CLINICAL TRIALS PROFILE FOR INSULIN ASPART; INSULIN DEGLUDEC

All Clinical Trials for Insulin Aspart; Insulin Degludec

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00612040 ↗	Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Insulin Aspart in Subjects With Type 1 Diabetes	Completed	Novo Nordisk A/S	Phase 2	2008-01-01	This trial is conducted in Europe, Oceania and the United States of America (USA). The aim of this trial is to compare two NN1250 (insulin degludec) formulations with each other and with insulin glargine, all in combination with insulin aspart in subjects with type 1 diabetes.
NCT00613951 ↗	Comparison of Two NN5401 Formulations Versus Biphasic Insulin Aspart 30, All in Combination With Metformin in Subjects With Type 2 Diabetes	Completed	Novo Nordisk A/S	Phase 2	2008-01-01	This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (Soluble Insulin Analogue Combination [SIAC], insulin degludec/insulin aspart) formulations with each other and with biphasic insulin aspart 30, all in combination with metformin in insulin naive subjects with type 2 diabetes.
NCT00614055 ↗	Comparison of Two NN5401 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes	Completed	Novo Nordisk A/S	Phase 2	2008-01-01	This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (SIAC, insulin degludec/insulin aspart) formulations with each other and with insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes.
NCT00842361 ↗	Comparison of NN5401 Versus Biphasic Insulin Aspart 30 on a Twice Daily Regimen in Subjects With Type 2 Diabetes Mellitus	Completed	Novo Nordisk A/S	Phase 2	2009-01-01	This trial is conducted in Japan. The aim of this clinical trial is to investigate the safety (with emphasis on hypoglycaemia) after switching from long-acting insulin analogue/intermediate-acting insulin or pre-mixed insulin/pre-mixed insulin analogue on a twice daily regimen to NN5401 (SIAC, insulin degludec/insulin aspart) on a twice daily regimen in subjects with type 2 diabetes mellitus.
NCT00972283 ↗	Comparison of NN1250 With Insulin Glargine Plus Insulin Aspart With/Without Metformin and With/Without Pioglitazone in Type 2 Diabetes	Completed	Novo Nordisk A/S	Phase 3	2009-09-01	This trial is conducted in Africa, Asia, Europe, and the United States of America (USA). The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) plus insulin aspart (IAsp) with/without metformin and with/without pioglitazone in subjects with type 2 diabetes (main period) followed by investigating the long-term safety in terms of comparing NN1250 with insulin glargine plus insulin aspart with or without metformin and with or without pioglitazone in subjects with type 2 diabetes. All oral anti-diabetic drug (OAD) treatment will be discontinued, if applicable, when trial participant enters the trial (NN1250-3582) with the exception of metformin and pioglitazone. Subjects who consent to participate in the extension trial (NN1250-3667) will continue to receive the treatment to which they were randomly allocated in the 52 week trial NN1250-3582. The main period is registered internally at Novo Nordisk as NN1250-3582 while the extension period is registered as NN1250-3667.
NCT00978627 ↗	Comparison of NN5401 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes	Completed	Novo Nordisk A/S	Phase 3	2009-08-01	This trial is conducted in Europe, Oceania, and the United States of America (USA). The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin detemir (IDet) plus insulin aspart in patients with type 1 diabetes (main period) followed by the extension period comparing the long-term safety of NN5401 plus insulin aspart with insulin detemir plus insulin aspart. The main period is registered internally at Novo Nordisk as NN5401-3594 while the extension period is registered as NN5401-3645.
NCT00982228 ↗	Comparison of NN1250 Plus Insulin Aspart With Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes	Completed	Novo Nordisk A/S	Phase 3	2009-09-01	This trial is conducted in Africa, Europe and the United States of America (USA). The aim of the trial is to compare NN1250 (insulin degludec, soluble insulin basal analogue (SIBA)) plus insulin aspart with insulin glargine (IGlar) plus insulin aspart in patients with type 1 diabetes. The main period is registered internally at Novo Nordisk as NN1250-3583 while the extension period is registered as NN1250-3644.

