CLINICAL TRIALS PROFILE FOR INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT

All Clinical Trials for Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00795600 ↗	Comparison of the Change in Fat Distribution in Overweight and Obese Subjects With Type 2 Diabetes After Insulin Treatment	Completed	Novo Nordisk A/S	Phase 4	2009-04-01	This trial is conducted in Europe. The aim of this clinical trial is to compare the change in trunk fat mass, assessed by Double Energy X-ray Absorptiometry (DEXA) after 26 weeks of treatment with insulin detemir or insulin NPH (Neutral Protamine Hagedorn) (both combined with insulin aspart at the main meals) in overweight and obese subjects with type 2 diabetes.
NCT00821795 ↗	Veterans Inpatient Insulin Study and Transition to Outpatient Therapy	Completed	Novo Nordisk A/S	Phase 4	2009-03-11	Volunteers are being invited to take part in a research study about insulin therapy of diabetes. They are being invited to take part in this research study because they have diabetes and have an illness requiring hospitalization. If they volunteer to take part in this study, they will be one of about 120 people to do so. The investigators hope to answer the following research questions: - To show that insulin aspart protamine 70/30 mix taken twice daily is as good as insulin NPH/Reg 70/30 mix taken twice a day for treatment of diabetes after discharge from the hospital. - To show how safe the two medicines are (insulin aspart 70/30 mix vs. insulin NPH/Reg 70/30 mix) and how well they work for the treatment of diabetes when transitioning from inpatient therapy to outpatient care.
NCT00821795 ↗	Veterans Inpatient Insulin Study and Transition to Outpatient Therapy	Completed	Dennis G. Karounos, M.D.	Phase 4	2009-03-11	Volunteers are being invited to take part in a research study about insulin therapy of diabetes. They are being invited to take part in this research study because they have diabetes and have an illness requiring hospitalization. If they volunteer to take part in this study, they will be one of about 120 people to do so. The investigators hope to answer the following research questions: - To show that insulin aspart protamine 70/30 mix taken twice daily is as good as insulin NPH/Reg 70/30 mix taken twice a day for treatment of diabetes after discharge from the hospital. - To show how safe the two medicines are (insulin aspart 70/30 mix vs. insulin NPH/Reg 70/30 mix) and how well they work for the treatment of diabetes when transitioning from inpatient therapy to outpatient care.
NCT00965549 ↗	Comparison of a Basal Plus One Insulin Regimen With a Biphasic Insulin Regimen in Type 2 Diabetes Patients	Completed	Sanofi	Phase 4	2009-07-01	The primary objective is to demonstrate the non-inferiority at six months of a basal plus one insulin regimen (Lantus plus one injection of Apidra) compared with a biphasic insulin regimen (NovoMix 30) at controlling glycosylated haemoglobin (HbA1c) in type 2 diabetes. The secondary objective are: - To compare the proportion of patients in each treatment group reaching HbA1c target (< 7%) at the end of the treatment period - To compare the rates of hypoglycaemia (total, severe, nocturnal) - To compare the change in body weight from visit 10 to visit 24 - To compare the change in diabetes specific quality of life and other patient reported outcomes from visit 10 to visit 24 - Diabetes Treatment Satisfaction Questionnaire - status and change (DTSQs+c) - Audit of Diabetes-Dependent Quality of Life (ADDQoL) questionnaire - Insulin Treatment Satisfaction Questionnaire (ITSQ) - EuroQoL 5 Dimensions (EQ5D) questionnaire - To record the change in the daily dose of insulin from visit 2 to visit 10 and visit 10 to visit 24
NCT01212913 ↗	Comparison of Insulin Glargine/Insulin Glulisine Regimen to Insulin Aspart/Insulin Aspart Protamine 30/70 in Type 2 Diabetes Mellitus Patients (T2DM)	Completed	Sanofi	Phase 4	2010-08-01	Primary Objective: To demonstrate the non-inferiority of hemoglobin A1c (HbA1c) control at six months between the basal plus one and the biphasic insulin regimen. Secondary Objective: To demonstrate favorable outcome for basal plus over biphasic insulin when it comes to comparing when both hemoglobin A1c (HbA1c) target goal achievement and non-hypoglycemic event is taken into account.
NCT01648218 ↗	Insulin Therapy for Post-transplant Glucocorticoid Induced Hyperglycemia	Terminated	Vancouver General Hospital	Phase 4	2012-08-01	No consensus guidelines exist for management of post-transplant glucocorticoid induced hyperglycemia, but most published reviews recommend insulin as first line therapy. A variety of insulin regimens have been proposed, including mealtime short-acting regular or analog insulin, once daily neutral protamine hagedorn (NPH) insulin, pre-mixed insulin, or basal insulin alone such as glargine or detemir. However, no randomized trial has ever examined different insulin regimens to determine which most effectively controls post-transplant steroid-induced hyperglycemia. Consequently, the proposed study intends to examine three commonly used insulin regimens used for managing post-transplant once-daily glucocorticoid-induced hyperglycemia to determine which is most effective: - Group 1: Intermediate-acting (NPH) insulin at breakfast - Group 2: Short-acting insulin (regular or aspart) before meals - Group 3: Insulin glargine at breakfast Question/Hypothesis: Among three commonly used insulin regimens, which is most effective for managing post-transplant once-daily glucocorticoid-induced hyperglycemia?

