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

Diabetic Retinopathy Clinical Trial

— CORRECT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02587741
• Other study ID #: Third SunYetSan
• Status: Recruiting
• Phase: Phase 0
• First received: October 18, 2015
• Last updated: October 25, 2015
• Start date: July 2015
• Est. completion date: July 2025

Study information

• Verified date: October 2015
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Chen Yanming, Doctor
• Phone: +8618922102818
• Email: 1211587508[@]qq.com
• Is FDA regulated: No
• Health authority: China:Sun Yet-san University
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: July 2025
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

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

Locations

Country	Name	City	State
China	the third affiliated hospital of Sun yet-san university	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

References & Publications (9)

Bao YQ, Zhou J, Zhou M, Cheng YJ, Lu W, Pan XP, Tang JL, Lu HJ, Jia WP. Glipizide controlled-release tablets, with or without acarbose, improve glycaemic variability in newly diagnosed Type 2 diabetes. Clin Exp Pharmacol Physiol. 2010 May;37(5-6):564-8. d — View Citation

Bott S, Tusek C, Jacobsen LV, Endahl L, Draeger E, Kapitza C, Heise T. Insulin detemir under steady-state conditions: no accumulation and constant metabolic effect over time with twice daily administration in subjects with Type 1 diabetes. Diabet Med. 200 — View Citation

Fischbacher CM, Bhopal R, Unwin N, Walker M, White M, Alberti KG. Maternal transmission of type 2 diabetes varies by ethnic group: cross-sectional survey of Europeans and South Asians. Diabetes Care. 2001 Sep;24(9):1685-6. — View Citation

Kempen JH, O'Colmain BJ, Leske MC, Haffner SM, Klein R, Moss SE, Taylor HR, Hamman RF; Eye Diseases Prevalence Research Group. The prevalence of diabetic retinopathy among adults in the United States. Arch Ophthalmol. 2004 Apr;122(4):552-63. — View Citation

Klein BE. Overview of epidemiologic studies of diabetic retinopathy. Ophthalmic Epidemiol. 2007 Jul-Aug;14(4):179-83. Review. — View Citation

Lin SD, Wang JS, Hsu SR, Sheu WH, Tu ST, Lee IT, Su SL, Lin SY, Wang SY, Hsieh MC. The beneficial effect of a-glucosidase inhibitor on glucose variability compared with sulfonylurea in Taiwanese type 2 diabetic patients inadequately controlled with metfor — View Citation

Mu P, Lu H, Zhang G, Chen Y, Fu J, Wang M, Shu J, Zeng L. Comparison of fasting capillary glucose variability between insulin glargine and NPH. Diabetes Res Clin Pract. 2011 Jan;91(1):e4-7. doi: 10.1016/j.diabres.2010.09.026. — View Citation

Muggeo M, Zoppini G, Bonora E, Brun E, Bonadonna RC, Moghetti P, Verlato G. Fasting plasma glucose variability predicts 10-year survival of type 2 diabetic patients: the Verona Diabetes Study. Diabetes Care. 2000 Jan;23(1):45-50. — View Citation

White NH, Sun W, Cleary PA, Danis RP, Davis MD, Hainsworth DP, Hubbard LD, Lachin JM, Nathan DM. Prolonged effect of intensive therapy on the risk of retinopathy complications in patients with type 1 diabetes mellitus: 10 years after the Diabetes Control — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Metabolic indices	Fasting blood glucose(FBG)in mmol/L, postprandial blood glucose(PBG)in mmol/L, glycosylated hemoglobin(GHbA1c)in percentage.total cholesterol(TC), low density lipoprotein(LDL) and high density lipoprotein(HDL)in mmol/L.	every three months in 5 years	Yes
Primary	The incidence of diabetic retinopathy	5-year incidence rate of diabetic retinopathy(%)	5years	Yes
Secondary	cardiovascular events	myocardial infarction, angina,or cardiac insufficiency with other causes	5 years	Yes
Secondary	renal failure	use urinary protein excretion rate(%) evaluate clinical course of diabetic nephropathy	5years	Yes
Secondary	glucose fluctuation	we use continuous glucose monitoring system(CGMS),made by Medtronic company USA,and assess within-day blood glucose excursions,Daytime blood sugar stability and the stability of postprandial blood glucose,including Standard Deviation Of Blood Glucose(SDBG)in mmol/L, largest amplitude of glycemic excursions(LAGE)in mmol/L, mean amplitude of glycemic excursions(MAGE) in mmol/L,low glycemic index(LBMI),coefficient variation fasting glucose parameters,Mean Of Daily Differences(MODD)in mmol/L.	every one year in 5years	Yes
Secondary	oxidative stress	Glyoxalase 1(GLO-1)in pg/ml,Advanced glycation end products(AGEs)in pg/ml,Soluble Receptor for advanced glycation end products(sRAGE)in pg/ml.	every one year in 5 years	Yes