UnknownNot Applicable

Efficacy and Safety of Chiglitazar Added to Glargine in Patients With Type 2 Diabetes

China128 participantsStarted 2023-10-31

Plain-language summary

The goal of this clinical trial is to evaluate the Efficacy and Safety of Chiglitazar Added to Patients with type 2 diabetes who do not respond well to metformin combined with insulin glargine. The main question it aims to answer are: • T2DM patients still cannot effectively control their blood sugar with the combination of insulin and metformin. The combination of follow-up treatment and hypoglycemic drugs is worth exploring, and it is necessary to explore and confirm the combination of effective and safe drugs for insulin resistance on the basis of the above treatment plans. Participants will be asked to receive either Chiglitazar or placebo in addition to metformin and insulin glargine 18 weeks. Researchers will compare placebo groups to see if the effective effect and safety indicators of Chiglitazar for reducing insulin dosage, lowering blood sugar, regulating blood lipids.

Who can participate

Age range

18 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: * 1.In accordance with the World Health Organization (WHO) issued in 1999 diabetes diagnostic criteriaType 2 diabetes mellitus (T2DM); * 2\. Male or female patients ≥18 years old; * 3, BMI≥18.5 Kg/m2, \< 35 Kg/m2; * 4, Glycosylated hemoglobin (HbA1C) \> 7.5%; ≤10.5%; * 5, Stable dose (insulin daily therapeutic dose change within ±20%) of glycerine or DI The therapeutic dose of Terterigu or NPH basal insulin is ≥0.25IU/kg/ day/or 20IU/ day； * 6, Stable basic insulin treatment combined with metformin (metformin dose ≥1000mg/Days or maximum tolerated dose) ≥3 months； * 7\. Voluntarily sign informed consent and agree to be randomly assigned to any experimental group. Exclusion Criteria: * 1, Type 1 diabetes or specific type diabetes; * 2\. Fasting blood glucose (FPG) exceeding 13.3 mmol/L (240 mg/dL); * 3, refractory hypertension \[that is, on the basis of improving lifestyle, the application of a reasonable and tolerable sufficient amount of 3 or more antihypertensive drugs (including diuretics) for more than 1 month still does not reach the standard, or take 4 or more antihypertensive drugs to effectively control blood pressure\]; * 4\. Triglyceride (TG) \> 500 mg /dL (5.65 mmol/L); * 5, is taking or in the last 1 month has taken fibrate drug treatment; * 6, lower limb edema or general edema; * 7\. Experienced 3 or more episodes of severe hypoglycemia and/or unintentional hypoglycemia in the 6 months prior to screening; * 8\. A definite diagnosis of osteo…

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

HbA1C

Timeframe: 18 weeks of treatment

Trial details

NCT IDNCT06007014

SponsorYanbing Li

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-30

View on ClinicalTrials.gov More Efficacy and Safety of Chiglitazar Sodium in the Treatment of T2DM Patients trials