Efficacy and Safety of THDB0206 Compared to Insulin Lispro Injection in Participants With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

A Phase 3, Randomized, Open-Label, Multicenter, Active-controlled Trial Comparing Efficacy and Safety of THDB0206 Injection With Insulin Lispro Injection Combined With Insulin Glargine Injection U-100 in Chinese Participants With Type 2 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05834868
• Other study ID #: THDB0206L02
• Status: Recruiting
• Phase: Phase 3
• Start date: May 6, 2022
• Est. completion date: October 31, 2024

Study information

• Verified date: April 2023
• Source: Tonghua Dongbao Pharmaceutical Co.,Ltd
• Contact: Xiaoyuan JIA
• Phone: +86 15638926891
• Email: jiaxiaoyuan[@]thdb.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a 26-week randomized, open-label, multicenter, active-controlled parallel group trial. The purpose of this study is to compare efficacy and safety of THDB0206 injection with insulin lispro injection combined with insulin glargine injection U-100 in Chinese participants with T2DM.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 805
• Est. completion date: October 31, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Body mass index: 18.0 kg/m^2~35.0 kg/m^2 (both inclusive) at the time of screening.

• HbA1c: 7.0%~10.0% (both inclusive) at the time of screening.

• Diagnosed with T2DM for 6 months or longer at the time of screening based on the World Health Organization (WHO) classification.

• Treated with stable insulin regimen as follow for at least 3 months with or without oral antidiabetic drug:

1. Basal insulin (neutral protamine Hagedorn [NPH] insulin, insulin glargine, insulin degludec, insulin detemir) in combination with at least 1 prandial injection of bolus insulin.

2. Premixed insulin at least twice daily.

Exclusion Criteria:

• Have other types of diabetes other than T2DM.

• Have used Glucagon-Like Peptide 1 (GLP-1) receptor agonist within 3 months prior to screening.

• Have had 1 or more episodes of severe hypoglycemia within the 6 months prior to screening.

• Have had 1 or more episodes of acute diabetic complications (diabetic ketoacidosis, hyperglycemic hyperosmolar state, diabetic lactic acidosis, etc.) within the 6 months prior to screening.

• With concomitant conditions at screening that may affect the evaluation of the study, including cardiovascular and cerebrovascular diseases, respiratory diseases, gastrointestinal diseases, liver diseases, kidney diseases, nervous system diseases, psychiatric diseases, hematological diseases, immune system diseases, endocrine system diseases, pancreatic diseases, and/or malignant tumors.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• THDB0206 Injection
Drug: THDB0206 Injection Injected subcutaneously three times a day. Dose was individually adjusted.
• Insulin Lispro Injection
Drug:Insulin Lispro Injection Injected subcutaneously three times a day. Dose was individually adjusted.

Locations

Country	Name	City	State
China	Zhongshan Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Tonghua Dongbao Pharmaceutical Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment		Week 26
Secondary	Change From Baseline in 1-hour Postprandial Glucose (PPG) Excursion at Week 26		Week 26
Secondary	Change From Baseline in 2-hour Postprandial Glucose (PPG) Excursion at Week 26		Week 26