Efficacy and Safety of SHR-3167 and Insulin Glargine in Type 2 Diabetes Subjects

NCT06688123 | Active Not Recruiting Phase 2

• 1 other identifier: SHR-3167-201
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of SHR-3167 compared with insulin glargine after treatment in insulin naïve subjects with type 2 diabetes treated with metformin alone or in combination with SGLT2 subjects.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change from baseline to week 20 in HbA1c (HemoglobinA1c)

  Change from baseline in HbA1c after 20 weeks of treatment.

  Week 0 to week 20.

Secondary Outcomes (4)

• Percentage of participants achieving HbA1c<7.0%

  Week 0 to week 20.

• Change from baseline to week 20 in fasting plasma glucose (FPG)

  Week 0 to week 20.

• Change from baseline to week 20 in self-measured blood glucose (SMBG) before breakfast

  Week 0 to week 20.

• Number of adverse events (AEs) during the trial

  Week 0 to week 24.

Study Arms (3)

SHR-3167 group A

EXPERIMENTAL

Drug: SHR-3167

SHR-3167 group B

EXPERIMENTAL

Drug: SHR-3167

Insulin glargine group

ACTIVE COMPARATOR

Drug: Insulin glargine

Interventions

SHR-3167 DRUG

Dose level 1.

SHR-3167 group A

Insulin glargine DRUG

Dose level 3.

Insulin glargine 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:

• Able and willing to provide a written informed consent.
• Diagnosed with type 2 diabetes mellitus ≥ 6 months prior to the day of screening.
• A stable dose of metformin alone or in combination with a stable dose of a SGLT2 inhibitor for 3 months prior to screening.
• Body mass index (BMI): 18.5\~35.0 kg/m2.
• HbA1c of 7.5%\~10.0% as assessed by the local laboratory.
• Insulin naïve.
• Female subjects and partners of male subjects who are of childbearing potential, have no fertility plan and agree to take highly effective contraceptive measures within 6 months after signing the informed consent form to the last dose, and have no plans to donate eggs/sperm; Female subjects of childbearing potential have a negative pregnancy test during the screening period and are not lactating.

You may not qualify if:

• Electrocardiogram (ECG) results show clinically significant abnormalities that may affect the safety of the subject.
• Poor blood pressure control at screening.
• Diagnosis or suspicion of type 1 diabetes mellitus, latent autoimmune diabetes mellitus in adult (LADA)，other special types of diabetes or secondary diabetes mellitus.
• ≥1 episode of severe hypoglycemia or asymptomatic hypoglycemia within 6 months prior to screening, or recurrent hypoglycemic events within 1 month prior to screening.
• History of diabetic ketoacidosis or hyperosmolar hyperglycemic state due to hyperglycemia within 6 months prior to screening.
• Presence of acute or chronic hepatitis, cirrhosis, or other serious liver disease other than non-alcoholic fatty liver disease.
• Those who have a history of severe cardiovascular and cerebrovascular diseases within 6 months before screening.
• Malignancy or history of malignancy within 5 years prior to screening.
• Participation in a clinical trial of any drug or medical device within 3 months prior to screening.
• Any other condition judged by the investigator to be likely to affect the subject's safety or interfere with the evaluation of trial results.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (2)

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, 210029, China

Location

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

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: November 12, 2024
• First Posted: November 14, 2024
• Study Start: January 8, 2025
• Primary Completion: March 30, 2026
• Study Completion: April 30, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

CN (2)