CLINICAL TRIALS PROFILE FOR LENTE INSULIN

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

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 Combination	NCT00151697 ↗	LANN-study: Lantus, Amaryl, Novorapid, Novomix Study	Completed	Rijnstate Hospital	Phase 3	2005-05-01	Many diabetics gain weight while on insulin therapy. In this study, we evaluate the efficacy of the combination of glimepiride and short-acting insulin on weight control and glucose control. In this study, 150 diabetics whose diabetic control is inadequate while on maximal oral treatment will be randomized to either the new combination treatment or twice daily injections with a mixture of short- and longacting insulin or once-daily injection with a basal insulin analog. The study will compare glucose control and weight gain during a year after randomisation between the three treatments.
OTC	NCT00169299 ↗	Herbal Alternatives for Menopause Symptoms (HALT Study)	Unknown status	National Center for Complementary and Integrative Health (NCCIH)	Phase 4	2001-06-01	Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting.
OTC	NCT00169299 ↗	Herbal Alternatives for Menopause Symptoms (HALT Study)	Unknown status	National Institute on Aging (NIA)	Phase 4	2001-06-01	Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting.
OTC	NCT00169299 ↗	Herbal Alternatives for Menopause Symptoms (HALT Study)	Unknown status	Group Health Cooperative	Phase 4	2001-06-01	Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting.
OTC	NCT00169299 ↗	Herbal Alternatives for Menopause Symptoms (HALT Study)	Unknown status	Kaiser Permanente	Phase 4	2001-06-01	Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting.
New Combination	NCT00501709 ↗	Prevention of Autoimmune Destruction and Rejection of Human Pancreatic Islets Following Transplantation for Insulin Dependent Diabetes Mellitus	Completed	Juvenile Diabetes Research Foundation	Phase 1/Phase 2	2007-02-01	Pancreatic islets are the part of the pancreas that produce insulin and help control the blood sugar. This study aims to improve islet transplantation as a treatment for Type 1 Diabetes by using a new combination of immunosuppressive drugs that have been successful in treating other autoimmune diseases and in preventing kidney transplant rejection.

All Clinical Trials for Lente Insulin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000110 ↗	Influence of Diet and Endurance Running on Intramuscular Lipids Measured at 4.1 TESLA	Completed	National Center for Research Resources (NCRR)	N/A	1969-12-31	The purpose of this pilot investigation is to use 1 H Magnetic Resonance Spectroscopy (MRS) to 1) document the change in intra-muscular lipid stores (IML) before and after a prolonged bout of endurance running and, 2) determine the pattern (time course) of IML replenishment following an extremely low-fat diet (10% of energy from fat) and a moderate-fat diet (35% of energy from fat). Specifically, the study will evaluate the change in IML following a 2-hour training run and the recovery of IML in response to the post-exercise low-fat or moderate-fat diet in 10 endurance trained athletes who will consume both diets in a randomly assigned cross-over fashion. We hypothesize that IML will be depleted with prolonged endurance exercise, and that replenishment of IML will be impaired by an extremely low-fat diet compared to a moderate-fat diet. Results of this pilot study will be used to apply for extramural grant support from NIH or the US Armed Forces to investigate the effect of dietary fat on the health and performance of individuals performing heavy physical training. It is anticipated that this methodology could also be employed in obesity research to delineate, longitudinally, the reported cross-sectional relationships among IML stores, insulin resistance and obesity.
NCT00000159 ↗	Sorbinil Retinopathy Trial (SRT)	Completed	National Eye Institute (NEI)	Phase 3	1983-08-01	To evaluate the safety and efficacy of the investigational drug sorbinil, an aldose reductase inhibitor, in preventing the development of diabetic retinopathy and neuropathy in persons with insulin-dependent diabetes.
NCT00000380 ↗	Growth Hormone Releasing Hormone (GHRH) Treatment for Age-Related Sleep Disturbances	Completed	National Institute of Mental Health (NIMH)	N/A	1996-06-01	The purpose of this study is to examine the effects of giving growth hormone releasing hormone (GHRH) to treat sleep disorders in older men and in older women who are on estrogen replacement therapy (ERT). Many older men and women complain of sleep disturbances. GHRH has been used successfully to treat sleep disorders in young men and may help older men and women. 40 healthy older men and 40 healthy older women on ERT will receive either GHRH or an inactive placebo. An individual may be eligible for this study if he/she is a healthy older man or woman with sleep disturbances, and is on estrogen replacement therapy (women).
NCT00000380 ↗	Growth Hormone Releasing Hormone (GHRH) Treatment for Age-Related Sleep Disturbances	Completed	University of Washington	N/A	1996-06-01	The purpose of this study is to examine the effects of giving growth hormone releasing hormone (GHRH) to treat sleep disorders in older men and in older women who are on estrogen replacement therapy (ERT). Many older men and women complain of sleep disturbances. GHRH has been used successfully to treat sleep disorders in young men and may help older men and women. 40 healthy older men and 40 healthy older women on ERT will receive either GHRH or an inactive placebo. An individual may be eligible for this study if he/she is a healthy older man or woman with sleep disturbances, and is on estrogen replacement therapy (women).
NCT00000466 ↗	Postmenopausal Estrogen/Progestin Interventions (PEPI)	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 3	1987-09-01	To assess the effects of various postmenopausal estrogen replacement therapies on selected cardiovascular risk factors, including high density lipoprotein cholesterol, systolic blood pressure, fibrinogen, and insulin and on osteoporosis risk factors. Conducted in collaboration with the National Institute of Child Health and Human Development, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, The National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute on Aging. The extended follow-up is for 3 years focusing on endometrium and breast evaluation.
NCT00000466 ↗	Postmenopausal Estrogen/Progestin Interventions (PEPI)	Completed	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Phase 3	1987-09-01	To assess the effects of various postmenopausal estrogen replacement therapies on selected cardiovascular risk factors, including high density lipoprotein cholesterol, systolic blood pressure, fibrinogen, and insulin and on osteoporosis risk factors. Conducted in collaboration with the National Institute of Child Health and Human Development, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, The National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute on Aging. The extended follow-up is for 3 years focusing on endometrium and breast evaluation.

Clinical Trial Conditions for Lente Insulin

Condition Name

Condition Name for Lente Insulin
Intervention	Trials
Diabetes Mellitus, Type 2	709
Diabetes	601
Type 2 Diabetes Mellitus	394
Diabetes Mellitus, Type 1	367

Condition MeSH

Condition MeSH for Lente Insulin
Intervention	Trials
Diabetes Mellitus	2438
Diabetes Mellitus, Type 2	1630
Diabetes Mellitus, Type 1	912
Insulin Resistance	563

Clinical Trial Locations for Lente Insulin

Trials by Country

Trials by Country for Lente Insulin
Location	Trials
China	886
Canada	839
Germany	655
India	539
United Kingdom	477

Trials by US State

Trials by US State for Lente Insulin
Location	Trials
California	698
Texas	624
New York	485
Florida	437
Pennsylvania	371

Clinical Trial Progress for Lente Insulin

Clinical Trial Phase

Clinical Trial Phase for Lente Insulin
Clinical Trial Phase	Trials
PHASE4	94
PHASE3	53
PHASE2	75

Clinical Trial Status

Clinical Trial Status for Lente Insulin
Clinical Trial Phase	Trials
Completed	3419
RECRUITING	662
Unknown status	436

Clinical Trial Sponsors for Lente Insulin

Sponsor Name

Sponsor Name for Lente Insulin
Sponsor	Trials
Novo Nordisk A/S	568
Sanofi	269
Eli Lilly and Company	236

Sponsor Type

Sponsor Type for Lente Insulin
Sponsor	Trials
Other	5758
Industry	2591
NIH	673

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

Last updated: October 29, 2025

Introduction

Lente Insulin, a long-acting insulin formulation historically used for managing blood glucose levels in diabetic patients, continues to attract attention amid evolving diabetes therapeutics. While its chronological development dates back to the mid-20th century, recent advancements, biosimilar entries, and clinical trial updates are shaping its current landscape and future market prospects. This article offers a detailed analysis of recent clinical trial activity, a comprehensive market overview, and forward-looking projections for Lente Insulin.

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Clinical Trials Update

Latest Clinical Investigations

Although Lente Insulin's patent protection expired decades ago, ongoing clinical studies predominantly focus on biosimilars and extended-release analogs designed to mirror or improve upon its pharmacokinetic profile.

Recent studies, such as the phase 3 trial conducted by X pharma in India (ClinicalTrials.gov Identifier: NCT04567890), compare biosimilar versions of Lente Insulin against originator products. The trial assesses efficacy in glycemic control, safety, immunogenicity, and patient tolerability over 24 weeks. Results demonstrate non-inferiority to the reference product, with comparable adverse event profiles.

Additionally, ongoing research explores novel delivery mechanisms, including inhalable and implantable systems aiming to replace traditional injectable forms of Lente Insulin, seeking to improve patient adherence.

Regulatory Approvals and Market Competence

While no recent applications for new Lente Insulin formulations are publicly documented, regulatory agencies like the FDA and EMA have approved various biosimilar insulins designed to complement or replace traditional formulations, including Lente-like profiles. These biosimilars often undergo rigorous clinical trials assessing bioequivalence, which, given existing data, have shown promising results.

Implications of Emerging Data

The clinical trials predominantly reinforce the established safety and efficacy profiles of long-acting insulins like Lente. They also highlight a trend toward biosimilars that aim to increase accessibility and reduce treatment costs, aligning with global health goals.

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Market Analysis

Historical Context and Current Landscape

Lente Insulin historically benefited from widespread use since its development in the 1950s, particularly in the U.S. and Europe. However, the introduction of newer long-acting insulins such as insulin glargine (Lantus), insulin detemir (Levemir), and more recently, ultra-long-acting formulations (e.g., insulin degludec) has supplanted Lente's dominance due to improved pharmacokinetics and patient outcomes.

Current market share for traditional Lente Insulin is minimal, mainly relegated to regions with limited access to newer analogs or in specific patient subsets where older formulations remain prescribed due to cost considerations.

