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Last Updated: January 5, 2025

CLINICAL TRIALS PROFILE FOR HUMULIN N


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All Clinical Trials for HUMULIN N

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00803972 ↗ Dose-Ranging, Pharmacokinetic (PK), Glucodynamic (GD), Safety and Tolerability Study of Subcutaneously (SC) Administered Humulin R and Humalog With or Without rHuPH20 Completed Halozyme Therapeutics Phase 1 2008-11-01 This is a single center, Phase I, open-label, single-blind (subjects blinded to the contents of each injection), 4 stage study designed to determine the PK, GD, safety, tolerability, and optimal ratio of rHuPH20 administered with fixed Humulin R or Humalog doses in healthy subjects.
NCT00774800 ↗ Phase II Pharmacokinetics Study of Humalog and Humulin-R With and Without rHuPH20 in Type 1 Diabetes Mellitus Completed Halozyme Therapeutics Phase 2 2008-10-01 Humalog and Humulin-R (recombinant human insulin) are Food and Drug Administration (FDA) approved medications for the treatment of diabetes mellitus. Recombinant human hyaluronidase PH20 (rHuPH20) is approved by the FDA for use as an aid in the absorption and dispersion of other injectable drugs. In this study, rHuPH20 will be co-administered with both Humalog and Humulin-R in order to determine if it improves the absorption of these insulins to more closely mimic the body's natural increase in insulin in response to a meal.
NCT00522210 ↗ Comparison of a Twice Daily Versus a Three Times Daily Insulin Regimen in Children With Type 1 Diabetes Completed University of Calgary N/A 2008-03-01 The purpose of this study is to determine whether there is a difference in blood sugar control (as measured by hemoglobin A1c (HA1c)), in children given twice daily insulin injections incorporating a new long acting insulin analogue (detemir) compared to children using their current three times a day insulin injections (with intermediate and rapid acting insulin).
NCT00657930 ↗ Observational Study in Type 2 Diabetes Treated by an Intensive Insulin Treatment (ICT) Containing Once Daily Levemir® (Insulin Detemir) Completed Novo Nordisk A/S 2008-03-01 This study is conducted in Europe. The aim of this observational study is to gain practical experience with once-daily Levemir administration in type 2 diabetes patients who were previously treated with Insulatard®, Humulin® N (NPH insulins) as basal insulin as part of their ICT under normal clinical practice conditions in Hungary.
NCT00705536 ↗ Pharmacokinetic (PK), Pharmacodynamic (PD), and Safety Study of Subcutaneously Administered Humalog® With and Without Recombinant Human Hyaluronidase (rHuPH20)and Humulin-R® With and Without rHuPH20 Completed Halozyme Therapeutics Phase 1 2007-12-01 The purpose of the study is to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of Humalog (insulin lispro) or Humulin-R (recombinant human insulin) when administered as a single subcutaneous (SC) injection of 20 units (U) with or without coadministration of recombinant human hyaluronidase PH20 (rHuPH20). The study hypothesizes that the time required to reach maximum insulin concentration (tmax) when insulin is administered with rHuPH20 will be comparable or shorter than the time required without rHuPH20.
NCT00532766 ↗ Evaluating Pharmacokinetics and Pharmacodynamics of Jusline Completed King Saud University N/A 2006-11-01 To evaluate the pharmacokinetic and pharmacodynamic profile of a new human insulin (Jusline) after subcutaneous administration, and to compare this profile with Humulin insulin.
NCT00646581 ↗ Effect of Single Dose Intranasal Insulin On Cognitive Function Completed University of Massachusetts, Worcester Phase 4 2006-10-01 The purpose of the study is to find out how a small dose of insulin might affect memory, the ability to concentrate, and improve your daily functioning in patients with schizophrenia and schizoaffective disorders. Insulin is not being used to treat diabetes in this study. The investigators propose a single dose, double-blinded, placebo-controlled trial of intranasal insulin in 40 subjects with schizophrenia or schizoaffective disorder to examine insulin's effect on cognition. The specific aims include: 1. Examine the effects of single doses of 40 IU intranasal insulin compared to placebo on cognitive functioning, including attention and memory. 2. Examine whether single dose of intranasal insulin administration will raise serum insulin level and decrease plasma glucose level Insulin will be delivered through an air spray pump into your nose. The investigators will be comparing one dose of insulin (40 International Units) with placebo, an inactive liquid.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 7 of 7 entries