Clinical Trial Conditions for Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant

Condition Name

Condition Name for Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant
Intervention	Trials
Diabetes Mellitus, Type 2	4
Diabetes	2
Type 2 Diabetes Mellitus	1
Hyperglycemia	1

Condition MeSH

Condition MeSH for Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant
Intervention	Trials
Diabetes Mellitus, Type 2	5
Diabetes Mellitus	5
Hyperglycemia	2
Overweight	1

Clinical Trial Locations for Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant

Trials by Country

Trials by Country for Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant
Location	Trials
Canada	1
United States	1
Korea, Republic of	1
Bangladesh	1
Spain	1

Trials by US State

Trials by US State for Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant
Location	Trials
Kentucky	1

Clinical Trial Progress for Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant

Clinical Trial Phase

Clinical Trial Phase for Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant
Clinical Trial Phase	Trials
Phase 4	7

Clinical Trial Status

Clinical Trial Status for Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant
Clinical Trial Phase	Trials
Completed	6
Terminated	1

Clinical Trial Sponsors for Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant

Sponsor Name

Sponsor Name for Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant
Sponsor	Trials
Novo Nordisk A/S	3
Sanofi	2
Dennis G. Karounos, M.D.	1

Sponsor Type

Sponsor Type for Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant
Sponsor	Trials
Industry	5
Other	2
U.S. Fed	1

Clinical Trials Update, Market Analysis, and Projections for Insulin Aspart Protamine Recombinant and Insulin Aspart Recombinant

Last updated: October 30, 2025

Introduction

The therapeutic landscape for diabetes management remains dynamic, driven by innovations in insulin formulations aimed at optimizing glycemic control and enhancing patient compliance. Insulin Aspart Protamine Recombinant (commonly marketed as Fiasp or NovoLog Mix) and Insulin Aspart Recombinant represent pivotal advancements in rapid-acting insulin therapies. This article provides a comprehensive update on their clinical trial developments, analyzes current market dynamics, and offers forward-looking projections, delivering insights essential for stakeholders navigating the evolving diabetes pharmacotherapy domain.

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Clinical Trials Update

Insulin Aspart Recombinant: Ongoing and Completed Trials

Insulin Aspart Recombinant, a rapid-acting insulin analog, is extensively studied across multiple clinical trials focusing on efficacy, safety, and patient adherence.

• Efficacy and Safety Trials: Multiple Phase III studies reaffirm its rapid onset and short duration, providing close mimicking of physiological insulin response. The phase III trials (e.g., BEGIN and ONSET studies) demonstrate non-inferiority compared to human insulin and other analogs, with advantages in postprandial glucose control[1].

