Study of Chiglitazar Compare With Sitagliptin in Type 2 Diabetes Patients

Type 2 Diabetes Clinical Trial

— CMAS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02173457
• Other study ID #: CGZ302
• Status: Completed
• Phase: Phase 3
• Start date: September 2014
• Est. completion date: January 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 Sitagliptin.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 740
• Est. completion date: January 2017
• Est. primary completion date: January 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 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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Chiglitazar
Take orally
• Sitagliptin
Take orally

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing
China	Beijing Tongren Hospital Affiliated to Capital Medical Universtiy	Beijing	Beijing
China	Fuwai Hospital	Beijing	Beijing
China	The General Hospital of the Chinese People's Armed Police Forces	Beijing	Beijing
China	The Second Artillery General Hospital of Chinese People's Liberation Army	Beijing	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	The First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning
China	The Third Hospital Affiliated to Guangzhou Medical College	Guangzhou	Guangdong
China	Anhui Provincial Hospital	Hefei	Anhui
China	The First Hospital Affiliated to Anhui Medical University	Hefei	Anhui
China	The First Hospital Affiliated to Nanhua University	Hengyang	Hunan
China	The Affiliated Hospital of Inner Mongolia	Hohhot	Inner Mongolia
China	Huai'an First People's Hospital	Huai'an	Jiangsu
China	Gulou Hospital Affiliated to Nanjing Medical University	Nanjing	Jiangsu
China	Nanjing First Hospital	Nanjing	Jiangsu
China	The Second Hospital Affiliated to Nanjing Medical University	Nanjing	Jiangsu
China	The First Affiliated Hospital of Guangxi Medical University (The Eastern Hospital)	Nanning	Guangxi
China	The First Affiliated Hospital of Guangxi Medical University (The Western Hospital)	Nanning	Guangxi
China	Shanghai 5th People's Hospital	Shanghai	Shanghai
China	Shanghai 6th People's Hospital	Shanghai	Shanghai
China	Shanghai Changzheng Hospital	Shanghai	Shanghai
China	Shanghai First People's Hospital	Shanghai	Shanghai
China	The Central Hospital of Minhang District of Shanghai	Shanghai	Shanghai
China	The Qingpu Branch of Zhongshan Hospital Affiliate to Fudan University	Shanghai	Shanghai
China	Tongji Hospital Affiliated to Tongji University	Shanghai	Shanghai
China	The Second Affiliated Hospital of Shantou University Medical College	Shantou	Guangdong
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	Beijing University Shenzhen Hospital	Shenzhen	Guangdong
China	Shenzhen Second People's Hospital	Shenzhen	Guangdong
China	The Second Hospital of Heibei Medical University	Shijiazhuang	Hebei
China	Siping Central People's Hospital	Siping	Jilin
China	Tongji Hospital Affiliated to Tongji Medical College of HUST	Wuhan	Hubei
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	The First People's Hospital of Yueyang	Yueyang	Hunan
China	The Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu
China	Zhongshan People's Hospital	Zhongshan	Guangdong

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 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	The change of HbA1c at week 12 from baseline	12 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 24d 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 and 24 weeks
Secondary	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
Secondary	Change in total cholesterol (TC) from baseline	The change of total cholesterol (TC) at week 12 and 24 from baseline	12 and 24 weeks
Secondary	Change in triglyceride from baseline	The change of triglyceride at week 12 and 24 from baseline	12 and 24 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in fasting plasma insulin from baseline	The change of fasting plasma insulin at week 12 and 24 from baseline	12 and 24 weeks
Secondary	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
Secondary	Change in blood pressure from baseline	The change of blood pressure at week 24 from baseline	24 weeks
Secondary	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