Insulin human isophane

Table of contents

• What is insulin human isophane?
• How does insulin human isophane work?
• Which conditions is it used or studied for?
• How is insulin human isophane given?
• What do the clinical trials show?
• What side effects are known?
• Which drug interactions are known?

What is insulin human isophane?

Insulin human isophane is an intermediate-acting human insulin, also known as NPH insulin (Neutral Protamine Hagedorn). It is classified as insulin (human) with ATC code A10AC01.^[1] The substance is authorised as a medicine and is sold under brand names including Humulin I and Insulatard.^[3] In the trial data provided, insulin human isophane appears as an auxiliary treatment in one trial, meaning it was used as a supporting medicine rather than as the main substance being investigated.^[1]

How does insulin human isophane work?

Insulin human isophane lowers blood sugar by helping glucose move from the blood into the body's cells, where it is used for energy. As an intermediate-acting insulin, it has an onset of action of about 30 minutes to 1.5 hours, a maximum effect between 1 and 12 hours depending on the product, and a duration of action of 22 to 24 hours.^[3] This means it works more slowly and lasts longer than short-acting insulins, helping to keep blood sugar levels stable between meals and overnight.

Which conditions is it used or studied for?

• Type 2 diabetes — insulin human isophane is used to help control blood sugar in adults with type 2 diabetes who need insulin.
• Type 1 diabetes — as a human insulin, it is also used in people with type 1 diabetes, although the trial data provided focuses on type 2 diabetes.

In the clinical trial data provided, insulin human isophane appears as an auxiliary treatment in a study of people with type 2 diabetes who were already treated with once-daily basal insulin with or without metformin.^[1]

How is insulin human isophane given?

Insulin human isophane is given by subcutaneous injection, which means it is injected under the skin.^[1] It is available as a suspension for injection in vials, cartridges, and pre-filled pens such as Humulin I KwikPen and Insulatard Penfill.^[3] The usual timing is about 30 minutes before meals or at bedtime, usually once or twice daily, depending on the individual's needs.^[3]

What do the clinical trials show?

The clinical trial data provided contains one completed Phase 3 trial (2022-502679-43-00) that studied cagrilintide semaglutide, not insulin human isophane itself. Insulin human isophane appears in this trial as an auxiliary treatment.^[1] The trial, called REIMAGINE 3, enrolled 274 people with type 2 diabetes who had inadequate blood sugar control on once-daily basal insulin with or without metformin. The primary outcome was the change in HbA1c, a measure of average blood sugar over the previous two to three months, from baseline at week 0 to the end of treatment at week 40.^[1] The trial was designed to confirm whether CagriSema was superior to placebo in lowering HbA1c.

What is the status of the trial?

The single trial in the data is completed.^[1] This means the study has finished and the results have been collected, although the outcomes are not reported in the data provided.

Who could take part in the trial?

The trial enrolled adults with type 2 diabetes who were already treated with once-daily basal insulin with or without metformin and whose blood sugar control was inadequate.^[1] Insulin human isophane was among the basal insulins listed in the trial interventions, alongside insulin degludec, insulin glargine, and insulin detemir.^[1]

What side effects are known?

The supplementary sources do not provide a dedicated list of side effects for insulin human isophane. However, the drug interaction source notes that hypoglycemia, or low blood sugar, is a known risk with insulin therapy, with signs and symptoms including headache, dizziness, drowsiness, nausea, hunger, tremor, weakness, sweating, and palpitations.^[2] Patients should be counselled on how to recognise and treat low blood glucose.^[2]

Which drug interactions are known?

Insulin human isophane can interact with other antidiabetic drugs, including other insulins such as insulin regular. When insulins are used together or with non-insulin antidiabetic agents, the blood sugar-lowering effect may be increased, which can raise the risk of hypoglycemia.^[2] Close monitoring for low blood sugar is recommended, particularly when therapy is started, stopped, or adjusted, and in people at higher risk such as older adults or those with kidney problems.^[2]