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

A Randomized, Open-label, Treat-to-target, Parallel-Controlled Phase II Clinical Study Investigating the Efficacy and Safety of SHR-3167 and Insulin Degludec in Type 2 Diabetic Subjects Treated With Basal Insulin With or Without Oral Antidiabetic Drugs

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07018453

Enrollment

173

Registered

2025-06-12

Start date

2025-07-16

Completion date

2026-05-31

Last updated

2025-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

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.

Interventions

DRUGSHR-3167

SHR-3167 Injection.

DRUGInsulin Degludec

Insulin Degludec Injection.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame
Change in glycosylated hemoglobin (HbA1c) from baseline.	16 weeks.

Secondary

Measure	Time frame
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026