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

NCT07018453 | Active Not Recruiting Phase 2

• 1 other identifier: SHR-3167-202
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in glycosylated hemoglobin (HbA1c) from baseline.

  16 weeks.

Secondary Outcomes (3)

• Proportion of subjects with glycosylated hemoglobin (HbA1c) < 7.0% from baseline.

  16 weeks.

• Change in fasting plasma glucose (FPG) from baseline.

  16 weeks.

• Change in self-measured (capillary) blood glucose (SMBG) from baseline.

  16 weeks.

Study Arms (3)

SHR-3167 Group A

EXPERIMENTAL

Drug: SHR-3167

SHR-3167 Group B

EXPERIMENTAL

Drug: SHR-3167

Insulin Degludec Group

ACTIVE COMPARATOR

Drug: Insulin Degludec

Interventions

SHR-3167 DRUG

SHR-3167 Injection.

SHR-3167 Group A; SHR-3167 Group B

Insulin Degludec DRUG

Insulin Degludec Injection.

Insulin Degludec Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (2)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

Location

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin degludec

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 12, 2025
• Study Start: July 16, 2025
• Primary Completion: February 1, 2026
• Study Completion: May 1, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

CN (2)