Type 2 DiabetesPhase 3NCT04807348

Chiglitazar Added to Metformin for Type 2 Diabetes

A Phase 3 study testing Chiglitazar 32mg, Chiglitazar 48mg and Metformin Hydrochloride in people with Type 2 Diabetes, run by Chipscreen Biosciences, Ltd. at 50 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: Chiglitazar 32mg, Chiglitazar 48mg and Metformin Hydrochloride
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 533 participants
Where: 50 sitesChina
Study dates: 6 Jul 2021to 10 Feb 2023
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

) Provide a signed and dated informed consent form;
) Men and women aged ≥ 18 years and ≤ 75 years;
) According to the World Health Organization ( the WHO ) 1999 criteria for the diagnosis of type 2 diabetes;
) 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;
) The local HbA1c value during the screening period: 7.5% ≤ HbA1c ≤ 11% ;
) The HbA1c value of the central laboratory before randomization: 7.0% ≤ HbA1c ≤ 10.5% ;

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) BMI ≥ 18.5 kg/m2 and ≤ 35 kg/m 2 ;
) Fasting C- peptide ≥ 0.5 nmol/L ;
) 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.

Who cannot join

) Type 1 diabetes;
) Pregnancy or lactation;
) The New York Heart Association (NYHA ) defines congestive heart failure as grade III or IV ;
) 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;
) Suffered from malignant tumors (except cured basal cell carcinoma) within 5 years before screening;
) Edema of lower limbs or edema of the whole body;

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) Moderate to severe renal insufficiency [ Calculated eGFR<60 ml/ ( min*1.73m2 ) using CKD - EPI formula ];
) urinary albumin-to-creatinine ratio of > 300 mg /g;
) Triglyceride> 5.6 mmol /L;
) 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
) 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;
) 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 ;
) History of illegal drug abuse within 12 months before screening ;
) Participated in other clinical trials within 90 days before screening ;
) Donated whole blood, plasma, or platelets within 3 months before screening.
) 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;
) The investigator judged that it is not suitable to participate in this clinical trial.

Trial locations and contacts

50 sites in 1 country.

City, postcode or hospital

50 sites in 1 country

China50 sites

Inner Mongolia Baotou Steel Hospital
Baotou, Inner Mongolia
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality
Beijing Luhe Hospital, Capital Medical University
Beijing, Beijing Municipality
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality
Beijing Tsinghua Chang Gung Memorial Hospital
Beijing, Beijing Municipality
Beijing University First Hospital
Beijing, Beijing Municipality
Chinese People's Liberation Army Rocket Army Characteristic Medical Center
Beijing, Beijing Municipality
Peking University People's Hospital
Beijing, Beijing Municipality
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality
The First People's Hospital of Chenzhou City
Chenzhou, Hunan
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
The First Hospital of Jilin University
Harbin, Jilin
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Jilin
The Second Hospital of Jilin University
Harbin, Jilin
Hefei Second People's Hospital
Hefei, Anhui
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Harrison International Peace Hospital
Hengshui, Hebei
The First People's Hospital of Huai'an
Huaian, Jiangsu
Huzhou Central Hospital
Huzhou, Zhejiang
Jinan Central Hospital
Jinan, Shandong
Qilu Hospital of Shandong University
Jinan, Shandong
Affiliated Hospital of Jining Medical College, Shandong Province
Jining, Shandong
Huaihe Hospital of Henan University
Kaifeng, Henan
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan
The Third People's Hospital of Luoyang City
Luoyang, Henan
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu
Nanjing First Hospital
Nanjing, Jiangsu
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
Yifu Hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu
Panjin Liaoyou Baoshihua Hospital
Panjin, Liaoning
Qingdao University Hospital
Qingdao, Shandong
Gongli Hospital, Pudong New Area, Shanghai
Shanghai, Shanghai Municipality
Shanghai Minhang District Central Hospital
Shanghai, Shanghai Municipality
Shanghai Pudong Hospital
Shanghai, Shanghai Municipality
Shanghai Seventh People's Hospital
Shanghai, Shanghai Municipality
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Shenzhen People's Hospital
Shenzhen, Guangdong
Union Shenzhen Hospital of Huazhong University of Science and Technology
Shenzhen, Guangdong
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei
Tangshan Workers' Hospital
Tangshan, Tianjin Municipality
Three Gorges Hospital Affiliated to Chongqing University
Wanzhou, Chongqing Municipality
Yijishan Hospital of Wannan Medical College
Wuhu, Anhui
Xinxiang Central Hospital
Xinxiang, Henan
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
Yueyang Second People's Hospital
Yueyang, Hunan
Central Hospital of Yuncheng City, Shanxi Province
Yuncheng, Shanxi
Zhuzhou Central Hospital
Zhuzhou, Hunan

Other trials in China

About this study

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)

The purpose of the trial is to evaluate the effect of Chiglitazar added to metformin to type 2 diabetes Inadequately controlled with metformin Monotherapy.

