A Trial Investigating the Dose Linearity and Safety of BC Combo THDB0207 in Subjects With Type 2 Diabetes

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

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 sequence will comprise 3 different single doses of BC Combo THDB0207 (Low dose, Medium dose, and High dose) and one single dose of Humalog® Mix25.

Subjects will come to the clinical trial centre in a fasted state in the morning of each dosing day and stay at the clinical trial centre until the 30-hour clamp procedures have been terminated.

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

Details

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

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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