Would it be appropriate to add Jardiance (Empagliflozin) to a T2DM patient's treatment plan with poor glycemic control on Metformin and Lantus (Insulin glargine)?

From the Guidelines

Yes, adding Jardiance (empagliflozin) would be appropriate for a type 2 diabetes patient with poor glycemic control despite being on Metformin and Lantus (insulin glargine). Empagliflozin is an SGLT2 inhibitor that works through a different mechanism than either metformin or insulin by promoting urinary glucose excretion, which helps lower blood glucose levels independently of insulin action. The typical starting dose is 10 mg once daily, taken in the morning, with the option to increase to 25 mg daily if needed and if tolerated. When adding empagliflozin, patients should be monitored for potential side effects including genital mycotic infections, urinary tract infections, and volume depletion. Patients should be advised to maintain adequate hydration and report symptoms of hypoglycemia, as insulin doses may need adjustment. Empagliflozin offers additional benefits beyond glycemic control, including cardiovascular risk reduction and potential renal protection, making it particularly valuable for T2DM patients with or at risk for cardiovascular disease. This triple therapy approach (metformin, basal insulin, and SGLT2 inhibitor) represents a complementary combination targeting multiple pathophysiological defects in type 2 diabetes.

Key considerations for the use of empagliflozin in this patient include:

• Monitoring for potential side effects such as genital mycotic infections, urinary tract infections, and volume depletion 1
• Advising patients to maintain adequate hydration and report symptoms of hypoglycemia 1
• Adjusting insulin doses as needed to minimize the risk of hypoglycemia 1
• Considering the potential benefits of empagliflozin on cardiovascular risk reduction and renal protection 1

Overall, the addition of empagliflozin to this patient's treatment plan is supported by recent evidence, including a systematic review and network meta-analysis of randomized controlled trials 1. This evidence suggests that SGLT2 inhibitors, such as empagliflozin, can reduce the risk of cardiovascular events and renal disease in patients with type 2 diabetes, making them a valuable addition to the treatment plan for patients with poor glycemic control despite being on metformin and insulin.

From the FDA Drug Label

A total of 494 patients with type 2 diabetes inadequately controlled on insulin, or insulin in combination with oral drugs participated in a double-blind, placebo-controlled study to evaluate the efficacy of JARDIANCE as add-on therapy to insulin over 78 weeks. Patients entered a 2-week placebo run-in period on basal insulin (e. g., insulin glargine, insulin detemir, or NPH insulin) with or without metformin and/or sulfonylurea background therapy. Following the run-in period, patients with inadequate glycemic control were randomized to the addition of JARDIANCE 10 mg, JARDIANCE 25 mg, or placebo JARDIANCE used in combination with insulin (with or without metformin and/or sulfonylurea) provided statistically significant reductions in HbA1c and FPG compared to placebo after both 18 and 78 weeks of treatment

Key Points:

• The patient has T2DM with poor glycemic control on Metformin and Lantus (Insulin glargine).
• The patient's HbA1c is 11.4, which is trending up from 8.9.
• Jardiance (Empagliflozin) has been shown to be effective as an add-on therapy to insulin in patients with inadequate glycemic control.
• The study results show that JARDIANCE used in combination with insulin (with or without metformin and/or sulfonylurea) provided statistically significant reductions in HbA1c and FPG compared to placebo.

Answer: It would be appropriate to consider adding Jardiance (Empagliflozin) to the patient's treatment plan, as it has been shown to be effective in improving glycemic control in patients with T2DM who are already on insulin therapy, such as Lantus (Insulin glargine), and Metformin 2.

From the Research

Patient Profile

• Type 2 Diabetes Mellitus (T2DM) patient with poor glycemic control
• Currently on Metformin and Lantus (Insulin glargine) 80 units daily
• HbA1c level of 11.4, trending up from 8.9
• Patient denies polyuria, polyphagia, or polydipsia
• Annual diabetic eye exam showed no diabetic retinopathy

Considerations for Adding Jardiance (Empagliflozin)

• Empagliflozin has been shown to improve glycemic control in patients with T2DM, particularly when added to basal insulin therapy 3
• A study found that empagliflozin reduced HbA1c levels, insulin dose, and weight in patients with T2DM on basal insulin, with a similar risk of hypoglycemia to placebo 3
• Another study demonstrated that adding empagliflozin to pioglitazone or pioglitazone plus metformin resulted in significant reductions in glycated hemoglobin levels, weight, and blood pressure, with a low risk of hypoglycemia 4
• However, empagliflozin has been associated with an increased risk of genital mycotic infections and urinary tract infections 3, 4

Renal Hemodynamic Effects

• A study comparing empagliflozin/linagliptin with metformin/insulin glargine found that empagliflozin reduced glomerular filtration rate (GFR) but preserved renal plasma flow (RPF), whereas metformin/insulin glargine reduced both GFR and RPF 5
• The study suggested that empagliflozin may have a more favorable renal hemodynamics profile compared to metformin/insulin glargine 5

Patient Education and Glycemic Control

• Improving patients' understanding of HbA1c values has been shown to improve glycemic control, particularly among those with poorly controlled diabetes 6
• Educating patients on the relationship between HbA1c and mean plasma glucose may help them better manage their diabetes and improve their glycemic control 6