Study of Chiglitazar Compare With Placebo in Type 2 Diabetes Patients (CMAP)

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

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Chiglitazar; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 535
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Peking University People's Hospital
    • Beijing, Beijing, China, 100000
      • Peking University Shougang Hospital
    • Beijing, Beijing, China, 100028
      • China Meitan General Hospital
    • Beijing, Beijing, China, 100101
      • The 306th Hospital of PLA
  • Chongqing
    • Chongqing, Chongqing, China, 400016
      • The First Affiliated Hospital of Chongqing Medical University
    • Chongqing, Chongqing, China, 404000
      • Chongqing Three Gorges Central Hospital
    • Chongqing, Chongqing, China, 400016
      • The Second Affiliated Hospital of Chongqing Medical University
  • Hebei
    • Cangzhou, Hebei, China, 061110
      • Cangzhou's Central Hospital
    • Hengshui, Hebei, China, 053000
      • Harrison International Peace Hospital
    • Shijiazhuang, Hebei, China, 050051
      • The Third Hospital of Hebei Medical University
    • Tangshan, Hebei, China, 063000
      • Tangshan Gongren Hospital
  • Heilongjiang
    • Ha'erbin, Heilongjiang, China, 150081
      • The First Affiliated Hospital of Ha'erbin Medical University
  • Hubei
    • Wuhan, Hubei, China, 430071
      • Zhongnan Hospital of Wuhan University
  • Hunan
    • Changsha, Hunan, China, 410001
      • The Second Xiangya Hospital of Central South University
    • Chenzhou, Hunan, China, 423000
      • Chenzhou First People's Hospital
  • Inner Mongolia
    • Baotou, Inner Mongolia, China, 014010
      • Baogang Hospital of Inner Mongilia
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • The people's hospital of Jiangsu province
    • Xuzhou, Jiangsu, China, 221000
      • The Affiliated Hospital of Xuzhou Medical College
  • Jilin
    • Changchun, Jilin, China, 130041
      • The Second Hospital of Jilin University
  • Shandong
    • Qingdao, Shandong, China, 266071
      • The Affiliated Hospital of Qingdao Medical University
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital Fudan University
    • Shanghai, Shanghai, China, 200092
      • Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
    • Shanghai, Shanghai, China, 200433
      • The Central Hospital of Yangpu District of Shanghai
  • Shanxi
    • Xi'an, Shanxi, China, 710032
      • The First Affiliated Hospital of The 4th Military Medical University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Huaxi Hopsital of Sichuan University
  • Tianjin
    • Tianjin, Tianjin, China, 300052
      • The General Hospital of Tianjin Medical University

Participation Criteria

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 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Patients administrate Chiglitazar 32mg once daily for 52 weeks	Drug: Chiglitazar; Take orally; Other Names: CS038
Experimental: Arm 2; Patients administrate Chiglitazar 48mg once daily for 52 weeks	Drug: Chiglitazar; Take orally; Other Names: CS038
Placebo Comparator: Arm 3; Patients administrate placebo for 24 weeks.From week 25 to 52, patients are randomly switched to Arm 1 and Arm 2, and receive the treatment accordingly.	Drug: Chiglitazar; Take orally; Other Names: CS038; Drug: Placebo; Take orally; Other Names: Plb

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chipscreen Biosciences, Ltd.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: April 22, 2014
• First Submitted That Met QC Criteria: April 22, 2014
• First Posted (Estimate): April 23, 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

Terms related to this study

• Keywords: Chiglitazar,diabetes,type 2 diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CGZ301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No