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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

173 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-16

Study Completion Date

2026-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SHR-3167 Group A

Group Type EXPERIMENTAL

SHR-3167

Intervention Type DRUG

SHR-3167 Injection.

SHR-3167 Group B

Group Type EXPERIMENTAL

SHR-3167

Intervention Type DRUG

SHR-3167 Injection.

Insulin Degludec Group

Group Type ACTIVE_COMPARATOR

Insulin Degludec

Intervention Type DRUG

Insulin Degludec Injection.

Interventions

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SHR-3167

SHR-3167 Injection.

Intervention Type DRUG

Insulin Degludec

Insulin Degludec Injection.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No