--- title: Chiglitazar Added to Metformin for Type 2 Diabetes nct_id: NCT04807348 overall_status: COMPLETED phase: PHASE3 sponsor: Chipscreen Biosciences, Ltd. study_type: INTERVENTIONAL primary_condition: Type 2 Diabetes countries: China canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04807348.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04807348" ct_last_update_post_date: 2024-07-15 last_seen_at: "2026-05-12T06:44:17.385Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Chiglitazar Added to Metformin for Type 2 Diabetes **Official Title:** A Randomised Double-blind Placebo Parallel Controlled Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of Chiglitazar Added to Metformin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy (RECAM) **NCT ID:** [NCT04807348](https://clinicaltrials.gov/study/NCT04807348) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 533 - **Lead Sponsor:** Chipscreen Biosciences, Ltd. - **Conditions:** Type 2 Diabetes - **Start Date:** 2021-07-06 - **Completion Date:** 2023-02-10 - **CT.gov Last Update:** 2024-07-15 ## Brief Summary The purpose of the trial is to evaluate the effect of Chiglitazar added to metformin to type 2 diabetes Inadequately controlled with metformin Monotherapy. ## Detailed Description This clinical trial is a multi-center, randomized, double-blind, placebo parallel control design, and uses superiority test to determine whether the experimental group is superior to the control group in terms of main efficacy endpoints. ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 75 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: 1. ) Provide a signed and dated informed consent form; 2. ) Men and women aged ≥ 18 years and ≤ 75 years; 3. ) According to the World Health Organization ( the WHO ) 1999 criteria for the diagnosis of type 2 diabetes; 4. ) After metformin stable dose monotherapy (≥1500 mg/day or maximum tolerated dose, but the maximum tolerated dose not \< l000 mg/day) for at least 8 weeks; 5. ) The local HbA1c value during the screening period: 7.5% ≤ HbA1c ≤ 11% ; 6. ) The HbA1c value of the central laboratory before randomization: 7.0% ≤ HbA1c ≤ 10.5% ; 7. ) BMI ≥ 18.5 kg/m2 and ≤ 35 kg/m 2 ; 8. ) Fasting C- peptide ≥ 0.5 nmol/L ; 9. ) Women of Childbearing Potential ( WOCBP ) should take reliable contraceptive measures at least 1 month before the screening, during the entire trial, and within 3 months after completing the trial; male subjects should take reliable contraceptive measures to avoid making their sexual partners to pregnant during the entire trial and within 3 months after the trial. Exclusion Criteria: 1. ) Type 1 diabetes; 2. ) Pregnancy or lactation; 3. ) The New York Heart Association (NYHA ) defines congestive heart failure as grade III or IV ; 4. ) Significant history of cardiovascular and cerebrovascular diseases within 6 months before screening, defined as myocardial infarction, coronary artery bypass graft or angioplasty, valvular disease or repair, unstable angina, transient brain Ischemic attack, or cerebrovascular accident; 5. ) Suffered from malignant tumors (except cured basal cell carcinoma) within 5 years before screening; 6. ) Edema of lower limbs or edema of the whole body; 7. ) Moderate to severe renal insufficiency \[ Calculated eGFR\<60 ml/ ( min\*1.73m2 ) using CKD - EPI formula \]; 8. ) urinary albumin-to-creatinine ratio of \> 300 mg /g; 9. ) Triglyceride\> 5.6 mmol /L; 10. ) Active liver disease and /or obvious liver function abnormalities, defined as AST\>2.5 times the upper limit of normal value and/or ALT\>2.5 times the upper limit of normal value and/or total bilirubin \>1.5 times the normal value Upper limit 11. ) Clinically significant arrhythmias in the electrocardiogram examination and treatment or intervention are required. The investigator judges that it is not suitable to participate in this clinical trial; 12. ) Human immunodeficiency virus (HIV) antibody-positive; Treponema pallidum antibody positive; positive hepatitis B surface antigen and HBV DNA quantification values were higher than the upper; HCV antibodies and HCV RNA quantification values were higher than the upper ; 13. ) History of illegal drug abuse within 12 months before screening ; 14. ) Participated in other clinical trials within 90 days before screening ; 15. ) Donated whole blood, plasma, or platelets within 3 months before screening. 