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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.

Tracking Information
First Submitted Date  ICMJE April 22, 2014
First Posted Date  ICMJE April 23, 2014
Last Update Posted Date October 25, 2019
Study Start Date  ICMJE June 2014
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2017)
Change in HbA1c from baseline after 24 weeks of treatment [ Time Frame: 24 weeks ]
The change of HbA1c at week 24 from baseline
Original Primary Outcome Measures  ICMJE
 (submitted: April 22, 2014)
Change in HbA1c from baseline after 24 weeks of treatment [ Time Frame: 24 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2017)
  • 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
  • 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
  • Change in HbA1c from baseline [ Time Frame: 12 weeks ]
    The change of HbA1c at week 12 from baseline
  • Change in HbA1c from baseline [ Time Frame: 52 weeks ]
    The change of HbA1c at week 52 from baseline
  • Percentage of patients that attained target HbA1c <7.0% [ Time Frame: 24 weeks ]
    Percentage of patients whose HbA1c at week 24 are < 7.0%
  • 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%
  • 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
  • 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
  • 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
  • Change in triglyceride from baseline [ Time Frame: 12,24 and 52 weeks ]
    The change of triglyceride at week 12, 24 and 52 from baseline
  • 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
  • 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
  • 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
  • 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
  • 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
  • Change in blood pressure from baseline [ Time Frame: 24 weeks ]
    The change of blood pressure at week 24 from baseline
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2014)
  • Change in HbA1c from baseline for patients with a baseline HbA1c >=8.5% [ Time Frame: 24 weeks ]
  • Change in HbA1c from baseline in patients with a baseline HbA1c < 8.5% [ Time Frame: 24 weeks ]
  • Change in HbA1c from baseline [ Time Frame: 12 weeks ]
  • Change in HbA1c from baseline [ Time Frame: 52 weeks ]
  • Percentage of patients that attained target HbA1c <7.0% [ Time Frame: 24 weeks ]
  • Percentage of patients whose HbA1c lowered by at least 0.5% [ Time Frame: 24 weeks ]
  • Change in fasting plasma glucose from baseline [ Time Frame: 12,24 and 52 weeks ]
  • Change in 2-h postprandial glucose (2hPPG) from baseline [ Time Frame: 12, 24 and 52 weeks ]
  • Change in total cholesterol (TC) from baseline [ Time Frame: 12, 24 and 52 weeks ]
  • Change in triglyceride from baseline [ Time Frame: 12,24 and 52 weeks ]
  • Change in high density lipoprotein cholesterol (HDL-C)from baseline [ Time Frame: 12, 24 and 52 weeks ]
  • Change in low density proprotein cholesterol (LDL-C) from baseline [ Time Frame: 12, 24 and 52 weeks ]
  • Change in free fatty acid (FFA) from baseline [ Time Frame: 12, 24 and 52 weeks ]
  • Change in fasting plasma insulin from baseline [ Time Frame: 12, 24 and 52 weeks ]
  • Insulin sensitivity [ Time Frame: 12, 24 and 52 weeks ]
  • Change in blood pressure from baseline [ Time Frame: 24 weeks ]
  • Percentage of patients who use rescue therapy [ Time Frame: 52 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Chiglitazar Compare With Placebo in Type 2 Diabetes Patients
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • Drug: Chiglitazar
    Take orally
    Other Name: CS038
  • Drug: Placebo
    Take orally
    Other Name: Plb
Study Arms  ICMJE
  • Experimental: Arm 1
    Patients administrate Chiglitazar 32mg once daily for 52 weeks
    Intervention: Drug: Chiglitazar
  • Experimental: Arm 2
    Patients administrate Chiglitazar 48mg once daily for 52 weeks
    Intervention: Drug: Chiglitazar
  • 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.
    Interventions:
    • Drug: Chiglitazar
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 16, 2018)
535
Original Estimated Enrollment  ICMJE
 (submitted: April 22, 2014)
534
Actual Study Completion Date  ICMJE November 2017
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02121717
Other Study ID Numbers  ICMJE CGZ301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Chipscreen Biosciences, Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Chipscreen Biosciences, Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Linong Ji, Dr. Peking University People's Hospital
PRS Account Chipscreen Biosciences, Ltd.
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP