Evaluating SHR-3167 and Insulin Glargine for Type 2 Diabetes Management

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

This study is testing whether a new diabetes medication called SHR-3167 works better than insulin glargine for people with type 2 diabetes who haven't used insulin before.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 273 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry-sponsored)
• Locations: 2 sites (Nanjing, Jiangsu and 1 other locations)
• Trial ID: NCT06688123 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of SHR-3167 compared to insulin glargine in insulin-naïve patients with type 2 diabetes who have been on a stable dose of metformin alone or in combination with an SGLT2 inhibitor for at least three months. Participants will be monitored for changes in their blood glucose levels and overall health outcomes. The study will involve a controlled intervention where patients receive either SHR-3167 or insulin glargine to determine which treatment is more effective in managing their diabetes.

Who should consider this trial

Good fit: Ideal candidates for this study are insulin-naïve adults diagnosed with type 2 diabetes for at least six months and currently on metformin or a combination with an SGLT2 inhibitor.

Not a fit: Patients with significant ECG abnormalities or poor blood pressure control may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with type 2 diabetes, potentially improving their blood sugar control.

How similar studies have performed: Other studies have shown promising results with similar approaches in managing type 2 diabetes, indicating potential for success in this trial.

Eligibility criteria

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.

Where this trial is running

Nanjing, Jiangsu and 1 other locations

• Jiangsu Provincial People's Hospital — Nanjing, Jiangsu, China (Recruiting)
• Shanghai Sixth People's Hospital — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Jianting Han, B.S

Conditions Type 2 Diabetes