Clinical trial NCT02173457: Study of Chiglitazar Compare With Sitagliptin 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 Sitagliptin-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: Chiglitazar
Sitagliptin
diabetes
type 2 diabetes
Lead sponsor: Chipscreen Biosciences, Ltd.
Sponsor class: INDUSTRY
First posted: 2014-06-25
Enrollment: 740
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 Sitagliptin.

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

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 \[blood pressure above the goal despite adherence to at least 3 optimally dosed antihypertensive medications (including diuretic) of different classes,or blood pressure is controlled to below the goal by at least different classes of drugs\];
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. Had or is having pancreatic diseases;
11. Heart failure (NYHA classification Stage III or IV), or left ventricular hypertrophy indicated by ECG;
12. Hepatic diseases such as hepatocirrhosis, active hepatitis,aspartate aminotransferase or alanine aminotransferase \> 2.5 fold of the upper limit of the normal range;
13. Kidney diseases or serum creatinine exceed the normal range: male \> 133 μmol/L or female \>108 μmol/L;
14. Had malignancy in the past 5 years, not including basal cell carcinoma;
15. Had or is currently receiving treatment that can alter blood glucose metabolism, including but not limited to diuretic,hormone (corticotropin or steroids),beta blockers;
16. Have the diseases that can alter blood glucose metabolism, including but not limited to active hepatitis, hyperthyroidism,or adrenal tumors;
17. Edema with unknown reason;
18. Alcohol or drug addiction;
19. Had participated other drugs' clinical trials in the 3 months before screening;
20. Pregnant or lactic women; or women of childbearing age who are not able to or is not willing to conduct contraception;
21. 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 for patients with a baseline HbA1c <8.5%
timeFrame: 24 weeks
measure: Change in HbA1c from baseline
timeFrame: 12 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 and 24 weeks
measure: Change in 2-h postprandial glucose (2hPPG) from baseline
timeFrame: 12 and 24 weeks
measure: Change in total cholesterol (TC) from baseline
timeFrame: 12 and 24 weeks
measure: Change in triglyceride from baseline
timeFrame: 12 and 24 weeks
measure: Change in high density lipoprotein cholesterol (HDL-C) from baseline
timeFrame: 12 and 24 weeks
measure: Change in low density proprotein cholesterol (LDL-C) from baseline
timeFrame: 12 and 24 weeks
measure: Change in free fatty acid (FFA) from baseline
timeFrame: 12 and 24 weeks
measure: Change in fasting plasma insulin from baseline
timeFrame: 12 and 24 weeks
measure: Insulin sensitivity assessed by the homeostatic model assessment (HOMA) at 12 and 24 weeks, compared with that of baseline
timeFrame: 12 and 24 weeks
measure: Change in blood pressure from baseline
timeFrame: 24 weeks
measure: Percentage of patients who discontinue the trial due to hyperglycemia
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Hefei
country: China
facility: The First Hospital Affiliated to Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
city: Beijing
country: China
facility: The General Hospital of the Chinese People's Armed Police Forces
state: Beijing
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
city: Beijing
country: China
facility: The Second Artillery General Hospital of Chinese People's Liberation Army
state: Beijing
city: Beijing
country: China
facility: Beijing Tongren Hospital Affiliated to Capital Medical Universtiy
state: Beijing
city: Guangzhou
country: China
facility: The Third Hospital Affiliated to Guangzhou Medical College
state: Guangdong
city: Shantou
country: China
facility: The Second Affiliated Hospital of Shantou University Medical College
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Beijing University Shenzhen Hospital
state: Guangdong
city: Zhongshan
country: China
facility: Zhongshan People's Hospital
state: Guangdong
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University (The Eastern Hospital)
state: Guangxi
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University (The Western Hospital)
state: Guangxi
city: Shijiazhuang
country: China
facility: The Second Hospital of Heibei Medical University
state: Hebei
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Tongji Medical College of HUST
state: Hubei
city: Hengyang
country: China
facility: The First Hospital Affiliated to Nanhua University
state: Hunan
city: Yueyang
country: China
facility: The First People's Hospital of Yueyang
state: Hunan
city: Hohhot
country: China
facility: The Affiliated Hospital of Inner Mongolia
state: Inner Mongolia
city: Huai'an
country: China
facility: Huai'an First People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Gulou Hospital Affiliated to Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: The Second Hospital Affiliated to Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Zhenjiang
country: China
facility: The Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Siping
country: China
facility: Siping Central People's Hospital
state: Jilin
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
city: Shanghai
country: China
facility: The Qingpu Branch of Zhongshan Hospital Affiliate to Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Tongji Hospital Affiliated to Tongji University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai First People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai 6th People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai 5th People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: The Central Hospital of Minhang District of Shanghai
state: Shanghai
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
Study officials:
affiliation: Shanghai 6th People's Hospital
name: Weiping Jia, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhou Y, Wang H, Wang Y, Xu X, Li F, Zhou J, Shan T, Huang R, Cai T, Liu X, Su X, Li H, Ma J. Comparative Evaluation of Chiglitazar and Sitagliptin on the Levels of Retinol-Binding Protein 4 and Its Correlation With Insulin Resistance in Patients With Type 2 Diabetes. Front Endocrinol (Lausanne). 2022 Apr 25;13:801271. doi: 10.3389/fendo.2022.801271. eCollection 2022.