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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Chiglitazar
Placebo
Sponsored by
Chipscreen Biosciences, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Chiglitazar,diabetes,type 2 diabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking University Shougang Hospital
  • China Meitan General Hospital
  • Peking University People's Hospital
  • The 306th Hospital of PLA
  • The First Affiliated Hospital of Chongqing Medical University
  • The Second Affiliated Hospital of Chongqing Medical University
  • Chongqing Three Gorges Central Hospital
  • Cangzhou's Central Hospital
  • Harrison International Peace Hospital
  • The Third Hospital of Hebei Medical University
  • Tangshan Gongren Hospital
  • The First Affiliated Hospital of Ha'erbin Medical University
  • Zhongnan Hospital of Wuhan University
  • The Second Xiangya Hospital of Central South University
  • Chenzhou First People's Hospital
  • Baogang Hospital of Inner Mongilia
  • The people's Hospital of Jiangsu Province
  • The Affiliated Hospital of Xuzhou Medical College
  • The Second Hospital of Jilin University
  • The Affiliated Hospital of Qingdao Medical University
  • Zhongshan Hospital Fudan University
  • Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
  • The Central Hospital of Yangpu District of Shanghai
  • The First Affiliated Hospital of The 4th Military Medical University
  • Huaxi Hopsital of Sichuan University
  • The General Hospital of Tianjin Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

Patients administrate Chiglitazar 32mg once daily for 52 weeks

Patients administrate Chiglitazar 48mg once daily for 52 weeks

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.

Outcomes

Primary Outcome Measures

Change in HbA1c from baseline after 24 weeks of treatment
The change of HbA1c at week 24 from baseline

Secondary Outcome Measures

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
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
Change in HbA1c from baseline
The change of HbA1c at week 12 from baseline
Change in HbA1c from baseline
The change of HbA1c at week 52 from baseline
Percentage of patients that attained target HbA1c <7.0%
Percentage of patients whose HbA1c at week 24 are < 7.0%
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%
Change in fasting plasma glucose from baseline
The change of fasting plasma glucose at week 12 and 24 from baseline
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
Change in total cholesterol (TC) from baseline
The change of total cholesterol (TC) at week 12, 24 and 52 from baseline
Change in triglyceride from baseline
The change of triglyceride at week 12, 24 and 52 from baseline
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
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
Change in free fatty acid (FFA) from baseline
The change of free fatty acid (FFA) at week 12, 24 and 52 from baseline
Change in fasting plasma insulin from baseline
The change of fasting plasma insulin at week 12, 24 and 52 from baseline
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
Change in blood pressure from baseline
The change of blood pressure at week 24 from baseline
Percentage of patients who use rescue therapy
The percentage of patients who use rescue therapy during the 52 weeks of treatment