Clinical Trial Conditions for HUMULIN N

Condition Name

54330-0.500.511.522.533.544.555.5Type 2 Diabetes MellitusDiabetes Mellitus, Type 2HyperglycemiaType 1 Diabetes Mellitus[disabled in preview]
Condition Name for HUMULIN N
Intervention Trials
Type 2 Diabetes Mellitus 5
Diabetes Mellitus, Type 2 4
Hyperglycemia 3
Type 1 Diabetes Mellitus 3
[disabled in preview] 0
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Condition MeSH

1711730024681012141618Diabetes MellitusDiabetes Mellitus, Type 2Diabetes Mellitus, Type 1Hyperglycemia[disabled in preview]
Condition MeSH for HUMULIN N
Intervention Trials
Diabetes Mellitus 17
Diabetes Mellitus, Type 2 11
Diabetes Mellitus, Type 1 7
Hyperglycemia 3
[disabled in preview] 0
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Clinical Trial Locations for HUMULIN N

Trials by Country

+
Trials by Country for HUMULIN N
Location Trials
United States 23
Italy 10
India 7
Canada 4
Germany 3
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Trials by US State

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Trials by US State for HUMULIN N
Location Trials
California 6
Texas 3
Minnesota 2
Arizona 2
Nebraska 1
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Clinical Trial Progress for HUMULIN N

Clinical Trial Phase

21.9%6.2%68.7%0024681012141618202224Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for HUMULIN N
Clinical Trial Phase Trials
Phase 4 7
Phase 3 2
Phase 2/Phase 3 1
[disabled in preview] 22
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Clinical Trial Status

71.4%8.6%5.7%14.3%002468101214161820222426CompletedRecruitingTerminated[disabled in preview]
Clinical Trial Status for HUMULIN N
Clinical Trial Phase Trials
Completed 25
Recruiting 3
Terminated 2
[disabled in preview] 5
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Clinical Trial Sponsors for HUMULIN N

Sponsor Name

trials01234567Halozyme TherapeuticsMayo ClinicGeropharm[disabled in preview]
Sponsor Name for HUMULIN N
Sponsor Trials
Halozyme Therapeutics 4
Mayo Clinic 2
Geropharm 2
[disabled in preview] 7
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Sponsor Type

71.2%26.9%00510152025303540OtherIndustryNIH[disabled in preview]
Sponsor Type for HUMULIN N
Sponsor Trials
Other 37
Industry 14
NIH 1
[disabled in preview] 0
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HUMULIN N Market Analysis and Financial Projection

HUMULIN N: Clinical Trials, Market Analysis, and Projections

Clinical Trials Update

Pharmacokinetic and Pharmacodynamic Equivalence

A recent phase-1 clinical trial, known as the RHINE-2 study, was conducted to establish the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of Biocon's Insulin-N (a biosimilar to Humulin N) and the US-licensed Humulin N. This study involved 90 healthy subjects in a single-center, double-blind, randomized, three-period, six-sequence, partially replicated crossover design.

  • The primary PK endpoints were the area under the insulin concentration-time curve from 0 to 24 hours (AUC ins.0-24h) and the maximum insulin concentration (C ins.max).
  • The primary PD endpoints were the area under the glucose infusion rate (GIR) curve from 0 to 24 hours (AUC GIR.0-24h) and the maximum GIR (GIR max)[1].

The results showed that Biocon's Insulin-N was equivalent to Humulin N for both PK and PD endpoints, indicating similar safety and efficacy profiles. This study is crucial for regulatory approvals and market acceptance of biosimilar insulins.

Market Analysis

Market Segmentation

The human recombinant insulin market, which includes Humulin N, is segmented based on product type, distribution channel, and region.

  • Product Type: Humulin N falls under the intermediate-acting human insulin category. The market also includes rapid-acting, short-acting, long-acting, and premixed human insulins[2].
  • Distribution Channel: The market is dominated by retail pharmacies, followed by hospital pharmacies. Online pharmacies are growing rapidly due to their convenience and rising popularity[2].
  • Brand Insights: Humulin, along with Insuman and Novolin, are key brands in the human recombinant insulin market. Humulin, specifically, is a significant player in the short-acting and intermediate-acting insulin segments[2][3].

