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

Study Overview
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Brief Summary
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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.

Detailed Description
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T2DM patients using insulin combined with metformin dual therapy regimen, still can not have effective control of blood sugar, the combination of follow-up treatment and hypoglycemic drugs is worth exploring, and it is necessary to base on the above treatment plans to explore and confirm the treatment of effective and safe drugs for insulin resistance. This study investigated the efficacy and safety of metformin combined with insulin glargine in the treatment of type 2 diabetes mellitus (T2DM) in patients who still have poor hypoglycemic effect, plus Chiglitazar 48mg/ day for 18 weeks. A total of 128 patients were expected to be included, and were randomly assigned 1:1 to the combination of metformin and insulin glargine combined with Chiglitazar sodium tablet 48mg/ day group. Metformin and insulin glargine combined with placebo group.

Official Title
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A Multi-Center, Randomised, Double-blind, Placebo Parallel Controlled Clinical Study to Evaluate the Efficacy and Safety of Chiglitazar Added to Glargine in Patients With Type 2 Diabetes

Conditions
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Efficacy and Safety of Chiglitazar Sodium in the Treatment of T2DM Patients, Metformin Combined With Insulin Glargine in the Treatment of Type 2 Diabetes Patients Who Still Have Poor Hypoglycemic Effect, 128 Patients Were Randomly Assigned 1:1, Metformin and Insulin Glargine Combined With Chiglitazar Sodium Tablets 48mg/ Day Group, Metformin and Insulin Glargine Combined With Placebo Group, InvestigatorInitiate Trial, Changes in HbA1C From Baseline at 18 Weeks of Treatment

Intervention / Treatment
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* Drug: Chiglitazar sodium
* Drug: Chiglitazar placebo


Participation Criteria
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Eligibility Criteria
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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 osteoporosis or any other known bone disease; 9. History of diabetic ketoacidosis, diabetic hyperglycemia hyperosmolar syndrome, lactic acidosis and other acute complications of diabetes; 10. Severe microvascular complications (proliferative retinopathy; Urinary albumin/creatinine ratio &gt; 300 mg/g; Marked peripheral neuropathy, etc.); 11. Large vascular lesions leading to hospital admission within 6 months before inclusion; 12, The New York Heart Association (NYHA) defines congestive heart failure as grade III or IV 13, significant liver and kidney dysfunction and systemic disease (significant liver dysfunction is defined as AST&gt; 2.5 times the upper limit of normal and/or ALT&gt; 2.5 times the upper limit of normal and/or total bilirubin &gt; 1.5 times the upper limit of normal value; Renal dysfunction was defined as moderate to severe renal insufficiency (eGFR&lt;60 ml/ (min*1.73m2)). 14. Use of other hypoglycemic agents not specified in the inclusion criteria (thiazolidinediones, GLP-1RA, premixed or fast-acting insulin) in the current or 3 months prior to screening, with the exception of short-term treatment with additional insulin (a total of 7 days or less) for complications; 15, pregnant or lactating women, women of childbearing age who are unable or unwilling to take adequate contraception; 16. Participating in clinical trials of other drugs or medical devices during or within 3 months prior to screening; 17. The investigator considers it inappropriate to participate in this clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Metformin and insulin glargine combined with Chiglitazar sodium tablets 48mg/ day group；Metformin and insulin glargine combined with placebo group.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Metformin and insulin glargine combined with sitaglitat sodium tablets 48mg/ day group; | Drug: Chiglitazar sodium<br>* tablets 48mg/ day administered for 18 weeks<br>|
| Placebo Comparator: Placebo group<br>Metformin and insulin glargine combined with placebo group | Drug: Chiglitazar placebo<br>* tablets 48mg/ day administered for 18 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1C | Changes in HbA1C from baseline | 18 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin | Changes in the daily dose of insulin from baseline | 6 weeks and 18 weeks of treatment | 
| Triglyceride | Changes in the daily dose of triglyceride from baseline | 18 weeks of treatment | 
| Fasting blood glucose | Changes in the daily dose of fasting blood glucose from baseline | 6 weeks and 18 weeks of treatment | 
| Fasting C-Peptide | Changes in the daily dose of fasting C-Peptide from baseline | 18 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T2DM, Chiglitazar, Randomised, Double-blind, Placebo Parallel Controlled