Full Information

First Posted
April 22, 2014
Last Updated
October 23, 2019
Sponsor
Chipscreen Biosciences, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02121717
Brief Title
Study of Chiglitazar Compare With Placebo in Type 2 Diabetes Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chipscreen Biosciences, Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Chiglitazar,diabetes,type 2 diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
535 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Patients administrate Chiglitazar 32mg once daily for 52 weeks
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Patients administrate Chiglitazar 48mg once daily for 52 weeks
Arm Title
Arm 3
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Chiglitazar
Other Intervention Name(s)
CS038
Intervention Description
Take orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Plb
Intervention Description
Take orally
Primary Outcome Measure Information:
Title
Change in HbA1c from baseline after 24 weeks of treatment
Description
The change of HbA1c at week 24 from baseline
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change in HbA1c from baseline for patients with a baseline HbA1c >=8.5%
Description
The change of HbA1c at week 24 from baseline for patients with a HbA1c >=8.5% at baseline
Time Frame
24 weeks
Title
Change in HbA1c from baseline in patients with a baseline HbA1c < 8.5%
Description
The change of HbA1c at week 24 from baseline for patients with a HbA1c < 8.5% at baseline
Time Frame
24 weeks
Title
Change in HbA1c from baseline
Description
The change of HbA1c at week 12 from baseline
Time Frame
12 weeks
Title
Change in HbA1c from baseline
Description
The change of HbA1c at week 52 from baseline
Time Frame
52 weeks
Title
Percentage of patients that attained target HbA1c <7.0%
Description
Percentage of patients whose HbA1c at week 24 are < 7.0%
Time Frame
24 weeks
Title
Percentage of patients whose HbA1c lowered by at least 0.5%
Description
Percentage of patients whose change of HbA1c at week 24 from baseline are >= 0.5%
Time Frame
24 weeks
Title
Change in fasting plasma glucose from baseline
Description
The change of fasting plasma glucose at week 12 and 24 from baseline
Time Frame
12,24 and 52 weeks
Title
Change in 2-h postprandial glucose (2hPPG) from baseline
Description
The change of 2-h postprandial glucose (2hPPG) at week 12, 24 and 52 from baseline
Time Frame
12, 24 and 52 weeks
Title
Change in total cholesterol (TC) from baseline
Description
The change of total cholesterol (TC) at week 12, 24 and 52 from baseline
Time Frame
12, 24 and 52 weeks
Title
Change in triglyceride from baseline
Description
The change of triglyceride at week 12, 24 and 52 from baseline
Time Frame
12,24 and 52 weeks
Title
Change in high density lipoprotein cholesterol (HDL-C)from baseline
Description
The change of high density lipoprotein cholesterol (HDL-C) at week week 12, 24 and 52 from baseline
Time Frame
12, 24 and 52 weeks
Title
Change in low density proprotein cholesterol (LDL-C) from baseline
Description
The change of low density lipoprotein cholesterol (LDL-C) at week 12, 24 and 52 from baseline
Time Frame
12, 24 and 52 weeks
Title
Change in free fatty acid (FFA) from baseline
Description
The change of free fatty acid (FFA) at week 12, 24 and 52 from baseline
Time Frame
12, 24 and 52 weeks
Title
Change in fasting plasma insulin from baseline
Description
The change of fasting plasma insulin at week 12, 24 and 52 from baseline
Time Frame
12, 24 and 52 weeks
Title
Insulin sensitivity assessed by the homeostatic model assessment (HOMA) at 12,24 and 52 weeks, compared with that of baseline
Description
The change of insulin sensitivity at week 12, 24 and 52 from baseline
Time Frame
12, 24 and 52 weeks
Title
Change in blood pressure from baseline
Description
The change of blood pressure at week 24 from baseline
Time Frame
24 weeks
Title
Percentage of patients who use rescue therapy
Description
The percentage of patients who use rescue therapy during the 52 weeks of treatment
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meet the WHO Diagnostic Criteria for Type 2 Diabetes (published on 1999); HbA1c≥ 7.5% and ≤ 10.0% after control of diet and exercises; Male and female,age between 18 and 70 years; BMI between 18.5-35kg/m2; Willing to be assigned to any treatment arm and sign inform consent. Exclusion Criteria: Type 1 diabetes; Treated by oral or injective antidiabetic drug before screening, including insulin and herb; Fasting plasma glucose > 13.3 mmol/L (240 mg/dL); 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]; Plasma triglyceride > 500 mg/dL (5.65 mmol/L); Is treating by fibrates; History of diabetic ketoacidosis,diabetic hyperglycemic hyperosmolar syndrome,lactic acidosis, diabetic hypoglycemia; or is currently combined with retinopathy, diabetic nephropathy and diabetic neuropathy; Had transient ischemic attack,cerebrovascular accident or unstable angina in the past 6 months; History of myocardial infarction or had conducted coronary angioplasty or coronary artery bypass graft surgery; Heart failure (NYHA classification Stage III or IV), or left ventricular hypertrophy indicated by ECG; Hepatic diseases such as hepatocirrhosis, active hepatitis,aspartate aminotransferase or alanine aminotransferase > 2.5 fold of the upper limit of the normal range; Kidney diseases or serum creatinine exceed the normal range: male > 133 μmol/L or female >108 μmol/L; Had malignancy in the past 5 years, not including basal cell carcinoma; Had or is currently receiving treatment that can alter blood glucose metabolism, including but not limited to diuretic,hormone (corticotropin or steroids),beta blockers; Have the diseases that can alter blood glucose metabolism, including but not limited to active hepatitis, hyperthyroidism,or adrenal tumors; Edema with unknown reason; Alcohol or drug addiction; Had participated other drugs' clinical trials in the 3 months before screening; Pregnant or lactic women; or women of childbearing age who are not able to or is not willing to conduct contraception; Any condition that make investigator consider the subject is not suitable to participate the trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linong Ji, Dr.
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Shougang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
China Meitan General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100028
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
The 306th Hospital of PLA
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100101
Country
China
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400016
Country
China
Facility Name
The Second Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400016
Country
China
Facility Name
Chongqing Three Gorges Central Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
404000
Country
China
Facility Name
Cangzhou's Central Hospital
City
Cangzhou
State/Province
Hebei
ZIP/Postal Code
061110
Country
China
Facility Name
Harrison International Peace Hospital
City
Hengshui
State/Province
Hebei
ZIP/Postal Code
053000
Country
China
Facility Name
The Third Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050051
Country
China
Facility Name
Tangshan Gongren Hospital
City
Tangshan
State/Province
Hebei
ZIP/Postal Code
063000
Country
China
Facility Name
The First Affiliated Hospital of Ha'erbin Medical University
City
Ha'erbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430071
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410001
Country
China
Facility Name
Chenzhou First People's Hospital
City
Chenzhou
State/Province
Hunan
ZIP/Postal Code
423000
Country
China
Facility Name
Baogang Hospital of Inner Mongilia
City
Baotou
State/Province
Inner Mongolia
ZIP/Postal Code
014010
Country
China
Facility Name
The people's Hospital of Jiangsu Province
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
The Affiliated Hospital of Xuzhou Medical College
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221000
Country
China
Facility Name
The Second Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130041
Country
China
Facility Name
The Affiliated Hospital of Qingdao Medical University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266071
Country
China
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Facility Name
The Central Hospital of Yangpu District of Shanghai
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
The First Affiliated Hospital of The 4th Military Medical University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
Facility Name
Huaxi Hopsital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
The General Hospital of Tianjin Medical University
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of Chiglitazar Compare With Placebo in Type 2 Diabetes Patients

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