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

NCT05373212 | Completed Phase 1

• 1 other identifier: CT048-ADO05
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• AUCTOTAL0-last

  Area under the total insulin concentration-time curve from t=0 to the last measured insulin concentration above LLOQ

  From t=0 to t=30 hours after IMP administration

• CmaxTOTAL

  Maximum total insulin concentration

  From t=0 to t=30 hours after IMP administration

Secondary Outcomes (41)

• AUCGIR 0-last

  From t=0 to t=30 hours after IMP administration

• GIRmax

  From t=0 to t=30 hours after IMP administration

• tGIRmax

  From t=0 to t=30 hours after IMP administration

• Tonset of action

  From t=0 to t=30 hours after IMP administration

• AUCGIR 0-6h

  From t=0 to t=6 hours

Study Arms (4)

BC Combo THDB0207 Low dose

EXPERIMENTAL

Single administration of BC Combo THDB0207 (Low dose)

Drug: Euglycemic clamp with BC Combo THDB0207

BC Combo THDB0207 Medium dose

EXPERIMENTAL

Single administration of BC Combo THDB0207 (Medium dose)

Drug: Euglycemic clamp with BC Combo THDB0207

BC Combo THDB0207 High dose

EXPERIMENTAL

Single administration of BC Combo THDB0207 (High dose)

Drug: Euglycemic clamp with BC Combo THDB0207

Humalog® Mix25

ACTIVE COMPARATOR

Single administration of Humalog® Mix25

Drug: Euglycemic clamp with Humalog® Mix25

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 High dose; BC Combo THDB0207 Low dose; BC Combo THDB0207 Medium dose

Euglycemic clamp with Humalog® Mix25 DRUG

Administration of a single dose of Humalog® Mix25 during an euglycemic clamp procedure.

Humalog® Mix25

Eligibility Criteria

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

You may qualify if:

• 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

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
• 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

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 2

Interventions

Glucose Clamp Technique

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Oliver Klein, 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: Four-period crossover

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 13, 2022
• Study Start: May 12, 2022
• Primary Completion: January 2, 2023
• Study Completion: January 2, 2023
• Last Updated: September 15, 2023

Record last verified: 2023-09

Locations

DE (1)