Market Size and Growth

The global short-acting insulin market, which includes Humulin, is projected to grow from USD 9257.1 million in 2021 to USD 10287.9 million by 2030, at a CAGR of 1.18%[3].

  • Humulin Segment: The Humulin segment, specifically, had a market value of USD 1283.7 million in 2021 and is anticipated to reach USD 1564.1 million by 2030, growing at a CAGR of 2.22%. This makes Humulin the fastest-growing segment among the short-acting insulins[3].

Regional Analysis

  • North America: This region leads the diabetes drug market, including traditional human insulin like Humulin N, due to high diabetes prevalence and a strong focus on diabetes care. The presence of influential organizations such as the American Diabetes Association also contributes to this dominance[4].

Projections

Market Growth Drivers

The growth of the human recombinant insulin market, including Humulin N, is driven by several factors:

  • Increasing Prevalence of Diabetes: The rising number of diagnosed diabetes cases globally is a significant driver. Initiatives by governments to manage and prevent diabetes also stimulate research and development in this market[3][4].
  • Cost-Effectiveness: Traditional human insulin like Humulin N is cost-effective, making it a preferred choice for many patients, especially in regions where affordability is a concern[4].

Challenges

Despite the growth projections, the market faces some challenges:

  • High Treatment Costs: The increasing cost of insulin can be a significant limitation for the global market. This has led to a demand for generic and biosimilar competitors, which could impact the market share of branded insulins like Humulin N[3].

Clinical Use and Safety

Mechanism of Action

Humulin N is an intermediate-acting human insulin that lowers blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. It also inhibits lipolysis and proteolysis and enhances protein synthesis[5].

Dosage and Administration

Humulin N is administered subcutaneously and the dosage is individualized based on metabolic needs, blood glucose monitoring results, and glycemic control goals. It is indicated for improving glycemic control in adult and pediatric patients with diabetes mellitus[5].

Safety Profile

Patients with renal impairment are at increased risk of hypoglycemia and may require more frequent dose adjustments. The safety profile of Humulin N, as demonstrated in clinical trials, is generally well-tolerated, with no serious adverse events reported in the RHINE-2 study[1][5].

Key Takeaways

  • Clinical Equivalence: Biocon's Insulin-N has been shown to be pharmacokinetically and pharmacodynamically equivalent to Humulin N, ensuring similar efficacy and safety.
  • Market Growth: The global short-acting and intermediate-acting insulin market, including Humulin N, is projected to grow steadily, driven by increasing diabetes prevalence and cost-effectiveness.
  • Regional Dominance: North America leads the market due to high diabetes prevalence and a strong focus on diabetes care.
  • Challenges: High treatment costs and the emergence of generic and biosimilar competitors could impact market dynamics.

FAQs

Q: What is the primary mechanism of action of Humulin N?

A: Humulin N lowers blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production[5].

Q: What are the key segments of the human recombinant insulin market?

A: The market is segmented by product type (rapid-acting, short-acting, intermediate-acting, long-acting, premixed), distribution channel (hospital pharmacies, retail pharmacies, online pharmacies), and region[2].

Q: How is the Humulin segment expected to grow in the short-acting insulin market?

A: The Humulin segment is anticipated to grow from USD 1283.7 million in 2021 to USD 1564.1 million by 2030, at a CAGR of 2.22%[3].

Q: What are the main drivers of the human recombinant insulin market growth?

A: The growth is driven by increasing diabetes prevalence, government initiatives, and the cost-effectiveness of traditional human insulins like Humulin N[3][4].

Q: What challenges does the human recombinant insulin market face?

A: High treatment costs and the emergence of generic and biosimilar competitors are significant challenges for the market[3].

Sources

  1. PubMed: Results from the RHINE-2 (Recombinant Human INsulin ... - PubMed
  2. Global Market Estimates: Global Human Recombinant Insulin - Market Analysis | Size
  3. Spherical Insights: Short-Acting Insulin Market Size, Share | Statistics 2030
  4. GlobeNewswire: Global Diabetes Drugs Market to Witness an Upsurge in Growth by 2030
  5. FDA: HUMULIN N - accessdata.fda.gov

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