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Effects of sitaglitat on islet function and metabolism in adults with latent autoimmune diabetes mellitus LADA: a randomized controlled open-label trial

Effects of sitaglitat on islet function and metabolism in adults with latent autoimmune diabetes mellitus LADA: a randomized controlled open-label trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098968
Enrollment
Unknown
Registered
2025-03-17
Start date
2025-03-31
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

Adult occult autoimmune diabetes

Interventions

Experimental group:Insulin+Chiglitazar48mg

Sponsors

Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of diabetes mellitus (WHO1999 standard); 2. Age 25-75 years old; 3. Not dependent on insulin therapy within 6 months after diagnosis of diabetes; 4. Duration =0.3nmol/L; 7.BMI>=25 Kg/m2, < 35 Kg/m2; 8. Voluntarily sign informed consent and agree to enter the trial group.

Exclusion criteria

Exclusion criteria: 1. Chronic or acute infection within 4 weeks prior to visit 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. History of any malignant tumors 7. A clear diagnosis of severe osteoporosis or any other known bone disease; 8. History of acute complications of diabetes such as diabetic ketoacidosis, diabetic hyperglycemia hyperosmolar syndrome and lactic acidosis; 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; 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 use adequate contraception; Participating in a clinical trial of another drug or medical device in or within 3 months prior to screening; 13. The investigator considers it inappropriate to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Change of ?C peptide (?CP= 2hCP-FCP) from baseline;

Secondary

MeasureTime frame
Changes in fasting C-peptide and C-peptide (2hCP) at 2 hours postprandial from baseline;Changes in insulin dosage from baseline;Changes in lipid indexes (TG, TC, LDL-C, HDL-C) from baseline;Changes in proinsulin and glucagon from baseline;Changes in HOMA2-ß from baseline;

Countries

China

Contacts

Public ContactMing Liu/Zheng Fangqiu

Tianjin Medical University General Hospital

mingliu@tmu.edu.cn+86 183 2201 7516

Outcome results

None listed

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