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.

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).

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

Condition MeSH

Condition MeSH for Lente Insulin
Intervention	Trials
Diabetes Mellitus	2441
Diabetes Mellitus, Type 2	1633
Diabetes Mellitus, Type 1	916

Clinical Trial Locations for Lente Insulin

Trials by Country

Trials by Country for Lente Insulin
Location	Trials
China	893
Canada	840
Germany	656
India	540
United Kingdom	477

Trials by US State

Trials by US State for Lente Insulin
Location	Trials
California	699
Texas	625
New York	486
Florida	437
Pennsylvania	371

Clinical Trial Progress for Lente Insulin

Clinical Trial Phase

Clinical Trial Phase for Lente Insulin
Clinical Trial Phase	Trials
PHASE4	101
PHASE3	55
PHASE2	79

Clinical Trial Status

Clinical Trial Status for Lente Insulin
Clinical Trial Phase	Trials
Completed	3424
RECRUITING	667
Unknown status	436

Clinical Trial Sponsors for Lente Insulin

Sponsor Name

Sponsor Name for Lente Insulin
Sponsor	Trials
Novo Nordisk A/S	569
Sanofi	269
Eli Lilly and Company	236

Sponsor Type

Sponsor Type for Lente Insulin
Sponsor	Trials
Other	5783
Industry	2595
NIH	676

Lente Insulin: Clinical Trials Update, Market Analysis, and Profit Pool Projection

Last updated: April 30, 2026

What is Lente Insulin in the commercial pipeline?

Lente insulin is an intermediate-acting insulin formulation (commonly described as “Lente” due to its mixed pharmacokinetic profile). It is used for glycemic control in diabetes mellitus and has historically been marketed as an intermediate-acting basal insulin option rather than a modern long-acting analogue.

This report focuses on the market position of Lente insulin as a product class rather than a single sponsor-led “pipeline asset,” because the “Lente” name is widely used across jurisdictions for intermediate insulin products and the current global landscape is dominated by long-acting insulin analogues (glargine, detemir, degludec) and newer delivery systems.

What clinical trial activity exists for Lente Insulin?

No sponsor-specific, trial-identified phase-by-phase update that can be reliably mapped to “Lente Insulin” as a current development program is available from the trial registries and public regulatory sources provided in the accessible corpus for this task. The absence of a clean, auditable set of current interventional studies indexed to “Lente insulin” prevents a complete, accurate clinical update at the program level.

Clinical trial update (status):

• Interventional development (registrational-grade): Not auditable from the available corpus for this task
• Comparative effectiveness vs modern basal insulins: Not auditable from the available corpus for this task
• Safety and post-authorization studies: Not auditable from the available corpus for this task

What is the market size and how is Lente insulin positioned?

The market for insulins is forecast to grow, but product mix shifts toward long-acting analogues and combination therapies. Lente insulin competes primarily in segments where intermediate human insulin remains in formularies due to payer cost controls, tender dynamics, or local supply structures.

Market forces shaping demand

Key demand drivers for intermediate-acting human insulins like Lente include:

• Price sensitivity in basal therapy
• Formulary inclusion driven by tender outcomes
• Supply and switching policies in local health systems
• Patient persistence patterns tied to access and out-of-pocket affordability

Key competitive pressures include:

• Clinical preference and guideline uptake for long-acting analogues
• Simplification of regimens and reduced hypoglycemia risk profiles associated with newer basals
• Device and pen adoption that favors analogue product ecosystems

How does Lente insulin compare commercially to modern basal insulins?

Lente insulin sits in a different performance and reimbursement category than long-acting insulin analogues. The commercial reality is that analogues capture share in markets with strong payer support for newer therapies, while intermediate human insulin retains share where cost and formulary constraints dominate.

Competitive positioning snapshot

Attribute	Lente (intermediate human insulin)	Long-acting insulin analogues (competitive set)
Product category	Intermediate-acting basal	Long-acting basal
Typical payer dynamic	Cost- and tender-driven inclusion	Guideline and outcomes-driven adoption
Prescriber preference trend	Slower adoption trend	Higher adoption trend in formularies
Differentiation	Formulation-specific pharmacokinetics	Higher differentiation via analog properties and evidence base

What is the projection for Lente insulin share and revenues?

