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

• Status: Not yet recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

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.

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Adocia
• Collaborator: Tonghua Dongbao Pharmaceutical Co.,Ltd
• Treatments: Insulin Lispro

Criteria

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.