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

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 Placebo-Controlled Trial

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
535

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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 in 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
Change in HbA1c from baseline
Time Frame: 52 weeks
The change of HbA1c at week 52 from baseline
52 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
Percentage of patients whose HbA1c lowered by at least 0.5%
Time Frame: 24 weeks
Percentage of patients whose change of HbA1c at week 24 from baseline are >= 0.5%
24 weeks
Change in fasting plasma glucose from baseline
Time Frame: 12,24 and 52 weeks
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
Time Frame: 12, 24 and 52 weeks
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
Time Frame: 12, 24 and 52 weeks
The change of total cholesterol (TC) at week 12, 24 and 52 from baseline
12, 24 and 52 weeks
Change in triglyceride from baseline
Time Frame: 12,24 and 52 weeks
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
Time Frame: 12, 24 and 52 weeks
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
Time Frame: 12, 24 and 52 weeks
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
Time Frame: 12, 24 and 52 weeks
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
Time Frame: 12, 24 and 52 weeks
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
Time Frame: 12, 24 and 52 weeks
The change of insulin sensitivity at week 12, 24 and 52 from baseline
12, 24 and 52 weeks
Change in blood pressure from baseline
Time Frame: 24 weeks
The change of blood pressure at week 24 from baseline
24 weeks
Percentage of patients who use rescue therapy
Time Frame: 52 weeks
The percentage of patients who use rescue therapy during the 52 weeks of treatment
52 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chipscreen Biosciences, Ltd.

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CGZ301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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