NCT04400760

The Effect of Dapagliflozin on Platelet Function testinG Profiles in Diabetic PatiEnts.

The Effect of Dapagliflozin on Platelet Function testinG Profiles in Diabetic PatiEnts: The EDGE Study.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: The University of The West Indies · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Sodium GLucose Transport 2 inhibitors (SGLT2I), including dapagliflozin, reduce the likelihood of hospitalization for heart failure and death in persons with type 2 diabetes, of which the mechanism has not been fully elucidated. The mechanistic effects of dapagliflozin on platelet function profiles have not yet been ascertained. It remains unclear if this reduction in cardiovascular death is mediated by decreased platelet reactivity.

Detailed description

Diabetes is highly prevalent in our setting. Dapagliflozin is now considered first-line treatment for diabetes, especially in the cardiovascular arena. The standard prescribed dosages of dapagliflozin will be employed in the research study (5 or 10 mg once daily). The reason the study team is interested in performing this study in our local setting is that if dapagliflozin does show a beneficial effect with either diabetic control or an antiplatelet effect, the team can then inform the Ministry of Health to acquire these relatively expensive medications in place of the older, less effective anti-diabetic drugs. The team has to demonstrate that they work effectively and safely in our population before approaching regulatory bodies with a robust recommendation that they are made available in the public healthcare sector. The patients that are to be selected will be relatively controlled on their current regimen, and thus not "miss out" on these medications after the study has been concluded as they are all available on the chronic disease assistance program (CDAP) such as metformin, gliclazide and insulin therapies. The study will aim to determine if dapagliflozin does demonstrate other latent antiplatelet effects that can potentially affect the cardiovascular/hematologic systems that have not investigated before.

Conditions

• Platelet Dysfunction

Interventions

Type	Name	Description
DRUG	DAPA Tx	The intervention, dapagliflozin will be administered 10mg per oral daily for two weeks.

Timeline

• Start date: 2020-05-01
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2020-05-26
• Last updated: 2023-11-07
• Results posted: 2023-11-07

Locations

1 site across 1 country: Trinidad and Tobago

Regulatory

• FDA-regulated drug study