Status:
COMPLETED
A Trial Investigating the Dose Linearity and Safety of BC Combo THDB0207 in Subjects With Type 2 Diabetes
Lead Sponsor:
Adocia
Collaborating Sponsors:
Tonghua Dongbao Pharmaceutical Co.,Ltd
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief 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. Each se...
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 tar...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 2 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05373212
Start Date
May 12 2022
End Date
January 2 2023
Last Update
September 15 2023
Active Locations (1)
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1
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany, 41460