Comparing a once-weekly drug with daily insulin degludec for type 2 diabetes
Tests once-weekly SHR-3167 against daily insulin in adults with type 2 diabetes.
Plain-language title generated from the registry record
Registry title: A Study Comparing SHR-3167 With Insulin Degludec in Adults With Type 2 Diabetes Currently Treated With Basal Insulin
Key facts
- Where
- Shanghai and Shenzhen, ChinaSee the 2 sites
- Phase
- Phase 3
Where in China
- Zhongshan Hospital Affiliated to Fudan UniversityShanghai, ChinaNo longer taking part
- The Third Affiliated Hospital of Sun Yat-sen UniversityShenzhen, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jiangsu HengRui Medicine Co., Ltd.
- Trial code
- NCT07913061
- Record updated
- 3 November 2026
- Original description
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.Read full original descriptionShow less
A Multicenter, Randomized, Open-Label, Parallel-Group, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Degludec in Adults With Type 2 Diabetes Currently Treated With Basal Insulin, With or Without Non-Insulin Antidiabetic Drugs
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.
Inclusion: Males and females, Age≥18 years old at the time of signing informed consent; Diagnosed with type 2 diabetes mellitus (T2DM) for at least 180 days prior to day of screening; Treatment with basal insulin with or without oral antidiabetic drugs at least 90 days prior to day of screening; 7.0% ≤ HbA1c ≤ 10.0% at screening.
Exclusion: Have a history of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the previous 6 months; 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); Malignancy within 5 years prior to screening or high risk of recurrence; Have a history of severe cardiovascular and cerebrovascular diseases within 6 months before screening; Uncontrolled hypertension(with or without antihypertensive treatment) : systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg at screening; Diagnosed or suspected with type 1 diabetes mellitus, latent autoimmune diabetes mellitus in adult (LADA), other special types of diabetes or secondary diabetes; Known or suspected allergy or intolerance to the test drug or excipient; Have acute or chronic hepatitis, liver cirrhosis, or a history of other serious liver diseases other than non-alcoholic fatty liver disease.