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

Phase 2

Not yet recruiting

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: SHR-3167; Drug: Insulin Degludec

• Registration Number: NCT07018453
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06
• Study First Submitted: 2025-06-05
• Study First Submitted QC: 2025-06-05
• Last Update Submitted: 2025-06-05
• Study First Posted: 2025-06-12
• Last Update Posted: 2025-06-12
• Primary Completion: 2025-12
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 153

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHR-3167 Group A	SHR-3167	-
SHR-3167 Group B	SHR-3167	-
Insulin Degludec Group	Insulin Degludec	-

Primary Outcome Measures

Name	Time	Method
Change in glycosylated hemoglobin (HbA1c) from baseline.	16 weeks.

Secondary Outcome Measures

Name	Time	Method
Change in self-measured (capillary) blood glucose (SMBG) from baseline.	16 weeks.
Proportion of subjects with glycosylated hemoglobin (HbA1c) < 7.0% from baseline.	16 weeks.
Change in fasting plasma glucose (FPG) from baseline.	16 weeks.

Trial Locations

Locations (2)

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China

Zhongshan Hospital Affiliated to Fudan University; 🇨🇳 Shanghai, Shanghai, China