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

Primary Purpose

Type 2 Diabetes

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
THDB0206 Injection
Insulin Lispro Injection
Sponsored by
Tonghua Dongbao Pharmaceutical Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhongshan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

THDB0206 Injection

Insulin Lispro Injection

Arm Description

Outcomes

Primary Outcome Measures

Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment

Secondary Outcome Measures

Change From Baseline in 1-hour Postprandial Glucose (PPG) Excursion at Week 26
Change From Baseline in 2-hour Postprandial Glucose (PPG) Excursion at Week 26

Full Information

First Posted
April 17, 2023
Last Updated
April 17, 2023
Sponsor
Tonghua Dongbao Pharmaceutical Co.,Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05834868
Brief Title
Efficacy and Safety of THDB0206 Compared to Insulin Lispro Injection in Participants With Type 2 Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 6, 2022 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tonghua Dongbao Pharmaceutical Co.,Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
805 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
THDB0206 Injection
Arm Type
Experimental
Arm Title
Insulin Lispro Injection
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
THDB0206 Injection
Intervention Description
Drug: THDB0206 Injection Injected subcutaneously three times a day. Dose was individually adjusted.
Intervention Type
Drug
Intervention Name(s)
Insulin Lispro Injection
Intervention Description
Drug:Insulin Lispro Injection Injected subcutaneously three times a day. Dose was individually adjusted.
Primary Outcome Measure Information:
Title
Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
Time Frame
Week 26
Secondary Outcome Measure Information:
Title
Change From Baseline in 1-hour Postprandial Glucose (PPG) Excursion at Week 26
Time Frame
Week 26
Title
Change From Baseline in 2-hour Postprandial Glucose (PPG) Excursion at Week 26
Time Frame
Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Basal insulin (neutral protamine Hagedorn [NPH] insulin, insulin glargine, insulin degludec, insulin detemir) in combination with at least 1 prandial injection of bolus insulin. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoyuan JIA
Phone
+86 15638926891
Email
jiaxiaoyuan@thdb.com
Facility Information:
Facility Name
Zhongshan Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoying LI

12. IPD Sharing Statement

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

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