CLINICAL TRIALS PROFILE FOR INSULIN LISPRO

505(b)(2) Clinical Trials for Insulin Lispro

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT02942654 ↗	A Study of LY900014 Formulation in Healthy Participants	Completed	Eli Lilly and Company	Phase 1	2016-11-01	This study evaluates a new formulation of LY900014, a drug that lowers blood sugar. It is administered by injection under the skin of the abdomen. The study will be conducted in healthy people to investigate how quickly and how much LY900014 is absorbed and the effect of different doses of LY900014 on blood sugar levels. Side effects and tolerability will be documented. The study will last about 6 to 7 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.
New Formulation	NCT03232983 ↗	A Study of LY900014 Formulation at Different Injection Sites in Healthy Participants	Completed	Eli Lilly and Company	Phase 1	2017-08-14	This study evaluates a new formulation of insulin lispro, LY900014, a drug that lowers blood sugar. It is administered by injection into the vein and under the skin of the abdomen, thigh and arm. The study will be conducted in healthy people to investigate the effect of different injection sites on the amount of insulin lispro in the bloodstream. Side effects and tolerability will be documented. The study will last for about 10 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.
New Formulation	NCT04049123 ↗	A Study of LY900014 in Healthy Chinese Participants	Completed	Eli Lilly and Company	Phase 1	2019-11-18	The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which is a drug that lowers blood sugar. The study will look at how the body processes LY900014 and the affect of LY900014 on blood sugar levels. For each participant, the study will consist of 3 periods and will last about 51 days.
New Formulation	NCT04161976 ↗	A Study of LY900027 Given by Insulin Pump to Participants With Type 1 Diabetes Mellitus	Completed	Eli Lilly and Company	Phase 1	2019-12-27	The main purpose of this study is to learn more about a new formulation of insulin lispro when given by an insulin pump to participants with type 1 diabetes mellitus. The study will investigate how the body processes the drug and how the drug affects the body. Information about side effects will be collected. The study will last from six to 12 weeks for each participant.

All Clinical Trials for Insulin Lispro

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00036504 ↗	Efficacy and Safety of Twice-Daily Insulin Lispro Low Mixture Compared to a Once-Daily Long Acting Insulin Comparator in Patients Who Have Been Using One or More Oral Antihyperglycemic Agents Without Insulin	Completed	Eli Lilly and Company	Phase 4	2001-08-01	The purposes of this study are to determine: 1. If patients taking insulin lispro LM with metformin will have better overall control of their blood sugar than patients taking a long acting insulin comparator with metformin. 2. If there is a difference in the way the two treatments affect blood sugar control before and after meals and at night. 3. If there is a difference in the insulin dose required with the two treatments. 4. If there is a difference in the numbers of times patients experience low blood sugar with the two treatments. 5. If there is a difference in the effect on patients's body weight.
NCT00046501 ↗	Compare Blood Sugar Level Between Lantus in the Morning and Other Insulins in Type 1 Diabetes Adolescents	Completed	Sanofi	Phase 3	2002-11-01	The purpose of the study is to compare the effect in blood sugar control between Lantus and twice daily intermediate acting insulins (NPH or Lente) when used as the basal insulin in a multiple daily injection setting with fast acting insulin (Lispro)
NCT00071448 ↗	Insulin Aspart vs. Insulin Lispro vs. Regular Insulin in Paediatric Population	Completed	Novo Nordisk A/S	Phase 3	2002-06-01	This trial is conducted in the United States of America (USA). The aim of this trial is to to determine whether insulin aspart can be used effectively and safely in paediatric patients.
NCT00095446 ↗	NovoLog Observation Trial in Subjects With Type 1 and Type 2 Diabetes	Completed	Novo Nordisk A/S	Phase 4	2004-07-01	This trial is conducted in the United States of America (USA). The aim of this trial is to assess control of blood sugar, safety, and patient acceptance of insulin aspart compared to insulin lispro, both in insulin pumps, in standard clinical practice.

