Clinical trial NCT06268977: Using of SGLt2 Inhibitors in Patients With Type 2 DM
Official title: Efficacy and Safety of Incorporating Sodium-glucose Cotransporter-2 Inhibitors to Regimens of Diabetes Patients Already Receiving Therapy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Type 2 Diabetes
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult diabetic type 2patients

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Effect of adding SGLTi on BP
timeFrame: Six months
measure: Effect of adding SGLTi on BMI
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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.
citation: 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.
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.