Efficacy and Safety of Empagliflozin as Add on in Patients with Type II Diabetes Mellitus (DM) Inadequately Controlled on Triple Drug Combination.

OBJECTIVES: Diabetes mellitus (DM) refers to a group of metabolic disorders characterized by hyperglycemia resulting from insulin resistance, insulin action or both. Despite availability of various treatment modalities it is difficult to achieve the desired glycemic control in many patients. In such patients new class of anti-diabetic agent sodium-glucose co-transporter II (SGLT2) inhibitors has been approved by FDA. SGLT-2 inhibitor Empagliflozin has been associated with HbA1c reduction and weight loss in a broad range of patients with type 2 Diabetes Mellitus (T2DM).

METHODS: An open label, interventional, single arm, 24 weeks study was done on 120 patients who were inadequately controlled on three oral hypoglycaemic agents and reluctant to take insulin therapy. Empagliflozin 25 mg once a day was added to ongoing triple drug therapy. Changes in glycemic parameters like fasting blood sugar levels, post-prandial blood sugar levels, HbA1C, body weight, systolic and diastolic blood pressure and safety profile were assessed at baseline, three months and sixth months. Study was conducted at MGM medical college and hospital, Aurangabad in collaboration with Department of Medicine.

RESULTS: Our study revealed Empagliflozin 25 mg once daily when used as add on to ongoing triple drug therapy has shown 3.02 % reduction in HbA1c and 3.83 kg reduction in bodyweight.

CONCLUSION: Empagliflozin a SGLT 2 inhibitor is a promising drug for reduction in HbA1c value and body weight in patients with T2DM who are inadequately controlled on triple drug therapy and are reluctant to insulin therapy.