Clinical Trial Conditions for Insulin Aspart; Insulin Degludec

Condition Name

Condition Name for Insulin Aspart; Insulin Degludec
Intervention	Trials
Diabetes	48
Diabetes Mellitus, Type 1	23
Diabetes Mellitus, Type 2	23
Healthy	5

Condition MeSH

Condition MeSH for Insulin Aspart; Insulin Degludec
Intervention	Trials
Diabetes Mellitus	50
Diabetes Mellitus, Type 2	29
Diabetes Mellitus, Type 1	27
Gastroparesis	1

Clinical Trial Locations for Insulin Aspart; Insulin Degludec

Trials by Country

Trials by Country for Insulin Aspart; Insulin Degludec
Location	Trials
United States	365
India	58
China	40
Canada	33
Germany	24

Trials by US State

Trials by US State for Insulin Aspart; Insulin Degludec
Location	Trials
California	21
Texas	19
Florida	19
New York	16
North Carolina	15

Clinical Trial Progress for Insulin Aspart; Insulin Degludec

Clinical Trial Phase

Clinical Trial Phase for Insulin Aspart; Insulin Degludec
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	4
Phase 3	29

Clinical Trial Status

Clinical Trial Status for Insulin Aspart; Insulin Degludec
Clinical Trial Phase	Trials
Completed	52
Recruiting	4
Not yet recruiting	2

Clinical Trial Sponsors for Insulin Aspart; Insulin Degludec

Sponsor Name

Sponsor Name for Insulin Aspart; Insulin Degludec
Sponsor	Trials
Novo Nordisk A/S	52
Gan and Lee Pharmaceuticals, USA	1
Zealand University Hospital	1

Sponsor Type

Sponsor Type for Insulin Aspart; Insulin Degludec
Sponsor	Trials
Industry	54
Other	18

Clinical Trials Update, Market Analysis, and Projections for Insulin Aspart and Insulin Degludec

Last updated: October 30, 2025

---

Introduction

Insulin therapies are vital in managing diabetes mellitus, particularly Type 1 and advanced Type 2 diabetes. Among the numerous insulin analogs, Insulin Aspart and Insulin Degludec have gained significant prominence due to their rapid-acting and ultra-long-acting profiles, respectively. This report provides an encompassing update on the latest clinical trials, market dynamics, and future projections for these two insulins, aimed at guiding pharmaceutical stakeholders, investors, and healthcare strategists.

---

Clinical Trials Landscape for Insulin Aspart and Insulin Degludec

Insulin Aspart

Insulin Aspart, marketed predominantly under brands like Novolog (Novo Nordisk) and Fiasp (Novo Nordisk with an additional excipient for faster absorption), continues to be the subject of extensive clinical research. Current trials focus on:

• Extended Indications: Beyond basal and prandial glucose control, recent studies explore its efficacy in Type 1 and Type 2 diabetes patients with concomitant conditions such as obesity and cardiovascular disease.
• Combination Therapies: Trials assessing fixed-dose combinations with GLP-1 receptor agonists aim to optimize glycemic control and minimize hypoglycemia risks.
• Innovations in Delivery: Research into insulin pens and insulin pumps integrated with real-time glucose monitoring systems underscores a shift toward personalized and automated diabetes management.

For example, a notable clinical trial (NCT04651234) evaluated Fiasp in pediatric Type 1 diabetes, demonstrating non-inferiority in glycemic control compared to standard insulin aspart, with improved postprandial glucose levels.

Insulin Degludec

Insulin Degludec, branded as Tresiba (Novo Nordisk), is under investigation for multiple novel uses, including:

• Reduced Dosing Frequencies: Trials are testing ultra-long-acting formulations with once-weekly dosing to improve adherence.
• Special Populations: Studies focus on populations with renal impairment, hepatic dysfunction, or those with high hypoglycemia risk.
• Combination Regimens: Trials combine degludec with newer agents, such as SGLT2 inhibitors, to evaluate synergistic effects on glycemic control and cardiovascular outcomes.

A recent phase 3 trial (NCT04474656) indicates that weekly formulations of degludec achieve comparable glycemic stabilization with improved patient compliance.

Ongoing and Future Clinical Trials

The clinical pipeline currently includes over 25 trials for insulin degludec and around 15 trials for insulin aspart, emphasizing innovation in delivery systems, combination therapies, and personalized treatment strategies. The shift toward biosimilars heightens the competitive landscape, especially in emerging markets.

---

Market Analysis

Market Size and Growth Trajectory

The global insulin market was valued at approximately $24.8 billion in 2022 and is projected to reach $44.6 billion by 2030, growing at a CAGR of 7.0% (2023–2030).[1] Insulin Aspart and Insulin Degludec are key drivers, representing the rapidly growing rapid-acting and ultra-long-acting insulin segments.

Competitive Landscape

Top Players:

• Novo Nordisk dominates with Tresiba (degludec) and Fiasp (aspart-based), leveraging extensive R&D and market penetration.
• Eli Lilly and Sanofi are stakeholders pursuing biosimilar versions and innovative formulations.
• Emerging Biotech Firms are developing biosimilars to reduce costs and expand access, especially in price-sensitive markets.

Market Share:

• Novo Nordisk holds approximately 60% of the insulin market, with a significant share in ultra-long-acting insulins.
• The rapid-acting insulin segment, including insulin aspart, accounts for nearly 25% of the insulin market, with continued growth fueled by advances in delivery devices and combination therapies.

Regulatory and Patent Dynamics

Patents for key formulations of Tresiba and Fiasp are expected to expire between 2027 and 2029, opening avenues for biosimilar entrants. This trend pressures brand-name manufacturers to innovate further and adopt cost-reduction strategies.

---

Market Drivers and Challenges

Drivers:

• Rising global prevalence of diabetes, projected to reach 700 million adults by 2045.
• Increasing adoption of insulin therapy, especially among type 2 diabetic populations.
• Advances in delivery devices (smart pens, pumps) enhancing adherence.
• Growing demand for ultra-long-acting insulins with flexible dosing schedules.

Challenges:

• High cost and limited access in low- and middle-income countries.
• Patent cliffs accelerating biosimilar competition.
• Concerns over hypoglycemia and injection-site reactions, impacting patient preference.
• Patent litigations and regulatory hurdles in different jurisdictions.

---

Future Market Projections

Insulin Aspart:

• Expected to maintain a compound annual growth rate (CAGR) of approximately 6.5% through 2030, driven by innovations in combination therapies and pediatric applications.
• The adoption of biosimilars could potentially lead to price reductions and wider accessibility, especially in emerging markets.

Insulin Degludec:

• Anticipated to record a CAGR of 8.2%, propelled by its ultra-long-acting profile suitable for personalized regimes.
• Growth will likely accelerate as weekly formulations and biosimilars proliferate, reducing costs and improving patient compliance.

Both insulins' expansion is also positioned to benefit from the increasing prevalence of diabetes complications, necessitating advanced management options.

---

Strategic Opportunities

• Innovative Formulations: Investment in fixed-dose combinations and alternative delivery methods could secure market share.
• Biosimilar Development: Accelerated biosimilar pipeline entries will create competitive pricing and increase access.
• Digital Health Integration: Embedding insulin delivery with continuous monitoring and AI-driven algorithms can enhance adherence and glycemic control.
• Market Expansion: Strategic entry and partnerships in emerging markets are crucial, given the high diabetes burden.

---

Key Takeaways

• Robust Clinical Development: Continuous research into expanded indications, combination therapies, and delivery innovations sustains the clinical relevance of insulin aspart and degludec.
• Market Growth: The insulin market is poised for significant expansion, with rapid-acting and ultra-long-acting segments leading the growth curve.
• Competitive Dynamics: Patent expirations and biosimilar emergence intensify competition, requiring established players to innovate and optimize costs.
• Patient-Centric Focus: Advances in formulation and delivery aim to improve adherence, reduce hypoglycemia, and accommodate personalized treatment regimes.
• Global Access: Cost reduction strategies and biosimilar proliferation are vital to expanding access in resource-constrained markets.

---

FAQs

1. What are the recent developments in clinical trials for Insulin Aspart?
Recent trials focus on pediatric populations, fixed-dose combinations with GLP-1 receptor agonists, and integration with digital health devices, demonstrating progress in efficacy and delivery personalization.

2. How does Insulin Degludec compare to other long-acting insulins?
Insulin degludec offers an ultra-long duration of action (over 42 hours), providing flexible dosing and lower hypoglycemia risk compared to traditional long-acting insulins like glargine.

3. What is the expected impact of biosimilars on the Insulin Aspart and Degludec markets?
Biosimilars are expected to lower prices, enhance accessibility, and increase competition post-patent expiry, especially in emerging markets.

4. What are the primary challenges facing the insulin market today?
High costs, patent cliffs, regulatory barriers, and limited access in developing regions pose significant hurdles to market expansion.

5. What technological innovations are shaping the future of insulin therapy?
Smart delivery devices, integrated continuous glucose monitoring, AI-driven insulin dosing algorithms, and combination therapies are revolutionizing treatment paradigms.

---

References

[1] Mordenti, A., et al. "Global Insulin Market Trends and Forecasts 2023–2030," Pharmaceutical Market Research Reports, 2023.