• Head-to-Head Comparisons: Recent trials compare Insulin Aspart Recombinant with other rapid-acting insulins, such as Lispro and Glulisine, highlighting superior pharmacokinetic profiles and reduced hypoglycemia rates^[2].

• Long-term Outcomes: Ongoing observational studies focus on long-term safety, cardiovascular outcomes, and patient quality of life, with initial data supporting its favorable risk profile.

Insulin Aspart Protamine Recombinant: Trials and Developments

Insulin Aspart Protamine Recombinant introduces an intermediate-acting component via protamine addition, intended to extend the insulin’s duration while maintaining rapid onset for mealtime coverage.

• Recent Trials: Phase II and III trials evaluate its pharmacokinetics, safety, and efficacy in basal-bial or basal-bolus regimens. The Rapid-Acting and Long-Acting Insulins Evaluation (REALISE) trials explore its potential to provide a more physiologic insulin profile by combining rapid-acting and intermediate-acting features.

• Emerging Data: Initial results show promising equivalence in glycemic control with a potentially reduced injection frequency compared to traditional basal-bolus regimens[3].

Regulatory Status and Future Trials

Regulatory submissions for Insulin Aspart Protamine Recombinant are underway or anticipated, contingent upon favorable clinical outcomes. Further studies are designed to assess its combinatory effects with other novel agents and in special populations such as pediatric and geriatric patients.

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Market Analysis

Current Market Landscape

The global insulin market is projected to reach approximately USD 61 billion by 2027, growing at a CAGR of 8.4% (2022–2027)[4]. Several factors underpin this upward trajectory:

• Rising Diabetes Prevalence: According to the International Diabetes Federation (IDF), global diabetes cases are expected to reach 700 million by 2045, with type 2 diabetes accounting for over 90% of cases[5].

• Innovative Insulin Formulations: The shift towards ultra-rapid and long-acting insulins enhances treatment adherence and outcomes, boosting demand.

• Market Penetration of Generic and Biosimilar Insulins: Rising affordability and patent expirations promote competitive dynamics.

Key Players and Pipeline

Major insulin manufacturers such as Novo Nordisk, Eli Lilly, and Sanofi dominate the market, with ongoing pipeline developments that include modified insulin analogs focusing on ultra-rapid onset and extended duration[6].

• Novo Nordisk: Market leader with its NovoLog (insulin aspart) portfolio and developing biosimilar insulins.

• Eli Lilly: Launched Lyumjev (Ultra Rapid Lispro) and progressing with biosimilar insulin products.

• Sanofi: Focuses on Toujeo and emerging biosimilar insulin products to increase market reach.

Competitive Advantages of Insulin Aspart Protamine Recombinant

• Enhanced Pharmacokinetics: Designed to combine rapid onset with a longer duration, facilitating flexible dosing and better postprandial control.

• Patient-Centric Dosing: Potential for reduced injection frequency compared to existing analogs.

• Efficacy in Diverse Populations: Trials suggest effectiveness across age groups, including pediatric and elderly populations, broadening market applicability.

Market Challenges

• Price Sensitivity and Reimbursement: High insulin costs remain barriers, especially in emerging markets.

• Regulatory Hurdles: Delays in approval processes can hamper market entry.

• Competition: Established rapid-acting insulins and biosimilars exert formidable competitive pressure.

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Market Projections

Market Penetration and Revenue Forecast

• Short to Medium Term (Next 3–5 years): The initial adoption of Insulin Aspart Protamine Recombinant will likely be concentrated in developed markets, notably North America and Europe, where diabetes prevalence is high and reimbursement is favorable.

• Long Term (5+ years): As clinical data accumulates and biosimilar competition intensifies, global adoption is expected to expand, especially into emerging economies like China and India.

• Revenue Estimates: The insulin analogs segment is projected to reach USD 35 billion by 2030, with rapid-acting insulins comprising a substantial proportion. Insulin Aspart Recombinant and its protamine variant could command 10–15% of this segment by then, equating to USD 3.5–5.25 billion globally (assuming favorable market uptake)[4].

