DiabetesNCT06191328
A Prospective, Open, Self-controlled Study of the Effects of Chiglitazar Sodium on Glucose and Lipid Metabolism in Patients With Type 2 Diabetes Mellitus (T2DM)
A study testing Chiglitazar sodium in people with Diabetes, run by Yufan Wang at 1 site in China.
Trial summary
The goal of this clinical trial is to learn about inour study aimed to evaluate serum lipid profiles of T2DM patients before and after Chiglitazar Sodium administration. The main question[s] it aims to answer are: Quantitative lipidomics information enables in-depth analysis of lipids and can reveal Chiglitazar… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Chiglitazar sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2024to 30 Dec 2025
- Phase
- Interventional
- 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
- Patients with type 2 diabetes (T2DM) WHO meet the diagnostic criteria for diabetes issued by the World Health Organization (WHO) in 1999;
- Male or female patients aged ≥18, ≤70 years;
- BMI≥18.5 Kg/m2, < 35 Kg/m2;
- Hemoglobin a1C (HbA1C) ≥7.5%; ≤10.5%;
- Triglyceride ≤500 mg /dL (5.65 mmol/L) (if the researchers judge that the transient increase caused by diet, etc., can be repeated detection)
- Total cholesterol (TC) ≤250mg/dl (6.45mmol/L)
- T2DM patients who are taking one or two kinds of oral hypoglycemic drugs with fixed dose ≥2 months and uncontrolled blood glucose.
- Voluntarily sign informed consent and agree to enter the trial group.
Who cannot join
- Type 1 diabetes or other specific type of diabetes
- Fasting blood glucose (FPG) > 13.3 mmol/L (240 mg/dL);
- Triglyceride (TG) > 500 mg /dL (5.65 mmol/L);
- Total cholesterol (TC) \> 250mg/dl (\> 6.45mmol/L);
- Refractory hypertension [that is, on the basis of improving the lifestyle, the blood pressure is still not up to standard after 1 month of applying a reasonably tolerable amount of 3 or more antihypertensive drugs (including diuretics), or the blood pressure can be effectively controlled by taking 4 or more antihypertensive drugs;
- Taking fibrates, statins, thiazolidinediones, insulin drugs;
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- A clear diagnosis of severe osteoporosis or any other known bone disease;
- A history of diabetic ketoacidosis, diabetic hyperglycemia hyperosmolar syndrome, lactic acidosis and other acute complications of diabetes;
- Severe microvascular complications (proliferative retinopathy; Urinary albumin/creatinine ratio \> 300 mg/g; Marked peripheral neuropathy, etc.);
- The New York Heart Association (NYHA) defines congestive heart failure as grade III or IV;
- Significant liver and kidney dysfunction and systemic disease (significant liver dysfunction is defined as AST\> 2.5 times the upper limit of normal and/or ALT\> 2.5 times the upper limit of normal and/or total bilirubin \> 1.5 times the upper limit of normal value; Renal dysfunction was defined as moderate to severe renal insufficiency (eGFR\<60 ml/ (min*1.73m2));
- Pregnant or lactating women, women of childbearing age who are unable or unwilling to take adequate contraception;
- Participating in a clinical trial of another drug or medical device in or within 3 months prior to screening;
- The investigator considers it inappropriate to participate in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, 200080
About this study
The goal of this clinical trial is to learn about inour study aimed to evaluate serum lipid profiles of T2DM patients before and after Chiglitazar Sodium administration.
The main question[s] it aims to answer are:
- Quantitative lipidomics information enables in-depth analysis of lipids and can reveal Chiglitazar Sodium-specific lipid metabolic patterns, thereby strengthening lipidomics as a promising tool for exploring the molecular mechanisms of T2DM.
- It can also be applied to other T2DM lipidomics studies to better understand lipid metabolism patterns and integration with other omics measures.
Read the detailed description
Chiglitazar Sodium for lipid profile abnormalities and its associated effective lipid molecular biomarkers have never been studied in patients with T2DM. Therefore, our study aimed to evaluate serum lipid profiles of T2DM patients before and after Chiglitazar Sodium administration using ultra-high performance liquid chromatography-Tandem quadrupole time-of-flight mass spectrometry (UPLC-QTOF-MS). For completeness, we also evaluated the effects of Chiglitazar Sodium treatment on metabolic markers associated with T2DM and its association with lipidomic changes.
