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Type 2 DiabetesPhase 3CMASNCT02173457

Study of Chiglitazar Compare With Sitagliptin in Type 2 Diabetes Patients

A Phase 3 study testing Chiglitazar and Sitagliptin in people with Type 2 Diabetes, run by Chipscreen Biosciences, Ltd. at 37 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 this study is to evaluate the efficacy and safety of Chiglitazar, compare with Sitagliptin. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
Chiglitazar and Sitagliptin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
740 participants
Where
37 sitesChina
Study dates
Sep 2014to Jan 2017
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 21Show fewer
  • 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;
  • Have the diseases that can alter blood glucose metabolism, including but not limited to active hepatitis, hyperthyroidism,or adrenal tumors;
  • Edema with unknown reason;
  • Alcohol or drug addiction;
  • Had participated other drugs' clinical trials in the 3 months before screening;
  • Pregnant or lactic women; or women of childbearing age who are not able to or is not willing to conduct contraception;
  • Any condition that make investigator consider the subject is not suitable to participate the trial.

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

China37 sites

  • Fuwai Hospital

    Beijing, Beijing Municipality, 100037

  • The General Hospital of the Chinese People's Armed Police Forces

    Beijing, Beijing Municipality, 100039

  • Beijing Tiantan Hospital

    Beijing, Beijing Municipality, 100050

  • The Second Artillery General Hospital of Chinese People's Liberation Army

    Beijing, Beijing Municipality, 100068

  • Beijing Tongren Hospital Affiliated to Capital Medical Universtiy

    Beijing, Beijing Municipality, 100730

  • The First Hospital of Jilin University

    Changchun, Jilin, 100031

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116044

  • The Third Hospital Affiliated to Guangzhou Medical College

    Guangzhou, Guangdong, 510360

  • Anhui Provincial Hospital

    Hefei, Anhui, 230001

  • The First Hospital Affiliated to Anhui Medical University

    Hefei, Anhui, 230022

  • The First Hospital Affiliated to Nanhua University

    Hengyang, Hunan, 421001

  • The Affiliated Hospital of Inner Mongolia

    Hohhot, Inner Mongolia, 010050

  • Huai'an First People's Hospital

    Huai'an, Jiangsu, 223300

  • Gulou Hospital Affiliated to Nanjing Medical University

    Nanjing, Jiangsu, 210008

  • The Second Hospital Affiliated to Nanjing Medical University

    Nanjing, Jiangsu, 210009

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210029

  • The First Affiliated Hospital of Guangxi Medical University (The Eastern Hospital)

    Nanning, Guangxi, 530021

  • The First Affiliated Hospital of Guangxi Medical University (The Western Hospital)

    Nanning, Guangxi, 530021

  • Shanghai Changzheng Hospital

    Shanghai, Shanghai Municipality, 200003

  • The Qingpu Branch of Zhongshan Hospital Affiliate to Fudan University

    Shanghai, Shanghai Municipality, 200043

  • Tongji Hospital Affiliated to Tongji University

    Shanghai, Shanghai Municipality, 200065

  • Shanghai First People's Hospital

    Shanghai, Shanghai Municipality, 200080

  • Shanghai 6th People's Hospital

    Shanghai, Shanghai Municipality, 200235

  • Shanghai 5th People's Hospital

    Shanghai, Shanghai Municipality, 200240

  • The Central Hospital of Minhang District of Shanghai

    Shanghai, Shanghai Municipality, 201199

  • The Second Affiliated Hospital of Shantou University Medical College

    Shantou, Guangdong, 512021

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong, 518000

  • Beijing University Shenzhen Hospital

    Shenzhen, Guangdong, 518036

  • The Second Hospital of Heibei Medical University

    Shijiazhuang, Hebei, 050000

  • Siping Central People's Hospital

    Siping, Jilin, 136000

  • Tongji Hospital Affiliated to Tongji Medical College of HUST

    Wuhan, Hubei, 430030

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shan'xi, 710061

  • The First People's Hospital of Yueyang

    Yueyang, Hunan, 414000

  • The Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, 212013

  • Zhongshan People's Hospital

    Zhongshan, Guangdong, 528403

Other trials in China

About this study

Official title: 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

The purpose of this study is to evaluate the efficacy and safety of Chiglitazar, compare with Sitagliptin.

Read the detailed description

The efficacy and safety will be compared between Chiglitazar and Sitagliptin after treatment of 24 weeks.

