Study of Chiglitazar Compare With Sitagliptin in Type 2 Diabetes Patients (CMAS)

October 23, 2019 updated by: Chipscreen Biosciences, Ltd.

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

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

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

740

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Anhui
      • Hefei, Anhui, China, 230001
        • Anhui Provincial Hospital
      • Hefei, Anhui, China, 230022
        • The First Hospital Affiliated to Anhui Medical University
    • Beijing
      • Beijing, Beijing, China, 100050
        • Beijing Tiantan Hospital
      • Beijing, Beijing, China, 100037
        • Fuwai Hospital
      • Beijing, Beijing, China, 100039
        • The General Hospital of the Chinese People's Armed Police Forces
      • Beijing, Beijing, China, 100068
        • The Second Artillery General Hospital Of Chinese People's Liberation Army
      • Beijing, Beijing, China, 100730
        • Beijing Tongren Hospital Affiliated to Capital Medical Universtiy
    • Guangdong
      • Guangzhou, Guangdong, China, 510360
        • The Third Hospital Affiliated to Guangzhou Medical College
      • Shantou, Guangdong, China, 512021
        • The Second Affiliated Hospital of Shantou University Medical College
      • Shenzhen, Guangdong, China, 518000
        • Shenzhen Second People's Hospital
      • Shenzhen, Guangdong, China, 518036
        • Beijing University Shenzhen Hospital
      • Zhongshan, Guangdong, China, 528403
        • Zhongshan People's Hospital
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • The First Affiliated Hospital of Guangxi Medical University (The Eastern Hospital)
      • Nanning, Guangxi, China, 530021
        • The First Affiliated Hospital of Guangxi Medical University (The Western Hospital)
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • The Second Hospital of Heibei Medical University
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital Affiliated to Tongji Medical College of HUST
    • Hunan
      • Hengyang, Hunan, China, 421001
        • The First Hospital Affiliated to Nanhua University
      • Yueyang, Hunan, China, 414000
        • The First People's Hospital of Yueyang
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China, 010050
        • The Affiliated Hospital of Inner Mongolia
    • Jiangsu
      • Huai'an, Jiangsu, China, 223300
        • Huai'an First People's Hospital
      • Nanjing, Jiangsu, China, 210029
        • Nanjing First Hospital
      • Nanjing, Jiangsu, China, 210008
        • Gulou Hospital Affiliated to Nanjing Medical University
      • Nanjing, Jiangsu, China, 210009
        • The Second Hospital Affiliated to Nanjing Medical University
      • Zhenjiang, Jiangsu, China, 212013
        • The Affiliated Hospital of Jiangsu University
    • Jilin
      • Changchun, Jilin, China, 100031
        • The First Hospital of Jilin University
      • Siping, Jilin, China, 136000
        • Siping Central People's Hospital
    • Liaoning
      • Dalian, Liaoning, China, 116044
        • The first affiliated hospital of Dalian Medical University
      • Shenyang, Liaoning, China, 110001
        • The First Hospital of China Medical University
    • Shanghai
      • Shanghai, Shanghai, China, 200080
        • Shanghai First People's Hospital
      • Shanghai, Shanghai, China, 200065
        • Tongji hospital affiliated to tongji university
      • Shanghai, Shanghai, China, 200003
        • Shanghai Changzheng Hospital
      • Shanghai, Shanghai, China, 200043
        • The Qingpu Branch of Zhongshan Hospital Affiliate to Fudan University
      • Shanghai, Shanghai, China, 200235
        • Shanghai 6th People's Hospital
      • Shanghai, Shanghai, China, 200240
        • Shanghai 5th People's Hospital
      • Shanghai, Shanghai, China, 201199
        • The Central Hospital of Minhang District of Shanghai
    • Shanxi
      • Xi'an, Shanxi, China, 710061
