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Type 2 DiabetesPhase 3CMAPNCT02121717

Study of Chiglitazar Compare With Placebo in Type 2 Diabetes Patients

A Phase 3 study testing Chiglitazar in people with Type 2 Diabetes, run by Chipscreen Biosciences, Ltd. at 26 sites in China.

Completed

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

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of Chiglitazar, compare with placebo. 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
535 participants
Where
26 sitesChina
Study dates
Jun 2014to Nov 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 4 different classes of drugs];
  • Plasma triglyceride > 500 mg/dL (5.65 mmol/L);
  • Is treating by fibrates;
Show all 20Show 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;
  • 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

26 sites in 1 country.

26 sites in 1 country

China26 sites

  • Baogang Hospital of Inner Mongilia

    Baotou, Inner Mongolia, 014010

  • Peking University Shougang Hospital

    Beijing, Beijing Municipality, 100000

  • China Meitan General Hospital

    Beijing, Beijing Municipality, 100028

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

  • The 306th Hospital of PLA

    Beijing, Beijing Municipality, 100101

  • Cangzhou's Central Hospital

    Cangzhou, Hebei, 061110

  • The Second Hospital of Jilin University

    Changchun, Jilin, 130041

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410001

  • Huaxi Hopsital of Sichuan University

    Chengdu, Sichuan, 610041

  • Chenzhou First People's Hospital

    Chenzhou, Hunan, 423000

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

  • Chongqing Three Gorges Central Hospital

    Chongqing, Chongqing Municipality, 404000

  • The First Affiliated Hospital of Ha'erbin Medical University

    Harbin, Heilongjiang, 150081

  • Harrison International Peace Hospital

    Hengshui, Hebei, 053000

  • The people's Hospital of Jiangsu Province

    Nanjing, Jiangsu, 210029

  • The Affiliated Hospital of Qingdao Medical University

    Qingdao, Shandong, 266071

  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200092

  • The Central Hospital of Yangpu District of Shanghai

    Shanghai, Shanghai Municipality, 200433

  • The Third Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050051

  • Tangshan Gongren Hospital

    Tangshan, Hebei, 063000

  • The General Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300052

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430071

  • The First Affiliated Hospital of The 4th Military Medical University

    Xi’an, Shanxi, 710032

  • The Affiliated Hospital of Xuzhou Medical College

    Xuzhou, Jiangsu, 221000

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 Placebo-Controlled Trial

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

Read the detailed description

The efficacy and safety will be compared between Chiglitazar and placebo after treatment of 24 weeks. The long term efficacy and safety of Chiglitazar will be evaluated after 52 weeks treatment.

Conditions
Type 2 Diabetes
Being tested
Chiglitazar, Placebo
Keywords
Chiglitazar,diabetes,type 2 diabetes
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.

  • ChiglitazarDrug

    Also called CS038

    Take orally

  • PlaceboDrug

    Also called Plb

    Take orally

Study groups in NCT02121717
Study groupRoleWhat they receive
Arm 1ExperimentalPatients administrate Chiglitazar 32mg once daily for 52 weeks
Receives: Drug: Chiglitazar
Arm 2ExperimentalPatients administrate Chiglitazar 48mg once daily for 52 weeks
Receives: Drug: Chiglitazar
Arm 3Placebo 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.
Receives: Drug: Chiglitazar; Drug: Placebo

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 (17)

  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 in 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. Change in HbA1c from baseline

    The change of HbA1c at week 52 from baseline

    Measured: 52 weeks

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

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

    Measured: 24 weeks

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

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

    Measured: 24 weeks

  7. Change in fasting plasma glucose from baseline

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

    Measured: 12,24 and 52 weeks

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

    The change of 2-h postprandial glucose (2hPPG) at week 12, 24 and 52 from baseline

    Measured: 12, 24 and 52 weeks

  9. Change in total cholesterol (TC) from baseline

    The change of total cholesterol (TC) at week 12, 24 and 52 from baseline

    Measured: 12, 24 and 52 weeks

  10. Change in triglyceride from baseline

    The change of triglyceride at week 12, 24 and 52 from baseline

    Measured: 12,24 and 52 weeks

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

    The change of high density lipoprotein cholesterol (HDL-C) at week week 12, 24 and 52 from baseline

    Measured: 12, 24 and 52 weeks

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

    The change of low density lipoprotein cholesterol (LDL-C) at week 12, 24 and 52 from baseline

    Measured: 12, 24 and 52 weeks

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

    The change of free fatty acid (FFA) at week 12, 24 and 52 from baseline

    Measured: 12, 24 and 52 weeks

  14. Change in fasting plasma insulin from baseline

    The change of fasting plasma insulin at week 12, 24 and 52 from baseline

    Measured: 12, 24 and 52 weeks

  15. Insulin sensitivity assessed by the homeostatic model assessment (HOMA) at 12,24 and 52 weeks, compared with that of baseline

    The change of insulin sensitivity at week 12, 24 and 52 from baseline

    Measured: 12, 24 and 52 weeks

  16. Change in blood pressure from baseline

    The change of blood pressure at week 24 from baseline

    Measured: 24 weeks

  17. Percentage of patients who use rescue therapy

    The percentage of patients who use rescue therapy during the 52 weeks of treatment

    Measured: 52 weeks

Timeline

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

  1. First posted23 Apr 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionNov 2017
  4. Study completionNov 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
535 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02121717
Sponsor's protocol ID
CGZ301
Acronym
CMAP
Status last verified
Oct 2019
First submitted
22 Apr 2014
Last updated
25 Oct 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Chiglitazar in people with Type 2 Diabetes, run by Chipscreen Biosciences, Ltd. at 26 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 20 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 26 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?

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 NCT02121717.

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.

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