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

NCT02587741 | Unknown Early Phase 1

• 1 other identifier: Third SunYetSan
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetic Retinopathy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The incidence of diabetic retinopathy

  5-year incidence rate of diabetic retinopathy（%）

  5years

Secondary Outcomes (4)

• cardiovascular events

  5 years

• renal failure

  5years

• glucose fluctuation

  every one year in 5years

• oxidative stress

  every one year in 5 years

Other Outcomes (1)

• Metabolic indices

  every three months in 5 years

Study Arms (3)

oral drugs

EXPERIMENTAL

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

Drug: Metformin

lantus

EXPERIMENTAL

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.

Drug: Lantus

Novomix30

EXPERIMENTAL

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 .

Drug: Novomix30

Interventions

Metformin DRUG

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

Also known as: gliclazide modified release tablets, acarbose

oral drugs

Lantus 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）

Also known as: Metformin, gliclazide modified release tablets, acarbose

lantus

Novomix30 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

Also known as: Metformin, gliclazide modified release tablets, acarbose

Novomix30

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• pregnant or lactating women;
• diabetes autoantibodies (GAD) antibodies positive;
• occurred state of diabetic ketoacidosis, diabetes, high permeability, diabetes lactic acidosis within a half years ;
• 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);
• hemoglobin disease history which can affect determination of HbA1c;
• 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.
• psychiatric patients;
• 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.;
• in eye surgery history, history of cataract surgery, and three months; Other serious diseases, the researchers think that don't fit into the patients

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

the third affiliated hospital of Sun yet-san university

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (11)

• Klein BE. Overview of epidemiologic studies of diabetic retinopathy. Ophthalmic Epidemiol. 2007 Jul-Aug;14(4):179-83. doi: 10.1080/09286580701396720.

  PMID: 17896294 RESULT

• 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. doi: 10.1001/archopht.122.4.552.

  PMID: 15078674 RESULT

• 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. doi: 10.2337/diacare.24.9.1685-a. No abstract available.

  PMID: 11522720 RESULT

• 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. doi: 10.2337/diacare.23.1.45.

  PMID: 10857967 RESULT

• 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 and Complications Trial. Arch Ophthalmol. 2008 Dec;126(12):1707-15. doi: 10.1001/archopht.126.12.1707.

  PMID: 19064853 RESULT

• Lin SD, Wang JS, Hsu SR, Sheu WH, Tu ST, Lee IT, Su SL, Lin SY, Wang SY, Hsieh MC. The beneficial effect of alpha-glucosidase inhibitor on glucose variability compared with sulfonylurea in Taiwanese type 2 diabetic patients inadequately controlled with metformin: preliminary data. J Diabetes Complications. 2011 Sep-Oct;25(5):332-8. doi: 10.1016/j.jdiacomp.2011.06.004. Epub 2011 Aug 2.

  PMID: 21813293 RESULT

• 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. doi: 10.1111/j.1440-1681.2010.05361.x. Epub 2010 Jan 17.

  PMID: 20082624 RESULT

• 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. 2006 May;23(5):522-8. doi: 10.1111/j.1464-5491.2006.01839.x.

  PMID: 16681561 RESULT

• 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.

  PMID: 20970870 RESULT

• Li S, Tang X, Luo Y, Wu B, Huang Z, Li Z, Peng L, Ling Y, Zhu J, Zhong J, Liu J, Chen Y. Impact of long-term glucose variability on coronary atherosclerosis progression in patients with type 2 diabetes: a 2.3 year follow-up study. Cardiovasc Diabetol. 2020 Sep 25;19(1):146. doi: 10.1186/s12933-020-01126-0.

  PMID: 32977802 DERIVED

• Tang X, Zhong J, Zhang H, Luo Y, Liu X, Peng L, Zhang Y, Qian X, Jiang B, Liu J, Li S, Chen Y. Visit-to-visit fasting plasma glucose variability is an important risk factor for long-term changes in left cardiac structure and function in patients with type 2 diabetes. Cardiovasc Diabetol. 2019 Apr 16;18(1):50. doi: 10.1186/s12933-019-0854-9.

  PMID: 30992008 DERIVED

MeSH Terms

Conditions

Diabetic Retinopathy; Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

Metformin; Acarbose; Insulin Glargine

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Trisaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Mu panwei, Doctor

  Employ

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen Yanming, Doctor

CONTACT

+8618922102818; 1211587508@qq.com

Zhu Bilian, Master

CONTACT

+8613580364394; bilianzhu@qq.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: October 18, 2015
• First Posted: October 27, 2015
• Study Start: July 1, 2015
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2025
• Last Updated: October 27, 2015

Record last verified: 2015-10

Locations

CN (1)