Using of SGLt2 Inhibitors in Patients With Type 2 DM

Type 2 Diabetes Clinical Trial

Official title:

Efficacy and Safety of Incorporating Sodium-glucose Cotransporter-2 Inhibitors to Regimens of Diabetes Patients Already Receiving Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06268977
• Other study ID #: SGLt2i in diabetic type 2
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: March 30, 2025

Study information

• Verified date: February 2024
• Source: Assiut University
• Contact: Caroline Refaat labib, Resident
• Phone: 01285655406
• Email: carolinereffat[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To detect the efficacy of SGLT2i in improving the metabolic parameters in patients with type 2 diabetes.

• To detect the side-effects of SGLT2i

Description:

Type 2 diabetes mellitus (T2DM) is a worldwide health problem, with a continuously increasing prevalence . Good management of blood glucose level is critical to delay progression of the underlying metabolic dysfunction and to reduce the risk of diabetic complications . Sodium-glucose cotransporter-2 inhibitors (SGLT2i) are a new class of antidiabetic drug acting by increasing urinary glucose excretion. First approved in 2014, SGLT2i have been widely used to treat patients with type 2 diabetes They are effective in reducing blood glucose, and surprisingly have shown benefits beyond glycaemic control .

Physicians have reported improved hypertension, heart failure, chronic kidney disease, fatty liver disease and obesity However, SGLT inhibitors are not magical drugs, and their use is not free of side effects ( Reported side effects include urinary tract infections, genital infection, dehydration, and hypotension, plus the usual side effects of antidiabetic medications as hypoglycemia . The optimum practical guideline for adding SGLT2 inhibitors to treatment regimens of patients with diabetes is controversial .Many local guidelines and treatment policies exist, yet we need to develop our own local policy at Assiut University hospitals to suit our patients needs and expectations, balancing between efficacy and side effects.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: March 30, 2025
• Est. primary completion date: March 1, 2025
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Adults (=18 years)

2. both genders ( male and female)

3. type 2 diabetic patients

Exclusion Criteria:

1. history of svere hypoglycemia

2. patients with history of weight loss

3. Patients with history of recurrent UTI

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• SGLT2 inhibitor
a class of prescription medicines that are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

Levine MJ. Empagliflozin for Type 2 Diabetes Mellitus: An Overview of Phase 3 Clinical Trials. Curr Diabetes Rev. 2017;13(4):405-423. doi: 10.2174/1573399812666160613113556. — View Citation

Sun H, Saeedi P, Karuranga S, Pinkepank M, Ogurtsova K, Duncan BB, Stein C, Basit A, Chan JCN, Mbanya JC, Pavkov ME, Ramachandaran A, Wild SH, James S, Herman WH, Zhang P, Bommer C, Kuo S, Boyko EJ, Magliano DJ. IDF Diabetes Atlas: Global, regional and country-level diabetes prevalence estimates for 2021 and projections for 2045. Diabetes Res Clin Pract. 2022 Jan;183:109119. doi: 10.1016/j.diabres.2021.109119. Epub 2021 Dec 6. Erratum In: Diabetes Res Clin Pract. 2023 Oct;204:110945. — View Citation

Vukadinovic D, Abdin A, Anker SD, Rosano GMC, Mahfoud F, Packer M, Butler J, Bohm M. Side effects and treatment initiation barriers of sodium-glucose cotransporter 2 inhibitors in heart failure: a systematic review and meta-analysis. Eur J Heart Fail. 2022 Sep;24(9):1625-1632. doi: 10.1002/ejhf.2584. Epub 2022 Jul 8. Erratum In: Eur J Heart Fail. 2023 Mar;25(3):444. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of adding SGLTi on BP	Compare the effect on blood pressure measurement ( SBP and DBP in mmHg) in SGLTi receivers and non SGLTi receivers	Six months
Primary	Effect of adding SGLTi on BMI	compare the effect on BMI ( weight in kg and height in m2) in SGLTi receivers and non SGLTi receivers.	Six months