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

NCT05373212 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-09-15

No results posted yet for this study

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

Interventions

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 Humalog® Mix25

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

Sponsors & Collaborators

  • Tonghua Dongbao Pharmaceutical Co.,Ltd

    collaborator INDUSTRY

  • Adocia

    lead INDUSTRY

Principal Investigators

  • Oliver Klein, MD · Profil Institut für Stoffwechselforschung GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05373212 on ClinicalTrials.gov