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
1 other identifier
interventional
535
1 country
26
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Chiglitazar, compare with placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 type-2-diabetes
Started Jun 2014
Longer than P75 for phase_3 type-2-diabetes
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2014
CompletedFirst Posted
Study publicly available on registry
April 23, 2014
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedOctober 25, 2019
October 1, 2019
3.4 years
April 22, 2014
October 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1c from baseline after 24 weeks of treatment
The change of HbA1c at week 24 from baseline
24 weeks
Secondary Outcomes (17)
Change in HbA1c from baseline for patients with a baseline HbA1c >=8.5%
24 weeks
Change in HbA1c from baseline in patients with a baseline HbA1c < 8.5%
24 weeks
Change in HbA1c from baseline
12 weeks
Change in HbA1c from baseline
52 weeks
Percentage of patients that attained target HbA1c <7.0%
24 weeks
- +12 more secondary outcomes
Study Arms (3)
Arm 1
EXPERIMENTALPatients administrate Chiglitazar 32mg once daily for 52 weeks
Arm 2
EXPERIMENTALPatients administrate Chiglitazar 48mg once daily for 52 weeks
Arm 3
PLACEBO COMPARATORPatients 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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Peking University Shougang Hospital
Beijing, Beijing Municipality, 100000, China
China Meitan General Hospital
Beijing, Beijing Municipality, 100028, China
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
The 306th Hospital of PLA
Beijing, Beijing Municipality, 100101, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
Chongqing Three Gorges Central Hospital
Chongqing, Chongqing Municipality, 404000, China
Cangzhou's Central Hospital
Cangzhou, Hebei, 061110, China
Harrison International Peace Hospital
Hengshui, Hebei, 053000, China
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050051, China
Tangshan Gongren Hospital
Tangshan, Hebei, 063000, China
The First Affiliated Hospital of Ha'erbin Medical University
Harbin, Heilongjiang, 150081, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410001, China
Chenzhou First People's Hospital
Chenzhou, Hunan, 423000, China
Baogang Hospital of Inner Mongilia
Baotou, Inner Mongolia, 014010, China
The people's Hospital of Jiangsu Province
Nanjing, Jiangsu, 210029, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, 221000, China
The Second Hospital of Jilin University
Changchun, Jilin, 130041, China
The Affiliated Hospital of Qingdao Medical University
Qingdao, Shandong, 266071, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032, China
Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200092, China
The Central Hospital of Yangpu District of Shanghai
Shanghai, Shanghai Municipality, 200433, China
The First Affiliated Hospital of The 4th Military Medical University
Xi’an, Shanxi, 710032, China
Huaxi Hopsital of Sichuan University
Chengdu, Sichuan, 610041, China
The General Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300052, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Linong Ji, Dr.
Peking University People's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2014
First Posted
April 23, 2014
Study Start
June 1, 2014
Primary Completion
November 1, 2017
Study Completion
November 1, 2017
Last Updated
October 25, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share