- Conditions
- Diabetes
- Being tested
- Chiglitazar sodium
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chiglitazar sodiumDrug
In patients with type 2 diabetes mellitus (T2DM), on the basis of one or two oral hypoglycemic agents combination with Chiglitazar sodium.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Drug: Chiglitazar sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Change in HbA1c from baseline
Measured: 12 weeks of treatment
Secondary outcomes (1)
Serum lipid profile
Changes from baseline in sphingomyelin (SMs), ceramide (CER), lysophosphatidylcholine (LPC), phosphatidylethanolamine (PEs), lysophosphatidylethanolamine (LPEs), and phosphatidylcholine (PC)
Measured: 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start31 Jan 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yufan Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yufan Wang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191328
- Sponsor's protocol ID
- CGZIIT013
- Status last verified
- Dec 2023
- First submitted
- 19 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open, Self-controlled Study of the Effects of Chiglitazar Sodium on Glucose and Lipid Metabolism in Patients With Type 2 Diabetes Mellitus (T2DM)
- ClinicalTrials.gov ID
- NCT06191328
- Acronym / sponsor ID
- CGZIIT013
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yufan WangUniversity, hospital or other
- Study start
- 31 Jan 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 5 Jan 2024 (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 goal of this clinical trial is to learn about inour study aimed to evaluate serum lipid profiles of T2DM patients before and after Chiglitazar Sodium administration.
The main question[s] it aims to answer are:
- Quantitative lipidomics information enables in-depth analysis of lipids and can reveal Chiglitazar Sodium-specific lipid metabolic patterns, thereby strengthening lipidomics as a promising tool for exploring the molecular mechanisms of T2DM.
- It can also be applied to other T2DM lipidomics studies to better understand lipid metabolism patterns and integration with other omics measures.
Detailed description
Chiglitazar Sodium for lipid profile abnormalities and its associated effective lipid molecular biomarkers have never been studied in patients with T2DM. Therefore, our study aimed to evaluate serum lipid profiles of T2DM patients before and after Chiglitazar Sodium administration using ultra-high performance liquid chromatography-Tandem quadrupole time-of-flight mass spectrometry (UPLC-QTOF-MS). For completeness, we also evaluated the effects of Chiglitazar Sodium treatment on metabolic markers associated with T2DM and its association with lipidomic changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Chiglitazar sodium |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with type 2 diabetes (T2DM) WHO meet the diagnostic criteria for diabetes issued by the World Health Organization (WHO) in 1999;
- Male or female patients aged ≥18, ≤70 years;
- BMI≥18.5 Kg/m2, < 35 Kg/m2;
- Hemoglobin a1C (HbA1C) ≥7.5%; ≤10.5%;
- Triglyceride ≤500 mg /dL (5.65 mmol/L) (if the researchers judge that the transient increase caused by diet, etc., can be repeated detection)
Key exclusion criteria (14 listed)
- Type 1 diabetes or other specific type of diabetes
- Fasting blood glucose (FPG) > 13.3 mmol/L (240 mg/dL);
- Triglyceride (TG) > 500 mg /dL (5.65 mmol/L);
- Total cholesterol (TC) \> 250mg/dl (\> 6.45mmol/L);
- Refractory hypertension [that is, on the basis of improving the lifestyle, the blood pressure is still not up to standard after 1 month of applying a reasonably tolerable amount of 3 or more antihypertensive drugs (including diuretics), or the blood pressure can be effectively controlled by taking 4 or more antihypertensive drugs;
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 sodiumIn patients with type 2 diabetes mellitus (T2DM), on the basis of one or two oral hypoglycemic agents combination with Chiglitazar sodium. | Drug | Intervention group |
Primary outcome
HbA1c
Time frame: 12 weeks of treatment
Change in HbA1c from baseline
1 secondary outcome
Serum lipid profile
Time frame: 12 weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chiglitazar sodium in people with Diabetes, run by Yufan Wang at 1 site 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 8 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Results are not available in the source record.
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?
HbA1c (time frame: 12 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2024.