Effect of SGLT2i on Diabetic Retinopathy in Type 2 Diabetes Mellitus Patients
NCT ID: NCT05310916
Last Updated: 2022-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
60 participants
INTERVENTIONAL
2022-06-06
2023-11-30
Brief Summary
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Detailed Description
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Eligible patients will be randomly assigned to one of the following 2 arms:
1. Group 1 (Control group) (n= 30): type 2 diabetes mellitus patients who will receive their oral antidiabetic for 12 weeks.
2. Group 2 (Test group) (n= 30): type 2 diabetes mellitus patients who will receive their oral antidiabetic along with dapagliflozin at a dose of 10 mg daily for 12 weeks.
A total of four visits one for baseline evaluation and one for end of study evaluation and two intermediate visits, the following will be performed in the visits:
1. Clinical Evaluation
1. Systolic and diastolic blood pressures recording.
2. Plasma glucose measurement.
2. Report any adverse effects that may appear
3. Blood samples will be taken at baseline and at 12-week visits
4. Follow up
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Test group
(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.
Dapagliflozin 10mg Tab plus another oral hypoglycemic agent
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.
Control group
(n=30): type 2 diabetes mellitus patients who will receive two oral antidiabetic agents for 12 weeks
Two oral hypoglycemic agents other than dapagliflozin
Two oral anti-diabetic agents not including sodium-glucose co-transporter 2 inhibitors
Interventions
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Dapagliflozin 10mg Tab plus another oral hypoglycemic agent
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 hypoglycemic agents other than dapagliflozin
Two oral anti-diabetic agents not including sodium-glucose co-transporter 2 inhibitors
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Glomerular filtration rates \> 60 mL/min.
3. Normal aspartate and alanine transaminase levels.
4. Controlled systolic and diastolic blood pressures
Exclusion Criteria
2. Patients who have HbA1c level ≥10% (86 mmol/mol) or a fasting plasma glucose level \>240 mg/dl.
3. Patients with a history of cardiovascular events within six months before enrolment.
4. Patients suffering from cataract or glaucoma.
5. Patients with volume depletion clinical signs.
6. Body mass index (BMI) \>40 kg/m2
7. Infectious or inflammatory diseases.
8. Neoplasm, or hematological disorders.
9. Pregnant or breast-feeding patients.
10. Active participation in another clinical study.
40 Years
70 Years
ALL
No
Sponsors
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Nidae Alaa
OTHER
Responsible Party
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Nidae Alaa
Principal Investigator
Principal Investigators
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Lamiaa M ElWakeel, PhD
Role: STUDY_DIRECTOR
Faculty of pharmacy Ain Shams University
Mona A Abd El Salam, MD
Role: STUDY_DIRECTOR
Faculty of Medicine Ain Shams University
Marwa A Ahmed, PhD
Role: STUDY_DIRECTOR
Faculty of pharmacy Ain Shams University
Nidae A Ismail, BSc
Role: PRINCIPAL_INVESTIGATOR
Faculty of pharmacy Ain Shams University
Locations
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Internal medicine and endocrinology department, Ain-shams university hospitals
Cairo, , Egypt
Countries
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Central Contacts
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References
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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.
Wong 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.
Sha 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.
Zhou 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.
Yao 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.
Peters 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.
Lahoti 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.
Chen 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.
Ott 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.
Related Links
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Protective Effect of Sodium-Glucose Co-Transporter 2 Inhibitor (Dapagliflozin) on Diabetic Retinopathy in Streptozotocin Induced Diabetes in Rats
Other Identifiers
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311311
Identifier Type: -
Identifier Source: org_study_id
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