Comparing diabetes treatments for diabetic retinopathy

Comparison of Diabetes Retinopathy Among Type 2 Diabetic Patients Treated With Different Regimens: a Multicentre Randomized Parallel-group Clinical Trial

This study is testing three different diabetes treatments to see which one best helps people with type 2 diabetes avoid worsening eye problems caused by diabetic retinopathy.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 600 (estimated)
• Ages: 30 Years to 65 Years
• Sex: All
• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT02587741 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of three different glucose-lowering regimens on the progression of diabetic retinopathy (DR) in patients with type 2 diabetes. The regimens include a single oral anti-diabetic drug, basal insulin combined with oral medication, and premixed insulin with oral medication. Over a five-year period, 600 participants will be monitored to assess blood glucose fluctuations and their impact on DR. The goal is to optimize diabetes treatment and provide evidence-based recommendations for managing DR.

Who should consider this trial

Good fit: Ideal candidates are adults aged 30-65 with type 2 diabetes diagnosed within the last five years and without existing diabetic retinopathy.

Not a fit: Patients who are pregnant, have certain diabetes-related complications, or have severe liver or kidney issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for preventing diabetic retinopathy in type 2 diabetes patients.

How similar studies have performed: While this approach is novel in its specific comparison of treatment regimens for DR, similar studies have shown the importance of glycemic control in managing diabetes-related complications.

Eligibility criteria

Inclusion Criteria:

1. aged 30-65;
2. diagnosed to be type 2 diabetes in accordance with the WHO diagnostic criteria in 1999 .
3. diabetes duration for 5 years or less;
4. the glycosylated hemoglobin (HbA1c) is higher than or equal to7.0% ;
5. body mass index (BMI) 20-35 kg/m2;
6. fluorescein fundus angiography (FFA) showed no diabetic retinopathy;
7. women of childbearing-age have birth control plan for 5 years plan;

Exclusion Criteria:

1. pregnant or lactating women;
2. diabetes autoantibodies (GAD) antibodies positive;
3. occurred state of diabetic ketoacidosis, diabetes, high permeability, diabetes lactic acidosis within a half years ;
4. aspartate aminotransferase (AST), alanine aminotransferase (ALT) 2.5 times higher than normal ceiling, and/or serum creatinine (Cr) or 133 umol/l (1.5 mg/dl);
5. hemoglobin disease history which can affect determination of HbA1c;
6. have received a coronary angioplasty, coronary artery stent implantation, coronary artery bypass surgery, there was myocardial infarction, unstable angina, and clinical significance of abnormal ecg, cerebrovascular accident, or transient ischemic attack.
7. psychiatric patients;
8. any eye eyesight \< 0.1 patients (WHO blind eye disease: keratitis, need serious cataract surgery, glaucoma, uveitis, high myopia shaft \> 26.5 mm, history of ocular trauma;Other ophthalmology medical history: the central vein occlusion, branch vein occlusion, wet sex senile macular degeneration, etc.;
9. in eye surgery history, history of cataract surgery, and three months; Other serious diseases, the researchers think that don't fit into the patients

Where this trial is running

Guangzhou, Guangdong

• the third affiliated hospital of Sun yet-san university — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Mu panwei, Doctor — Employ
• Study coordinator: Chen Yanming, Doctor

Conditions Diabetic Retinopathy; type 2 diabetes mellitus; glucose fluctuation; oxidative stress; Insulin; Oral drugs