Are Novolin NPH (Neutral Protamine Hagedorn) (insulin) and Humulin (human insulin) comparable?

From the Guidelines

Novolin NPH and Humulin N (not Humulin K) are comparable insulin products, and their use should be guided by individual patient needs and medical supervision. Both are intermediate-acting NPH (Neutral Protamine Hagedorn) insulins that typically begin working within 1-2 hours, peak in 4-8 hours, and last approximately 12-18 hours [ 1 ]. They contain the same type of insulin (human insulin) and are used similarly for diabetes management. The main difference is that they are made by different manufacturers - Novolin NPH by Novo Nordisk and Humulin N by Eli Lilly.

Key Considerations

• Patients switching between these products should do so under medical supervision as there may be slight variations in individual response despite their similar pharmacological profiles [ 1 ].
• The standard dosing schedule is typically twice daily, with injections given before breakfast and at bedtime, but specific dosing should be individualized based on blood glucose monitoring and determined by a healthcare provider.
• According to the World Health Organization guidelines, human insulin, including NPH insulin, is recommended for managing blood glucose in adults with type 1 diabetes and in adults with type 2 diabetes for whom insulin is indicated [ 1 ].
• Long-acting insulin analogues may be considered for patients with frequent severe hypoglycemia, but the decision should be based on individual patient needs and the potential benefits and risks [ 1 ].

Evidence-Based Decision Making

The decision to use Novolin NPH or Humulin N should be based on the individual patient's needs, medical history, and response to treatment. While both products are comparable, the choice between them may depend on factors such as cost, availability, and patient preference. Healthcare providers should consider the latest evidence and guidelines when making decisions about insulin therapy, including the potential benefits and risks of different insulin products [ 1 ].

From the Research

Comparison of Novolin NPH and Humulin N

• Novolin NPH and Humulin N are both intermediate-acting human insulins, but their comparability can be assessed based on available studies.
• A study published in 2023 2 compared the pharmacokinetic and pharmacodynamic equivalence of Biocon's biosimilar insulin N with US-licensed Humulin N formulation in healthy subjects, showing that Biocon's Insulin-N was equivalent to Humulin-N for primary PK and PD endpoints.
• Another study from 2022 3 demonstrated the bioequivalence of a regular human insulin produced by Bioton S.A. versus Humulin R, a regular insulin produced by Eli Lilly, in participants with type 1 diabetes.
• However, the provided studies do not directly compare Novolin NPH and Humulin N, but rather compare other insulins or formulations.
• A study from 2009 4 compared insulin analogs and human insulins in the treatment of patients with diabetic ketoacidosis, finding that regular and glulisine insulin are equally effective during acute treatment, but a transition to subcutaneous glargine and glulisine resulted in similar glycemic control with a lower rate of hypoglycemia than with NPH and regular insulin.
• A cost-effectiveness study from 2016 5 compared biphasic insulin aspart 30 with NPH plus regular human insulin in type 2 diabetes patients, finding that biphasic insulin aspart 30 was associated with fewer hypoglycemic events, less weight gain, and higher quality-adjusted life years, and was more cost-effective.
• A study from 2020 6 compared the effects of long-term treatment with (ultra-)long-acting insulin analogues with NPH insulin in adults with type 2 diabetes mellitus, finding that insulin glargine and insulin detemir resulted in fewer participants experiencing hypoglycaemia when compared with NPH insulin.

Key Findings

• Biocon's Insulin-N was found to be equivalent to Humulin-N for primary PK and PD endpoints 2.
• The experimental product regular human insulin and comparator Humulin R are bioequivalent in patients with type 1 diabetes 3.
• Regular and glulisine insulin are equally effective during acute treatment of diabetic ketoacidosis, but a transition to subcutaneous glargine and glulisine resulted in similar glycemic control with a lower rate of hypoglycemia than with NPH and regular insulin 4.
• Biphasic insulin aspart 30 was associated with fewer hypoglycemic events, less weight gain, and higher quality-adjusted life years, and was more cost-effective than NPH plus regular human insulin in type 2 diabetes patients 5.
• Insulin glargine and insulin detemir resulted in fewer participants experiencing hypoglycaemia when compared with NPH insulin 6.