Read the 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.

Conditions: Type 2 Diabetes
Being tested: Chiglitazar 32mg, Chiglitazar 48mg, Placebo, Metformin Hydrochloride
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Chiglitazar 32mgDrug
Also called Bilessglu, CS038
Administrated once daily
Chiglitazar 48mgDrug
Also called Bilessglu, CS038
Administrated once daily
PlaceboDrug
Also called Chiglitazar simulator
Placebo of Chiglitazar
Metformin HydrochlorideDrug
Also called Glucophage
most tolerable dose

Study groups in NCT04807348
Study group	Role	What they receive
Chiglitazar sodium 32mg QD+metformin	Experimental	Chiglitazar 32mg qd+metformin Receives: Drug: Chiglitazar 32mg; Drug: Metformin Hydrochloride
Chiglitazar sodium 48 mg QD+metformin	Experimental	Chiglitazar 48 mg qd+metformin Receives: Drug: Chiglitazar 48mg; Drug: Metformin Hydrochloride
placebo+metformin	Placebo comparator	placebo+metformin Receives: Drug: Placebo; Drug: Metformin Hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

percentage of HbA1c change from baseline
central lab test
Measured: 24 weeks

Secondary outcomes (5)

Changes in blood fasting plasma glucose level from baseline
central lab test
Measured: 12 and 24 weeks
Changes of HOMA-the IR value from baseline
model calculated
Measured: 12 and 24 weeks
Changes of blood lipids level from baseline
includeing TC, LDL-C, HDL-C, VLDL-C, non-HDL-C, TG, FFA, ApoA1, ApoB
Measured: 12 and 24 weeks
percentage of AEs
safety
Measured: 28 weeks
number of participants with lab abnormality
number or rate of founds in lab tests
Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jul 202110 Feb 2023

First posted19 Mar 2021
Study start6 Jul 2021
Primary completion10 Feb 2023
Study completion10 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
More trials run by Chipscreen Biosciences, Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 533 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04807348
Sponsor's protocol ID: CGZ303
Status last verified: Jul 2024
First submitted: 17 Mar 2021
Last updated: 15 Jul 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Ji L, Song W, Fang H, Li W, Geng J, Wang Y, Guo L, Cai H, Yang T, Li H, Yang G, Li Q, Liu K, Li S, Liu Y, Shi F, Li X, Gao X, Tian H, Ji Q, Su Q, Zhou Z, Wang W, Zhou Z, Li X, Xu Y, Ning Z, Cao H, Pan D, Yao H, Lu X, Jia W. Efficacy and safety of chiglitazar, a novel peroxisome proliferator-activated receptor pan-agonist, in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, phase 3 trial (CMAP). Sci Bull (Beijing). 2021 Aug 15;66(15):1571-1580. doi: 10.1016/j.scib.2021.03.019. Epub 2021 Mar 23.
PubMed 36654286
Jia W, Ma J, Miao H, Wang C, Wang X, Li Q, Lu W, Yang J, Zhang L, Yang J, Wang G, Zhang X, Zhang M, Sun L, Yu X, Du J, Shi B, Xiao C, Zhu D, Liu H, Zhong L, Xu C, Xu Q, Liang G, Zhang Y, Li G, Gu M, Liu J, Yuan G, Yan Z, Yan D, Ye S, Zhang F, Ning Z, Cao H, Pan D, Yao H, Lu X, Ji L. Chiglitazar monotherapy with sitagliptin as an active comparator in patients with type 2 diabetes: a randomized, double-blind, phase 3 trial (CMAS). Sci Bull (Beijing). 2021 Aug 15;66(15):1581-1590. doi: 10.1016/j.scib.2021.02.027. Epub 2021 Feb 16.
PubMed 36654287
Gao L, Ji L, Yan X, Cheng Z, Zhang X, Sun W, Ma J, Song W, Liu Y, Lin X, Pang W, Cao H, Chen B, Li Z, Lu X; RECAM Study Group. Efficacy and safety of chiglitazar add-on to metformin in type 2 diabetes mellitus (RECAM study). Diabetes Obes Metab. 2025 Nov;27(11):6243-6253. doi: 10.1111/dom.70009. Epub 2025 Aug 22.
PubMed 40842343

