Efficacy and Safety of SHR-3167 and Insulin Glargine in Type 2 Diabetes Subjects
Key facts
- Where
- Nanjing és Shanghai, KínaSee the 2 sites
- Phase
- 2. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Where in Kína
- Jiangsu Provincial People's HospitalNanjing, 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
- NCT06688123
- Record updated
- 2026. június 4.
- Original description
The purpose of this study is to evaluate the efficacy and safety of SHR-3167 compared with insulin glargine after treatment in insulin naïve subjects with type 2 diabetes treated with metformin alone or in combination with SGLT2 subjects.Read full original descriptionShow less
A Randomized, Open-label, Treat-to-target, Parallel-controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-3167 and Insulin Glargine in Patients With Type 2 Diabetes Mellitus With Metformin Alone or in Combination With SGLT2 Inhibitors
The purpose of this study is to evaluate the efficacy and safety of SHR-3167 compared with insulin glargine after treatment in insulin naïve subjects with type 2 diabetes treated with metformin alone or in combination with SGLT2 subjects.
Inclusion: Able and willing to provide a written informed consent; Diagnosed with type 2 diabetes mellitus ≥ 6 months prior to the day of screening; A stable dose of metformin alone or in combination with a stable dose of a SGLT2 inhibitor for 3 months prior to screening; Body mass index (BMI): 18.5~35.0 kg/m2; HbA1c of 7.5%~10.0% as assessed by the local laboratory; Insulin naïve; Female subjects and partners of male subjects who are of childbearing potential, have no fertility plan and agree to take highly effective contraceptive measures within 6 months after signing the informed consent form to the last dose, and have no plans to donate eggs/sperm; Female subjects of childbearing potential have a negative pregnancy test during the screening period and are not lactating.
Exclusion: ≥1 episode of severe hypoglycemia or asymptomatic hypoglycemia within 6 months prior to screening, or recurrent hypoglycemic events within 1 month prior to screening; History of diabetic ketoacidosis or hyperosmolar hyperglycemic state due to hyperglycemia within 6 months prior to screening; Those who have a history of severe cardiovascular and cerebrovascular diseases within 6 months before screening; Received any diabetes mellitus or weight-loss medication outside the inclusion criteria within 3 months prior to screening; Participation in a clinical trial of any drug or medical device within 3 months prior to screening; Diagnosis or suspicion of type 1 diabetes mellitus, latent autoimmune diabetes mellitus in adult (LADA)，other special types of diabetes or secondary diabetes mellitus; Presence of acute or chronic hepatitis, cirrhosis, or other serious liver disease other than non-alcoholic fatty liver disease; Malignancy or history of malignancy within 5 years prior to screening; Any other condition judged by the investigator to be likely to affect the subject's safety or interfere with the evaluation of trial results; Electrocardiogram (ECG) results show clinically significant abnormalities that may affect the safety of the subject; Poor blood pressure control at screening.