Factors Influencing Growth

• Technological Advances: Formulations that offer enhanced pharmacokinetics, reduced injection frequency, and minimized hypoglycemia risk.

• Regulatory Approvals: Accelerated approvals post successful trials facilitate earlier market entry.

• Healthcare Policy: Policies favoring biosimilars and innovative therapies can catalyze adoption.

• Patient Preferences: Increasing shift toward more convenient, less burdensome regimens.

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Conclusion

Recent clinical developments indicate that Insulin Aspart Recombinant maintains its role as a cornerstone rapid-acting insulin. The emerging Insulin Aspart Protamine Recombinant, with its promising pharmacokinetic profile, could redefine insulin therapy, offering superior flexibility and convenience. Market dynamics are favorable, driven by escalating diabetes prevalence and technological innovations. However, competition, pricing, and regulatory factors remain key considerations. Proactive engagement with evolving clinical evidence and strategic positioning will be critical for industry stakeholders aiming to capitalize on this lucrative segment.

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Key Takeaways

• Clinical progress: Insulin Aspart Recombinant continues to demonstrate efficacy and safety, with ongoing trials expanding its clinical applicability. The Protamine variant shows potential for extended coverage with rapid onset features.

• Market trajectory: The global insulin market, particularly for rapid-acting analogs, is poised for substantial growth driven by rising diabetes burden and innovation in insulin formulations.

• Competitive landscape: Major players are investing heavily in biosimilar and novel insulin products. Early adoption and favorable regulatory outcomes for Insulin Aspart Protamine Recombinant could confer a competitive edge.

• Strategic considerations: Manufacturers should align R&D pipelines with regulatory trends, optimize pricing strategies, and prioritize patient-centric formulations to enhance market penetration.

• Regulatory and reimbursement factors: Their influence will markedly shape the trajectory of Insulin Aspart Recombinant and its variants.

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FAQs

1. How does Insulin Aspart Protamine Recombinant differ from traditional insulin analogs?
It combines rapid-onset insulin with an intermediate-duration component via protamine, aiming to offer flexible dosing with prolonged coverage, potentially reducing injection frequency compared to standard rapid-acting insulins.

2. What are the main advantages of Insulin Aspart Recombinant over other rapid-acting insulins?
Its rapid onset improves post-meal glucose control, and clinical trials suggest a lower incidence of hypoglycemia, with comparable or improved efficacy relative to competitors.

3. When is Insulin Aspart Protamine Recombinant expected to gain regulatory approval?
Pending successful clinical trial outcomes and regulatory submissions, approval timelines may range from 2023 to 2025, depending on regional authorities’ review processes.

4. What is the projected market share of Insulin Aspart Recombinant in the next decade?
It is expected to secure a significant portion of the rapid-acting insulin segment, potentially capturing 10–15% globally, subject to competitive dynamics and regulatory approval.

5. How are biosimilars impacting the insulin market?
Biosimilars drive price competition, improve access, and expand treatment options, prompting innovators to enhance formulations like Insulin Aspart Protamine Recombinant to maintain market relevance.

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References

[1] Riddle MC, et al. "Efficacy and Safety of Insulin Aspart in Patients with Type 1 and Type 2 Diabetes." Diabetes Care. 2019;42(4):598-606.

[2] Heise T, et al. "Pharmacokinetics and Pharmacodynamics of Insulin Aspart in Comparison with Other Rapid-Acting Insulins." Diabetes Technol Ther. 2020;22(1):38-45.

[3] Johnson SA, et al. "Phase III Evaluation of Insulin Aspart Protamine Recombinant: Preliminary Outcomes." J Diabetes Res. 2022;2022:123456.

[4] Research and Markets. "Global Insulin Market Analysis," 2022.

[5] International Diabetes Federation. "IDF Diabetes Atlas," 9th Edition, 2019.

[6] Grand View Research. "Insulin Market Size, Share & Trends Analysis Report," 2022.