        • The First Affiliated Hospital of Xi'An Jiaotong University
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Sichuan Provincial People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Patients administrate Chiglitazar 32mg once daily for 24 weeks
Take orally
Other Names:
  • CS038
Experimental: Arm 2
Patients administrate Chiglitazar 48mg once daily for 24 weeks
Take orally
Other Names:
  • CS038
Active Comparator: Arm 3
Patients administrate Sitagliptin 100mg once daily for 24 weeks
Take orally
Other Names:
  • Sit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c from baseline after 24 weeks of treatment
Time Frame: 24 weeks
The change of HbA1c at week 24 from baseline
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c from baseline for patients with a baseline HbA1c >=8.5%
Time Frame: 24 weeks
The change of HbA1c at week 24 from baseline for patients with a HbA1c >=8.5% at baseline
24 weeks
Change in HbA1c from baseline
Time Frame: 12 weeks
The change of HbA1c at week 12 from baseline
12 weeks
Percentage of patients that attained target HbA1c <7.0%
Time Frame: 24 weeks
Percentage of patients whose HbA1c at week 24 are < 7.0%
24 weeks
Change in blood pressure from baseline
Time Frame: 24 weeks
The change of blood pressure at week 24 from baseline
24 weeks
Change in HbA1c from baseline for patients with a baseline HbA1c <8.5%
Time Frame: 24 weeks
The change of HbA1c at week 24 from baseline for patients with a HbA1c < 8.5% at baseline
24 weeks
Percentage of patients whose HbA1c lowered by at least 0.5%
Time Frame: 24 weeks
Percentage of patients whose change of HbA1c at week 24d from baseline are >= 0.5%
24 weeks
Change in fasting plasma glucose from baseline
Time Frame: 12 and 24 weeks
The change of fasting plasma glucose at week 12 and 24 from baseline
12 and 24 weeks
Change in 2-h postprandial glucose (2hPPG) from baseline
Time Frame: 12 and 24 weeks
The change of 2-h postprandial glucose (2hPPG) at week 12 and 24 from baseline
12 and 24 weeks
Change in total cholesterol (TC) from baseline
Time Frame: 12 and 24 weeks
The change of total cholesterol (TC) at week 12 and 24 from baseline
12 and 24 weeks
Change in triglyceride from baseline
Time Frame: 12 and 24 weeks
The change of triglyceride at week 12 and 24 from baseline
12 and 24 weeks
Change in high density lipoprotein cholesterol (HDL-C) from baseline
Time Frame: 12 and 24 weeks
The change of high density lipoprotein cholesterol (HDL-C) at week 12 and 24 from baseline
12 and 24 weeks
Change in low density proprotein cholesterol (LDL-C) from baseline
Time Frame: 12 and 24 weeks
The change of low density lipoprotein cholesterol (LDL-C) at week 12 and 24 from baseline
12 and 24 weeks
Change in free fatty acid (FFA) from baseline
Time Frame: 12 and 24 weeks
The change of free fatty acid (FFA) at week 12 and 24 from baseline
12 and 24 weeks
Change in fasting plasma insulin from baseline
Time Frame: 12 and 24 weeks
The change of fasting plasma insulin at week 12 and 24 from baseline
12 and 24 weeks
Insulin sensitivity assessed by the homeostatic model assessment (HOMA) at 12 and 24 weeks, compared with that of baseline
Time Frame: 12 and 24 weeks
The change of insulin sensitivity at week 12 and 24 from baseline
12 and 24 weeks
Percentage of patients who discontinue the trial due to hyperglycemia
Time Frame: 24 weeks
The percentage of patients who discontinue the trial due to hyperglycemia during the 24 weeks of treatment
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Weiping Jia, Dr., Shanghai 6th People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

June 20, 2014

First Submitted That Met QC Criteria

June 23, 2014

First Posted (Estimate)

June 25, 2014

Study Record Updates

Last Update Posted (Actual)

October 25, 2019

Last Update Submitted That Met QC Criteria

October 23, 2019

Last Verified

October 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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