Type 1 Diabetes Clinical Trial
Official title:
A Trial Comparing the Pharmacodynamics and Pharmacokinetics of BC Combo THDB0207 and Lantus® and Humalog® in Subjects With Type 1 Diabetes
Verified date | September 2023 |
Source | Adocia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 28, 2022 |
Est. primary completion date | October 28, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 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. |
Country | Name | City | State |
---|---|---|---|
Germany | Profil Institut für Stoffwechselforschung GmbH | Neuss |
Lead Sponsor | Collaborator |
---|---|
Adocia | Tonghua Dongbao Pharmaceutical Co.,Ltd |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | AUCGIR 0-6h | Area under the glucose infusion rate curve until 6 hours after dosing of BC Combo THDB0207 and Lantus® | From t=0 to t=6 hours after IMP administration | |
Primary | AUCGIR 6-24h | Area under the glucose infusion rate curve from 6 hours to 24 hours after dosing of BC Combo THDB0207 and Humalog® | From t=6 to t=24 hours after IMP administration | |
Secondary | AUCGIR 0-last | Area under the glucose infusion rate curve from 0 hours until the end of clamp | From t=0 to t=24 hours after IMP administration | |
Secondary | AUCGIR 0-4h | Area under the glucose infusion rate curve from 0 hours until 4 hours | From t=0 to t=4 hours after IMP administration | |
Secondary | GIRmax | Maximum glucose infusion rate | From t=0 to t=24 hours | |
Secondary | tGIRmax | Time to maximum glucose infusion rate | From t=0 to t=24 hours | |
Secondary | tonset of action | Time until Plasma Glucose (PG) has decreased by at least 5 mg/dL from the baseline PG value. | From t=0 to t=24 hours after IMP administration | |
Secondary | AUCINS 0-6h | Area under the insulin concentration-time curve from 0 hours until 6 hours | From t=0 to t=6 hours after IMP administration | |
Secondary | AUCINS 0-24h | Area under the insulin concentration-time curve from 0 hours until 24 hours | From t=0 to t=24 hours after IMP administration | |
Secondary | AUCINS 6-24h | Area under the insulin concentration-time curve from 6 hours until 24 hours | From t=6 to t=24 hours after IMP administration | |
Secondary | AUCINS 4-12h | Area under the insulin concentration-time curve from 4 hours until 12 hours | From t=4 to t=12 hours after IMP administration | |
Secondary | AUCINS 0-4h | Area under the insulin concentration-time curve from 0 hours until 4 hours | From t=0 to t=4 hours after IMP administration | |
Secondary | AUCINSlast | Area under the insulin concentration-time curve from t=0 to the last measured insulin concentration above LLOQ | From t=0 to t=24 hours | |
Secondary | Cmax INS | Maximum insulin concentration | From t=0 to t=24 hours after IMP administration | |
Secondary | RBA | Relative bioavailability of BC Combo THDB0207 vs Humalog® | From t=0 to t=24 hours after IMP administration | |
Secondary | AUCBC 0-12h | Area under the BC449 concentration-time curve from 0 hours until 12 hours | From t=0 to t=12 hours after IMP administration | |
Secondary | AUCBC 0-24h | Area under the BC449 concentration-time curve from 0 hours until 24 hours | From t=0 to t=24 hours after IMP administration | |
Secondary | AUCBC 0-last | Area under the BC449 concentration-time curve from t=0 to the last measured BC449 concentration above LLOQ | From t=0 to t=144 hours after IMP administration | |
Secondary | Adverse Events | Incidence of Adverse Events | From the first IMP administration to the follow-up visit (i.e. up to 11 weeks) | |
Secondary | Local tolerability | Incidence of injection site reactions | From the first IMP administration to the follow-up visit (i.e. up to 11 weeks) |
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