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Diabetic RetinopathyEarly Phase 1CORRECTNCT02587741

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

A Early Phase 1 study testing Metformin, Lantus and Novomix30 in people with Diabetic Retinopathy, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Diabetic retinopathy (DR) is an important cause of blindness. Read more about this study

Who is it for?
Ages 30 to 65 years
Conditions the study is for
Diabetic Retinopathy
What is being tested?
Metformin, Lantus and Novomix30
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
1 siteChina
Study dates
Jul 2015to Jul 2025
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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.
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Chen Yanming, Doctor contact

+8618922102818

1211587508@qq.com

Zhu Bilian, Master contact

+8613580364394

bilianzhu@qq.com

China1 site, 1 recruiting

  • the third affiliated hospital of Sun yet-san university

    Guangzhou, Guangdong, 510000

    Zhu Bilian, master, +8613580364394, bilianzhu@qq.com

    Tang Xixiang, master, +8613570434387, txx_8711@126.com

    Recruiting

Other trials in China

About this study

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

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

Read the 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.

Being tested
Metformin, Lantus, Novomix30
Keywords
type 2 diabetes mellitus, Diabetic Retinopathy, glucose fluctuation, oxidative stress, Insulin, Oral drugs
Medical subject headings
Diabetic Retinopathy, Diabetes Mellitus, Type 2, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MetforminDrug

    Also called gliclazide modified release tablets, acarbose

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

  • LantusDrug

    Also called Metformin, gliclazide modified release tablets, acarbose

    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）

  • Novomix30Drug

    Also called Metformin, gliclazide modified release tablets, acarbose

    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

Study groups in NCT02587741
Study groupRoleWhat they receive
oral drugsExperimentaloral 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
Receives: Drug: Metformin
lantusExperimentalbasal 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.
Receives: Drug: Lantus
Novomix30Experimentalpremixed 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 .
Receives: Drug: Novomix30

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of diabetic retinopathy

    5-year incidence rate of diabetic retinopathy（%）

    Measured: 5years

Secondary outcomes (4)

  1. cardiovascular events

    myocardial infarction, angina,or cardiac insufficiency with other causes

    Measured: 5 years

  2. renal failure

    use urinary protein excretion rate（%） evaluate clinical course of diabetic nephropathy

    Measured: 5years

  3. 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.

    Measured: every one year in 5years

  4. 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.

    Measured: every one year in 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionJul 2023 (estimated)
  4. Study completionJul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02587741
Sponsor's protocol ID
Third SunYetSan
Acronym
CORRECT
Status last verified
Oct 2015
First submitted
18 Oct 2015
Last updated
27 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

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

    PubMed 17896294

  • 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.

    PubMed 15078674

  • 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.

    PubMed 11522720

  • 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.

    PubMed 10857967

  • 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.

    PubMed 19064853

  • 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.

    PubMed 21813293

  • 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.

    PubMed 20082624

  • 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.

    PubMed 16681561

  • 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.

    PubMed 20970870

  • 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.

    PubMed 32977802

  • 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.

    PubMed 30992008

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Metformin, Lantus and Novomix30 in people with Diabetic Retinopathy, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chen Yanming, Doctor (+8618922102818, 1211587508@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of diabetic retinopathy (time frame: 5years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02587741, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2015.

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