Study of Chiglitazar Compare With Placebo in Type 2 Diabetes Patients (CMAP)

Chipscreen Biosciences

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Chiglitazar; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02121717

CGZ301

Details and patient eligibility

About

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

Full description

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.

Enrollment: 535 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Meet the WHO Diagnostic Criteria for Type 2 Diabetes (published on 1999);
2. HbA1c≥ 7.5% and ≤ 10.0% after control of diet and exercises;
3. Male and female,age between 18 and 70 years;
4. BMI between 18.5-35kg/m2;
5. Willing to be assigned to any treatment arm and sign inform consent.

Exclusion criteria

1. Type 1 diabetes;
2. Treated by oral or injective antidiabetic drug before screening, including insulin and herb;
3. Fasting plasma glucose > 13.3 mmol/L (240 mg/dL);
4. 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];
5. Plasma triglyceride > 500 mg/dL (5.65 mmol/L);
6. Is treating by fibrates;
7. History of diabetic ketoacidosis,diabetic hyperglycemic hyperosmolar syndrome,lactic acidosis, diabetic hypoglycemia; or is currently combined with retinopathy, diabetic nephropathy and diabetic neuropathy;
8. Had transient ischemic attack,cerebrovascular accident or unstable angina in the past 6 months;
9. History of myocardial infarction or had conducted coronary angioplasty or coronary artery bypass graft surgery;
10. Heart failure (NYHA classification Stage III or IV), or left ventricular hypertrophy indicated by ECG;
11. Hepatic diseases such as hepatocirrhosis, active hepatitis,aspartate aminotransferase or alanine aminotransferase > 2.5 fold of the upper limit of the normal range;
12. Kidney diseases or serum creatinine exceed the normal range: male > 133 μmol/L or female >108 μmol/L;
13. Had malignancy in the past 5 years, not including basal cell carcinoma;
14. Had or is currently receiving treatment that can alter blood glucose metabolism, including but not limited to diuretic,hormone (corticotropin or steroids),beta blockers;
15. Have the diseases that can alter blood glucose metabolism, including but not limited to active hepatitis, hyperthyroidism,or adrenal tumors;
16. Edema with unknown reason;
17. Alcohol or drug addiction;
18. Had participated other drugs' clinical trials in the 3 months before screening;
19. Pregnant or lactic women; or women of childbearing age who are not able to or is not willing to conduct contraception;
20. Any condition that make investigator consider the subject is not suitable to participate the trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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535 participants in 3 patient groups, including a placebo group

Arm 1

Experimental group

Description:

Patients administrate Chiglitazar 32mg once daily for 52 weeks

Treatment:

Drug: Chiglitazar

Arm 2

Experimental group

Description:

Patients administrate Chiglitazar 48mg once daily for 52 weeks

Treatment:

Drug: Chiglitazar

Arm 3

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: Chiglitazar