Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Key facts
- Where
- Nanjing és Shanghai, KínaSee the 2 sites
- Phase
- 3. fázis
Where in Kína
- First Affiliated Hospital of Nanjing Medical UniversityNanjing, KínaNo longer taking part
- Shanghai Sixth People's HospitalShanghai, KínaNo 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
- NCT07920939
- Record updated
- 2026. november 6.
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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.