drugset / Trial / NCT05373212

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

NCT05373212

RandomizedCrossoverDouble-blindTreatment

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.

Timeline

Start
2022-05-12
Primary completion
2023-01-02
Completion
2023-01-02

Drugs

EvaluationDrugModalityDoseRoute
Subject BC Combo THDB0207 Unknown Subcutaneous
Comparator Humalog® Mix25 Protein / enzyme biologic Subcutaneous