What is the best treatment plan for a patient with poorly controlled diabetes (Diabetes Mellitus) and an elevated Hemoglobin A1C (HbA1C) level, currently taking Metformin (Biguanide)?

From the Guidelines

For a 71-year-old patient with poorly controlled diabetes and an elevated HbA1C of 11.5% despite Metformin therapy, the recommended approach is to add a second medication while maintaining the current Metformin dose. A GLP-1 receptor agonist like semaglutide (Ozempic, starting at 0.25mg weekly, increasing to 0.5mg after 4 weeks) would be an excellent addition due to its proven efficacy in lowering HbA1C, promoting weight loss, and providing cardiovascular benefits, as supported by recent guidelines 1. Alternatively, an SGLT-2 inhibitor such as empagliflozin (Jardiance, 10mg daily) could be added, which offers similar cardiovascular benefits plus renal protection. Some key points to consider in the management of this patient include:

• Lifestyle modifications remain essential, including a balanced diet limiting refined carbohydrates, regular physical activity (150 minutes weekly of moderate exercise), and consistent blood glucose monitoring.
• Treatment goals should target an HbA1C below 7% for most patients, though this may be individualized based on age and comorbidities, as suggested by the American Diabetes Association 1.
• The choice of medication added to metformin should be based on the clinical characteristics of the patient and their preferences, including the presence of established ASCVD or indicators of high ASCVD risk, other comorbidities, and risk for specific adverse drug effects.
• The dual therapy approach addresses the progressive nature of diabetes, where beta cell function gradually declines over time, requiring intensification beyond metformin monotherapy to maintain glycemic control and prevent complications, as highlighted in the standards of care in diabetes-2025 1.

From the FDA Drug Label

At Week 24, treatment with JARDIANCE 10 mg or 25 mg daily provided statistically significant reductions in HbA1c (p-value <0. 0001), FPG, and body weight compared with placebo A total of 637 patients with type 2 diabetes participated in a double-blind, placebo-controlled study to evaluate the efficacy and safety of JARDIANCE in combination with metformin Patients with type 2 diabetes inadequately controlled on at least 1500 mg of metformin per day entered an open-label 2 week placebo run-in. At the end of the run-in period, patients who remained inadequately controlled and had an HbA1c between 7 and 10% were randomized to placebo, JARDIANCE 10 mg, or JARDIANCE 25 mg

The patient is taking 1000 mg Metformin BID, which is less than the 1500 mg per day used in the study. However, considering the patient's elevated HbA1c level of 11.5, which is higher than the range of 7-10% in the study, and the fact that the patient is already taking Metformin, adding JARDIANCE (Empagliflozin) to the treatment plan could be considered.

• The study shows that JARDIANCE in combination with Metformin provides statistically significant reductions in HbA1c.
• The patient's current Metformin dose is 1000 mg BID, which is lower than the dose used in the study.
• Close monitoring of the patient's condition and adjustment of the treatment plan as needed is recommended. 2

From the Research

Treatment Plan for Poorly Controlled Diabetes

The patient in question has an HbA1c level of 11.5, indicating poorly controlled diabetes, and is currently taking 1000 mg Metformin BID. To improve glycemic control, several treatment options can be considered:

• Adding a second-line medication to Metformin, such as empagliflozin, a sodium-glucose cotransporter 2 inhibitor, which has been shown to be effective in reducing HbA1c levels 3
• Using a fixed-dose combination of dapagliflozin, glimepiride, and extended-release metformin, which has been demonstrated to be effective in achieving glycemic control in patients with type 2 diabetes poorly controlled by metformin and glimepiride 4
• Implementing an initial triple combination of metformin, sitagliptin, and empagliflozin, which has been shown to lead to achievement of the glycemic target goal and improvement in metabolic function and albuminuria 5
• Considering the use of real-time continuous glucose monitoring (rt-CGM) with structured education, which has been found to improve glycemic outcomes in insulin-treated adults with poorly controlled type 2 diabetes 6

Key Considerations

When selecting a treatment plan, it is essential to consider the patient's individual needs and circumstances, including:

• The patient's current medication regimen and potential interactions with new medications
• The patient's renal function and potential need for dose adjustments
• The patient's risk of hypoglycemia and potential need for glucose monitoring
• The patient's access to and ability to use rt-CGM and structured education

Potential Treatment Options

Based on the available evidence, potential treatment options for the patient include:

• Adding empagliflozin to the patient's current metformin regimen 3
• Switching to a fixed-dose combination of dapagliflozin, glimepiride, and extended-release metformin 4
• Initiating an initial triple combination of metformin, sitagliptin, and empagliflozin 5
• Implementing rt-CGM with structured education to improve glycemic outcomes 6