A Trial Comparing the Pharmacodynamics and Pharmacokinetics of BC Combo THDB0207 and Lantus® and Humalog® in Subjects With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Euglycemic clamp with BC Combo THDB0207; Euglycemic clamp with Lantus®; Euglycemic clamp with Humalog®
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administration of a single dose of BC Combo THDB0207 during an euglycemic clamp procedure.; Administration of a single dose of Lantus® during an euglycemic clamp procedure.; Administration of a single dose of Humalog® during an euglycemic clamp procedure.
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Three-period crossover
Masking: Double (Participant, Investigator)
Primary purpose: Treatment