Real World Case Study of 12 Weeks to Assess Glycemic and Non-Glycemic Changes with SGLT2I from Database of Six Type 2 Diabetic Patients

Abstract

Background: Clinical practice guidelines are flexible when it comes to choice of therapy after using metformin in type 2 diabetes mellitus (T2DM). Sodium-glucose co-transporter inhibitors (SGLT2Is) are a new group of antidiabetic drugs which cause reduction in weight and visceral fat and waist circumference and thus lead to reduction of blood glucose level as well as decreases insulin resistance in type 2 diabetes mellitus (T2DM) patients. Whether their extra-glycemic property is retained even in real-world setting is a question that needs to be addressed.
Methods: We have follow-up data of 6 patients collected from the authors’ clinic records and analyzed the effect of SGLT-2Is on anthropometric, metabolic and inflammatory parameters. Patients were treated as per the routine standard of care without any experimentation on them. The patients’ physical parameters (weight, waist hip ratio), C-reactive protein, packed cell volume and Hemoglobin, HOMA-Insulin resistance and HbA1c were determined at baseline and at last follow-up visit. P-value was computed by Wilcoxon Signed Rank test.
Results: After a mean study duration of 12 weeks in six patients (meeting appropriate preset inclusion criteria), there was significant reduction in weight from 73 ± 2.48 kg (mean ± SEM) to 67.83 ± 2.32 kg (reduction of 5.17 ± 2.14; p=0.003). The significant weight reduction accompanied with significant increase in the packed cell volume (PCV) from 36.17 ± 2.05 (mean ± SEM) to 39.07 ± 1.81 (increase of 2.90 ± 2.07%; p=0.027). This supports that SGLT-2Is induces weight loss due to reduction in body fluid. The waist circumference also reduced from 106.96 ± 7.96 to 102.33 ± 5.98. The hemoglobin also increased significantly from 11.85 ± 0.6 to 12.77 ± 0.681. Other parameters such as waist hip ratio, HOMA-IR, HbA1c remained unchanged demonstrating no additional effect of SGLT-2Is on insulin resistance.
Conclusion: In real-life scenario, this study shows that there is a statistically significant reduction in weight and waist circumference and increase in hemoglobin and hematocrit values with SGLT2I within only 12 weeks period irrespective of baseline HbA1c and any telephonic follow-up for lifestyle interventions. Real-world practice differs a lot from a randomized control Trial setting where many things are not possible to be done but these drugs maintain their extra glycemic benefits even in real world setting.