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Clinical observation of pioglitazone or sitaglipta sodium combined with metformin in the treatment of newly diagnosed type 2 diabetes with fatty liver

Clinical observation of pioglitazone or sitaglipta sodium combined with metformin in the treatment of newly diagnosed type 2 diabetes with fatty liver

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100193
Enrollment
Unknown
Registered
2025-04-03
Start date
2025-04-15
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

First diagnosis of type 2 diabetes mellitus combined with non-alcoholic fatty liver disease

Interventions

Pioglitazone Metformin Group:Pioglitazone metformin tablets (15/500mg), taken twice a day (bid)
chiglitazar + Metformin Group:chiglitazar (32mg) combined with Metformin (0.5mg), taken twice a day (bid).

Sponsors

The First Affiliated Hospital of Chengdu Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed patients who meet the diagnostic criteria for type 2 diabetes mellitus (T2DM); 2. Confirmed diagnosis of metabolic-associated fatty liver disease (MAFLD); 3. Male and female patients aged between 18 and 75 years; 4. Body mass index (BMI) between 18.5 and 35.0 kg/m^2; 5. Glycated hemoglobin (HbA1c) level between 7.5% and 10.0%; 6. Patients who have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding women; 2. A history of using insulin or other antidiabetic medications; 3. Severe renal insufficiency, cardiovascular diseases, or other conditions affecting insulin resistance; 4. Recent use of medications that may affect insulin sensitivity.

Design outcomes

Primary

MeasureTime frame
Glycated hemoglobin;Homeostasis model assessment of insulin resistance ;Ultrasound liver elastography to assess liver fibrosis;Fasting blood glucose;Postprandial 2-hour blood glucose ;Total cholesterol ;Triglycerides ;High-density lipoprotein cholesterol ;Low-density lipoprotein cholesterol ;Alanine aminotransferase ;Aspartate aminotransferase;

Secondary

MeasureTime frame
Visceral fat content;Body mass index (BMI);Bone markers;

Countries

China

Contacts

Public ContactYao Li

The First Affiliated Hospital of Chengdu Medical College

240877508@qq.com+86 182 0052 6790

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026