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

Hengrui Medicine

Status and phase: Enrolling; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: SHR-3167; Drug: Insulin glargine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06688123

SHR-3167-201

Details and patient eligibility

About

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.

Enrollment: 273 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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273 participants in 3 patient groups

SHR-3167 group A

Experimental group

Treatment:

Drug: SHR-3167

Drug: SHR-3167

SHR-3167 group B

Experimental group

Treatment:

Drug: SHR-3167

Drug: SHR-3167

Insulin glargine group

Active Comparator group

Treatment:

Drug: Insulin glargine