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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT


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All Clinical Trials for Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00487240 ↗ Comparison of Two Basal Insulin Therapies for Patients With Type 1 Diabetes Completed Eli Lilly and Company Phase 3 2007-06-01 The purpose of this study is to examine the efficacy and safety of insulin lispro protamine suspension (ILPS) as compared to insulin detemir as basal insulin combined with mealtime insulin therapy in patients with type 1 diabetes. A gatekeeper strategy will be employed for sequentially testing the secondary objectives.
NCT00494013 ↗ Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY) Completed Eli Lilly and Company Phase 3 2007-08-01 The purpose of this study is to examine the effectiveness and safety of insulin lispro protamine suspension (ILPS) as compared to insulin detemir as basal insulin therapy in adults with type 2 diabetes. A gatekeeper strategy will be employed for sequentially testing the secondary objectives.
NCT00510952 ↗ Comparison of Two Basal Insulins for Patients With Type 2 Diabetes on Anti-Hyperglycemic Medications (IOPE) Completed Eli Lilly and Company Phase 3 2007-08-01 The purpose of this study is to examine the effectiveness and safety of insulin lispro protamine suspension (ILPS) as compared to insulin glargine as basal insulin therapy in adults with type 2 diabetes.
NCT00560417 ↗ Comparison of Two Basal Insulins for Patients With Type 2 Diabetes Taking Oral Diabetes Medicines and Exenatide Completed Eli Lilly and Company Phase 3 2007-11-01 This study will compare insulin lispro protamine suspension (ILPS) and insulin glargine in combination with the patient's oral diabetes medications and exenatide, for their ability to control blood sugar in patients with type 2 diabetes.
NCT00641407 ↗ Bedtime Insulins and Oral Antihyperglycemic Drugs in Type 2 Diabetes Completed Second University of Naples Phase 4 2007-01-01 The maintenance of nearly normal glycemic levels reduces the risk of diabetic complications, but is difficult to achieve, despite the administration of escalating doses of oral antidiabetic drugs, such as metformin, sulfonylureas, and thiazolidinediones. Most patients eventually require insulin which usually is added when glycemic control with a regimen of oral antidiabetic agents becomes suboptimal. The aims of the present study were: 1) To compare the clinical efficacy of insulin glargine and neutral protamine lispro (NPL) insulin when added to ongoing oral therapy in poorly controlled type 2 diabetic patients; 2) to find out the possibility to phenotype the patient who may benefit more by the single treatment. This an open-label, randomized, parallel, 36-week comparative study was performed between January 2007 and March 2008 at a single centre.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant

Condition Name

Condition Name for Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant
Intervention Trials
Diabetes Mellitus, Type 2 4
Type 2 Diabetes Mellitus 2
Diabetes, Type I 1
Hyperglycemia 1
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Condition MeSH

Condition MeSH for Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant
Intervention Trials
Diabetes Mellitus 9
Diabetes Mellitus, Type 2 7
Hyperglycemia 1
Hypoglycemia 1
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Clinical Trial Locations for Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant

Trials by Country

Trials by Country for Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant
Location Trials
United States 61
United Kingdom 4
Mexico 3
Greece 2
Romania 2
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Trials by US State

Trials by US State for Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant
Location Trials
Texas 4
New York 3
Louisiana 3
Kentucky 3
Indiana 3
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Clinical Trial Progress for Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant

Clinical Trial Phase

Clinical Trial Phase for Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant
Clinical Trial Phase Trials
Phase 4 3
Phase 3 6
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant
Clinical Trial Phase Trials
Completed 10
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Clinical Trial Sponsors for Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant

Sponsor Name

Sponsor Name for Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant
Sponsor Trials
Eli Lilly and Company 5
Sanofi 1
Baylor College of Medicine 1
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Sponsor Type

Sponsor Type for Insulin Lispro Protamine Recombinant; Insulin Lispro Recombinant
Sponsor Trials
Industry 6
Other 5
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Insulin Lispro: Clinical Trials, Market Analysis, and Projections

Introduction to Insulin Lispro

Insulin lispro, a rapid-acting insulin analogue, has revolutionized the management of diabetes by offering a faster onset and shorter duration of action compared to traditional human insulin. Developed by Eli Lilly, insulin lispro is marketed under the trade names Humalog, Humalog Mix25, and Humalog Mix50.

Clinical Trials and Development

Early Clinical Trials

Insulin lispro has been extensively studied in clinical trials to evaluate its efficacy and safety. A notable study published in PubMed involved a double-blind crossover trial where insulin lispro was compared to human regular insulin in patients with type 1 diabetes using continuous subcutaneous insulin infusion (CSII). The results showed that insulin lispro improved glycemic control without increasing the risk of hypoglycemia[3].

Recent Clinical Trials in China

In China, several domestic pharmaceutical companies are advancing in the clinical trials of insulin lispro. For instance, in October 2018, Tonghua Dongbao Pharmaceutical Co., Ltd. announced that the China Food and Drug Administration (CFDA) had approved the clinical trials of its Recombinant Lispro Insulin Injection, Mixed Protamine Zinc Recombinant Human Insulin Lispro Injection (25R), and Mixed Protamine Zinc Recombinant Human Insulin Lispro Injection (50R)[1][2][4].

