What is the appropriate dose and type (regular vs. basal) of insulin for a patient with uncontrolled diabetes and an HbA1c (Hemoglobin A1c) level of 9%?

From the Guidelines

Insulin Therapy for Uncontrolled Diabetes

For a patient with uncontrolled diabetes and an HbA1c of 9%, initiation of insulin therapy is recommended 1.

Basal Insulin

A suitable starting regimen may include a basal insulin, such as glargine (Lantus) or detemir (Levemir), at a dose of 10 units once daily, or 0.1 to 0.2 units/kg of body weight per day, with adjustments made by 10% to 15%, or 2 to 4 units, once or twice weekly until the fasting blood glucose target is met 1.

Rapid-Acting Insulin

In addition to basal insulin, rapid-acting insulin analogues, such as aspart (Novolog) or lispro (Humalog), may be prescribed at a dose of 4 U per meal, 0.1 U/kg per meal, or 10% of the basal insulin dose per meal if the HbA1c level is less than 8% 1.

Premixed Insulin

Alternatively, premixed insulin products, containing both basal and bolus insulin, may be considered at a dose of 10-12 units twice daily 1.

• Key considerations include:
  • Cost-effectiveness of insulin products, particularly in light of substantial price increases over the past decade 1.
  • The potential for intermediate-acting insulin (NPH) to be a more affordable option for some patients, despite newer products causing less hypoglycemia 1.
  • The importance of comprehensive education about blood glucose monitoring, nutrition, and hypoglycemia recognition and treatment for patients receiving insulin therapy 1.

From the FDA Drug Label

To evaluate the administration of Insulin Lispro via external insulin pumps, two open-label, crossover design studies were performed in patients with type 1 diabetes. A 6-month randomized, crossover, open-label, active-controlled study was conducted in insulin-treated patients with type 2 diabetes (n=722) to assess the safety and efficacy of Insulin Lispro for 3 months followed by Humulin R for 3 months or the reverse sequence Insulin Lispro was administered by subcutaneous injection immediately before meals and Humulin R was administered 30 to 45 minutes before meals. Humulin® N [NPH human insulin (rDNA origin) isophane suspension] or Humulin U was administered once or twice daily as the basal insulin.

The appropriate dose and type of insulin for a patient with uncontrolled diabetes and an HbA1c level of 9% cannot be directly determined from the provided information.

• Key points:
  • The provided studies do not directly address the specific HbA1c level of 9%.
  • The studies compare the efficacy of Insulin Lispro to Humulin R in patients with type 1 and type 2 diabetes.
  • The administration of Insulin Lispro immediately before meals and Humulin R 30 to 45 minutes before meals is mentioned.
  • The use of Humulin N or Humulin U as basal insulin is also mentioned. However, the FDA label does not provide a clear answer to the question of the appropriate dose and type of insulin for a patient with an HbA1c level of 9%. 2

From the Research

Insulin Therapy for Uncontrolled Diabetes

• Insulin therapy is recommended for patients with type 2 diabetes mellitus and an initial A1C level greater than 9 percent, or if diabetes is uncontrolled despite optimal oral glycemic therapy 3.
• The preferred method of insulin initiation in type 2 diabetes is to begin by adding a long-acting (basal) insulin or once-daily premixed/co-formulation insulin or twice-daily premixed insulin, alone or in combination with glucagon-like peptide-1 receptor agonist (GLP-1 RA) or in combination with other oral antidiabetic drugs (OADs) 4.

Dose and Type of Insulin

• Insulin therapy may be initiated as augmentation, starting at 0.3 unit per kg, or as replacement, starting at 0.6 to 1.0 unit per kg 3.
• When using replacement therapy, 50 percent of the total daily insulin dose is given as basal, and 50 percent as bolus, divided up before breakfast, lunch, and dinner 3.
• A study comparing premixed, bolus, and basal insulin found that hypoglycemia was more common with premixed and bolus insulin, and weight gain was more common with bolus insulin 3.

Alternative Treatment Options

• A randomized trial compared the efficacy and safety of treating patients with type 2 diabetes and highly elevated HbA1c levels with basal-bolus insulin or a glucagon-like peptide-1 receptor agonist plus basal insulin, and found that the latter resulted in better glycemic control and body weight, lower insulin dosage and hypoglycemia, and improved quality of life 5.
• Another study found that insulin degludec/liraglutide fixed-ratio combination (IDegLira) was noninferior to basal-bolus insulin in patients with uncontrolled type 2 diabetes, with lower rates of hypoglycemia and weight loss 6.

Short-term Intensive Insulin Therapy

• Short-term intensive insulin therapy could be the preferred option for new onset type 2 diabetes mellitus patients with HbA1c > 9, as it can quickly normalize glycemic control, improve β-cell function, and reduce glucagonemia 7.
• A meta-analysis found that short-term intensive insulin therapy resulted in a higher proportion of patients in drug-free remission, with improved β-cell function and decreased insulin resistance 7.