Last Updated: June 17, 2026

CLINICAL TRIALS PROFILE FOR INSULIN ZINC SUSP EXTENDED BEEF


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505(b)(2) Clinical Trials for Insulin Zinc Susp Extended Beef

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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Insulin Zinc Susp Extended Beef

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).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Insulin Zinc Susp Extended Beef

Condition Name

Condition Name for Insulin Zinc Susp Extended Beef
Intervention Trials
Diabetes Mellitus, Type 2 709
Diabetes 601
Type 2 Diabetes Mellitus 394
Diabetes Mellitus, Type 1 368
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Condition MeSH

Condition MeSH for Insulin Zinc Susp Extended Beef
Intervention Trials
Diabetes Mellitus 2441
Diabetes Mellitus, Type 2 1633
Diabetes Mellitus, Type 1 916
Insulin Resistance 568
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Clinical Trial Locations for Insulin Zinc Susp Extended Beef

Trials by Country

Trials by Country for Insulin Zinc Susp Extended Beef
Location Trials
China 893
Canada 840
Germany 656
India 540
United Kingdom 477
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Trials by US State

Trials by US State for Insulin Zinc Susp Extended Beef
Location Trials
California 699
Texas 625
New York 486
Florida 437
Pennsylvania 371
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Clinical Trial Progress for Insulin Zinc Susp Extended Beef

Clinical Trial Phase

Clinical Trial Phase for Insulin Zinc Susp Extended Beef
Clinical Trial Phase Trials
PHASE4 101
PHASE3 55
PHASE2 79
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Clinical Trial Status

Clinical Trial Status for Insulin Zinc Susp Extended Beef
Clinical Trial Phase Trials
Completed 3424
RECRUITING 667
Unknown status 436
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Clinical Trial Sponsors for Insulin Zinc Susp Extended Beef

Sponsor Name

Sponsor Name for Insulin Zinc Susp Extended Beef
Sponsor Trials
Novo Nordisk A/S 569
Sanofi 269
Eli Lilly and Company 236
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Sponsor Type

Sponsor Type for Insulin Zinc Susp Extended Beef
Sponsor Trials
Other 5783
Industry 2595
NIH 676
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Last updated: May 17, 2026

Insulin Zinc Suspension Extended Beef: Clinical Trials Update, Market Analysis, and Revenue Projection (2024-2034)

What is insulin zinc susp extended beef and how is it used clinically?

Insulin zinc suspension extended beef is a long-acting insulin formulation used for glycemic control in diabetes mellitus. It is typically administered subcutaneously with dosing individualized to fasting and postprandial glucose targets. The formulation uses zinc to extend insulin residence time, producing a prolonged insulin effect compared with short-acting insulins.

Which patient populations use it?

  • Adults with type 1 diabetes (as basal insulin support alongside rapid-acting insulin for meals)
  • Adults and pediatric patients with type 2 diabetes requiring basal insulin
  • Patients transitioning from other basal insulins where availability, cost, or formulary placement drives selection

What differentiation exists versus other basal insulins?

The competitive frame is long-acting insulin products, including:

  • Intermediate-acting insulins (e.g., NPH insulin)
  • Modern basal analogs (e.g., glargine, detemir, degludec)
  • Long-acting biosimilars and follow-on products

For investors and licensing teams, the key commercial distinction is not “clinical superiority” but access, reimbursement, and switching friction relative to basal analogs.

What clinical trials are ongoing for insulin zinc susp extended beef?

No complete, reliable trial set can be produced from the information provided. A clinical trials update requires specific identifiers (drug master file entry, branded product names, NDA/ANDA/BLAs, registry links) to map study status, endpoints, and timelines to this exact “insulin zinc susp extended beef” product.

How does insulin zinc susp extended beef compare with basal insulin competitors?

Featured search intent here is competitive positioning and therapeutic substitution risk. Without the product’s specific regulatory identity (brand/NDA/strength/formulation label) and jurisdictional availability, a fully accurate competitive comparison cannot be completed.

That said, the market structure for basal insulin is consistent:

Competitive substitution dynamics

  • Basal insulin analogs tend to displace intermediate-acting insulins due to flatter profiles, lower nocturnal hypoglycemia, and patient preference.
  • NPH and other older formulations remain competitive in cost-sensitive settings and where formularies mandate cost-utility.

Switching barriers

  • Patient stability and titration inertia
  • Payer step therapy
  • Hospital and clinic procurement contracts
  • Device and administration workflow (pen vs vial/syringe ecosystems)

What is the market size for basal insulin and where does this product fit?

A product-level market analysis requires the specific marketed product identity and sales reporting mapping. “Insulin zinc susp extended beef” is not a standardized global INN-level product name used in sales reporting, and multiple jurisdictions may market similar or overlapping formulations under different label names.

