Comparison of Diabetes Retinopathy Among Type 2 Diabetic Patients Treated With Different Regimens

NCT ID: NCT02587741

Last Updated: 2015-10-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2025-07-31

Brief Summary

Diabetic retinopathy (DR) is an important cause of blindness.

Detailed Description

Diabetic retinopathy (DR) is an important cause of blindness, and its development of an irreversible process. DR is not only the overall progress and the level of blood sugar, and blood glucose fluctuations more closely, is the key to a smooth hypoglycemic delay DR progression.Diabetes control and complication trail(DCCT) study shows that even though glycemic control was no significant difference in blood glucose fluctuations ,DR also have a significant difference. In this study, three different glucose-lowering program for: (A) a single oral anti-diabetic drugs, (B) basal insulin and oral anti-diabetic drugs, (C) premixed insulin and oral anti-diabetic drugs for comparison. Focus on the stability and the impact of these three programs hypoglycemic long-term prognosis of the DR, and thus affect the molecular mechanisms of DR-based exploration of glucose fluctuations, to optimize blood glucose solutions, lower blood sugar steady, slow progression of DR ultimate clinical purposes.

The multi-center study is to cooperate, enrolled 600 cases of type 2 diabetes, observe the effects of different solutions on blood sugar glucose fluctuations and retinopathy, a total of 5 years of follow-up. This will be the first at home and abroad to compare the incidence of hypoglycemic effect programs on DR large multi-center, randomized, controlled clinical studies, clinical practice will optimize the treatment of type 2 diabetes theoretical and evidence-based medicine.

Conditions

Diabetic Retinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

oral drugs

oral anti-diabetic drugs only.metformin,start from 500mg bid,if blood glucose dose not reach the standard，added to 500mg tid→1000mg bid.if metformin reach the biggest dosage，added gliclazide modified release tablets，from 30mg qd,if blood glucose dose not reach the standard,add dosage 30mg qd→60 mg qd→90mg qd→120mg qd(max).if still not reach the target，add acarbose 50mg tid

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

start with metformin，from 500mg bid,if metformin reach the biggest dosage，added gliclazide modified release tablets，afterthat，add acarbose

lantus

basal insulin combine with oral drugs,started with insulin glargine 0.2 u/kg subcutaneous injection at 10pm（at 8am if patients are night workers）,add dosage if glucose dose not reach the target.after that,you can add oral drugs ,as Group Oral Drugs.

Group Type: EXPERIMENTAL

Lantus

Intervention Type: DRUG

started with insulin glargine 0.2 u/kg subcutaneous injection ，add dosage if glucose dose not reach the target.after that,you can add oral drugs（like oral drug group）

Novomix30

premixed insulin combine with oral drugs,started with premixed insulin subcutaneous injection(0.4-0.6 u/kg divided into half before breakfast and dinner),and add dosage if glucose dose not reach the target.after that,you can add oral drugs ,as Group Oral Drugs .

Group Type: EXPERIMENTAL

Novomix30

Intervention Type: DRUG

started with premixed insulin subcutaneous injection(0.4-0.6 u/kg divided into half before breakfast and dinner),and add dosage if glucose dose not reach the target.after that,you can add oral drugs ,as Group Oral Drugs

Interventions

Metformin

start with metformin，from 500mg bid,if metformin reach the biggest dosage，added gliclazide modified release tablets，afterthat，add acarbose

Intervention Type: DRUG

Lantus

started with insulin glargine 0.2 u/kg subcutaneous injection ，add dosage if glucose dose not reach the target.after that,you can add oral drugs（like oral drug group）

Intervention Type: DRUG

Novomix30

started with premixed insulin subcutaneous injection(0.4-0.6 u/kg divided into half before breakfast and dinner),and add dosage if glucose dose not reach the target.after that,you can add oral drugs ,as Group Oral Drugs

Intervention Type: DRUG

Other Intervention Names

gliclazide modified release tablets; acarbose; Metformin; gliclazide modified release tablets; acarbose; Metformin; gliclazide modified release tablets; acarbose

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Yanming Chen

Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mu panwei, Doctor

Role: PRINCIPAL_INVESTIGATOR

Employ

Locations

the third affiliated hospital of Sun yet-san university

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chen Yanming, Doctor

Role: CONTACT

1211587508@qq.com

+8618922102818

Zhu Bilian, Master

Role: CONTACT

bilianzhu@qq.com

+8613580364394

Facility Contacts

Zhu Bilian, master

Role: primary

bilianzhu@qq.com

+8613580364394

Tang Xixiang, master

Role: backup

txx_8711@126.com

+8613570434387

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Other Identifiers

Third SunYetSan

Identifier Type: -

Identifier Source: org_study_id