To Compare the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin.
NCT ID: NCT05702073
Last Updated: 2025-03-13
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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COMPLETED
PHASE3
423 participants
INTERVENTIONAL
2023-03-31
2024-06-11
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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INS068
INS068 injection
INS068 injected subcutaneously once daily. Treat-to-target dose titration during the trial
IGlar
Insulin Glargine
Insulin Glargine injected subcutaneously once daily. Treat-to-target dose titration during the trial
Interventions
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INS068 injection
INS068 injected subcutaneously once daily. Treat-to-target dose titration during the trial
Insulin Glargine
Insulin Glargine injected subcutaneously once daily. Treat-to-target dose titration during the trial
Eligibility Criteria
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Inclusion Criteria
2. HbA1c 7.0% \~ 10.0% (Both inclusive) at screening;
3. Treated with Basal insulin ≥10U /day for at least 8 weeks prior to screening.
Exclusion Criteria
2. Hospitalization for diabetic ketoacidosis or hyperglycemic hyperosmolar state within the previous 6 months.
3. Potentially unstable diabetic retinopathy or macular degeneration that requires treatment (e.g., laser, surgical, or injectable medications) within the previous 6 months.
4. Received premixed insulin, mealtime insulin, or insulin pump therapy within 8 weeks prior to screening.
5. Participated in clinical trials of any approved or unapproved investigational drug/treatment within the previous 1 month or 5 half-life period, whichever is longer, prior to screening.
6. Women who are pregnant, breastfeeding or planning to conceive, or women of childbearing potential are reluctant to use appropriate contraception during the trial and for at least 14 days after the last dose of the investigational medicinal drug; Anycircumstances that the investigator judges might not be suitable to participate in the trial..
18 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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INS068-301
Identifier Type: -
Identifier Source: org_study_id
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