NCT07913061Not yet recruitingPhase 3
A Study Comparing SHR-3167 With Insulin Degludec in Adults With Type 2 Diabetes Currently Treated With Basal Insulin
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
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 680 (estimated)
- First submitted
- 28 Oct 2026
- Start date
- Nov 2026
- Primary completion date
- Jan 2028
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Diseases
- Type 2 diabetes
- NCT number
- NCT07913061
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 680
- From Nov 2026 to the primary completion date, Jan 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongshan Hospital Affiliated to Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| The Third Affiliated Hospital of Sun Yat-sen University Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.