Efficacy and Safety of SHR-3167 and Insulin Glargine in Type 2 Diabetes Subjects

NCT ID: NCT06688123

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 275 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-08
• Study Completion Date: 2026-04-30

Brief 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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHR-3167 group A

Group Type: EXPERIMENTAL

SHR-3167

Intervention Type: DRUG

Dose level 1.

SHR-3167 group B

Group Type: EXPERIMENTAL

SHR-3167

Intervention Type: DRUG

Dose level 2.

Insulin glargine group

Group Type: ACTIVE_COMPARATOR

Insulin glargine

Intervention Type: DRUG

Dose level 3.

Interventions

SHR-3167

Dose level 1.

Intervention Type: DRUG

SHR-3167

Dose level 2.

Intervention Type: DRUG

Insulin glargine

Dose level 3.

Intervention Type: DRUG

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.

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

SHR-3167-201

Identifier Type: -

Identifier Source: org_study_id