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Not yet taking people in ChinaPhase 3

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.

Key facts

Who runs it
Jiangsu HengRui Medicine Co., Ltd.
Where
Shanghai and Shenzhen, ChinaSee the 2 sites
Trial code
Registry title
A Study Comparing SHR-3167 With Insulin Degludec in Adults With Type 2 Diabetes Currently Treated With Basal Insulin
Status
Not yet recruiting
Phase
Phase 3
People taking part
680 people, planned
Started
Nov 2026
Expected to end
Feb 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • SHR-3167
  • insulin degludec
Record updated
3 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with type 2 diabetes who already use basal insulin. It compares once-weekly SHR-3167 with once-daily insulin degludec.

Age
18 years or older
Sex
Men and women can join
Disease stage
Type 2 diabetes for at least 180 days before screening, with HbA1c between 7.0% (53 mmol/mol) and 10.0% (86 mmol/mol) at screening
Earlier treatment
Basal insulin, with or without oral antidiabetic drugs, for at least 90 days before screening
Biomarker or test result
HbA1c from 7.0% (53 mmol/mol) to 10.0% (86 mmol/mol) at screening

Main reasons for not taking part

  • Type 1 diabetes, LADA, or other special or secondary types of diabetes
  • Uncontrolled high blood pressure: systolic 160 mmHg or higher, or diastolic 100 mmHg or higher
  • Diabetic ketoacidosis or hyperglycemic hyperosmolar state in the past 6 months
  • Hepatitis, liver cirrhosis, or other serious liver disease (fatty liver disease not caused by alcohol is allowed)
  • Cancer in the past 5 years or a high risk of it coming back

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in China

  • Zhongshan Hospital Affiliated to Fudan UniversityShanghai, ChinaContact: Xiaoying Li (principal investigator)No longer taking part
  • The Third Affiliated Hospital of Sun Yat-sen UniversityShenzhen, ChinaContact: Yanming Chen (principal investigator)No longer taking part

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • SHR-3167 GroupTreatment being tested

    SHR-3167.

    Treatment: SHR-3167

  • Insulin Degludec GroupExisting treatment, for comparison

    Insulin degludec.

    Treatment: insulin degludec

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Comparing a once-weekly drug with daily insulin degludec for type 2 diabetesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
3 November 2026