A Study Comparing SHR-3167 and Insulin Degludec in Type 2 Diabetic Subjects Treated With Basal Insulin With or Without Oral Antidiabetic Drugs

Launched by JIANGSU HENGRUI MEDICINE CO., LTD. · Jun 5, 2025

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ClinConnect Summary

This clinical trial is looking at two different medications, SHR-3167 and Insulin Degludec, to see how well they control blood sugar levels in people with type 2 diabetes. The study focuses on participants who have been using a type of insulin called basal insulin for at least 90 days, with or without other diabetes medications. The goal is to determine if SHR-3167 is as safe and effective as Insulin Degludec in managing blood sugar levels.

To be eligible for this trial, participants need to be between 18 and 65 years old and have been diagnosed with type 2 diabetes for at least six months. They should also have a specific range of blood sugar levels (measured by a test called HbA1c) at the time of screening. However, people with certain health issues, like severe high blood pressure or specific types of diabetes other than type 2, cannot participate. If you qualify and decide to join, you will be closely monitored throughout the study to ensure your safety and to gather information on how well the medications work.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Males and females, 18 - 65 years old at the time of signing informed consent.
• • 2. Diagnosed with type 2 diabetes mellitus (T2DM) for at least 6 months prior to the day of screening.
• • 3. Treatment with basal insulin with or without oral antidiabetic drugs at least 90 days prior to the day of screening.
• • 4. 6.5% ≤ HbA1c ≤ 10.0% at screening.
• Exclusion Criteria:
• • 1. Uncontrollable hypertension (with or without antihypertensive treatment) : systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg at screening.
• • 2. Diagnosed or suspected with type 1 diabetes mellitus, latent autoimmune diabetes mellitus in adult (LADA), other special types of diabetes or secondary diabetes.
• • 3. Known or suspected allergy or intolerance to the test drug or excipient.
• • 4. There was a history of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the previous 6 months.
• • 5. There is acute or chronic hepatitis, liver cirrhosis, or a history of other serious liver diseases other than non-alcoholic fatty liver disease.
• • 6. There is hyperthyroidism or hypothyroidism requiring treatment.
• • 7. Malignancy within 5 years prior to screening or high risk of recurrence.
• • 8. Those who have a history of severe cardiovascular and cerebrovascular diseases within 6 months before screening.
• • 9. Participated in clinical trials of any drug or medical device within 3 months prior to screening.