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT04807348
Acronym / sponsor ID: CGZ303
Conditions: Type 2 Diabetes
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 533 participants (actual)
Lead sponsor: Chipscreen Biosciences, Ltd.Industry (pharma, biotech, devices)
Study start: 6 Jul 2021 (actual)
Primary completion: 10 Feb 2023 (actual)
Study completion: 10 Feb 2023 (actual)
First posted: 19 Mar 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Chiglitazar sodium 32mg QD+metformin	Experimental	Drug: Chiglitazar 32mg, Drug: Metformin HydrochlorideChiglitazar 32mg qd+metformin
Chiglitazar sodium 48 mg QD+metformin	Experimental	Drug: Chiglitazar 48mg, Drug: Metformin HydrochlorideChiglitazar 48 mg qd+metformin
placebo+metformin	Placebo comparator	Drug: Placebo, Drug: Metformin Hydrochlorideplacebo+metformin

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

) Provide a signed and dated informed consent form;
) Men and women aged ≥ 18 years and ≤ 75 years;
) According to the World Health Organization ( the WHO ) 1999 criteria for the diagnosis of type 2 diabetes;
) 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;
) The local HbA1c value during the screening period: 7.5% ≤ HbA1c ≤ 11% ;

Key exclusion criteria (17 listed)

) Type 1 diabetes;
) Pregnancy or lactation;
) The New York Heart Association (NYHA ) defines congestive heart failure as grade III or IV ;
) 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;
) Suffered from malignant tumors (except cured basal cell carcinoma) within 5 years before screening;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Chiglitazar 32mgAlso: Bilessglu, CS038Administrated once daily	Drug	Chiglitazar sodium 32mg QD+metformin
Chiglitazar 48mgAlso: Bilessglu, CS038Administrated once daily	Drug	Chiglitazar sodium 48 mg QD+metformin
PlaceboAlso: Chiglitazar simulatorPlacebo of Chiglitazar	Drug	placebo+metformin
Metformin HydrochlorideAlso: Glucophagemost tolerable dose	Drug	Chiglitazar sodium 32mg QD+metformin, Chiglitazar sodium 48 mg QD+metformin, placebo+metformin

Primary outcome

percentage of HbA1c change from baseline
Time frame: 24 weeks
central lab test

5 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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
Results publication: PubMed 36654286Ji L, Song W, Fang H, Li W, Geng J, Wang Y, Guo L, Cai H, Yang T, Li H, Yang G, Li Q, Liu K, Li S, Liu Y, Shi F, Li X, Gao X, Tian H, Ji Q, Su Q, Zhou Z, Wang W, Zhou Z, Li X, Xu Y, Ning Z, Cao H, Pan D, Yao H, Lu X, Jia W. Efficacy and safety of chiglitazar, a novel peroxisome proliferator-activated receptor pan-agonist, in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, phase 3 trial (CMAP). Sci Bull (Beijing). 2021 Aug 15;66(15):1571-1580. doi: 10.1016/j.scib.2021.03.019. Epub 2021 Mar 23.
Results publication: PubMed 36654287Jia W, Ma J, Miao H, Wang C, Wang X, Li Q, Lu W, Yang J, Zhang L, Yang J, Wang G, Zhang X, Zhang M, Sun L, Yu X, Du J, Shi B, Xiao C, Zhu D, Liu H, Zhong L, Xu C, Xu Q, Liang G, Zhang Y, Li G, Gu M, Liu J, Yuan G, Yan Z, Yan D, Ye S, Zhang F, Ning Z, Cao H, Pan D, Yao H, Lu X, Ji L. Chiglitazar monotherapy with sitagliptin as an active comparator in patients with type 2 diabetes: a randomized, double-blind, phase 3 trial (CMAS). Sci Bull (Beijing). 2021 Aug 15;66(15):1581-1590. doi: 10.1016/j.scib.2021.02.027. Epub 2021 Feb 16.
Derived from this study: PubMed 40842343Gao L, Ji L, Yan X, Cheng Z, Zhang X, Sun W, Ma J, Song W, Liu Y, Lin X, Pang W, Cao H, Chen B, Li Z, Lu X; RECAM Study Group. Efficacy and safety of chiglitazar add-on to metformin in type 2 diabetes mellitus (RECAM study). Diabetes Obes Metab. 2025 Nov;27(11):6243-6253. doi: 10.1111/dom.70009. Epub 2025 Aug 22.
Individual participant dataSharing planned: No

Related trials for Type 2 Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
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Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Recruiting
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A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Linong Ji, Prof. principal investigator

Peking University People's Hospital

50 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Chiglitazar 32mg, Chiglitazar 48mg and Metformin Hydrochloride in people with Type 2 Diabetes, run by Chipscreen Biosciences, Ltd. at 50 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

percentage of HbA1c change from baseline (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04807348, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024; AzTrials last refreshed its copy on 6 Nov 2026.