NCT05373199

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Adocia · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

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 stabilised at a target level of 100 mg/dL by means of an intravenous infusion of glucose or insulin. IMP administration will be done by an unblinded person by means of subcutaneous injections in the abdominal wall. Following each dosing a euglycaemic glucose clamp procedure will be carried out for up to 24 hours. The pharmacodynamic assessment will be based on the time course of glucose infusion rate (GIR) and plasma glucose. Plasma insulin concentrations will be measured using a specific validated bioanalytical method differentiating concentrations of insulin glargine, of its main metabolites insulin glargine-M1 and insulin glargine-M2, and of insulin lispro. Pharmacokinetic assessments will be based on total insulin (INS) concentration (insulin glargine + insulin glargine-M1 + insulin glargine-M2 + insulin lispro). The investigation of PK properties of the BC449 excipient after dosing with BC Combo THDB0207 will be based on blood samples collected during the clamp procedure and at daily outpatient visits until 144 hours after dose administration.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DRUG	Euglycemic clamp with BC Combo THDB0207	Administration of a single dose of BC Combo THDB0207 during an euglycemic clamp procedure.
DRUG	Euglycemic clamp with Lantus®	Administration of a single dose of Lantus® during an euglycemic clamp procedure.
DRUG	Euglycemic clamp with Humalog®	Administration of a single dose of Humalog® during an euglycemic clamp procedure.

Timeline

• Start date: 2022-05-12
• Primary completion: 2022-10-28
• Completion: 2022-10-28
• First posted: 2022-05-13
• Last updated: 2023-09-15

Locations

1 site across 1 country: Germany