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Home / Company News / IDF 2023丨Debut of the Phase III Clinical Evidence in China for Rapilin30
IDF 2023丨Debut of the Phase III Clinical Evidence in China for Rapilin30
Date:2023-12-08
  •  The Phase III clinical study results have revealed that in patients with type 1 or type 2 diabetes, Gan & Lee Pharmaceuticals' Insulin Aspart 30 Injection (Rapilin? 30) is similar in efficacy to NovoMix? 30

  • The study indicates that Rapilin? 30 shares comparable safety and tolerability with NovoMix? 30


In December 2023, at the International Diabetes Federation (IDF) Virtual Congress 2023, Gan & Lee Pharmaceuticals unveiled the Phase III clinical study data of its self-developed Insulin Aspart 30 Injection (Rapilin? 30) for the first time. The results showed that Rapilin? 30 is similar in efficacy and safety to the reference product, NovoMix? 30. This study provides strong evidence supporting the use of Rapilin? 30 in diabetes treatment.


The study was a multicenter, randomized, open-label, parallel-group Phase III clinical trial. It enrolled 569 patients with type 1 or type 2 diabetes (7.0% < HbA1c ≤ 13.0%, FBG ≥ 7.8 mmol/L) who required insulin therapy. Participants, previously on a stable dose of one or two oral hypoglycemic agents for over three months but still not meeting glycemic targets, were randomly assigned in a 3:1 ratio to receive either Rapilin? 30 (N = 428) or NovoMix? 30 (N = 141) twice daily before breakfast and dinner. The treatment lasted for 24 weeks, with insulin dosages adjusted based on pre-dinner and pre-breakfast blood glucose levels. The efficacy was evaluated based on changes in glycated hemoglobin (HbA1c), the percentage of patients achieving target HbA1c levels (<7.0% and ≤6.5%), changes in fasting blood glucose (FBG), and 2-hour postprandial glucose (2hPPG) after 24 weeks of treatment. Safety was compared by analyzing hypoglycemic events and adverse events (including local injection reactions) at 24 weeks.


The results showed that the efficacy of Rapilin? 30 was not inferior to NovoMix? 30. After 24 weeks, the mean HbA1c change from baseline was -1.73% (Rapilin? 30) and -1.64% (NovoMix? 30) with no significant difference between two treatment groups (F=0.77, P=0.3794). The least-squares (LS) mean HbA1c difference was 0.09% (95% CI: -0.11, 0.28), meeting the predefined non-inferiority criteria (i.e., upper limit ≤0.4%).


In addition, comparable results were reported for mean 2hPPG (-5.18 and -4.05 mmol/L, P=0.3298) and FPG (-2.79 and -2.60 mmol/L, P=0.8061) in the Rapilin? 30 and NovoMix? 30 groups, respectively. Additionally, the proportion of patients achieving target HbA1c levels and the percentage of patients with at least a 1% reduction in HbA1c were similar between the two groups.


The analysis of hypoglycemic events revealed that the incidence of hypoglycemia in the Rapilin? 30 group and the NovoMix? 30 group was not significantly different (P=0.74). Apart from hypoglycemic events, the occurrence of adverse events (AEs) reported in both groups was similar. The incidence of drug-related adverse events (IP-related AEs) and serious adverse events (SAEs) was less than 5%, mainly including local injection reactions, injection site induration, and rash.


The trial results demonstrate that Gan & Lee Pharmaceuticals' Insulin Aspart 30 Injection (Rapilin? 30) is equivalent in its therapeutic effect on patients with type 1 and type 2 diabetes to NovoMix? 30, with comparable safety and tolerability profiles during treatment.


Phase III Clinical Study of Rapilin? 30 in China

As the first domestically produced Insulin Aspart 30 Injection in China, this key Phase III clinical study demonstrates that Gan & Lee Pharmaceuticals' Rapilin? 30 is similar in efficacy, safety, and tolerability to the reference product NovoMix? 30 in diabetic patients. The study was led by Professor Wenying Yang of China-Japan Friendship Hospital and conducted across 19 research institutions nationwide. It was designed as a randomized, open-label, parallel-group trial, enrolling 569 patients with type 1 or type 2 diabetes to explore the comparability in efficacy and safety of Rapilin? 30 and NovoMix? 30 after 24 weeks of continuous administration.

For further information on the Phase III clinical study results of Rapilin? 30 in China, please visit the Gan & Lee Pharmaceuticals Diabetes Products Medical Information website at https://www.ganleediabetes.com/.

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About Rapilin? 30

Rapilin? 30 (generic name: Insulin Aspart 30 Injection) contains 30% soluble Insulin Aspart and 70% protamine-crystallized Insulin Aspart. It is approved for the treatment of diabetes and was launched in China in 2021. Insulin Aspart 30 Injection is a biphasic insulin formulation. Depending on the patient's blood sugar levels, a once or twice daily injection regimen can be chosen. Generally, it should be injected immediately before meals, but if necessary, it can also be administered immediately after meals. As a biosimilar, Rapilin? 30 demonstrates high similarity in quality, safety, and efficacy to the already approved reference drug (original reference product).


About Gan & Lee

Gan & Lee Pharmaceuticals has developed the first Chinese domestic biosynthetic human insulin. Currently, we have six core insulin products, including five insulin analog varieties: long-acting glargine injection (Basalin?), fast-acting lispro injection (Prandilin?), fast-acting aspart injection (Rapilin?), mixed protamine zinc lispro injection (25R) (Prandilin?25), aspart 30 injection (Rapilin?30), and one human insulin injection - mixed protamine human insulin injection (30R) (Similin?30). We have two approved medical devices in China, namely reusable insulin injection pen (GanleePen), and disposable pen needle (GanleeFine?).

 

In the future, Gan & Lee strives to achieve a comprehensive coverage in the field of diabetes diagnosis and treatment. Moving forward to advance our goal of becoming a world-class pharmaceutical company, we will also take an active part in developing new chemical entities, and work on the treatment of cardiovascular diseases, metabolic diseases, cancer, and other therapeutics.



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