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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02121717
Recruitment Status : Completed
First Posted : April 23, 2014
Last Update Posted : October 25, 2019
Sponsor:
Information provided by (Responsible Party):
Chipscreen Biosciences, Ltd.

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Chiglitazar Drug: Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 535 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : June 2014
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1
Patients administrate Chiglitazar 32mg once daily for 52 weeks
 Drug: Chiglitazar
Take orally
Other Name: CS038
Experimental: Arm 2
Patients administrate Chiglitazar 48mg once daily for 52 weeks
 Drug: Chiglitazar
Take orally
Other Name: 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 Name: CS038

Drug: Placebo
Take orally
Other Name: Plb


Outcome Measures
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Primary Outcome Measures :
  1. Change in HbA1c from baseline after 24 weeks of treatment [ Time Frame: 24 weeks ]
    The change of HbA1c at week 24 from baseline


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Change in HbA1c from baseline [ Time Frame: 12 weeks ]
    The change of HbA1c at week 12 from baseline

  4. Change in HbA1c from baseline [ Time Frame: 52 weeks ]
    The change of HbA1c at week 52 from baseline

  5. Percentage of patients that attained target HbA1c <7.0% [ Time Frame: 24 weeks ]
    Percentage of patients whose HbA1c at week 24 are < 7.0%

  6. 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%

  7. 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

  8. 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

  9. 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

  10. Change in triglyceride from baseline [ Time Frame: 12,24 and 52 weeks ]
    The change of triglyceride at week 12, 24 and 52 from baseline

  11. 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. 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

  13. 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

  14. 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

  15. 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

  16. Change in blood pressure from baseline [ Time Frame: 24 weeks ]
    The change of blood pressure at week 24 from baseline

  17. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02121717


Locations
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Sponsors and Collaborators
Chipscreen Biosciences, Ltd.
Investigators
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Principal Investigator: Linong Ji, Dr. Peking University People's Hospital
More Information
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Responsible Party: Chipscreen Biosciences, Ltd.
ClinicalTrials.gov Identifier: NCT02121717    
Other Study ID Numbers: CGZ301
First Posted: April 23, 2014    Key Record Dates
Last Update Posted: October 25, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Chipscreen Biosciences, Ltd.:
Chiglitazar,diabetes,type 2 diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases