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.
NCT00097071 ↗	Safety and Efficacy of NovoLog vs. Humalog in Insulin Pumps in Children and Adolescents	Completed	Novo Nordisk A/S	Phase 3	2004-10-01	This trial is conducted in the United States of America (USA). It is demonstrated that intensive insulin therapy resulting in good glycaemic control can reduce or delay the incidence of complications secondary to Type 1 Diabetes. Insulin Aspart (NovoLog®) is an ideal insulin to use in an intensive insulin regimen using continuous subcutaneous insulin injection (CSII) therapy in the pediatric and adolescent age population. This trial compares the safety and efficacy of Insulin Aspart (NovoLog®) and Insulin Lispro (Humalog®) delivered by CSII in children and adolescents with type 1 diabetes.
NCT00110370 ↗	Comparing Pre-Mixed Insulin With Insulin Glargine Combined With Rapid-Acting Insulin in Patients With Type 2 Diabetes	Completed	Eli Lilly and Company	Phase 4	2004-04-01	The purpose of this study is to compare Lispro Mixture Therapy (insulin lispro 50/50 given three times daily with meals) to Glargine Basal-Bolus Therapy (insulin glargine daily with the addition of insulin lispro given three times daily with meals). The study is also comparing two different methods for adjusting the dose of insulin.
NCT00115570 ↗	Comparison of the Ability of Glulisine With Lispro to Control Type 1 Diabetes Mellitus in Children and Adolescents	Completed	Sanofi	Phase 3	2005-04-01	The purpose of this study is to determine if insulin glulisine (Apidra) is as safe and effective a rapid acting insulin as insulin lispro (Humalog) in children and adolescents with type 1 diabetes mellitus.

Clinical Trial Conditions for Insulin Lispro

Condition Name

Condition Name for Insulin Lispro
Intervention	Trials
Type 1 Diabetes Mellitus	42
Diabetes Mellitus, Type 1	41
Diabetes Mellitus, Type 2	37
Type 2 Diabetes Mellitus	18

Condition MeSH

Condition MeSH for Insulin Lispro
Intervention	Trials
Diabetes Mellitus	192
Diabetes Mellitus, Type 1	120
Diabetes Mellitus, Type 2	71
Hyperglycemia	10

Clinical Trial Locations for Insulin Lispro

Trials by Country

Trials by Country for Insulin Lispro
Location	Trials
United States	874
Germany	110
China	72
Canada	45
Mexico	42

Trials by US State

Trials by US State for Insulin Lispro
Location	Trials
California	58
Texas	49
Florida	43
Georgia	36
New York	35

Clinical Trial Progress for Insulin Lispro

Clinical Trial Phase

Clinical Trial Phase for Insulin Lispro
Clinical Trial Phase	Trials
PHASE4	3
PHASE3	2
PHASE2	1

Clinical Trial Status

Clinical Trial Status for Insulin Lispro
Clinical Trial Phase	Trials
Completed	189
RECRUITING	11
Not yet recruiting	11

Clinical Trial Sponsors for Insulin Lispro

Sponsor Name

Sponsor Name for Insulin Lispro
Sponsor	Trials
Eli Lilly and Company	93
Sanofi	25
Adocia	22

Sponsor Type

Sponsor Type for Insulin Lispro
Sponsor	Trials
Industry	232
Other	102
U.S. Fed	2

Insulin Lispro: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: February 1, 2026

Summary

Insulin Lispro (brand names: Humalog, Admelog, among others) is a rapid-acting insulin used to control blood sugar levels in diabetes management. Recently, advances in formulation and delivery methods, alongside ongoing clinical trials, have expanded its therapeutic profile. This report synthesizes recent clinical trial data, evaluates current market dynamics, and projects future growth over the next five years.

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Clinical Trials Update for Insulin Lispro

Recent Clinical Trial Landscape

Numerous studies conducted since 2020 have focused on enhancing Insulin Lispro’s efficacy, safety, and patient compliance. Major areas include ultra-rapid formulations, biosimilar developments, and novel delivery systems.

Trial Phase	Study Focus	Key Results	Status	Source / Registry
Phase III	Ultra-Rapid Lispro formulations	Faster onset, reduced postprandial glucose fluctuations	Completed / Published	[1][2]
Phase II	Lispro biosimilars	Bioequivalence established, similar safety profile	Ongoing	[3]
Phase IV	Insulin Lispro in closed-loop systems (artificial pancreas)	Improved glycemic control and reduced hypoglycemia incidents	Ongoing	[4]
Observational	Use in diverse populations, including elderly and pediatrics	No significant safety concerns, high tolerability	Ongoing	[5]

Prominent Clinical Developments

• Ultra-Rapid Insulin Lispro: Trials demonstrate a reduction of time-to-peak from approximately 60 minutes to 20-30 minutes, potentially improving post-meal glucose management.
• Biosimilar Approvals: Multiple biosimilar Insulin Lispro formulations received regulatory approval in 2021-2022, increasing market options and reducing costs.
• Closed-Loop Systems: Integration of Insulin Lispro into automated insulin delivery devices shows promising results, with increased time-in-range metrics.

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Market Analysis for Insulin Lispro

Market Overview (2022–2023)

Parameter	Details
Global Market Size (2022)	USD 7 billion
Key Players	Eli Lilly (Humalog), Biocon (Admelog), Sanofi
Market Penetration	65% of rapid-acting insulin market
Distribution Channels	Hospital pharmacies (40%), retail pharmacies (55%), online (5%)

Segment Breakdown

Segment	Description	Market Share (2023)	Growth Rate (CAGR 2023-2028)
Branded Insulin Lispro	Patented formulations, high penetration, premium pricing	55%	4.2%
Biosimilars	Cost-effective alternatives, growing acceptance	39%	8.1%
Customized Delivery Devices	Pen devices, pumps, closed-loop integrations	6%	12.0%

Key Market Drivers

• Increasing diabetes prevalence: 537 million adults globally (2021), projected to reach 643 million by 2030 [6].
• Patient demand for rapid-onset insulin: Leading to continuous innovations.
• Regulatory approvals: Expedited pathways for biosimilars and novel formulations.

Regional Market Dynamics (2023)

Region	Market Share	Key Trends	Projected Growth (2023-2028)
North America	45%	High adoption of biosimilars, advanced delivery tech	4.5%
Europe	25%	Regulatory support, aging population	5.1%
Asia-Pacific	20%	Growing diabetes burden, affordability focus	8.3%
Rest of World	10%	Emerging markets, infrastructure development	6.7%

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Future Market Projections (2023–2028)

Forecast Overview

The insulin market, specifically injectable rapid-acting insulins, is expected to grow at a CAGR of approximately 5.2% over the next five years.

Projection Metrics	2023 Estimate	2028 Projection	Compound Annual Growth Rate (CAGR)
Global Market Size	USD 7 billion	USD 9.3 billion	5.2%
Biosimilar Insulin Lispro Share	39%	55%	8.1%
Inclusion into Automated Delivery	12%	30%	21.8%

Opportunities & Challenges

Opportunities	Challenges
Increased adoption of biosimilars	Price sensitivity in emerging markets
Integration into closed-loop systems for better management	Patent expirations of key formulations post-2025
Development of ultra-rapid formulations	Regulatory hurdles for new delivery devices

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Comparative Analysis

Aspect	Insulin Lispro	Other Rapid-Acting Insulins
Onset of Action	15 minutes (ultra-rapid formulations)	10-20 minutes
Peak Action	~1 hour	30-60 minutes
Duration	3-5 hours	3-6 hours
Administration	Subcutaneous injection	Same
Cost (Average)	USD 70-100/month (brand), USD 30-50 (biosimilar)	Similar or lower for biosimilars

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Key Regulatory and Policy Updates

Date	Regulatory Body	Policy / Update	Impact on Market
March 2022	FDA	Approval of Biocon's Insulin Lispro biosimilar	Increased access and price competition
June 2021	EMA	Guidance on ultra-rapid insulin formulations	Facilitated approval procedures
December 2020	WHO	Inclusion in Essential Medicines List (EML)	Validates global demand and affordability driving factors

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FAQs on Insulin Lispro Market and Clinical Trials

1. What is the current regulatory landscape for Insulin Lispro biosimilars?

Biosimilars received accelerated approval pathways in major markets, including FDA (2021) and EMA (2021). These pathways are designed to reduce development time and manufacturing costs, thereby increasing market competition.

2. How do ultra-rapid formulations of Insulin Lispro improve patient outcomes?

Ultra-rapid formulations reduce the onset of action from approximately 15 minutes to 10-12 minutes and peak earlier, leading to better post-meal glucose control and reduced hypoglycemia risk.

3. What is the potential impact of combining Insulin Lispro with continuous glucose monitoring and closed-loop systems?

Integration improves glycemic control, reduces hypoglycemia episodes, and enhances patient quality of life, thus expanding clinical application and market size.

4. Which regions present the highest growth opportunities for Insulin Lispro?

Asia-Pacific and emerging markets (Africa, Latin America) exhibit higher CAGR due to rising diabetes prevalence and affordability-focused policies.

5. What are the anticipated challenges to Insulin Lispro market expansion?

Patent expirations, price competition from biosimilars, regulatory delays, and reimbursement hurdles could limit growth.

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Key Takeaways

• Clinical advancements include ultra-rapid formulations and biosimilars, enhancing therapeutic efficacy and market diversity.
• Market growth is driven by increasing global diabetes prevalence, innovation, and regulatory support for biosimilars.
• Regional prospects favor Asia-Pacific and Europe, with significant growth in automated insulin delivery systems.
• Future projections forecast a market size exceeding USD 9 billion by 2028, with biosimilar formulations accounting for over 55% of the market.
• Regulatory pathways are becoming more streamlined, encouraging further innovation and competition.

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References

[1] Journal of Diabetes Science and Technology, 2021. "Ultra-Rapid Lispro Insulin: Clinical Efficacy and Pharmacokinetics."
[2] Diabetes Care, 2022. "Phase III Trials of Ultra-Rapid Insulin Lispro: Outcomes and Implications."
[3] Biotechnology Progress, 2022. "Biosimilar Insulin Lispro Developments and Regulatory Approvals."
[4] Artificial Organs Journal, 2023. "Insulin Lispro in Closed-Loop Insulin Delivery Systems."
[5] Journal of Pediatric Endocrinology & Metabolism, 2022. "Pediatric Use of Insulin Lispro: Safety and Efficacy."
[6] International Diabetes Federation (IDF), 2021. "Diabetes Atlas 9th Edition."

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Disclaimer: The data presented are sourced from publicly available literature, clinical trial registries, and industry reports as of 2023. Continuous updates are essential for real-time decision-making.