Not yet taking people in ChinaPhase 3
Weekly SHR-3167 Versus Daily Insulin Glargine in Type 2 Diabetes
Compares weekly SHR-3167 with daily insulin glargine in adults with type 2 diabetes.
Key facts
- Who runs it
- Jiangsu HengRui Medicine Co., Ltd.
- Where
- Nanjing and Shanghai, ChinaSee the 2 sites
- Trial code
- Registry title
- Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
- Status
- Not yet recruiting
- Phase
- Phase 3
- People taking part
- 450 people, planned
- Started
- Nov 2026
- Expected to end
- Jul 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- SHR-3167 Injection
- Insulin glargine (IGlar)
- Record updated
- 6 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 have never used insulin and whose blood sugar is not well controlled on non-insulin diabetes drugs.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Type 2 diabetes diagnosed at least 180 days before screening. HbA1c between 7.0% (53 mmol/mol) and 11.0% (97 mmol/mol). BMI of 40.0 kg/m² or less.
- Earlier treatment
- Must have taken 1 to 3 non-insulin diabetes drugs at a stable dose for at least 90 days. No insulin use in the past 2 years.
- Biomarker or test result
- HbA1c between 7.0% (53 mmol/mol) and 11.0% (97 mmol/mol) at screening, measured by the central lab.
Main reasons for not taking part
- Type 1 diabetes, LADA, specific types of diabetes or secondary diabetes
- Severe low blood sugar in the past 6 months, or 2 or more episodes of level 3 low blood sugar in the past year
- Diabetic ketoacidosis, lactic acidosis or hyperglycemic hyperosmolar state in the past 6 months
- Cancer within the past 5 years or high risk of cancer
- Another drug or device trial within 90 days
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- Before participating in any activities related to this trial, I have agreed and signed the informed consent form, and I am willing and able to follow the trial protocol to complete the study
- I am 18 years or older when signing the informed consent, with no gender restriction
- According to the 'Chinese Guidelines for Diabetes Prevention and Treatment (2024 edition)', I have been diagnosed with T2DM for at least 180 days before screening
- Before screening, I have been on stable treatment with 1 to 3 of non-insulin antihyperglycemic drugs for at least 90 days
- At screening, my HbA1c measured by the central lab is between 7.0% and 11.0%, inclusive
- At screening, my body mass index (BMI) is ≤40.0 kg/m²
- Female participants of childbearing potential and male participants with partners of childbearing potential agree to use effective contraception after signing the informed consent, and have no plans to donate eggs/sperm; women of childbearing potential have a negative pregnancy test during the screening period and are not breastfeeding
Who cannot take part
- Participation in any drug or medical device clinical trial within 90 days
- Diagnosis or suspected type 1 diabetes (T1DM), latent autoimmune diabetes in adults (LADA), specific types of diabetes, or secondary diabetes
- Malignant tumors within the past 5 years, or high risk of cancer onset/recurrence, or presence of potential malignant tumors
- Any condition that the investigator deems may endanger participant safety, interfere with trial outcome evaluation, affect protocol compliance, or otherwise make participation inappropriate
- Abnormal ECG findings that are clinically significant and may affect participant safety
- Poorly controlled blood pressure
- level 2 or 3 hypoglycemia or hypoglycemia with unconsciousness in the past 6 months; or ≥2 episodes of level 3 hypoglycemia in the past year before screening
- Diabetic ketoacidosis, lactic acidosis, or hyperglycemic hyperosmolar state/coma within the past 6 months
- Severe chronic diabetic complications; or non-proliferative diabetic retinopathy requiring local treatment
- Use of insulin within the 2 years
Where in China
- First Affiliated Hospital of Nanjing Medical UniversityNanjing, ChinaContact: Yun Liu (principal investigator)No longer taking part
- Shanghai Sixth People's HospitalShanghai, ChinaContact: Weiping Jia (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 SHR-3167 versus Insulin glargine in insulin-naive type 2 diabetes inadequately controlled on non-insulin anti-diabetic drugs. The hypothesis is that SHR-3167 is non-inferior to insulin glargine in the change of HbA1c from baseline after 26 weeks of treatment.
The 2 groups in the trial
- Treatment group ATreatment being tested
SHR-3167 Injection
Treatment: SHR-3167 Injection
- Treatment group BExisting treatment, for comparison
Insulin glargine (IGlar)
Treatment: Insulin glargine (IGlar)
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase III, Multicenter, Randomized, Open-Label, Parallel-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
- Plain-language title
- Weekly SHR-3167 Versus Daily Insulin Glargine in 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
- 6 November 2026