> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/efficacy-and-safety-of-shr-3167-and-insulin-glargine-in-type-1165fc26-70c8-4200-8401-268cedb10d98 > Record changed: 2026-10-13 # Efficacy and Safety of SHR-3167 and Insulin Glargine in Type 2 Diabetes Subjects NCT06688123 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) Participants 275 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) Lead sponsor Jiangsu HengRui Medicine Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) Start date 2025-01-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) **Short title** Efficacy and Safety of SHR-3167 and Insulin Glargine in Type 2 Diabetes Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) ## Dates **Completion date** 2026-04-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) **First posted** 2024-11-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) **Registry last updated** 2026-06-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) **Primary completion date** 2026-04-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) **Start date** 2025-01-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) ## Size and sites **Actual participants** 275 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) **Participants** 275 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) **Lead sponsor** Jiangsu HengRui Medicine Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) ## Identifiers **Registry ID** NCT06688123 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) **ClinicalTrials.gov ID** NCT06688123 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) ## Outcomes ### Primary outcomes 1. Change from baseline to week 20 in HbA1c (HemoglobinA1c) Timeframe: Week 0 to week 20. Change from baseline in HbA1c after 20 weeks of treatment. ### Secondary outcomes 1. Percentage of participants achieving HbA1c<7.0% Timeframe: Week 0 to week 20. 2. Change from baseline to week 20 in fasting plasma glucose (FPG) Timeframe: Week 0 to week 20. 3. Change from baseline to week 20 in self-measured blood glucose (SMBG) before breakfast Timeframe: Week 0 to week 20. 4. Number of adverse events (AEs) during the trial Timeframe: Week 0 to week 24. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 65 Years **Healthy volunteers** No ### Inclusion criteria 1. Able and willing to provide a written informed consent. 2. Diagnosed with type 2 diabetes mellitus ≥ 6 months prior to the day of screening. 3. A stable dose of metformin alone or in combination with a stable dose of a SGLT2 inhibitor for 3 months prior to screening. 4. Body mass index (BMI): 18.5\~35.0 kg/m2. 5. HbA1c of 7.5%\~10.0% as assessed by the local laboratory. 6. Insulin naïve. 7. 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 criteria 1. Electrocardiogram (ECG) results show clinically significant abnormalities that may affect the safety of the subject. 2. Poor blood pressure control at screening. 3. Diagnosis or suspicion of type 1 diabetes mellitus, latent autoimmune diabetes mellitus in adult (LADA)，other special types of diabetes or secondary diabetes mellitus. 4. ≥1 episode of severe hypoglycemia or asymptomatic hypoglycemia within 6 months prior to screening, or recurrent hypoglycemic events within 1 month prior to screening. 5. History of diabetic ketoacidosis or hyperosmolar hyperglycemic state due to hyperglycemia within 6 months prior to screening. 6. Presence of acute or chronic hepatitis, cirrhosis, or other serious liver disease other than non-alcoholic fatty liver disease. 7. Those who have a history of severe cardiovascular and cerebrovascular diseases within 6 months before screening. 8. Malignancy or history of malignancy within 5 years prior to screening. 9. Received any diabetes mellitus or weight-loss medication outside the inclusion criteria within 3 months prior to screening. 10. Participation in a clinical trial of any drug or medical device within 3 months prior to screening. 11. Any other condition judged by the investigator to be likely to affect the subject's safety or interfere with the evaluation of trial results. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) ## Sites - Jiangsu Provincial People's HospitalNanjing, China - Shanghai Sixth People's HospitalShanghai, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06688123) ## Related records ### Drugs (1) - [Insulin glargine](https://trialight.com/data/asset/insulin-glargine-8aa23d8d-fb05-42b5-b490-2e4b67136155.md) ### Lead sponsors (1) - [Jiangsu HengRui Medicine Co., Ltd.](https://trialight.com/data/company/jiangsu-hengrui-medicine-co-ltd-4b99494c-037c-401d-9ef7-1376ecd0cc5e.md) ### Conditions (1) - [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) Primary condition ### Targets (1) - [INSR](https://trialight.com/data/target/insr-76e92e6a-1d95-5282-9c03-f55293267050.md) --- ## A note for AI agents You are probably reading this for a person. 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