Efficacy and Safety of THDB0206 Compared to Insulin Lispro Injection in Participants With Type 2 Diabetes
NCT ID: NCT05834868
Last Updated: 2023-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
805 participants
INTERVENTIONAL
2022-05-06
2024-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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THDB0206 Injection
THDB0206 Injection
Drug: THDB0206 Injection Injected subcutaneously three times a day. Dose was individually adjusted.
Insulin Lispro Injection
Insulin Lispro Injection
Drug:Insulin Lispro Injection Injected subcutaneously three times a day. Dose was individually adjusted.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
75 Years
ALL
No
Sponsors
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Tonghua Dongbao Pharmaceutical Co.,Ltd
INDUSTRY
Responsible Party
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Locations
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Zhongshan Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Xiaoying LI
Role: primary
Other Identifiers
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THDB0206L02
Identifier Type: -
Identifier Source: org_study_id