Without a precise branded/regulatory mapping (NDA number, label, concentration, pack size, and geography), a defensible market sizing and share estimate cannot be produced.

What revenue projection is realistic for insulin zinc susp extended beef from 2024 to 2034?

A projection requires:

  • Current unit volumes and pricing (net of rebates)
  • Geography split (US/EU/LatAm/MEA/APAC)
  • Contracting structure and tender dynamics
  • Expected generics/biosimilars displacement
  • Patent and exclusivity timeline (if any)

No complete basis is available to produce a complete and accurate projection.

When does insulin zinc susp extended beef lose exclusivity?

Exclusivity timelines depend on the specific regulatory approval and jurisdiction:

  • US: Orange Book patent listings tied to a specific NDA
  • EU: supplementary protection certificates (SPCs) tied to marketing authorization
  • Other: data exclusivity regimes and orphan status (if applicable)

No Orange Book or equivalent exclusivity record can be mapped from the input.

What patents protect insulin zinc susp extended beef, and how strong is the patent estate?

A patent estate assessment requires:

  • Active ingredient mapping to specific US patents listed in the Orange Book (if applicable)
  • Key formulation/method-of-use/manufacturing patents
  • Jurisdictional coverage
  • Expiration and terminal disclaimer status
  • Litigation history or licensing settlements

The dataset needed to enumerate patents cannot be built from the information provided, so no complete or accurate patent list can be produced.

What patent litigation affects insulin zinc susp extended beef (Paragraph IV, ANDA, or biosimilar challenges)?

Litigation coverage requires specific case identifiers and the relevant FDA filing (ANDA/505(b)(2) equivalents) and paragraph IV status.

No litigation record can be accurately connected to “insulin zinc susp extended beef” without the regulatory identifiers needed for docket mapping.

What is the Orange Book status of insulin zinc susp extended beef?

Orange Book status requires the exact US product identifier (listed drug name tied to an NDA). The input does not include any NDA number, label name, strength, dosage form, or manufacturer that would allow a definitive Orange Book lookup.

Which generic entry risks exist for insulin zinc susp extended beef?

Generic risk hinges on:

  • Whether the product is protected by listed patents and/or enforceable composition-of-matter or method-of-use patents
  • Whether market entry is constrained by manufacturing/IP barriers or regulatory exclusivities
  • Whether substitution is easy at the pharmacy level (vial vs pen, concentration matching)
  • Whether payers impose step therapy

A complete generic entry risk map cannot be produced without patent and regulatory linkage.

How do formulation and device patents affect market access for this product?

Formulation and device IP often dictates:

  • Extended-release mechanism
  • Zinc particle characteristics and stability
  • Manufacturing process controls (crystallization, particle size distribution, viscosity)
  • Device compatibility for delivery pens

No specific formulation or process patent set can be identified from the provided information, so barrier analysis cannot be completed.

What manufacturing and supply chain risks exist for insulin zinc susp extended beef?

Supply risks for insulin products typically relate to:

  • Raw material sourcing
  • Sterility assurance capacity
  • Cold chain logistics
  • Batch consistency requirements
  • Capacity at contract manufacturers

A product-specific supply chain risk assessment requires known manufacturers, plants, and distribution structure, which are not provided.

Which companies supply insulin zinc susp extended beef and what is the competitive landscape?

A competitive landscape requires:

  • List of labeled suppliers by geography
  • Authorized generics and rebrands
  • Tender/contract holders
  • Buyer concentration (hospital systems vs retail)

No supplier list can be built from the input.

Key Takeaways

  • Insulin zinc suspension extended beef is a long-acting basal insulin used for glycemic control, typically via subcutaneous dosing.
  • A complete clinical trials update, patent/exclusivity map, Orange Book status, litigation assessment, and revenue projection cannot be produced from the provided information because the specific regulatory product identity (NDA/label/strength/manufacturer) is not supplied.
  • Market outcomes for basal insulin are primarily driven by substitution versus intermediate and analog basal insulins, payer contracting, and switching friction rather than short-term clinical differentiation.

FAQs

  1. How do zinc-extended insulin suspensions compare with NPH insulin for nocturnal hypoglycemia risk?
  2. What FDA pathway would apply to follow-on versions of insulin zinc suspensions (505(b)(2) vs ANDA)?
  3. How do payers typically evaluate older basal insulins versus insulin glargine and insulin degludec?
  4. What manufacturing quality attributes matter most for zinc insulin suspensions (particle size, stability, viscosity)?
  5. What data would determine whether a generic insulin zinc suspension can be substituted at the pharmacy level?

References

  1. (No citable sources were provided in the prompt; no source-backed registry, patent, or FDA status mapping can be generated from the provided information.)

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