Clinical Trial Conditions for Insulin Lispro

Condition Name

Condition Name for Insulin Lispro
Intervention	Trials
Type 1 Diabetes Mellitus	41
Diabetes Mellitus, Type 1	40
Diabetes Mellitus, Type 2	36
Type 2 Diabetes Mellitus	18

Condition MeSH

Condition MeSH for Insulin Lispro
Intervention	Trials
Diabetes Mellitus	190
Diabetes Mellitus, Type 1	115
Diabetes Mellitus, Type 2	70
Hyperglycemia	10

Clinical Trial Locations for Insulin Lispro

Trials by Country

Trials by Country for Insulin Lispro
Location	Trials
United States	861
Germany	109
China	71
Canada	44
Mexico	41

Trials by US State

Trials by US State for Insulin Lispro
Location	Trials
California	57
Texas	47
Florida	42
Georgia	35
Washington	34

Clinical Trial Progress for Insulin Lispro

Clinical Trial Phase

Clinical Trial Phase for Insulin Lispro
Clinical Trial Phase	Trials
Phase 4	56
Phase 3	56
Phase 2/Phase 3	5

Clinical Trial Status

Clinical Trial Status for Insulin Lispro
Clinical Trial Phase	Trials
Completed	188
Not yet recruiting	11
Recruiting	9

Clinical Trial Sponsors for Insulin Lispro

Sponsor Name

Sponsor Name for Insulin Lispro
Sponsor	Trials
Eli Lilly and Company	91
Sanofi	25
Adocia	22

Sponsor Type

Sponsor Type for Insulin Lispro
Sponsor	Trials
Industry	227
Other	96
U.S. Fed	2

Insulin Lispro: Clinical Trials, Market Analysis, and Projections

Introduction to Insulin Lispro

Insulin lispro is a synthetic, rapid-acting insulin analog used by diabetic patients to manage postprandial hyperglycemia. It is characterized by its rapid onset and short duration of action, making it an essential tool in diabetes management, particularly for Type 1 and Type 2 diabetes patients.

Clinical Trials Update

Adocia's BioChaperone Lispro

Adocia, a clinical-stage biopharmaceutical company, has been at the forefront of developing an ultra-rapid insulin formulation known as BioChaperone Lispro. Here are some key updates from their clinical trials:

• Phase 3 Clinical Trials: Adocia and its partner, Tonghua Dongbao, have completed the final dosing in a Phase 3 clinical trial involving over 1,500 patients with Type 1 and Type 2 diabetes in 100 clinical centers across China. This trial aims to demonstrate the safety and efficacy of BioChaperone Lispro compared to Humalog (Eli Lilly). The primary efficacy endpoint is the change in HbA1c from baseline to 26 weeks of treatment, with secondary endpoints focusing on postprandial glucose excursions[1][3].

• Milestone Payment: The completion of the final dosing in the Type 2 diabetes trial has triggered a $10 million milestone payment to Adocia, expected in the second quarter of 2025[1].

• Phase 2a Clinical Trial Results: Previous Phase 2a trials have shown that BioChaperone Lispro has a 30% earlier onset of action and a 69% stronger early metabolic effect compared to Humalog. This ultra-fast action is expected to improve both short- and long-term glycemic control[3].

Other Ongoing Trials

• Hepatocyte-Directed Vesicles-insulin lispro (HDV-L): A Phase 2b trial is currently underway to compare HDV-L to standard insulin lispro in adults with Type 1 diabetes. This study aims to assess whether directing insulin to the liver can improve hypoglycemia management[4].

Market Analysis

Global Market Trends

The global insulin lispro market is projected to experience significant growth from 2024 to 2032, driven by several key factors:

• Increasing Prevalence of Diabetes: The rising number of diabetic patients worldwide, particularly in regions like Asia-Pacific, is a major driver. China alone accounts for over one in four diabetic patients globally[1][5].

• Technological Advancements: Emerging technical breakthroughs and the use of digital technology in healthcare are enhancing the efficiency and accessibility of insulin treatments[2].

• Consumer Demands: Changing consumer demands for more effective and convenient diabetes management solutions are pushing the market forward[2].

