Diabetic RetinopathyPhase 3NCT05310916
Effect of SGLT2i on Diabetic Retinopathy in Type 2 Diabetes Mellitus Patients
A Phase 3 study testing Dapagliflozin 10mg Tab plus another oral hypoglycemic agent and Two oral hypoglycemic agents other than dapagliflozin in people with Diabetic Retinopathy, run by Nidae Alaa at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Dapagliflozin 10mg Tab plus another oral hypoglycemic agent and Two oral hypoglycemic agents other than dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Jun 2022to Nov 2023
- Phase
- Phase 3
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Infectious or inflammatory diseases.
- Neoplasm, or hematological disorders.
- Pregnant or breast-feeding patients.
- Active participation in another clinical study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Internal medicine and endocrinology department, Ain-shams university hospitals
Cairo
About this study
Official title: Evaluation of the Effect of Sodium-Glucose Cotransporter-2 (SGLT2) Inhibitors on Diabetic Retinopathy in Patients With Type 2 Diabetes Mellitus
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.
Read the detailed description
All type 2 diabetes mellitus patients presenting to the endocrinology department, ASU Hospitals, who were diagnosed with mild to moderate non-proliferative diabetic retinopathy will be assessed for eligibility.
Eligible patients will be randomly assigned to one of the following 2 arms:
- Group 1 (Control group) (n= 30): type 2 diabetes mellitus patients who will receive their oral antidiabetic for 12 weeks.
- 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:
- Clinical Evaluation
- Systolic and diastolic blood pressures recording.
- Plasma glucose measurement.
- Report any adverse effects that may appear
- Blood samples will be taken at baseline and at 12-week visits
- Follow up
- Conditions
- Diabetic Retinopathy
- Being tested
- Dapagliflozin 10mg Tab plus another oral hypoglycemic agent, Two oral hypoglycemic agents other than dapagliflozin
- Keywords
- Diabetic retinopathy, Sodium-glucose cotransporter-2 inhibitor
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10mg Tab plus another oral hypoglycemic agentDrug
Also called Diglifloz 10mg Tab
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 dapagliflozinDrug
Also called Oral anti-diabetic agents
Two oral anti-diabetic agents not including sodium-glucose co-transporter 2 inhibitors
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Dapagliflozin 10mg Tab plus another oral hypoglycemic agent |
| Control group | Active comparator | (n=30): type 2 diabetes mellitus patients who will receive two oral antidiabetic agents for 12 weeks Receives: Drug: Two oral hypoglycemic agents other than dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Evaluation of the study biomarkers, IL-6, and VEGF
Interleukin-6 (IL-6)//inflammatory biomarker Vascular endothelial growth factor (VEGF)//angiogenic biomarker
Measured: 12 weeks
Secondary outcomes (1)
Occurrence of adverse events
No potential risks are expected when the study patients are selected according to the determined inclusion criteria but maybe occur Nausea, abdominal pain, polyuria, thrush, genital or urinary tract infections
Measured: (1-90)days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start6 Jun 2022
- Primary completionMay 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nidae Alaa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nidae Alaa, Ain Shams University
- Investigators
- Lamiaa M ElWakeel, PhD, Study director, Faculty of pharmacy Ain Shams UniversityMona A Abd El Salam, MD, Study director, Faculty of Medicine Ain Shams UniversityMarwa A Ahmed, PhD, Study director, Faculty of pharmacy Ain Shams UniversityNidae A Ismail, BSc, Principal investigator, Faculty of pharmacy Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310916
- Sponsor's protocol ID
- 311311
- Status last verified
- Jun 2022
- First submitted
- 27 Mar 2022
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29219149Wong 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.
PubMed 27159554Sha 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.
PubMed 33274239Zhou 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.
PubMed 31019585Yao 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.
PubMed 30644770Peters 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.
PubMed 26078479Lahoti 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.
PubMed 33634250Chen 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.
PubMed 31491943Ott 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.
PubMed 28231831
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Sodium-Glucose Cotransporter-2 (SGLT2) Inhibitors on Diabetic Retinopathy in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05310916
- Acronym / sponsor ID
- 311311
- Conditions
- Diabetic Retinopathy
- Keywords
- Diabetic retinopathy, Sodium-glucose cotransporter-2 inhibitor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nidae AlaaUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
All type 2 diabetes mellitus patients presenting to the endocrinology department, ASU Hospitals, who were diagnosed with mild to moderate non-proliferative diabetic retinopathy will be assessed for eligibility.
Eligible patients will be randomly assigned to one of the following 2 arms:
- Group 1 (Control group) (n= 30): type 2 diabetes mellitus patients who will receive their oral antidiabetic for 12 weeks.
- 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:
- Clinical Evaluation
- Systolic and diastolic blood pressures recording.
- Plasma glucose measurement.
- Report any adverse effects that may appear
- Blood samples will be taken at baseline and at 12-week visits
- Follow up
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Drug: Dapagliflozin 10mg Tab plus another oral hypoglycemic agent(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 | Drug: Two oral hypoglycemic agents other than dapagliflozin(n=30): type 2 diabetes mellitus patients who will receive two oral antidiabetic agents for 12 weeks |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin 10mg Tab plus another oral hypoglycemic agentAlso: Diglifloz 10mg TabDapagliflozin 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. | Drug | Test group |
| Two oral hypoglycemic agents other than dapagliflozinAlso: Oral anti-diabetic agentsTwo oral anti-diabetic agents not including sodium-glucose co-transporter 2 inhibitors | Drug | Control group |
Primary outcome
Severity of retinopathy
Time frame: 12 weeks
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.
Evaluation of the study biomarkers, IL-6, and VEGF
Time frame: 12 weeks
Interleukin-6 (IL-6)//inflammatory biomarker Vascular endothelial growth factor (VEGF)//angiogenic biomarker
1 secondary outcome
Occurrence of adverse events
Time frame: (1-90)days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Background: PubMed 29219149Zheng 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.
- Background: PubMed 27159554Wong 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.
- Background: PubMed 33274239Sha 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.
- Background: PubMed 31019585Zhou 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.
- Background: PubMed 30644770Yao 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.
- Background: PubMed 26078479Peters 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.
- Background: PubMed 33634250Lahoti 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.
- Background: PubMed 31491943Chen 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.
- Background: PubMed 28231831Ott 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.
- Protective Effect of Sodium-Glucose Co-Transporter 2 Inhibitor (Dapagliflozin) on Diabetic Retinopathy in Streptozotocin Induced Diabetes in RatsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lamiaa M ElWakeel, PhD study director
Faculty of pharmacy Ain Shams University
Mona A Abd El Salam, MD study director
Faculty of Medicine Ain Shams University
Marwa A Ahmed, PhD study director
Faculty of pharmacy Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dapagliflozin 10mg Tab plus another oral hypoglycemic agent and Two oral hypoglycemic agents other than dapagliflozin in people with Diabetic Retinopathy, run by Nidae Alaa at 1 site in Egypt.
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 4 inclusion and 10 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 10 Jun 2022. 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 Egypt. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Nidae A Ismail, BSc (00201157820751, Nidae.Alaa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of retinopathy (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 NCT05310916, which also lists 9 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 10 Jun 2022.