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

Primary Purpose

Diabetic Retinopathy

Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Metformin
Lantus
Novomix30
Sponsored by
Third Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetic Retinopathy focused on measuring type 2 diabetes mellitus, Diabetic Retinopathy, glucose fluctuation, oxidative stress, Insulin, Oral drugs

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • the third affiliated hospital of Sun yet-san universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

oral drugs

lantus

Novomix30

Arm Description

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

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.

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 .

Outcomes

Primary Outcome Measures

The incidence of diabetic retinopathy
5-year incidence rate of diabetic retinopathy（%）

Secondary Outcome Measures

cardiovascular events
myocardial infarction, angina,or cardiac insufficiency with other causes
renal failure
use urinary protein excretion rate（%） evaluate clinical course of diabetic nephropathy
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.
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.

Full Information

First Posted
October 18, 2015
Last Updated
October 25, 2015
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02587741
Brief Title
Comparison of Diabetes Retinopathy Among Type 2 Diabetic Patients Treated With Different Regimens
Acronym
CORRECT
Official Title
Comparison of Diabetes Retinopathy Among Type 2 Diabetic Patients Treated With Different Regimens: a Multicentre Randomized Parallel-group Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Recruiting
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
Keywords
type 2 diabetes mellitus, Diabetic Retinopathy, glucose fluctuation, oxidative stress, Insulin, Oral drugs

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
oral drugs
Arm Type
Experimental
Arm Description
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
Arm Title
lantus
Arm Type
Experimental
Arm Description
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.
Arm Title
Novomix30
Arm Type
Experimental
Arm Description
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 .
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
gliclazide modified release tablets, acarbose
Intervention Description
start with metformin，from 500mg bid,if metformin reach the biggest dosage，added gliclazide modified release tablets，afterthat，add acarbose
Intervention Type
Drug
Intervention Name(s)
Lantus
Other Intervention Name(s)
Metformin, gliclazide modified release tablets, acarbose
Intervention Description
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
Intervention Name(s)
Novomix30
Other Intervention Name(s)
Metformin, gliclazide modified release tablets, acarbose
Intervention Description
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
Primary Outcome Measure Information:
Title
The incidence of diabetic retinopathy
Description
5-year incidence rate of diabetic retinopathy（%）
Time Frame
5years
Secondary Outcome Measure Information:
Title
cardiovascular events
Description
myocardial infarction, angina,or cardiac insufficiency with other causes
Time Frame
5 years
Title
renal failure
Description
use urinary protein excretion rate（%） evaluate clinical course of diabetic nephropathy
Time Frame
5years
Title
glucose fluctuation
Description
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.
Time Frame
every one year in 5years
Title
oxidative stress
Description
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.
Time Frame
every one year in 5 years
Other Pre-specified Outcome Measures:
Title
Metabolic indices
Description
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.
Time Frame
every three months in 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Yanming, Doctor
Phone
+8618922102818
Email
1211587508@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhu Bilian, Master
Phone
+8613580364394
Email
bilianzhu@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mu panwei, Doctor
Organizational Affiliation
Employ
Official's Role
Principal Investigator
Facility Information:
Facility Name
the third affiliated hospital of Sun yet-san university
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhu Bilian, master
Phone
+8613580364394
Email
bilianzhu@qq.com
First Name & Middle Initial & Last Name & Degree
Tang Xixiang, master
Phone
+8613570434387
Email
txx_8711@126.com

12. IPD Sharing Statement

Citations:
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17896294
Citation
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Results Reference
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PubMed Identifier
15078674
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. doi: 10.1001/archopht.122.4.552.
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PubMed Identifier
11522720
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. doi: 10.2337/diacare.24.9.1685-a. No abstract available.
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Citation
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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 and Complications Trial. Arch Ophthalmol. 2008 Dec;126(12):1707-15. doi: 10.1001/archopht.126.12.1707.
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Comparison of Diabetes Retinopathy Among Type 2 Diabetic Patients Treated With Different Regimens

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