Clinical trial NCT02121717: Study of Chiglitazar Compare With Placebo in Type 2 Diabetes Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: Chiglitazar,diabetes,type 2 diabetes
Lead sponsor: Chipscreen Biosciences, Ltd.
Sponsor class: INDUSTRY
First posted: 2014-04-23
Enrollment: 535
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in HbA1c from baseline after 24 weeks of treatment
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in HbA1c from baseline for patients with a baseline HbA1c >=8.5%
timeFrame: 24 weeks
measure: Change in HbA1c from baseline in patients with a baseline HbA1c < 8.5%
timeFrame: 24 weeks
measure: Change in HbA1c from baseline
timeFrame: 12 weeks
measure: Change in HbA1c from baseline
timeFrame: 52 weeks
measure: Percentage of patients that attained target HbA1c <7.0%
timeFrame: 24 weeks
measure: Percentage of patients whose HbA1c lowered by at least 0.5%
timeFrame: 24 weeks
measure: Change in fasting plasma glucose from baseline
timeFrame: 12,24 and 52 weeks
measure: Change in 2-h postprandial glucose (2hPPG) from baseline
timeFrame: 12, 24 and 52 weeks
measure: Change in total cholesterol (TC) from baseline
timeFrame: 12, 24 and 52 weeks
measure: Change in triglyceride from baseline
timeFrame: 12,24 and 52 weeks
measure: Change in high density lipoprotein cholesterol (HDL-C)from baseline
timeFrame: 12, 24 and 52 weeks
measure: Change in low density proprotein cholesterol (LDL-C) from baseline
timeFrame: 12, 24 and 52 weeks
measure: Change in free fatty acid (FFA) from baseline
timeFrame: 12, 24 and 52 weeks
measure: Change in fasting plasma insulin from baseline
timeFrame: 12, 24 and 52 weeks
measure: Insulin sensitivity assessed by the homeostatic model assessment (HOMA) at 12,24 and 52 weeks, compared with that of baseline
timeFrame: 12, 24 and 52 weeks
measure: Change in blood pressure from baseline
timeFrame: 24 weeks
measure: Percentage of patients who use rescue therapy
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Shougang Hospital
state: Beijing
city: Beijing
country: China
facility: China Meitan General Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: The 306th Hospital of PLA
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: Chongqing Three Gorges Central Hospital
state: Chongqing
city: Cangzhou
country: China
facility: Cangzhou's Central Hospital
state: Hebei
city: Hengshui
country: China
facility: Harrison International Peace Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: The Third Hospital of Hebei Medical University
state: Hebei
city: Tangshan
country: China
facility: Tangshan Gongren Hospital
state: Hebei
city: Ha'erbin
country: China
facility: The First Affiliated Hospital of Ha'erbin Medical University
state: Heilongjiang
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Chenzhou
country: China
facility: Chenzhou First People's Hospital
state: Hunan
city: Baotou
country: China
facility: Baogang Hospital of Inner Mongilia
state: Inner Mongolia
city: Nanjing
country: China
facility: The people's Hospital of Jiangsu Province
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical College
state: Jiangsu
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao Medical University
state: Shandong
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: The Central Hospital of Yangpu District of Shanghai
state: Shanghai
city: Xi'an
country: China
facility: The First Affiliated Hospital of The 4th Military Medical University
state: Shanxi
city: Chengdu
country: China
facility: Huaxi Hopsital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: The General Hospital of Tianjin Medical University
state: Tianjin
Study officials:
affiliation: Peking University People's Hospital
name: Linong Ji, Dr.
role: PRINCIPAL_INVESTIGATOR
References: