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

NCT05373199 | Completed Phase 1

• 1 other identifier: CT047-ADO05
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (2)

• AUCGIR 0-6h

  Area under the glucose infusion rate curve until 6 hours after dosing of BC Combo THDB0207 and Lantus®

  From t=0 to t=6 hours after IMP administration

• AUCGIR 6-24h

  Area under the glucose infusion rate curve from 6 hours to 24 hours after dosing of BC Combo THDB0207 and Humalog®

  From t=6 to t=24 hours after IMP administration

Secondary Outcomes (18)

• AUCGIR 0-last

  From t=0 to t=24 hours after IMP administration

• AUCGIR 0-4h

  From t=0 to t=4 hours after IMP administration

• GIRmax

  From t=0 to t=24 hours

• tGIRmax

  From t=0 to t=24 hours

• tonset of action

  From t=0 to t=24 hours after IMP administration

Study Arms (3)

BC Combo THDB0207

EXPERIMENTAL

Single administration of BC Combo THDB0207

Drug: Euglycemic clamp with BC Combo THDB0207

Lantus®

ACTIVE COMPARATOR

Single administration of Lantus®

Drug: Euglycemic clamp with Lantus®

Humalog®

ACTIVE COMPARATOR

Single administration of Humalog®

Drug: Euglycemic clamp with Humalog®

Interventions

Euglycemic clamp with BC Combo THDB0207 DRUG

Administration of a single dose of BC Combo THDB0207 during an euglycemic clamp procedure.

BC Combo THDB0207

Euglycemic clamp with Lantus® DRUG

Administration of a single dose of Lantus® during an euglycemic clamp procedure.

Lantus®

Euglycemic clamp with Humalog® DRUG

Administration of a single dose of Humalog® during an euglycemic clamp procedure.

Humalog®

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Type 1 diabetes mellitus (as diagnosed clinically) for ≥ 12 months
• HbA1c ≤8.5%
• Total insulin dose of \< 1.2 U/kg/day
• BMI between 20.0 and 29.9 kg/m2 (both inclusive)
• Treated with insulin regimen for ≥ 12 months prior to screening
• Using multiple dosing insulin therapy (MDI) with basal and bolus insulin or insulin pump therapy (continuous subcutaneous insulin infusion, CSII)
• Fasting C-peptide \<= 0.30 nmol/L

You may not qualify if:

• Known or suspected hypersensitivity to the IMPs or any of the excipients or to any component of the IMP formulation.
• Type 2 diabetes mellitus
• Use of oral antidiabetic drugs (OADs) and/or GLP-1 receptor agonists (e.g. exenatide, liraglutide)
• 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 \>139 mmHg and/or diastolic blood pressure \< 50 mmHg or \> 89 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.
• More than one episode of severe hypoglycaemia with seizure, coma or requiring assistance of another person during the past 6 months or hypoglycaemia unawareness as judged by the investigator
• Women of childbearing potential who are not using a highly effective contraceptive method.

Sponsors & Collaborators

• Adocia: lead
• Tonghua Dongbao Pharmaceutical Co.,Ltd: collaborator

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Glucose Clamp Technique; Insulin Glargine; Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Chemistry Techniques, Analytical; Investigative Techniques; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Study Officials

• Marc Stoffel, MD

  Profil Institut für Stoffwechselforschung GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Three-period crossover

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 13, 2022
• Study Start: May 12, 2022
• Primary Completion: October 28, 2022
• Study Completion: October 28, 2022
• Last Updated: September 15, 2023

Record last verified: 2023-09

Locations

DE (1)