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NCT07913061
A Study Comparing SHR-3167 With Insulin Degludec in Adults With Type 2 Diabetes Currently Treated With Basal Insulin
Conditions: Diabetes Mellitus, Type 2
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 680
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Location: The Third Affiliated Hospital of Sun Yat-sen University Shenzhen Guangdong
Summary
The purpose of this study is to evaluate efficacy and safety of once-weekly SHR-3167 and once-daily Insulin Degludec in participants with Type 2 diabetes that has been treated with basal insulin. The study consists of a screening period, a treatment period and a safety follow-up period. The study will last up to 33 weeks.
Eligibility Criteria
Inclusion Criteria:
1. Males and females, Age≥18 years old at the time of signing informed consent.
2. Diagnosed with type 2 diabetes mellitus (T2DM) for at least 180 days prior to day of screening.
3. Treatment with basal insulin with or without oral antidiabetic drugs at least 90 days prior to day of screening.
4. 7.0% ≤ HbA1c ≤ 10.0% at screening.
Exclusion Criteria:
1. Uncontrolled 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. Have a history of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the previous 6 months.
5. Have acute or chronic hepatitis, liver cirrhosis, or a history of other serious liver diseases other than non-alcoholic fatty liver disease.
6. Have hyperthyroidism (including clinical hyperthyroidism and subclinical hyperthyroidism), regardless of whether it is in the treatment stage; or hypothyroidism that requires treatment (those who have received a stable dose of thyroid hormone replacement therapy for ≥ 90 days and are willing to continue the stable treatment during the trial are excluded).
7. Malignancy within 5 years prior to screening or high risk of recurrence.
8. Have a history of severe cardiovascular and cerebrovascular diseases within 6 months before screening.
Source: ClinicalTrials.gov (NCT07913061). StuddyBuddy aggregates publicly available trial information.