Ireland
--:--IST
Starting soon Phase 3

Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes

NCT07920939 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2026-11
Last updated
2026-11-06

Condition(s) studied

Type 2 Diabetes

Investigational drug(s) / intervention(s)

SHR-3167 Injection →Insulin glargine (IGlar) →

SHR-3167 Injection: SHR-3167 Injection

Insulin glargine (IGlar): Insulin glargine (IGlar)

Study summary

The purpose of this study is to evaluate efficacy and safety of SHR-3167 versus Insulin glargine in insulin-naive type 2 diabetes inadequately controlled on non-insulin anti-diabetic drugs. The hypothesis is that SHR-3167 is non-inferior to insulin glargine in the change of HbA1c from baseline after 26 weeks of treatment.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Before participating in any activities related to this trial, I have agreed and signed the informed consent form, and I am willing and able to follow the trial protocol to complete the study. 2. I am 18 years or older when signing the informed consent, with no gender restriction. 3. According to the 'Chinese Guidelines for Diabetes Prevention and Treatment (2024 edition)', I have been diagnosed with T2DM for at least 180 days before screening. 4. Before screening, I have been on stable treatment with 1 to 3 of non-insulin antihyperglycemic drugs for at least 90 days. 5. At screening, my HbA1c measured by the central lab is between 7.0% and 11.0%, inclusive. 6. At screening, my body mass index (BMI) is ≤40.0 kg/m². 7. Female participants of childbearing potential and male participants with partners of childbearing potential agree to use effective contraception after signing the informed consent, and have no plans to donate eggs/sperm; women of childbearing potential have a negative pregnancy test during the screening period and are not breastfeeding. Exclusion Criteria: 1. Abnormal ECG findings that are clinically significant and may affect participant safety. 2. Poorly controlled blood pressure. 3. Diagnosis or suspected type 1 diabetes (T1DM), latent autoimmune diabetes in adults (LADA), specific types of diabetes, or secondary diabetes. 4. level 2 or 3 hypoglycemia or hypoglycemia with unconsciousness in the past 6 months; or ≥2 episodes of level 3 hypoglycemia in the past year before screening. 5. Diabetic ketoacidosis, lactic acidosis, or hyperglycemic hyperosmolar state/coma within the past 6 months. 6. Severe chronic diabetic complications; or non-proliferative diabetic retinopathy requiring local treatment. 7. Malignant tumors within the past 5 years, or high risk of cancer onset/recurrence, or presence of potential malignant tumors. 8. Use of insulin within the 2 years 9. Participation in any drug or medical device clinical trial within 90 days. 10. Any condition that the investigator deems may endanger participant safety, interfere with trial outcome evaluation, affect protocol compliance, or otherwise make participation inappropriate.

Primary outcome measure(s)

  • Change in HbA1c from baseline to week 26 (non-inferiority test) — baseline to week 26

Trial sites (2)

FacilityCityRegionStatus
First Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu
Shanghai Sixth People's Hospital Shanghai Shanghai Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07920939 on ClinicalTrials.gov ↗ ← All trials in China