Market Analysis in China

Market Size and Growth

The market for insulin lispro in China has seen significant growth since its introduction. By the end of 2020, the annual sales value of insulin lispro had increased from less than CNY 7 million in 2005 to CNY 254 million. This growth is largely driven by the increasing number of diabetic patients in China, which exceeded 113 million by the end of 2020[1][2].

Major Manufacturers

Currently, the Chinese market for insulin lispro is dominated by Eli Lilly and Gan & Lee Pharmaceuticals. Eli Lilly's products, including Humalog, Humalog Mix25, and Humalog Mix50, held more than 96% of the market share by sales value in 2020, although this share is slowly declining as other domestic companies enter the market[1][2].

Pricing and Accessibility

The prices of insulin lispro products in China vary, but the market is expected to become more competitive as more domestic manufacturers launch their versions. This competition is likely to make these essential drugs more accessible to a broader population of diabetic patients[1][2].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the insulin lispro market in China. While the pandemic disrupted supply chains and healthcare services, the increased focus on healthcare and the need for effective diabetes management have also driven demand for insulin lispro. The market has shown resilience, and the long-term growth prospects remain positive[1][2].

Factors Affecting Market Development

Increasing Prevalence of Diabetes

The rising number of diabetic patients in China is a key driver of the insulin lispro market. With 30% to 40% of type 2 diabetes patients eventually becoming insulin-dependent, the demand for insulin lispro is expected to continue growing[1][2].

Government Approvals and Regulations

Government approvals and regulatory support are crucial for the entry of new products into the market. The CFDA's approval of clinical trials for domestic companies like Tonghua Dongbao Pharmaceutical Co., Ltd. is a significant factor in the market's expansion[1][2][4].

Competition from Domestic Manufacturers

The entry of more domestic pharmaceutical companies into the insulin lispro market is expected to increase competition, potentially driving down prices and improving accessibility. This competition is also likely to spur innovation and improve product quality[1][2].

Market Projections

Future Growth Potential

Given the increasing prevalence of diabetes and the growing demand for effective insulin therapies, the Chinese market for insulin lispro is projected to continue its growth trajectory. The market is expected to see the launch of more products from domestic manufacturers, which will further expand the market size and reach[1][2].

Global Context

Globally, the market for Mixed Protamine Zinc Recombinant Human Insulin Lispro Injection is also expected to grow, with projections indicating significant increases by 2029. This global trend is likely to influence and support the growth of the Chinese market[5].

Key Takeaways

  • Clinical Trials: Insulin lispro has shown efficacy in clinical trials, improving glycemic control without increasing hypoglycemia risk.
  • Market Growth: The Chinese market for insulin lispro has grown significantly since 2005, driven by the increasing number of diabetic patients.
  • Major Manufacturers: Eli Lilly and Gan & Lee Pharmaceuticals currently dominate the market, but other domestic companies are entering.
  • Impact of COVID-19: The pandemic has had a mixed impact, but long-term growth prospects remain positive.
  • Future Projections: The market is expected to grow with more domestic products launching and increasing competition.

FAQs

Q: What is insulin lispro, and how does it differ from traditional insulin?

A: Insulin lispro is a rapid-acting insulin analogue that has a faster onset and shorter duration of action compared to traditional human insulin, making it more aligned with physiological meal insulin secretion[3].

Q: Which companies are currently manufacturing insulin lispro in China?

A: The primary manufacturers in China are Eli Lilly and Gan & Lee Pharmaceuticals, with other domestic companies like Tonghua Dongbao Pharmaceutical Co., Ltd. entering the market through approved clinical trials[1][2].

Q: How has the COVID-19 pandemic affected the insulin lispro market in China?

A: The pandemic has had a mixed impact, disrupting supply chains but also increasing demand for effective diabetes management, leading to a resilient market with positive long-term growth prospects[1][2].

Q: What are the key factors driving the growth of the insulin lispro market in China?

A: The increasing prevalence of diabetes, government approvals, and the entry of more domestic manufacturers are key drivers of market growth[1][2].

Q: What are the projections for the future growth of the insulin lispro market?

A: The market is expected to continue growing with the launch of more products from domestic manufacturers, increasing competition, and a rising demand driven by the growing number of diabetic patients[1][2][5].

Sources

  1. ResearchAndMarkets.com: "Investigation Report on China's Recombinant Lispro Insulin Market, 2021-2025"[1].
  2. GlobeNewswire: "China Recombinant Lispro Insulin Markets, 2016-2020 & 2021-2025"[2].
  3. PubMed: "Insulin lispro in CSII: results of a double-blind crossover study"[3].
  4. GlobeNewswire: "China Recombinant Lispro Insulin Markets, 2016-2020 & 2021-2025"[4].
  5. Valuates Reports: "Global Mixed Protamine Zinc Recombinant Human Insulin Lispro Injection Market"[5].

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