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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THDB0206 Injection | Experimental |
| |
| Insulin Lispro Injection | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THDB0206 Injection | Drug | Drug: THDB0206 Injection Injected subcutaneously three times a day. Dose was individually adjusted. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment | Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 1-hour Postprandial Glucose (PPG) Excursion at Week 26 | Week 26 | |
| Change From Baseline in 2-hour Postprandial Glucose (PPG) Excursion at Week 26 | Week 26 |
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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:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital | Shanghai | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Insulin Lispro Injection | Drug | Drug:Insulin Lispro Injection Injected subcutaneously three times a day. Dose was individually adjusted. |
|
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |