Study of Chiglitazar Compare With Sitagliptin in Type 2 Diabetes Patients
CMAS
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 Sitagliptin-Controlled Trial
1 other identifier
interventional
740
1 country
37
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Chiglitazar, compare with Sitagliptin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes
Started Sep 2014
Typical duration for phase_3 type-2-diabetes
37 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
June 20, 2014
CompletedFirst Posted
Study publicly available on registry
June 25, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedOctober 25, 2019
October 1, 2019
2.3 years
June 20, 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 (16)
Change in HbA1c from baseline for patients with a baseline HbA1c >=8.5%
24 weeks
Change in HbA1c from baseline for patients with a baseline HbA1c <8.5%
24 weeks
Change in HbA1c from baseline
12 weeks
Percentage of patients that attained target HbA1c <7.0%
24 weeks
Percentage of patients whose HbA1c lowered by at least 0.5%
24 weeks
- +11 more secondary outcomes
Study Arms (3)
Arm 1
EXPERIMENTALPatients administrate Chiglitazar 32mg once daily for 24 weeks
Arm 2
EXPERIMENTALPatients administrate Chiglitazar 48mg once daily for 24 weeks
Arm 3
ACTIVE COMPARATORPatients administrate Sitagliptin 100mg once daily for 24 weeks
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 \[blood pressure above the goal despite adherence to at least 3 optimally dosed antihypertensive medications (including diuretic) of different classes,or blood pressure is controlled to below the goal by at least different classes of drugs\];
- 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;
- Had or is having pancreatic diseases;
- 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;
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Anhui Provincial Hospital
Hefei, Anhui, 230001, China
The First Hospital Affiliated to Anhui Medical University
Hefei, Anhui, 230022, China
Fuwai Hospital
Beijing, Beijing Municipality, 100037, China
The General Hospital of the Chinese People's Armed Police Forces
Beijing, Beijing Municipality, 100039, China
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100050, China
The Second Artillery General Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, 100068, China
Beijing Tongren Hospital Affiliated to Capital Medical Universtiy
Beijing, Beijing Municipality, 100730, China
The Third Hospital Affiliated to Guangzhou Medical College
Guangzhou, Guangdong, 510360, China
The Second Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, 512021, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518000, China
Beijing University Shenzhen Hospital
Shenzhen, Guangdong, 518036, China
Zhongshan People's Hospital
Zhongshan, Guangdong, 528403, China
The First Affiliated Hospital of Guangxi Medical University (The Eastern Hospital)
Nanning, Guangxi, 530021, China
The First Affiliated Hospital of Guangxi Medical University (The Western Hospital)
Nanning, Guangxi, 530021, China
The Second Hospital of Heibei Medical University
Shijiazhuang, Hebei, 050000, China
Tongji Hospital Affiliated to Tongji Medical College of HUST
Wuhan, Hubei, 430030, China
The First Hospital Affiliated to Nanhua University
Hengyang, Hunan, 421001, China
The First People's Hospital of Yueyang
Yueyang, Hunan, 414000, China
The Affiliated Hospital of Inner Mongolia
Hohhot, Inner Mongolia, 010050, China
Huai'an First People's Hospital
Huai'an, Jiangsu, 223300, China
Gulou Hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu, 210008, China
The Second Hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu, 210009, China
Nanjing First Hospital
Nanjing, Jiangsu, 210029, China
The Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212013, China
The First Hospital of Jilin University
Changchun, Jilin, 100031, China
Siping Central People's Hospital
Siping, Jilin, 136000, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116044, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shan'xi, 710061, China
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200003, China
The Qingpu Branch of Zhongshan Hospital Affiliate to Fudan University
Shanghai, Shanghai Municipality, 200043, China
Tongji Hospital Affiliated to Tongji University
Shanghai, Shanghai Municipality, 200065, China
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, 200080, China
Shanghai 6th People's Hospital
Shanghai, Shanghai Municipality, 200235, China
Shanghai 5th People's Hospital
Shanghai, Shanghai Municipality, 200240, China
The Central Hospital of Minhang District of Shanghai
Shanghai, Shanghai Municipality, 201199, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
Related Publications (2)
Wang Y, Zhou Y, Zhou X, Su X, Xu X, Li H, Ma J. Effect of Chiglitazar and Sitagliptin on Bone Mineral Density and Body Composition in Untreated Patients with Type 2 Diabetes. Diabetes Metab Syndr Obes. 2023 Dec 27;16:4205-4214. doi: 10.2147/DMSO.S439479. eCollection 2023.
PMID: 38162801DERIVEDZhou Y, Wang H, Wang Y, Xu X, Li F, Zhou J, Shan T, Huang R, Cai T, Liu X, Su X, Li H, Ma J. Comparative Evaluation of Chiglitazar and Sitagliptin on the Levels of Retinol-Binding Protein 4 and Its Correlation With Insulin Resistance in Patients With Type 2 Diabetes. Front Endocrinol (Lausanne). 2022 Apr 25;13:801271. doi: 10.3389/fendo.2022.801271. eCollection 2022.
PMID: 35547000DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Weiping Jia, Dr.
Shanghai 6th 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
June 20, 2014
First Posted
June 25, 2014
Study Start
September 1, 2014
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
October 25, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share