What is the management plan for a patient with uncontrolled type 2 diabetes mellitus (T2DM) with a hemoglobin A1c (HbA1c) level indicating poor glycemic control, currently on metformin (Metformin), glipizide (Glipizide), and insulin degludec (Degludec) 22 units daily?

From the Guidelines

The patient with uncontrolled Type 2 diabetes mellitus and an HbA1c >14% should have their treatment regimen intensified by adding an SGLT-2 inhibitor or a GLP-1 agonist to their current metformin and insulin therapy, as recommended by the American College of Physicians 1.

Current Medications

The patient is currently taking metformin 1000 mg PO BID, glipizide 10 mg PO daily, and Degludec insulin 22 units daily.

Recommendations

• Continue metformin 1000 mg PO BID, as it improves insulin sensitivity and is a first-line therapy for type 2 diabetes 1.
• Continue glipizide 10 mg PO daily, as it stimulates insulin secretion and is part of the patient's current regimen.
• Consider adding an SGLT-2 inhibitor or a GLP-1 agonist to the patient's regimen, as these medications have been shown to improve glycemic control and reduce the risk of cardiovascular complications in patients with type 2 diabetes 1.
• The current insulin regimen with Degludec 22 units daily may need to be adjusted based on the patient's glucose patterns and response to the new medication.

Monitoring and Follow-up

The patient should monitor their blood glucose levels regularly and schedule a follow-up appointment in 2-4 weeks to reassess their glycemic control and make any necessary adjustments to their medication regimen.

Key Considerations

• The patient's significantly elevated HbA1c level indicates a need for intensified treatment to reduce the risk of long-term complications associated with uncontrolled diabetes.
• The addition of an SGLT-2 inhibitor or a GLP-1 agonist to the patient's regimen is supported by high-certainty evidence and is likely to improve their glycemic control and reduce their risk of cardiovascular complications 1.

From the FDA Drug Label

The efficacy of Insulin Degludec was evaluated in a 52-week randomized, open-label, multicenter trial that enrolled 1030 insulin naïve patients with type 2 diabetes mellitus inadequately controlled on one or more oral antidiabetic agents (OADs). At week 52, the difference in HbA1c reduction from baseline between Insulin Degludec and insulin glargine U-100 was 0.09% with a 95% confidence interval of [-0.04%; 0.22%] and met the pre-specified non-inferiority margin (0.4%); The mean dose after 52 weeks was 56 U for Insulin Degludec.

The patient's current HbA1c is >14, which is uncontrolled and not at goal. The patient is currently taking 22 units of Insulin Degludec daily.

• The studies show that the mean dose after 52 weeks was 56 U for Insulin Degludec, which is higher than the patient's current dose.
• However, the patient's HbA1c level is significantly higher than the baseline HbA1c levels in the studies.
• No conclusion can be drawn from the provided studies regarding the optimal dose of Insulin Degludec for this patient, as the studies do not provide information on patients with HbA1c levels >14. 2

From the Research

Medication Management for Type 2 Diabetes Mellitus

• The patient's current medication regimen includes metformin 1000 mg PO BID, glipizide 10 gm PO daily, and degleudec 22 units daily 3.
• The patient's last HbA1c level was >14, indicating uncontrolled diabetes.
• According to the American Association of Clinical Endocrinologists and the American Diabetes Association, insulin administration should be considered for patients with type 2 diabetes and HbA1c levels exceeding 9.0% and 10%, respectively 3.
• However, studies have shown that dual oral agent approaches, such as metformin plus a sulfonylurea, pioglitazone, or sitagliptin, can be effective in reducing HbA1c levels, even in patients with baseline HbA1c >11% 3.
• The use of SGLT2 inhibitors, such as canagliflozin, dapagliflozin, and empagliflozin, in combination with metformin, has been shown to be effective in improving glycemic control and reducing the risk of metabolic acidosis 4, 5, 6.
• GLP-1 receptor agonists, such as exenatide and liraglutide, have also been shown to be effective in reducing HbA1c levels and improving cardiovascular outcomes, and may be considered as an alternative to insulin therapy 3, 7.
• The combination of an SGLT2 inhibitor and a GLP-1 receptor agonist may be a complementary approach to the treatment of type 2 diabetes, with beneficial effects on glycemic control, body weight, and cardiovascular risk factors 7.

Considerations for Medication Changes

• The patient's current medication regimen may need to be adjusted to achieve better glycemic control.
• The use of insulin therapy may be considered, but the patient's high HbA1c level and lack of control on current medications may indicate a need for alternative or additional therapies.
• The addition of an SGLT2 inhibitor or a GLP-1 receptor agonist to the patient's current medication regimen may be considered, based on the patient's individual needs and medical history.
• The patient's medication regimen should be regularly monitored and adjusted as needed to achieve optimal glycemic control and minimize the risk of adverse effects.