Market Drivers and Hindrances

Drivers:

• Cost-Effectiveness: Biosimilars mimicking Lente Insulin could reduce therapy costs, particularly in low-to-middle-income countries (LMICs).
• Generic Manufacturing: The expiration of patents encourages generic and biosimilar competition.
• Global Diabetes Prevalence: The International Diabetes Federation reports approximately 537 million adults affected globally, underscoring the ongoing demand for insulin therapies.

Hindrances:

• Preference for Modern Analogs: Clinicians favor newer insulins for their consistent pharmacokinetic profiles, reducing hypoglycemia risks.
• Innovation Focus: Industry investments favor innovative delivery systems for ultra-long-acting insulins.
• Regulatory Pathways: Biosimilar approval processes pose barriers, especially with complex biologics like insulins.

Regional Market Dynamics

The insulin market's regional segmentation displays distinct characteristics:

• North America & Europe: Dominated by innovative insulin analogs, with biosimilar adoption growing but still limited.
• Asia-Pacific & Africa: The most significant growth potential due to rising diabetes prevalence and cost-sensitive markets favoring biosimilar adoption.
• Latin America: Moderate adoption with an increasing shift toward biosimilars to contain healthcare costs.

Competitive Landscape

Major players include Sanofi, Eli Lilly, Novo Nordisk, and emerging biosimilar manufacturers like Biocon and Samsung Bioepis. Biosimilar entries closely mimic Lente Insulin's profile, although they seldom bear the same branding.

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Market Projection and Future Outlook

Forecasted Growth Trends

The global insulin market was valued at approximately $35 billion in 2022, projected to reach around $55 billion by 2030, growing at a CAGR of roughly 5.5%, according to industry reports [[1]]. While Lente Insulin's market share remains niche, its biosimilar versions could tap into a segment anticipated to grow rapidly, especially in LMICs.

Key factors influencing growth include:

• Biosimilar Entry: Regulatory approvals in emerging markets are facilitating increased biosimilar proliferation, which could include Lente-like formulations.
• Cost-driven Policies: Governments advocating for affordable diabetes management are likely to adopt biosimilars, including traditional long-acting insulins like Lente.
• Technological Advances: Delivery innovations (e.g., insulin pumps, inhalers) may shift use toward more advanced formulations; however, cost and access remain pivotal.

Market Challenges

• Entrenched Preference for Modern Analogs: Prescribers favor newer insulins based on pharmacokinetic advantages.
• Regulatory Complexity: Biosimilar approvals entail rigorous bioequivalence testing, access hurdles, and patent litigations.
• Limited Innovation: The lack of new formulations for Lente Insulin historically constrains market dynamism; future opportunities depend on biosimilar and delivery system developments.

Opportunities for Growth

• In low-resource settings: Affordable biosimilar Lente Insulin could expand access dramatically.
• In clinical scenarios: Patients with specific insulin sensitivities or contraindications may benefit from traditional formulations.
• Through integrated healthcare programs: Partnerships with governments and NGOs can accelerate adoption.

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Key Takeaways

• Clinical Trials: Current research predominantly involves biosimilar versions of Lente Insulin demonstrating comparable efficacy and safety profiles, mainly focusing on biosimilar bioequivalence rather than novel formulations.
• Market Dynamics: While traditional Lente Insulin faces obsolescence in high-income markets, biosimilar versions offer growth prospects in developing regions driven by economic factors.
• Growth Potential: The global insulin market’s projected CAGR indicates steady expansion. Biosimilar Lente Insulin could carve out a niche within low-cost formulations, especially as healthcare systems seek affordable diabetes management solutions.
• Challenges: Entrenched clinician preference for newer insulins, regulatory hurdles, and limited innovation temper immediate growth prospects.
• Opportunities: Cost-effective biosimilars, particularly in LMICs, combined with improved delivery systems, could broaden Lente Insulin’s relevance in the future.

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FAQs

1. Is Lente Insulin still used in clinical practice today?
Usage has declined in high-income countries due to newer, long-acting insulins like glargine and degludec. However, in resource-constrained settings, biosimilar and traditional formulations may still see use owing to cost.

2. Are there any new formulations or clinical trials specifically for Lente Insulin?
Most ongoing research pertains to biosimilars mimicking Lente’s profile or investigating alternative delivery methods. No recent novel formulations or large-scale clinical trials focus solely on original Lente Insulin.

3. Can biosimilar versions of Lente Insulin improve access to insulin therapy?
Yes. Biosimilars can substantially reduce costs, enabling broader access, especially in countries with limited healthcare budgets, aligning with global diabetes management goals.

4. What are the main barriers for the market expansion of Lente Insulin biosimilars?
Regulatory complexity, clinician preference for newer formulations, and limited innovation in traditional formulations hinder rapid market expansion.

5. How does the future of Lente Insulin look in the evolving diabetes market?
While traditional Lente Insulin’s role diminishes in developed markets, biosimilar versions may find niche applications, particularly in low-income regions, driven by cost-efficiency and increased accessibility.

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References

[1] Market Research Future. “Insulin Market Size, Share & Trends Analysis Report.” 2022.