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
Condition(s) studied
Type 2 Diabetes
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
| First Affiliated Hospital of Nanjing Medical University |
Nanjing |
Jiangsu |
|
| Shanghai Sixth People's Hospital |
Shanghai |
Shanghai Municipality |
|
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