Conditions
Type 2 Diabetes
Being tested
Chiglitazar, Sitagliptin
Keywords
Chiglitazar, Sitagliptin, diabetes, type 2 diabetes
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

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

  • ChiglitazarDrug

    Also called CS038

    Take orally

  • SitagliptinDrug

    Also called Sit

    Take orally

Study groups in NCT02173457
Study groupRoleWhat they receive
Arm 1ExperimentalPatients administrate Chiglitazar 32mg once daily for 24 weeks
Receives: Drug: Chiglitazar
Arm 2ExperimentalPatients administrate Chiglitazar 48mg once daily for 24 weeks
Receives: Drug: Chiglitazar
Arm 3Active comparatorPatients administrate Sitagliptin 100mg once daily for 24 weeks
Receives: Drug: Sitagliptin

What is being measured

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

  1. Change in HbA1c from baseline after 24 weeks of treatment

    The change of HbA1c at week 24 from baseline

    Measured: 24 weeks

Secondary outcomes (16)

  1. Change in HbA1c from baseline for patients with a baseline HbA1c >=8.5%

    The change of HbA1c at week 24 from baseline for patients with a HbA1c >=8.5% at baseline

    Measured: 24 weeks

  2. Change in HbA1c from baseline for patients with a baseline HbA1c <8.5%

    The change of HbA1c at week 24 from baseline for patients with a HbA1c < 8.5% at baseline

    Measured: 24 weeks

  3. Change in HbA1c from baseline

    The change of HbA1c at week 12 from baseline

    Measured: 12 weeks

  4. Percentage of patients that attained target HbA1c <7.0%

    Percentage of patients whose HbA1c at week 24 are < 7.0%

    Measured: 24 weeks

  5. Percentage of patients whose HbA1c lowered by at least 0.5%

    Percentage of patients whose change of HbA1c at week 24d from baseline are >= 0.5%

    Measured: 24 weeks

  6. Change in fasting plasma glucose from baseline

    The change of fasting plasma glucose at week 12 and 24 from baseline

    Measured: 12 and 24 weeks

  7. Change in 2-h postprandial glucose (2hPPG) from baseline

    The change of 2-h postprandial glucose (2hPPG) at week 12 and 24 from baseline

    Measured: 12 and 24 weeks

  8. Change in total cholesterol (TC) from baseline

    The change of total cholesterol (TC) at week 12 and 24 from baseline

    Measured: 12 and 24 weeks

  9. Change in triglyceride from baseline

    The change of triglyceride at week 12 and 24 from baseline

    Measured: 12 and 24 weeks

  10. Change in high density lipoprotein cholesterol (HDL-C) from baseline

    The change of high density lipoprotein cholesterol (HDL-C) at week 12 and 24 from baseline

    Measured: 12 and 24 weeks

  11. Change in low density proprotein cholesterol (LDL-C) from baseline

    The change of low density lipoprotein cholesterol (LDL-C) at week 12 and 24 from baseline

    Measured: 12 and 24 weeks

  12. Change in free fatty acid (FFA) from baseline

    The change of free fatty acid (FFA) at week 12 and 24 from baseline

    Measured: 12 and 24 weeks

  13. Change in fasting plasma insulin from baseline

    The change of fasting plasma insulin at week 12 and 24 from baseline

    Measured: 12 and 24 weeks

  14. Insulin sensitivity assessed by the homeostatic model assessment (HOMA) at 12 and 24 weeks, compared with that of baseline

    The change of insulin sensitivity at week 12 and 24 from baseline

    Measured: 12 and 24 weeks

  15. Change in blood pressure from baseline

    The change of blood pressure at week 24 from baseline

    Measured: 24 weeks

  16. Percentage of patients who discontinue the trial due to hyperglycemia

    The percentage of patients who discontinue the trial due to hyperglycemia during the 24 weeks of treatment

    Measured: 24 weeks

Timeline

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

  1. First posted25 Jun 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionJan 2017
  4. Study completionJan 2017

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
740 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02173457
Sponsor's protocol ID
CGZ302
Acronym
CMAS
Status last verified
Oct 2019
First submitted
20 Jun 2014
Last updated
25 Oct 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 38162801

  • Zhou 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.

    PubMed 35547000

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Chiglitazar and Sitagliptin in people with Type 2 Diabetes, run by Chipscreen Biosciences, Ltd. at 37 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 5 inclusion and 21 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 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 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. 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?

Change in HbA1c from baseline after 24 weeks of treatment (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 NCT02173457, which also lists 2 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 25 Oct 2019; AzTrials last refreshed its copy on 7 Nov 2026.

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