Status:
COMPLETED
A Trial Comparing the Pharmacodynamics and Pharmacokinetics of BC Combo THDB0207 and Lantus® and Humalog® in Subjects With Type 1 Diabetes
Lead Sponsor:
Adocia
Collaborating Sponsors:
Tonghua Dongbao Pharmaceutical Co.,Ltd
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief 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...
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 stabilis...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05373199
Start Date
May 12 2022
End Date
October 28 2022
Last Update
September 15 2023
Active Locations (1)
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1
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany, 41460