Study of Chiglitazar Compare With Placebo in Type 2 Diabetes Patients

Type 2 Diabetes Clinical Trial

— CMAP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02121717
• Other study ID #: CGZ301
• Status: Completed
• Phase: Phase 3
• Start date: June 2014
• Est. completion date: November 2017

Study information

• Verified date: October 2019
• Source: Chipscreen Biosciences, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 535
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Chiglitazar
Take orally
• Placebo
Take orally

Locations

Country	Name	City	State
China	Baogang Hospital of Inner Mongilia	Baotou	Inner Mongolia
China	China Meitan General Hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	Peking University Shougang Hospital	Beijing	Beijing
China	The 306th Hospital of PLA	Beijing	Beijing
China	Cangzhou's Central Hospital	Cangzhou	Hebei
China	The Second Hospital of Jilin University	Changchun	Jilin
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	Huaxi Hopsital of Sichuan University	Chengdu	Sichuan
China	Chenzhou First People's Hospital	Chenzhou	Hunan
China	Chongqing Three Gorges Central Hospital	Chongqing	Chongqing
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	The Second Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	The First Affiliated Hospital of Ha'erbin Medical University	Ha'erbin	Heilongjiang
China	Harrison International Peace Hospital	Hengshui	Hebei
China	The people's Hospital of Jiangsu Province	Nanjing	Jiangsu
China	The Affiliated Hospital of Qingdao Medical University	Qingdao	Shandong
China	The Central Hospital of Yangpu District of Shanghai	Shanghai	Shanghai
China	Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Zhongshan Hospital Fudan University	Shanghai	Shanghai
China	The Third Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Tangshan Gongren Hospital	Tangshan	Hebei
China	The General Hospital of Tianjin Medical University	Tianjin	Tianjin
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei
China	The First Affiliated Hospital of The 4th Military Medical University	Xi'an	Shanxi
China	The Affiliated Hospital of Xuzhou Medical College	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Chipscreen Biosciences, Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c from baseline after 24 weeks of treatment	The change of HbA1c at week 24 from baseline	24 weeks
Secondary	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
Secondary	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
Secondary	Change in HbA1c from baseline	The change of HbA1c at week 12 from baseline	12 weeks
Secondary	Change in HbA1c from baseline	The change of HbA1c at week 52 from baseline	52 weeks
Secondary	Percentage of patients that attained target HbA1c <7.0%	Percentage of patients whose HbA1c at week 24 are < 7.0%	24 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in triglyceride from baseline	The change of triglyceride at week 12, 24 and 52 from baseline	12,24 and 52 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in blood pressure from baseline	The change of blood pressure at week 24 from baseline	24 weeks
Secondary	Percentage of patients who use rescue therapy	The percentage of patients who use rescue therapy during the 52 weeks of treatment	52 weeks