Study of Chiglitazar Compare With Placebo in Type 2 Diabetes Patients

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of Chiglitazar, compare with placebo.

Detailed Description
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The efficacy and safety will be compared between Chiglitazar and placebo after treatment of 24 weeks. The long term efficacy and safety of Chiglitazar will be evaluated after 52 weeks treatment.

Official Title
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Phase III Study of Chiglitazar in Patients With Type 2 Diabetes Mellitus and Insufficient Glycemic Control Despite Diet and Exercise -- A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Trial

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Chiglitazar
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet the WHO Diagnostic Criteria for Type 2 Diabetes (published on 1999); HbA1c≥ 7.5% and ≤ 10.0% after control of diet and exercises; Male and female,age between 18 and 70 years; BMI between 18.5-35kg/m2; Willing to be assigned to any treatment arm and sign inform consent. Exclusion Criteria: Type 1 diabetes; Treated by oral or injective antidiabetic drug before screening, including insulin and herb; Fasting plasma glucose > 13.3 mmol/L (240 mg/dL); Resistant hypertension [blood pressure above the goal despite adherence to at least 3 optimally dosed antihypertensive medications (including diuretic) of different classes,or blood pressure is controlled to below the goal by at least 4 different classes of drugs]; Plasma triglyceride > 500 mg/dL (5.65 mmol/L); Is treating by fibrates; History of diabetic ketoacidosis,diabetic hyperglycemic hyperosmolar syndrome,lactic acidosis, diabetic hypoglycemia; or is currently combined with retinopathy, diabetic nephropathy and diabetic neuropathy; Had transient ischemic attack,cerebrovascular accident or unstable angina in the past 6 months; History of myocardial infarction or had conducted coronary angioplasty or coronary artery bypass graft surgery; Heart failure (NYHA classification Stage III or IV), or left ventricular hypertrophy indicated by ECG; Hepatic diseases such as hepatocirrhosis, active hepatitis,aspartate aminotransferase or alanine aminotransferase > 2.5 fold of the upper limit of the normal range; Kidney diseases or serum creatinine exceed the normal range: male > 133 μmol/L or female >108 μmol/L; Had malignancy in the past 5 years, not including basal cell carcinoma; Had or is currently receiving treatment that can alter blood glucose metabolism, including but not limited to diuretic,hormone (corticotropin or steroids),beta blockers; Have the diseases that can alter blood glucose metabolism, including but not limited to active hepatitis, hyperthyroidism,or adrenal tumors; Edema with unknown reason; Alcohol or drug addiction; Had participated other drugs' clinical trials in the 3 months before screening; Pregnant or lactic women; or women of childbearing age who are not able to or is not willing to conduct contraception; Any condition that make investigator consider the subject is not suitable to participate the trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Patients administrate Chiglitazar 32mg once daily for 52 weeks | Drug: Chiglitazar<br>* Take orally<br>* Other names: CS038;|
| Experimental: Arm 2<br>Patients administrate Chiglitazar 48mg once daily for 52 weeks | Drug: Chiglitazar<br>* Take orally<br>* Other names: CS038;|
| Placebo Comparator: Arm 3<br>Patients administrate placebo for 24 weeks.From week 25 to 52, patients are randomly switched to Arm 1 and Arm 2, and receive the treatment accordingly. | Drug: Chiglitazar<br>* Take orally<br>* Other names: CS038;Drug: Placebo<br>* Take orally<br>* Other names: Plb;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c from baseline after 24 weeks of treatment | The change of HbA1c at week 24 from baseline | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c from baseline for patients with a baseline HbA1c >=8.5% | The change of HbA1c at week 24 from baseline for patients with a HbA1c >=8.5% at baseline | 24 weeks | 
| Change in HbA1c from baseline in patients with a baseline HbA1c < 8.5% | The change of HbA1c at week 24 from baseline for patients with a HbA1c < 8.5% at baseline | 24 weeks | 
| Change in HbA1c from baseline | The change of HbA1c at week 12 from baseline | 12 weeks | 
| Change in HbA1c from baseline | The change of HbA1c at week 52 from baseline | 52 weeks | 
| Percentage of patients that attained target HbA1c <7.0% | Percentage of patients whose HbA1c at week 24 are < 7.0% | 24 weeks | 
| Percentage of patients whose HbA1c lowered by at least 0.5% | Percentage of patients whose change of HbA1c at week 24 from baseline are >= 0.5% | 24 weeks | 
| Change in fasting plasma glucose from baseline | The change of fasting plasma glucose at week 12 and 24 from baseline | 12,24 and 52 weeks | 
| Change in 2-h postprandial glucose (2hPPG) from baseline | The change of 2-h postprandial glucose (2hPPG) at week 12, 24 and 52 from baseline | 12, 24 and 52 weeks | 
| Change in total cholesterol (TC) from baseline | The change of total cholesterol (TC) at week 12, 24 and 52 from baseline | 12, 24 and 52 weeks | 
| Change in triglyceride from baseline | The change of triglyceride at week 12, 24 and 52 from baseline | 12,24 and 52 weeks | 
| Change in high density lipoprotein cholesterol (HDL-C)from baseline | The change of high density lipoprotein cholesterol (HDL-C) at week week 12, 24 and 52 from baseline | 12, 24 and 52 weeks | 
| Change in low density proprotein cholesterol (LDL-C) from baseline | The change of low density lipoprotein cholesterol (LDL-C) at week 12, 24 and 52 from baseline | 12, 24 and 52 weeks | 
| Change in free fatty acid (FFA) from baseline | The change of free fatty acid (FFA) at week 12, 24 and 52 from baseline | 12, 24 and 52 weeks | 
| Change in fasting plasma insulin from baseline | The change of fasting plasma insulin at week 12, 24 and 52 from baseline | 12, 24 and 52 weeks | 
| Insulin sensitivity assessed by the homeostatic model assessment (HOMA) at 12,24 and 52 weeks, compared with that of baseline | The change of insulin sensitivity at week 12, 24 and 52 from baseline | 12, 24 and 52 weeks | 
| Change in blood pressure from baseline | The change of blood pressure at week 24 from baseline | 24 weeks | 
| Percentage of patients who use rescue therapy | The percentage of patients who use rescue therapy during the 52 weeks of treatment | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chiglitazar,diabetes,type 2 diabetes