Efficacy and Safety of THDB0206 Compared to Insulin Lispro Injection in Participants With Type 2 Diabetes
NCT05834868
Phase
Phase 3
Recruitment status
Completed
Participants
1,040
Lead sponsor
Tonghua Dongbao Pharmaceutical Co.,Ltd
Start date
2022-05-06
Number of sites
- 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.
- Short 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2024-12-31
- First posted
- 2023-04-28
- Registry last updated
- 2025-12-22
- Primary completion date
- 2024-12-10
- Start date
- 2022-05-06
- Actual participants
- 1,040
- Participants
- 1,040
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Tonghua Dongbao Pharmaceutical Co.,Ltd
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05834868
- ClinicalTrials.gov ID
- NCT05834868
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Sources for study design
Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
Timeframe: Week 26
Change From Baseline in 1-hour Postprandial Glucose (PPG) Excursion at Week 26
Timeframe: Week 26
Change From Baseline in 2-hour Postprandial Glucose (PPG) Excursion at Week 26
Timeframe: Week 26
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
-
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.
- 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.
Sources for eligibility
- Zhongshan HospitalShanghai, China
Sources for sites
Related records
Drugs (2)
Lead sponsors (1)
Conditions (1)
- Type 2 diabetes mellitus Primary condition