What are the recommendations to improve glycemic control in a patient with Poor Glycemic Control on Lantus (Insulin Glargine) and Jardiance (Empagliflozin), who refuses GLP-1 (Glucagon-Like Peptide-1) agonist and Metformin?

Management of Poorly Controlled Type 2 Diabetes

For a 63-year-old male with HbA1c of 11.6% on Lantus 60 units daily and Jardiance 10mg daily who refuses GLP-1 agonist and metformin, the most effective approach is to add a rapid-acting insulin analog before meals (prandial insulin) to his current basal insulin regimen.

Current Treatment Assessment

The patient has very poor glycemic control (HbA1c 11.6%) despite being on:

• Basal insulin (Lantus 60 units daily)
• SGLT2 inhibitor (Jardiance 10mg daily)

Key limitations:

• Patient refuses GLP-1 receptor agonists
• Patient refuses metformin
• Current regimen is clearly insufficient for glycemic control

Recommended Treatment Intensification

Primary Recommendation

1. Add prandial (mealtime) insulin to the current basal insulin regimen
   • Start with a rapid-acting insulin analog (lispro, aspart, or glulisine) before the largest meal of the day 1
   • Initial dose can be 4 units or 10% of the basal dose before the largest meal
   • Titrate by 1-2 units every 3 days until target postprandial glucose is achieved
   • If HbA1c remains above target after 3 months, add mealtime insulin before additional meals

Alternative Options (if prandial insulin is refused)

1. Consider a premixed insulin regimen

   • Switch from Lantus to twice-daily premixed insulin (70/30 NPH/regular, 70/30 aspart mix, or 75/25 lispro mix) 1
   • Initial dose can be calculated as 80% of total daily Lantus dose, split into two injections before breakfast and dinner

2. Add a DPP-4 inhibitor

   • Although less potent than other options, may provide modest additional glycemic control
   • Lower risk of hypoglycemia compared to increasing insulin dose or adding sulfonylureas

3. Consider U-500 regular insulin

   • For patients requiring large insulin doses (>200 units/day)
   • Has both prandial and basal properties 1
   • Requires careful monitoring due to concentrated formulation

Monitoring and Follow-up

• Check HbA1c after 3 months of treatment adjustment
• Monitor both fasting and postprandial glucose levels
• Assess for hypoglycemia and provide education on recognition and management
• Consider continuous glucose monitoring if available to identify glucose patterns

Important Considerations

• Insulin intensification is necessary: With HbA1c >10%, insulin therapy intensification is strongly indicated 1
• Glucose toxicity: At this severely elevated HbA1c level, glucose toxicity is likely present, which requires insulin therapy to reverse 1
• Combination injectable therapy: When basal insulin has been titrated to an acceptable fasting glucose but HbA1c remains above target (as in this case), combination injectable therapy is indicated 1
• Hypoglycemia risk: Educate patient on hypoglycemia recognition and management, especially when intensifying insulin therapy

Pitfalls to Avoid

1. Therapeutic inertia: Delaying insulin intensification despite severely elevated HbA1c
2. Overreliance on oral agents: At this HbA1c level, oral agents alone are unlikely to achieve adequate control
3. Ignoring postprandial glucose excursions: Basal insulin primarily controls fasting glucose; adding prandial insulin addresses postprandial hyperglycemia
4. Inadequate patient education: Ensure proper insulin administration technique and hypoglycemia management

Rationale for Recommendation

The ADA and other guidelines clearly indicate that when basal insulin has been titrated to an acceptable fasting blood glucose level (or if the dose is >0.5 U/kg per day) and HbA1c remains above target, combination injectable therapy should be considered 1. With an HbA1c of 11.6%, this patient requires more aggressive therapy than his current regimen provides.

Given the patient's refusal of GLP-1 receptor agonists and metformin, adding prandial insulin to his basal insulin regimen represents the most evidence-based approach to improve glycemic control and reduce the risk of diabetes-related complications.