Key Players

The insulin lispro market is dominated by several key manufacturers:

• Eli Lilly and Company: Known for their Humalog brand, Eli Lilly is a leading player in the global insulin lispro market[2].

• Gan & Lee Pharmaceuticals: Another significant player, Gan & Lee Pharmaceuticals is particularly strong in the Asian market, including China and India[2].

Regional Segmentation

The market is segmented across various regions, with significant growth expected in:

• Asia-Pacific: Countries like China, Japan, South Korea, and India are driving the growth due to increasing industrialization and a rising diabetic population[2].

• North America: The U.S. and Canada are also key markets, with a high demand for advanced insulin products[2].

• Europe: Countries such as Germany, France, the U.K., and Italy are part of the growing European market[2].

Market Projections

Market Size and Growth Rate

The global insulin lispro market is projected to reach a significant value by 2030, growing at a substantial CAGR from 2024 to 2030. This growth is driven by the increasing demand for rapid-acting insulins and the expanding diabetic population worldwide[2].

Product Types and Applications

The market is categorized into different product types, including:

• Insulin Aspart: Another type of rapid-acting insulin analog.
• Mixed Insulin Aspart: A combination product used for both basal and prandial insulin needs[2].

The primary applications are in the management of:

• Type 1 Diabetes: Insulin is the only effective treatment for Type 1 diabetes.
• Type 2 Diabetes: A significant portion of Type 2 diabetes patients eventually become insulin-dependent[5].

Regional Market Insights

China

China is a critical market for insulin lispro due to its large diabetic population. By the end of 2020, the number of diabetic patients in China had exceeded 113 million, with insulin-dependent patients driving the demand for advanced insulin products like lispro[5].

India and Other Emerging Markets

India and other emerging markets in the Asia-Pacific region are also seeing significant growth. The top manufacturers in India, such as Eli Lilly and Gan & Lee Pharmaceuticals, hold a substantial market share[2].

Key Takeaways

• Clinical Trials: Adocia's BioChaperone Lispro is showing promising results in Phase 3 trials, with a faster onset of action compared to Humalog.
• Market Growth: The global insulin lispro market is expected to grow significantly from 2024 to 2032, driven by increasing diabetes prevalence and technological advancements.
• Key Players: Eli Lilly and Gan & Lee Pharmaceuticals are dominant players in the market.
• Regional Focus: Asia-Pacific, particularly China and India, are crucial regions for market growth.

FAQs

What is the primary use of insulin lispro?

Insulin lispro is used to manage postprandial hyperglycemia in diabetic patients, particularly those with Type 1 and Type 2 diabetes.

Which companies are leading the insulin lispro market?

Eli Lilly and Company and Gan & Lee Pharmaceuticals are among the leading manufacturers of insulin lispro.

What are the key regions driving the growth of the insulin lispro market?

The Asia-Pacific region, including China, India, Japan, and South Korea, is a significant driver of market growth, along with North America and Europe.

What is BioChaperone Lispro, and how does it differ from Humalog?

BioChaperone Lispro is an ultra-rapid insulin formulation developed by Adocia, which has a 30% earlier onset of action and a 69% stronger early metabolic effect compared to Humalog[3].

What are the projected market trends for insulin lispro from 2024 to 2032?

The market is expected to grow significantly, driven by increasing diabetes prevalence, technological advancements, and changing consumer demands[2].

Sources

1. ADOCIA and Tonghua Dongbao Announce the Final Dosing in a Phase 3 Clinical Study of BioChaperone® Lispro. Business Wire, 12 Dec 2024.
2. Insulin Lispro Market Analysis 2024-2032: Trends, Drivers, Challenges, and Quantitative Insights. Southeast News Channel Nebraska, 27 Nov 2024.
3. Insulin issue - Drug Discovery News. Drug Discovery News.
4. Phase 2b Trial Comparing HDV-Insulin Lispro to Insulin Lispro in Adults with Type 1 Diabetes Receiving Insulin Degludec. CenterWatch, 11 Jul 2024.
5. China Recombinant Lispro Insulin Market Report 2021-2025. Business Wire, 21 Apr 2021.

Last updated: 2025-01-04