139 mmHg and/or diastolic blood pressure < 50 mmHg or > 89 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.
  • More than one episode of severe hypoglycaemia with seizure, coma or requiring assistance of another person during the past 6 months or hypoglycaemia unawareness as judged by the investigator
  • Women of childbearing potential who are not using a highly effective contraceptive method.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Profil Institut für Stoffwechselforschung GmbH

    Neuss, 41460

Other trials in Germany

About this study

This is a randomised, double-blind, three-period crossover euglycaemic clamp trial comparing pharmacokinetics and pharmacodynamics of BC Combo THDB0207 and Lantus® and Humalog® in subjects with type 1 diabetes.

Each subject will be randomly allocated to one of the 6 treatment sequences and will be administered single subcutaneous doses of BC Combo THDB0207, Lantus®, and Humalog® at three 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 24-hour clamp procedures have been terminated. Patients will return to the clinical trial centre for outpatient blood sampling visits for analysis of BC449 excipient until 144 hours after each dosing.

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 (ClampArt). 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 24 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 (INS) concentration (insulin glargine + insulin glargine-M1 + insulin glargine-M2 + insulin lispro).

The investigation of PK properties of the BC449 excipient after dosing with BC Combo THDB0207 will be based on blood samples collected during the clamp procedure and at daily outpatient visits until 144 hours after dose administration.

Conditions
Type 1 Diabetes
Being tested
Euglycemic clamp with BC Combo THDB0207, Euglycemic clamp with Lantus®, Euglycemic clamp with Humalog®
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.

  • Euglycemic clamp with BC Combo THDB0207Drug

    Administration of a single dose of BC Combo THDB0207 during an euglycemic clamp procedure.

  • Euglycemic clamp with Lantus®Drug

    Administration of a single dose of Lantus® during an euglycemic clamp procedure.

  • Euglycemic clamp with Humalog®Drug

    Administration of a single dose of Humalog® during an euglycemic clamp procedure.

Study groups in NCT05373199
Study groupRoleWhat they receive
BC Combo THDB0207ExperimentalSingle administration of BC Combo THDB0207
Receives: Drug: Euglycemic clamp with BC Combo THDB0207
Lantus®Active comparatorSingle administration of Lantus®
Receives: Drug: Euglycemic clamp with Lantus®
Humalog®Active comparatorSingle administration of Humalog®
Receives: Drug: Euglycemic clamp with Humalog®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUCGIR 0-6h

    Area under the glucose infusion rate curve until 6 hours after dosing of BC Combo THDB0207 and Lantus®

    Measured: From t=0 to t=6 hours after IMP administration

  2. AUCGIR 6-24h

    Area under the glucose infusion rate curve from 6 hours to 24 hours after dosing of BC Combo THDB0207 and Humalog®

    Measured: From t=6 to t=24 hours after IMP administration

Secondary outcomes (18)

  1. AUCGIR 0-last

    Area under the glucose infusion rate curve from 0 hours until the end of clamp

    Measured: From t=0 to t=24 hours after IMP administration

  2. AUCGIR 0-4h

    Area under the glucose infusion rate curve from 0 hours until 4 hours

    Measured: From t=0 to t=4 hours after IMP administration

  3. GIRmax

    Maximum glucose infusion rate

    Measured: From t=0 to t=24 hours

  4. tGIRmax

    Time to maximum glucose infusion rate

    Measured: From t=0 to t=24 hours

  5. 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=24 hours after IMP administration

  6. AUCINS 0-6h

    Area under the insulin concentration-time curve from 0 hours until 6 hours

    Measured: From t=0 to t=6 hours after IMP administration

  7. AUCINS 0-24h

    Area under the insulin concentration-time curve from 0 hours until 24 hours

    Measured: From t=0 to t=24 hours after IMP administration

  8. AUCINS 6-24h

    Area under the insulin concentration-time curve from 6 hours until 24 hours

    Measured: From t=6 to t=24 hours after IMP administration

  9. AUCINS 4-12h

    Area under the insulin concentration-time curve from 4 hours until 12 hours

    Measured: From t=4 to t=12 hours after IMP administration

  10. AUCINS 0-4h

    Area under the insulin concentration-time curve from 0 hours until 4 hours

    Measured: From t=0 to t=4 hours after IMP administration

  11. AUCINSlast

    Area under the insulin concentration-time curve from t=0 to the last measured insulin concentration above LLOQ

    Measured: From t=0 to t=24 hours

  12. Cmax INS

    Maximum insulin concentration

    Measured: From t=0 to t=24 hours after IMP administration

  13. RBA

    Relative bioavailability of BC Combo THDB0207 vs Humalog®

    Measured: From t=0 to t=24 hours after IMP administration

  14. AUCBC 0-12h

    Area under the BC449 concentration-time curve from 0 hours until 12 hours

    Measured: From t=0 to t=12 hours after IMP administration

  15. AUCBC 0-24h

    Area under the BC449 concentration-time curve from 0 hours until 24 hours

    Measured: From t=0 to t=24 hours after IMP administration

  16. AUCBC 0-last

    Area under the BC449 concentration-time curve from t=0 to the last measured BC449 concentration above LLOQ

    Measured: From t=0 to t=144 hours after IMP administration

  17. Adverse Events

    Incidence of Adverse Events

    Measured: From the first IMP administration to the follow-up visit (i.e. up to 11 weeks)

  18. Local tolerability

    Incidence of injection site reactions

    Measured: From the first IMP administration to the follow-up visit (i.e. up to 11 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2022
  2. Study start12 May 2022
  3. Primary completion28 Oct 2022
  4. Study completion28 Oct 2022

Resources

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
Three-period crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05373199
Sponsor's protocol ID
CT047-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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Euglycemic clamp with BC Combo THDB0207, Euglycemic clamp with Lantus® and Euglycemic clamp with Humalog® in people with Type 1 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 7 inclusion and 10 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?

AUCGIR 0-6h (time frame: From t=0 to t=6 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?

On the ClinicalTrials.gov record for NCT05373199.

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.

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