16. ) Before randomization, the investigator judged that the subjects had poor compliance with the study protocol or drug treatment, defined as the subjects taking less than 80% or more than 120% of the prescribed dose of chiglitazar/ placebo or metformin; 17. ) The investigator judged that it is not suitable to participate in this clinical trial. ``` ## Arms - **Chiglitazar sodium 32mg QD+metformin** (EXPERIMENTAL) — Chiglitazar 32mg qd+metformin - **Chiglitazar sodium 48 mg QD+metformin** (EXPERIMENTAL) — Chiglitazar 48 mg qd+metformin - **placebo+metformin** (PLACEBO_COMPARATOR) — placebo+metformin ## Interventions - **Chiglitazar 32mg** (DRUG) — Administrated once daily - **Chiglitazar 48mg** (DRUG) — Administrated once daily - **Placebo** (DRUG) — Placebo of Chiglitazar - **Metformin Hydrochloride** (DRUG) — most tolerable dose ## Primary Outcomes - **percentage of HbA1c change from baseline** _(time frame: 24 weeks)_ — central lab test ## Secondary Outcomes - **Changes in blood fasting plasma glucose level from baseline** _(time frame: 12 and 24 weeks)_ - **Changes of HOMA-the IR value from baseline** _(time frame: 12 and 24 weeks)_ - **Changes of blood lipids level from baseline** _(time frame: 12 and 24 weeks)_ - **percentage of AEs** _(time frame: 28 weeks)_ - **number of participants with lab abnormality** _(time frame: 24 weeks)_ ## Locations (50) - Hefei Second People's Hospital, Hefei, Anhui, China - The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China - The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China - Yijishan Hospital of Wannan Medical College, Wuhu, Anhui, China - Beijing Chaoyang Hospital, Capital Medical University, Beijing, Beijing Municipality, China - Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing Municipality, China - Beijing Luhe Hospital, Capital Medical University, Beijing, Beijing Municipality, China - Beijing Tongren Hospital, Capital Medical University, Beijing, Beijing Municipality, China - Beijing Tsinghua Chang Gung Memorial Hospital, Beijing, Beijing Municipality, China - Beijing University First Hospital, Beijing, Beijing Municipality, China - Chinese People's Liberation Army Rocket Army Characteristic Medical Center, Beijing, Beijing Municipality, China - Peking University People's Hospital, Beijing, Beijing Municipality, China - Xuanwu Hospital, Capital Medical University, Beijing, Beijing Municipality, China - The Second Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, China - Three Gorges Hospital Affiliated to Chongqing University, Wanzhou, Chongqing Municipality, China - Shenzhen People's Hospital, Shenzhen, Guangdong, China - Union Shenzhen Hospital of Huazhong University of Science and Technology, Shenzhen, Guangdong, China - Harrison International Peace Hospital, Hengshui, Hebei, China - The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China - The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China - Huaihe Hospital of Henan University, Kaifeng, Henan, China - The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, Henan, China - The Third People's Hospital of Luoyang City, Luoyang, Henan, China - Xinxiang Central Hospital, Xinxiang, Henan, China - The First People's Hospital of Chenzhou City, Chenzhou, Hunan, China - Yueyang Second People's Hospital, Yueyang, Hunan, China - Zhuzhou Central Hospital, Zhuzhou, Hunan, China - Inner Mongolia Baotou Steel Hospital, Baotou, Inner Mongolia, China - The First People's Hospital of Huai'an, Huaian, Jiangsu, China - Jiangsu Provincial People's Hospital, Nanjing, Jiangsu, China - Nanjing First Hospital, Nanjing, Jiangsu, China - The Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China - Yifu Hospital Affiliated to Nanjing Medical University, Nanjing, Jiangsu, China - Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China - The First Hospital of Jilin University, Harbin, Jilin, China - The Fourth Affiliated Hospital of Harbin Medical University, Harbin, Jilin, China - The Second Hospital of Jilin University, Harbin, Jilin, China - Panjin Liaoyou Baoshihua Hospital, Panjin, Liaoning, China - Jinan Central Hospital, Jinan, Shandong, China - Qilu Hospital of Shandong University, Jinan, Shandong, China - Affiliated Hospital of Jining Medical College, Shandong Province, Jining, Shandong, China - Qingdao University Hospital, Qingdao, Shandong, China - Gongli Hospital, Pudong New Area, Shanghai, Shanghai, Shanghai Municipality, China - Shanghai Minhang