A Study Comparing SHR-3167 and Insulin Degludec in Type 2 Diabetic Subjects Treated With Basal Insulin With or Without Oral Antidiabetic Drugs

Hengrui Medicine

Status and phase: Active, not recruiting; Phase 2

Conditions: Type 2 Diabetes Mellitus

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT07018453

SHR-3167-202

Details and patient eligibility

About

The purpose of this study is to evaluate the glycemic control and safety of SHR-3167 and Insulin Degludec in type 2 diabetic participants treated with basal insulin with or without oral antidiabetic drugs.

Enrollment: 173 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males and females, 18 - 65 years old at the time of signing informed consent.
2. Diagnosed with type 2 diabetes mellitus (T2DM) for at least 6 months prior to the day of screening.
3. Treatment with basal insulin with or without oral antidiabetic drugs at least 90 days prior to the day of screening.
4. 6.5% ≤ HbA1c ≤ 10.0% at screening.

Exclusion criteria

1. Uncontrollable hypertension (with or without antihypertensive treatment) : systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg at screening.
2. Diagnosed or suspected with type 1 diabetes mellitus, latent autoimmune diabetes mellitus in adult (LADA), other special types of diabetes or secondary diabetes.
3. Known or suspected allergy or intolerance to the test drug or excipient.
4. There was a history of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the previous 6 months.
5. There is acute or chronic hepatitis, liver cirrhosis, or a history of other serious liver diseases other than non-alcoholic fatty liver disease.
6. There is hyperthyroidism or hypothyroidism requiring treatment.
7. Malignancy within 5 years prior to screening or high risk of recurrence.
8. Those who have a history of severe cardiovascular and cerebrovascular diseases within 6 months before screening.
9. Participated in clinical trials of any drug or medical device within 3 months prior to screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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173 participants in 3 patient groups

SHR-3167 Group A

Experimental group

Treatment:

Drug: SHR-3167

SHR-3167 Group B

Experimental group

Treatment:

Drug: SHR-3167

Insulin Degludec Group

Active Comparator group

Treatment:

Drug: Insulin Degludec