Effect of SGLT2i on Diabetic Retinopathy in Type 2 Diabetes Mellitus Patients
Evaluation of the Effect of Sodium-Glucose Cotransporter-2 (SGLT2) Inhibitors on Diabetic Retinopathy in Patients With Type 2 Diabetes Mellitus
1 other identifier
interventional
60
1 country
1
Brief Summary
A prospective, randomized, open-label, controlled clinical trial will be conducted at the endocrinology department - Ain Shams University (ASU) hospital. Sixty patients will be enrolled into the study. 30 of which will receive dapagliflozin 10mg tab once daily and the other thirty will receive their standard antidiabetic therapy for 12 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2022
CompletedFirst Posted
Study publicly available on registry
April 5, 2022
CompletedStudy Start
First participant enrolled
June 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2023
CompletedJune 10, 2022
June 1, 2022
11 months
March 27, 2022
June 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Severity of retinopathy
evaluate the change of stage of disease according to diabetic retinopathy severity scale,, Which is the International Clinical Disease Severity Scale (ICDSS) for DR. This scale classified the severity of disease into five stages ( No apparent retinopathy, Mild Non proliferative Diabetic retinopathy (NPDR) ,Mod NPDR, Severe NPDR ,Proliferative Diabetic Retinopathy) depend on eye examination. higher scores mean worse outcome.
12 weeks
Evaluation of the study biomarkers, IL-6, and VEGF
Interleukin-6 (IL-6)//inflammatory biomarker Vascular endothelial growth factor (VEGF)//angiogenic biomarker
12 weeks
Secondary Outcomes (1)
Occurrence of adverse events
(1-90)days
Study Arms (2)
Test group
EXPERIMENTAL(n=30): type 2 diabetes mellitus patients who will receive an oral antidiabetic along with dapagliflozin at a dose of 10 mg daily for 12 weeks.
Control group
ACTIVE COMPARATOR(n=30): type 2 diabetes mellitus patients who will receive two oral antidiabetic agents for 12 weeks
Interventions
Dapagliflozin is a member of Sodium-glucose co-transporter 2 inhibitors class which in addition to its glucose control effect, has reno-protective and cardioprotective effects, controls blood pressure and causes weight loss.
Two oral anti-diabetic agents not including sodium-glucose co-transporter 2 inhibitors
Eligibility Criteria
You may qualify if:
- Female or male aged between 40 and 70 years old.
- Glomerular filtration rates \> 60 mL/min.
- Normal aspartate and alanine transaminase levels.
- Controlled systolic and diastolic blood pressures
You may not qualify if:
- Patients using insulin or more than one oral anti-diabetic drug.
- Patients who have HbA1c level ≥10% (86 mmol/mol) or a fasting plasma glucose level \>240 mg/dl.
- Patients with a history of cardiovascular events within six months before enrolment.
- Patients suffering from cataract or glaucoma.
- Patients with volume depletion clinical signs.
- Body mass index (BMI) \>40 kg/m2
- Infectious or inflammatory diseases.
- Neoplasm, or hematological disorders.
- Pregnant or breast-feeding patients.
- Active participation in another clinical study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nidae Alaalead
Study Sites (1)
Internal medicine and endocrinology department, Ain-shams university hospitals
Cairo, Egypt
Related Publications (9)
Zheng Y, Ley SH, Hu FB. Global aetiology and epidemiology of type 2 diabetes mellitus and its complications. Nat Rev Endocrinol. 2018 Feb;14(2):88-98. doi: 10.1038/nrendo.2017.151. Epub 2017 Dec 8.
PMID: 29219149BACKGROUNDWong TY, Cheung CM, Larsen M, Sharma S, Simo R. Diabetic retinopathy. Nat Rev Dis Primers. 2016 Mar 17;2:16012. doi: 10.1038/nrdp.2016.12.
PMID: 27159554BACKGROUNDSha W, Wen S, Chen L, Xu B, Lei T, Zhou L. The Role of SGLT2 Inhibitor on the Treatment of Diabetic Retinopathy. J Diabetes Res. 2020 Nov 12;2020:8867875. doi: 10.1155/2020/8867875. eCollection 2020.
PMID: 33274239BACKGROUNDZhou Z, Ju H, Sun M, Chen H. Serum Vascular Endothelial Growth Factor Levels Correlate with Severity of Retinopathy in Diabetic Patients: A Systematic Review and Meta-Analysis. Dis Markers. 2019 Mar 24;2019:9401628. doi: 10.1155/2019/9401628. eCollection 2019.
PMID: 31019585BACKGROUNDYao Y, Li R, Du J, Long L, Li X, Luo N. Interleukin-6 and Diabetic Retinopathy: A Systematic Review and Meta-Analysis. Curr Eye Res. 2019 May;44(5):564-574. doi: 10.1080/02713683.2019.1570274. Epub 2019 Feb 4.
PMID: 30644770BACKGROUNDPeters AL, Buschur EO, Buse JB, Cohan P, Diner JC, Hirsch IB. Euglycemic Diabetic Ketoacidosis: A Potential Complication of Treatment With Sodium-Glucose Cotransporter 2 Inhibition. Diabetes Care. 2015 Sep;38(9):1687-93. doi: 10.2337/dc15-0843. Epub 2015 Jun 15.
PMID: 26078479BACKGROUNDLahoti S, Nashawi M, Sheikh O, Massop D, Mir M, Chilton R. Sodium-glucose co-transporter 2 inhibitors and diabetic retinopathy: insights into preservation of sight and looking beyond. Cardiovasc Endocrinol Metab. 2020 May 18;10(1):3-13. doi: 10.1097/XCE.0000000000000209. eCollection 2021 Mar.
PMID: 33634250BACKGROUNDChen YY, Wu TT, Ho CY, Yeh TC, Sun GC, Kung YH, Wong TY, Tseng CJ, Cheng PW. Dapagliflozin Prevents NOX- and SGLT2-Dependent Oxidative Stress in Lens Cells Exposed to Fructose-Induced Diabetes Mellitus. Int J Mol Sci. 2019 Sep 5;20(18):4357. doi: 10.3390/ijms20184357.
PMID: 31491943BACKGROUNDOtt C, Jumar A, Striepe K, Friedrich S, Karg MV, Bramlage P, Schmieder RE. A randomised study of the impact of the SGLT2 inhibitor dapagliflozin on microvascular and macrovascular circulation. Cardiovasc Diabetol. 2017 Feb 23;16(1):26. doi: 10.1186/s12933-017-0510-1.
PMID: 28231831BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lamiaa M ElWakeel, PhD
Faculty of pharmacy Ain Shams University
- STUDY DIRECTOR
Mona A Abd El Salam, MD
Faculty of Medicine Ain Shams University
- STUDY DIRECTOR
Marwa A Ahmed, PhD
Faculty of pharmacy Ain Shams University
- PRINCIPAL INVESTIGATOR
Nidae A Ismail, BSc
Faculty of pharmacy Ain Shams University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 27, 2022
First Posted
April 5, 2022
Study Start
June 6, 2022
Primary Completion
May 1, 2023
Study Completion
November 1, 2023
Last Updated
June 10, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share