District Central Hospital, Shanghai, Shanghai Municipality, China - Shanghai Pudong Hospital, Shanghai, Shanghai Municipality, China - Shanghai Seventh People's Hospital, Shanghai, Shanghai Municipality, China - Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai Municipality, China - Central Hospital of Yuncheng City, Shanxi Province, Yuncheng, Shanxi, China - Tangshan Workers' Hospital, Tangshan, Tianjin Municipality, China - Huzhou Central Hospital, Huzhou, Zhejiang, China ## Recent Field Changes (last 30 days) - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.hefei second people's hospital|hefei|anhui|china` — added _(2026-05-12)_ - `locations.the first affiliated hospital of anhui medical university|hefei|anhui|china` — added _(2026-05-12)_ - `locations.the second affiliated hospital of anhui medical university|hefei|anhui|china` — added _(2026-05-12)_ - `locations.yijishan hospital of wannan medical college|wuhu|anhui|china` — added _(2026-05-12)_ - `locations.beijing chaoyang hospital, capital medical university|beijing|beijing municipality|china` — added _(2026-05-12)_ - `locations.beijing friendship hospital, capital medical university|beijing|beijing municipality|china` — added _(2026-05-12)_ - `locations.beijing luhe hospital, capital medical university|beijing|beijing municipality|china` — added _(2026-05-12)_ - `locations.beijing tongren hospital, capital medical university|beijing|beijing municipality|china` — added _(2026-05-12)_ - `locations.beijing tsinghua chang gung memorial hospital|beijing|beijing municipality|china` — added _(2026-05-12)_ - `locations.beijing university first hospital|beijing|beijing municipality|china` — added _(2026-05-12)_ - `locations.chinese people's liberation army rocket army characteristic medical center|beijing|beijing municipality|china` — added _(2026-05-12)_ - `locations.peking university people's hospital|beijing|beijing municipality|china` — added _(2026-05-12)_ - `locations.xuanwu hospital, capital medical university|beijing|beijing municipality|china` — added _(2026-05-12)_ - `locations.the second affiliated hospital of chongqing medical university|chongqing|chongqing municipality|china` — added _(2026-05-12)_ - `locations.three gorges hospital affiliated to chongqing university|wanzhou|chongqing municipality|china` — added _(2026-05-12)_ - `locations.shenzhen people's hospital|shenzhen|guangdong|china` — added _(2026-05-12)_ - `locations.union shenzhen hospital of huazhong university of science and technology|shenzhen|guangdong|china` — added _(2026-05-12)_ - `locations.harrison international peace hospital|hengshui|hebei|china` — added _(2026-05-12)_ - `locations.the second hospital of hebei medical university|shijiazhuang|hebei|china` — added _(2026-05-12)_ - `locations.the third hospital of hebei medical university|shijiazhuang|hebei|china` — added _(2026-05-12)_ - `locations.huaihe hospital of henan university|kaifeng|henan|china` — added _(2026-05-12)_ - `locations.the first affiliated hospital of henan university of science and technology|luoyang|henan|china` — added _(2026-05-12)_ - `locations.the third people's hospital of luoyang city|luoyang|henan|china` — added _(2026-05-12)_ - `locations.xinxiang central hospital|xinxiang|henan|china` — added _(2026-05-12)_ - `locations.the first people's hospital of chenzhou city|chenzhou|hunan|china` — added _(2026-05-12)_ - `locations.yueyang second people's hospital|yueyang|hunan|china` — added _(2026-05-12)_ - `locations.zhuzhou central hospital|zhuzhou|hunan|china` — added _(2026-05-12)_ - `locations.inner mongolia baotou steel hospital|baotou|inner mongolia|china` — added _(2026-05-12)_ - `locations.the first people's hospital of huai'an|huaian|jiangsu|china` — added _(2026-05-12)_ - `locations.jiangsu provincial people's hospital|nanjing|jiangsu|china` — added _(2026-05-12)_ - `locations.nanjing first hospital|nanjing|jiangsu|china` — added _(2026-05-12)_ - `locations.the second affiliated hospital of nanjing medical university|nanjing|jiangsu|china` — added _(2026-05-12)_ - `locations.yifu hospital affiliated to nanjing medical university|nanjing|jiangsu|china` — added _(2026-05-12)_ - `locations.affiliated hospital of xuzhou medical university|xuzhou|jiangsu|china` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT04807348.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT04807348* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*