A Study Comparing Safety and Efficacy of SHR-3167 Fixed-Dose Titration and Individualized-Dose Ti… (NCT07472725) | Clinical Trial Compass
Active — Not RecruitingPhase 2
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
China102 participantsStarted 2026-04-11
Plain-language summary
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.
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
. Males and females, 18-65 years old at the time of signing informed consent.
. Diagnosed with type 2 diabetes mellitus (T2DM) for at least 6 months prior to day of screening.
. 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.
. 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
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.
1Since this is a Phase 2 trial for SHR-3167, what is currently known — and not yet known — about how safe this drug is compared to the oral medications I'm already taking for my Type 2 diabetes?
2The main thing this trial is measuring is how often participants have hypoglycemic events — low blood sugar episodes — so how does my personal history with low blood sugar affect whether this study might be appropriate for me to discuss joining?
3The trial is active but no longer enrolling new participants, so does that mean there's a chance I could still be considered, or should we focus our conversation on other treatment options that are available to me right now?
4This study compares fixed-dose titration versus individualized-dose titration of SHR-3167 — can you explain what that difference means for how I'd be managing my medication day-to-day if I were in a study like this?
5Given that my diabetes is described as 'inadequately controlled' with oral medications — which matches what this trial targets — would you recommend trying a different approved medication first, or is a trial like this worth exploring as a next step?
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
The percentage of participants who experienced at least one hypoglycemic event.
Timeframe: From the baseline to 20-weeks treatment.
. Uncontrollable hypertension: systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening.
. Diagnosed or suspected with type 1 diabetes mellitus, latent autoimmune diabetes mellitus in adult (LADA), other special types of diabetes or secondary diabetes.
. Known or suspected allergy or intolerance to the test drug or excipient.
. There was a history of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the previous 6 months.
. There is acute or chronic hepatitis, liver cirrhosis, or a history of other serious liver diseases.
. Malignancy within 5 years prior to screening or high risk of recurrence.
. Those who have a history of severe cardiovascular and cerebrovascular diseases within 6 months before screening.
. Participated in clinical trials of any drug or medical device within 3 months prior to screening.