Active ingredient: Insulin Lispro
Chemical name: 28B-L-Lysine-29B-L-proline insulin
Chemical structural formula:
Molecular formula: C257H383N65O77S6
Molecular weight: 5808
Excipients: Zinc oxide, M-cresol, Glycerin, Sodium phosphate dibasic anhydrous, Hydrochloric acid (for pH adjustment), Sodium hydroxide (for pH adjustment), Water for injections.
The onset of action of insulin lispro is fast (about 15 minutes), so the time interval between administration and meal can be shorter (0-15 minutes before a meal for insulin lispro) compared to regular insulin (45 minutes after additional administration). The onset of action of insulin lispro is fast, and the duration of action is shorter (2-5 hours) compared to regular insulin.
The pharmacokinetics of insulin lispro indicates that it is a rapidly absorbed compound, reaching peak blood concentrations 30-70 minutes after subcutaneous injection. When considering the clinical significance of these kinetics, it is best to look at the glucose utilization curve.
The following content is intended to answer your questions only and is not intended to be used for promotional purposes or as a clinical medication guidance.
※ Product Characteristics
● What is the basic information about Prandilin®?
The generic name of Prandilin® is insulin lispro injection, and it contains insulin lispro as its active ingredient. It is indicated for the treatment of diabetes in people who require insulin to maintain normal blood glucose levels. Prandilin®️ received marketing approval in China in 2007. Insulin lispro is known for its rapid onset of action and is typically taken close to meals (about 15 minutes before). The specific dosage of insulin lispro should be determined by a healthcare professional based on the individual needs of the patient. Notably, Prandilin® is classified as a biosimilar, meaning it closely mirrors the quality, safety, and efficacy of the authorized reference (originator) product.
● Will Prandilin® cause liver and kidney problems like some oral hypoglycemic drugs?
Prandilin® is not associated with liver or kidney problems. The liver and kidneys are involved in the elimination of the body's own insulin. The introduction of exogenous insulin does not place an additional burden on these organs. In cases of liver or kidney dysfunction, the need for insulin may be reduced due to the reduced breakdown of endogenous insulin. Therefore, people using insulin should continue to monitor their blood glucose levels and adjust their dose if necessary.
● Is injecting Prandilin® addictive? Could higher doses lead to dependence?
Prandilin® is not associated with addiction or dependence. Addiction is when an individual develops an intense craving for a substance to obtain psychological or physiological effects, leading to uncontrollable and compulsive use. Unlike addictive substances, Prandilin® is a form of insulin, a natural hormone that is essential for metabolic processes and the maintenance of life. The use of insulin is determined by factors such as blood glucose control and the functioning of the body's β cells. It is not addictive and its necessity is dictated by medical considerations rather than addictive tendencies.
● What are the precautions for the use of Prandilin® in special populations? Are there efficacy and safety data?
Pregnant and breastfeeding women: Extensive pregnancy exposure data in the literature suggest that insulin lispro has no adverse effects during pregnancy or on fetal or neonatal health (as stated in the prescribing information). The 2009 International Diabetes Federation Guidelines for Diabetes Mellitus in Pregnancy also classify insulin lispro as non-transplacental (as stated in the prescribing information).
Children: Use with caution. There are no clinical trial results specific to Chinese children, and efficacy and safety in this population have not been established. Results from clinical trials involving 61 children aged 2-11 years and 481 adolescents aged 9-19 years suggest that the pharmacodynamic properties of insulin lispro in children are similar to those observed in adults (as stated in the prescribing information).
Older people: No special instructions, please refer to the [Dosage] in the prescribing information or follow doctor's advice.
※ Clinical Study
● What are the pharmacokinetics/pharmacodynamics (PK/PD) of Prandilin®️ compared to the reference drug, the original insulin lispro?
In 2021, Gan & Lee Pharmaceuticals (the applicant) conducted a Phase 1 clinical trial using a randomized, double-blind, triple-crossover design with positive glucose clamp techniques. The results, reported by Zijlstra et al. at the American Diabetes Association (ADA), showed that Prandilin®️ was bioequivalent to the original reference insulin lispro product available in the US and EU. This equivalence covered both pharmacokinetic (PK) and pharmacodynamic (PD) aspects. In addition, the study included 38 healthy male subjects and the safety profile of Prandilin®️ was very similar to that of the reference drug.
The key pharmacokinetic (PK) parameters, Cmax and AUC0–12h, showed PK bioequivalence between Prandilin®️ and the original reference drug. This equivalence was demonstrated by the 90% confidence intervals (CIs) falling entirely within the predefined PK similarity range of 80% to 125%.
Figure 1 Comparison of mean PK curves (±SEMs) and primary endpoints
The key pharmacodynamic (PD) measures, GIRmax and AUCGIR.0-24h, showed a comparable glucose infusion rate (GIR) pattern between Prandilin®️ and the original reference drug. The PD endpoints met bioequivalence criteria with both the 90% and 95% confidence intervals (CIs) ranging from 80.00% to 120.00% similarity.
Figure 2 Comparison of mean PD curves (±SEMs) and primary endpoints
Consistent and comparable safety was observed across the three treatment groups, with all insulin types being well tolerated. The incidence of adverse events was similar and there were minimal cases of injection site reactions.
※ Clinical Application
● Does Prandilin®️ require a higher dosage than the original insulin lispro to achieve equivalent efficacy?
Prandilin®️ did not differ in dosage compared with the original insulin lispro. A bioequivalence trial was conducted in Germany, and no difference in pharmacodynamic and pharmacokinetic parameters between Prandilin®️ and the original insulin lispro in humans was found through a glucose clamp test lasting 12 h (Zijlstra et al., 2021).
● Can Prandilin® (cartridge) be used with an insulin pump?
Prandilin®️ can be administered via an insulin pump. The prescribing information introduces catheter occlusion and infusion site reactions when using insulin pumps with this product and human insulin.
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