Phase III clinical study of new 'super fast-acting' insulin in adults with type 1 diabetes meets primary endpoint

*Read only for medical professionals Reference Diabetes is a chronic disease that causes high blood sugar
.

The International Diabetes Federation (IDF) estimates that in 2021, the number of adults with diabetes in the world will be approximately 537 million, of which China is 140.
9 million, ranking first
;
Insulin is considered an effective treatment for lowering hyperglycemia and is suitable for the treatment of patients with type 1 diabetes (T1DM) and type 2 diabetes (T2DM) when adequate glycemic control cannot be achieved by diet, exercise or other hypoglycemic drugs
.

 According to the secretion pattern of physiological insulin, insulin is divided into basal insulin and prandial insulin
.

Current prandial insulins include short-acting human insulin and rapid-acting insulin analogs [2]
.

For prandial insulin, the speed of onset of action is critical—rapid-acting insulin analogs more closely resemble the physiologic prandial insulin secretion profile than short-acting human insulin, resulting in better and faster postprandial blood glucose control [2]
.

However, the "super speed" of insulin is coming! On February 9, 2022, Eli Lilly announced a 26-week Phase III clinical study (I8B-FH-ITSD) comparing the efficacy and safety of the superfast-acting insulin lispro Lyumjev with insulin lispro in adult patients with T1DM.
The primary study endpoint was met
.

Super-fast-acting insulin significantly improves postprandial blood glucose fluctuation ITSD study is a prospective, randomized, double-blind, multi-country, multi-center, prospective, randomized, double-blind, multi-national, multi-center, clinical trial comparing the efficacy and safety of super fast-acting insulin lispro and insulin lispro combined with basal insulin, respectively, in the treatment of adult T1DM patients.
Phase III positive-controlled clinical study (ClinicalTrials.
gov, NCT03952130)
.

The primary endpoint of the study was non-inferior to baseline change in glycated hemoglobin (HbA1c) at week 26 following subcutaneous injection of super-fast-acting insulin lispro 0-2 minutes before meals in combination with basal insulin (insulin glargine or insulin degludec) in adult patients with T1DM.
Insulin lispro
.

A total of 354 adult T1DM patients (including 285 Chinese patients) were included in this study, and 30 research centers around the world participated in the study
.

The study demonstrated that fast-acting insulin lispro was non-inferior to insulin lispro in change from baseline in HbA1c at 26 weeks [least squares (LS) mean difference (fast-acting insulin lispro-lispro) at a 0.
4% noninferiority margin Insulin) = 0.
07%, 95% confidence interval (CI): -0.
11% to 0.
24%], the primary endpoint was met
.

 In the key multiplicity adjustment objective, fast-acting insulin lispro significantly improved 1-hour postprandial glycemic variability compared with insulin lispro (LS mean difference = -1.
0 mmol/L, 95% CI: -1.
6 mmol/L ~ -0.
3mmol/L, p=0.
003) and 2-hour postprandial blood glucose fluctuations (LS mean difference = -1.
4mmol/L, 95%CI: -2.
3mmol/L ~ -0.
6mmol/L, p=0.
001)
.

In terms of safety, super fast-acting insulin lispro and fast-acting insulin lispro have similar safety profiles, and the two treatment groups have similar incidences of overall hypoglycemia, recorded symptomatic hypoglycemia, and severe hypoglycemia; adverse reactions and injection sites during treatment in the two groups The rate of reaction was similar
.

Studies have confirmed that, compared with the traditional prandial insulin lispro, super fast-acting insulin lispro can provide adult T1DM patients with a prandial insulin with better improvement in postprandial blood glucose fluctuation and better safety and tolerance
.

The super fast-acting insulin is closer to the physiological insulin secretion at mealtime.
The existing mealtime insulin is still unable to match the speed of blood sugar rise after carbohydrate absorption in time
.

Super fast-acting insulin lispro Lyumjev is a super fast-acting insulin analog developed by Eli Lilly.
It has the dual pharmacokinetic characteristics of fast onset and fast metabolism, and is closer to the physiological insulin secretion during meals
.

Compared with the existing fast-acting insulin analog insulin lispro, super fast-acting insulin lispro significantly improved postprandial blood glucose fluctuations and brought more benefits
.

 Since its first global approval in March 2020, the ultra-rapid-acting insulin lispro 100units/mL has been marketed in the United States, the European Union, the United Kingdom, Japan and other countries, and is suitable for improving blood sugar control in adult diabetic patients
.

   Statement 1.
Lyumjev is an investigational drug and has not been approved in China
.

2.
Eli Lilly does not recommend the use of any unapproved drug/indication
.

References: [1]IDF Diabetes Atlas 2021[WWW].
[2]Yimei Mu, Dalong Zhu, Yan Li, et al.
Expert guidance on the clinical application of fast-acting insulin analogs [J].
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