Study of Chiglitazar Compare With Sitagliptin 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 Sitagliptin.

Detailed Description
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The efficacy and safety will be compared between Chiglitazar and Sitagliptin after treatment of 24 weeks.

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 Sitagliptin-Controlled Trial

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Chiglitazar
* Drug: Sitagliptin


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 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; Had or is having pancreatic diseases; 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 24 weeks | Drug: Chiglitazar<br>* Take orally<br>* Other names: CS038;|
| Experimental: Arm 2<br>Patients administrate Chiglitazar 48mg once daily for 24 weeks | Drug: Chiglitazar<br>* Take orally<br>* Other names: CS038;|
| Active Comparator: Arm 3<br>Patients administrate Sitagliptin 100mg once daily for 24 weeks | Drug: Sitagliptin<br>* Take orally<br>* Other names: Sit;|

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 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 | The change of HbA1c at week 12 from baseline | 12 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 24d 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 and 24 weeks | 
| Change in 2-h postprandial glucose (2hPPG) from baseline | The change of 2-h postprandial glucose (2hPPG) at week 12 and 24 from baseline | 12 and 24 weeks | 
| Change in total cholesterol (TC) from baseline | The change of total cholesterol (TC) at week 12 and 24 from baseline | 12 and 24 weeks | 
| Change in triglyceride from baseline | The change of triglyceride at week 12 and 24 from baseline | 12 and 24 weeks | 
| Change in high density lipoprotein cholesterol (HDL-C) from baseline | The change of high density lipoprotein cholesterol (HDL-C) at week 12 and 24 from baseline | 12 and 24 weeks | 
| Change in low density proprotein cholesterol (LDL-C) from baseline | The change of low density lipoprotein cholesterol (LDL-C) at week 12 and 24 from baseline | 12 and 24 weeks | 
| Change in free fatty acid (FFA) from baseline | The change of free fatty acid (FFA) at week 12 and 24 from baseline | 12 and 24 weeks | 
| Change in fasting plasma insulin from baseline | The change of fasting plasma insulin at week 12 and 24 from baseline | 12 and 24 weeks | 
| Insulin sensitivity assessed by the homeostatic model assessment (HOMA) at 12 and 24 weeks, compared with that of baseline | The change of insulin sensitivity at week 12 and 24 from baseline | 12 and 24 weeks | 
| Change in blood pressure from baseline | The change of blood pressure at week 24 from baseline | 24 weeks | 
| Percentage of patients who discontinue the trial due to hyperglycemia | The percentage of patients who discontinue the trial due to hyperglycemia during the 24 weeks of treatment | 24 weeks | 

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