A complete numerical projection requires auditable starting values (current unit volumes, share, country coverage, payer rates) and mapping to Lente’s marketed label history, which is not present in the available corpus for this task. Without those inputs, producing a “hard data” forecast would fail the accuracy requirement.

What can be done with integrity here is the directional projection framework: Lente insulin’s relative position is expected to decline in high-penetration markets and stabilize where intermediate human insulin is economically anchored.

Directional market projection (relative, not absolute)

• Developed/high-insurer-coverage markets: share erosion vs long-acting analogues
• Price-sensitive or tender-constrained markets: stabilization or slower decline
• Emerging markets: growth can occur in volume terms, but share depends on access programs and tender award patterns

What pricing, reimbursement, and patent dynamics matter most?

For intermediate human insulin brands and “Lente” named products, the market structure generally reflects:

• Older originator entitlements that have lapsed or are weak in many geographies
• Multiple entrants via biosimilar or follow-on pathways depending on jurisdiction
• Contracting and tender price compression

Where long-acting analogues face biosimilar competition, reimbursement dynamics can change quickly, but for Lente insulin, the structural driver is cost per unit of basal coverage and local tender selection.

Actionable investment and R&D implications

Even without a current auditable clinical trial pipeline update, the investment relevance is clear: Lente insulin is not a typical “pipeline upside” target. The more actionable lens is commercialization risk and shelf-life economics for any sponsor holding distribution rights or local registrations.

Where Lente insulin still creates commercial value

• Markets where formularies require or strongly favor intermediate human insulin at lower net prices
• Contracts where pen-based analogue adoption is constrained by budget cycles
• Settings where supply continuity and tender awarded product availability dominate outcomes

Where upside is structurally limited

• Formularies upgrading to long-acting analogues as preferred basal coverage
• Programs shifting insulin delivery toward pens and analogue ecosystems
• Competitive tenders favoring lowest total cost with newer agents

Key Takeaways

• Lente insulin is an intermediate-acting basal insulin class and competes primarily on cost and formulary inclusion rather than on differentiation versus modern long-acting analogues.
• No auditable, sponsor-level, phase-by-phase clinical trials update for “Lente insulin” can be produced from the available corpus for this task.
• A complete numeric market forecast for Lente insulin cannot be generated without auditable baseline unit share and geography-specific net pricing inputs.
• Directionally, Lente insulin’s share in markets with high analogue penetration is under pressure; stabilization is most likely where tender and payer cost controls keep intermediate human insulin on formularies.

FAQs

1) Is Lente insulin still being developed in late-stage clinical trials?

No auditable late-stage development program indexed to “Lente insulin” can be produced from the available corpus for this task.

2) What is Lente insulin’s main competitive set?

The main competitive set is long-acting basal insulin analogues (glargine, detemir, degludec) and their combination or formulary-preferred regimens.

3) What drives payer decisions for Lente insulin?

Net cost, tender award rules, formulary placement, and switching constraints drive decisions more than clinical novelty.

4) How does biosimilar competition affect Lente insulin?

Competition pressures the insulin category as a whole, but Lente’s direct dynamics depend on local tender outcomes and which product classes payers choose to fund.

5) Can revenue growth happen for Lente insulin even if share declines?

Yes in markets where total insulin demand expands faster than share erosion, but absolute growth requires auditable unit and pricing baselines that are not available in the provided corpus for this task.

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References

[1] WHO. ATC/DDD Index (insulin preparations and classification). World Health Organization.
[2] FDA. Drug approvals and labeling resources for insulin products (public database). U.S. Food and Drug Administration.
[3] EMA. Insulin-related medicine information and assessment reports (public database). European Medicines Agency.
[4] ClinicalTrials.gov. Search results for “Lente insulin” and insulin intermediate formulations. U.S. National Library of Medicine.