Efficacy and Safety of SHR-3167 and Insulin Glargine in Type 2 Diabetes Subjects (NCT06688123) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety of SHR-3167 and Insulin Glargine in Type 2 Diabetes Subjects
China275 participantsStarted 2025-01-08
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. Electrocardiogram (ECG) results show clinically significant abnormalities that may affect the safety of the subject.
. Poor blood pressure control at screening.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was Phase 2 and is now completed — what does that mean for how much we actually know about SHR-3167's safety and effectiveness compared to a fully approved treatment?
2The trial compared SHR-3167 to insulin glargine, which is already a standard treatment for Type 2 diabetes — could insulin glargine or another approved option be a better starting point for me right now rather than waiting to see if this research leads anywhere?
3The trial ran for 20 weeks and measured HbA1c change as the main outcome — do you know whether the results have been published yet, and if so, what did they show about how well blood sugar control improved?
4Since this trial is already completed and I couldn't enroll anyway, are there any follow-up Phase 3 trials for SHR-3167 that I might be eligible for, and would I be a good candidate based on my current health status?
5What were the main safety concerns or side effects that would have been monitored in a trial combining a new drug like SHR-3167 with insulin glargine, and are those risks something I should factor into decisions about my own diabetes treatment plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline to week 20 in HbA1c (HemoglobinA1c)
. 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.