A Study Comparing Safety and Efficacy of SHR-3167 Fixed-Dose Titration and Individualized-Dose Titration in Adults With Type 2 Diabetes Inadequately Controlled With Oral Antihyperglycemic Agents

June 3, 2026 updated by: Jiangsu HengRui Medicine Co., Ltd.

A Randomized, Open-Label, Treat-to-Target, Parallel-Controlled Phase II Clinical Study to Evaluate the Safety and Efficacy of Fixed-Dose Titration and Individualized-Dose Titration of SHR-3167 in Adults With Type 2 Diabetes Inadequately Controlled With Oral Antihyperglycemic Agents

The purpose of this study is to evaluate the safety and glycemic control of SHR-3167 fixed-dose titration and individualized-dose titration in adults with Type 2 Diabetes inadequately controlled with oral antihyperglycemic agents.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518000
        • Peking University Shenzhen Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210003
        • Nanjing Drum Tower Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 day of screening.
  3. During the screening process, at least one of the oral antihyperglycemic agents must be used (no more than 3 types), and the treatment must be stable for at least 2 months.
  4. Female participants of childbearing potential and their partners are male participants of childbearing potential, who have no fertility plan and agree to take high-efficiency contraceptive measures within 4 months after signing the informed consent form and have no plans to donate eggs/sperm; Female participants of childbearing potential have a negative pregnancy test during the screening period and are not lactating.

Exclusion Criteria:

  1. Uncontrollable hypertension: 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.
  6. Malignancy within 5 years prior to screening or high risk of recurrence.
  7. Those who have a history of severe cardiovascular and cerebrovascular diseases within 6 months before screening.
  8. Participated in clinical trials of any drug or medical device within 3 months prior to screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SHR-3167 fixed-dose titration group
Drug: SHR-3167 Injection
SHR-3167 injection.
Drug: SHR-3167 Injection Placebo
SHR-3167 injection placebo.
Experimental: SHR-3167 individualized-dose titration group
Drug: SHR-3167 Injection
SHR-3167 injection.
Drug: SHR-3167 Injection Placebo
SHR-3167 injection placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The percentage of participants who experienced at least one hypoglycemic event.
Time Frame: From the baseline to 20-weeks treatment.
From the baseline to 20-weeks treatment.

Secondary Outcome Measures

Outcome Measure
Time Frame
The event rate of hypoglycemic events.
Time Frame: From the baseline to 20-weeks treatment.
From the baseline to 20-weeks treatment.
Change in glycosylated hemoglobin (HbA1c) from baseline.
Time Frame: From the baseline to 20-weeks treatment.
From the baseline to 20-weeks treatment.
Change in fasting plasma glucose (FPG) from baseline.
Time Frame: From the baseline to 20-weeks treatment.
From the baseline to 20-weeks treatment.
The relative change in HbA1c after 20-weeks treatment compared to the baseline level.
Time Frame: From the baseline to 20-weeks treatment.
From the baseline to 20-weeks treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

March 11, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-3167-203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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