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Not yet recruitingNCT06191328Updated Jan 5, 2024

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)

An interventional study of Chiglitazar sodium in Diabetes, sponsored by Yufan Wang. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-01-05.

Sponsored by Yufan Wang · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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 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.

02

Conditions studied

03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 40 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Yufan Wang is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients with type 2 diabetes (T2DM) WHO meet the diagnostic criteria for diabetes issued by the World Health Organization (WHO) in 1999;
  2. Male or female patients aged ≥18, ≤70 years;
  3. BMI≥18.5 Kg/m2, \< 35 Kg/m2;
  4. Hemoglobin a1C (HbA1C) ≥7.5%; ≤10.5%;
  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)
  6. Total cholesterol (TC) ≤250mg/dl (6.45mmol/L)
  7. T2DM patients who are taking one or two kinds of oral hypoglycemic drugs with fixed dose ≥2 months and uncontrolled blood glucose.
  8. Voluntarily sign informed consent and agree to enter the trial group.

Exclusion criteria

Exclusion Criteria:

  1. Type 1 diabetes or other specific type of diabetes
  2. Fasting blood glucose (FPG) > 13.3 mmol/L (240 mg/dL);
  3. Triglyceride (TG) > 500 mg /dL (5.65 mmol/L);
  4. Total cholesterol (TC) > 250mg/dl (> 6.45mmol/L);
  5. 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;
  6. Taking fibrates, statins, thiazolidinediones, insulin drugs;
  7. A clear diagnosis of severe osteoporosis or any other known bone disease;
  8. A history of diabetic ketoacidosis, diabetic hyperglycemia hyperosmolar syndrome, lactic acidosis and other acute complications of diabetes;
  9. Severe microvascular complications (proliferative retinopathy; Urinary albumin/creatinine ratio > 300 mg/g; Marked peripheral neuropathy, etc.);
  10. The New York Heart Association (NYHA) defines congestive heart failure as grade III or IV;
  11. 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));
  12. Pregnant or lactating women, women of childbearing age who are unable or unwilling to take adequate contraception;
  13. Participating in a clinical trial of another drug or medical device in or within 3 months prior to screening;
  14. The investigator considers it inappropriate to participate in this clinical trial.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Intervention group

    Drug: Chiglitazar sodium

Interventions

  • DrugChiglitazar sodium

    In patients with type 2 diabetes mellitus (T2DM), on the basis of one or two oral hypoglycemic agents combination with Chiglitazar sodium.

06

What researchers measure

Primary outcomes

  1. HbA1c

    Change in HbA1c from baseline

    Time frame: 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)

    Time frame: 12 weeks of treatment

07

Study locations

1 site
  • Shanghai First People's Hospital
    Shanghai, Shanghai 200080, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06191328
Lead sponsor
Yufan Wang
Responsible party
Yufan Wang (Professor, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine) — Sponsor-investigator
First posted
Jan 5, 2024
Start date
Jan 31, 2024 (estimated)
Primary completion
Jun 30, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Jan 5, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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