CLINICAL TRIALS PROFILE FOR INSULIN ASPART

Biosimilar Clinical Trials for insulin aspart

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05539872 ↗	Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar Rapid-Acting Insulin Aspart (I004) and NovoLog After Single-Dose Subcutaneous Administration to Healthy Volunteers	Recruiting	Amphastar Pharmaceuticals, Inc.	Phase 2/Phase 3	2022-08-22	This study is a randomized, double-blinded, two-treatment, two-period, two-sequence crossover pivotal Biosimilar study. The purpose of this study is to establish pharmacokinetic (PK) and pharmacodynamics (PD) biosimilarity of proposed biosimilar I004 and the US-approved NovoLog.
NCT05802862 ↗	A Study of Insulin Degludec/Insulin Aspart Biosimilar (22011) Compared With Insulin Degludec/Insulin Aspart(Ryzodeg) in Participants With Type 2 Diabetes in China	Not yet recruiting	Sunshine Lake Pharma Co., Ltd.	Phase 3	2023-05-01	The purpose of this study is to see if Insulin Degludec/Insulin Aspart (22011) compared to Insulin Degludec/Insulin Aspart (Ryzodeg) is similar in safety and effect in participants with type 2 diabetes (T2D).

All Clinical Trials for insulin aspart

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00046150 ↗	12 Week,Comparing Safety of HMR1964 & Insulin Aspart Used in Continuous Subcutaneous Infusion in Type 1 Diabetes.	Completed	Sanofi	Phase 3	2002-05-01	The purpose of this study is to compare the safety of HMR 1964 and insulin aspart when used in external pumps with respect to catheter occlusions, GHb assessment, insulin doses, blood glucose parameters, hypoglycemic episodes, unexplained hyperglycemia, adverse events, laboratory data, and vital signs.
NCT00065130 ↗	Safety and Efficacy of Insulin Aspart vs. Regular Human Insulin in Gestational Diabetes	Completed	Novo Nordisk A/S	Phase 3	2000-04-01	This trial is conducted in the United States of America (USA). The purpose of this study is to test whether NovoLog (insulin aspart) is a safe and at least as effective alternative to regular human insulin for the control of blood glucose after meals in women who develop diabetes during pregnancy.
NCT00071448 ↗	Insulin Aspart vs. Insulin Lispro vs. Regular Insulin in Paediatric Population	Completed	Novo Nordisk A/S	Phase 3	2002-06-01	This trial is conducted in the United States of America (USA). The aim of this trial is to to determine whether insulin aspart can be used effectively and safely in paediatric patients.
NCT00082407 ↗	Exenatide Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin	Completed	Eli Lilly and Company	Phase 3	2003-11-01	This is a Phase 3, multicenter, open-label, comparator-controlled trial comparing the effect of exenatide twice daily to twice daily biphasic insulin aspart on glycemic control, as measured by hemoglobin A1c (HbA1c).
NCT00082407 ↗	Exenatide Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin	Completed	AstraZeneca	Phase 3	2003-11-01	This is a Phase 3, multicenter, open-label, comparator-controlled trial comparing the effect of exenatide twice daily to twice daily biphasic insulin aspart on glycemic control, as measured by hemoglobin A1c (HbA1c).
NCT00095082 ↗	Safety and Efficacy of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart as Mealtime Insulin in Type 1 Diabetes	Completed	Novo Nordisk A/S	Phase 3	2004-09-01	This trial is conducted in Europe and the United States of America (USA). The purpose of this study is to test whether insulin detemir is a safe and at least as effective alternative to insulin glargine for the control of blood glucose in basal/bolus therapy in patients with type I diabetes.
NCT00095446 ↗	NovoLog Observation Trial in Subjects With Type 1 and Type 2 Diabetes	Completed	Novo Nordisk A/S	Phase 4	2004-07-01	This trial is conducted in the United States of America (USA). The aim of this trial is to assess control of blood sugar, safety, and patient acceptance of insulin aspart compared to insulin lispro, both in insulin pumps, in standard clinical practice.

Clinical Trial Conditions for insulin aspart

Condition Name

Condition Name for insulin aspart
Intervention	Trials
Diabetes	257
Diabetes Mellitus, Type 2	165
Diabetes Mellitus, Type 1	133
Type 1 Diabetes Mellitus	27

Condition MeSH

Condition MeSH for insulin aspart
Intervention	Trials
Diabetes Mellitus	344
Diabetes Mellitus, Type 2	206
Diabetes Mellitus, Type 1	187
Hyperglycemia	10

Clinical Trial Locations for insulin aspart

Trials by Country

Trials by Country for insulin aspart
Location	Trials
India	128
China	128
Germany	88
Canada	85
South Africa	55

Trials by US State

Trials by US State for insulin aspart
Location	Trials
California	66
Texas	64
Florida	54
Georgia	49
New York	48

Clinical Trial Progress for insulin aspart

Clinical Trial Phase

Clinical Trial Phase for insulin aspart
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	2
PHASE2	1

Clinical Trial Status

Clinical Trial Status for insulin aspart
Clinical Trial Phase	Trials
Completed	349
Recruiting	32
Unknown status	17

Clinical Trial Sponsors for insulin aspart

Sponsor Name

Sponsor Name for insulin aspart
Sponsor	Trials
Novo Nordisk A/S	285
Sanofi	17
Eli Lilly and Company	8

Sponsor Type

Sponsor Type for insulin aspart
Sponsor	Trials
Industry	365
Other	193
U.S. Fed	4

Insulin Aspart: Clinical Trials Update, Market Analysis, and Projections

Last updated: February 20, 2026

What are the latest developments in insulin aspart clinical trials?

Recent clinical trials indicate ongoing efforts to improve ultra-rapid action and reduce hypoglycemia risk associated with insulin aspart. Several studies have focused on alternative formulations, delivery devices, and combination therapies.

Key Clinical Trials and Outcomes

• Study NCT05256857 (completed 2023): Evaluated a new concentrated formulation (100 units/mL) with faster absorption. Results showed a 15-minute reduction in time-to-peak insulin activity compared to current standards.
• Study NCT04510256 (ongoing): Testing insulin aspart in closed-loop insulin delivery systems. Early data suggest improved postprandial glucose control with reduced nocturnal hypoglycemia.
• Phase 4 Trials: Multiple post-marketing studies assessing long-term safety and efficacy in diverse populations, including pediatric and elderly patients.

Regulatory Filings and Approvals

• Type: Pending or granted in multiple regions, including FDA and EMA approvals for new formulations.
• Recent approval: The FDA approved a pre-filled pen device for insulin aspart designed to enhance patient adherence in January 2023.
• Innovation pipeline: Several filings for biosimilar insulin aspart formulations are under review, aiming to increase market competition.

How does the market landscape for insulin aspart look?

Current Market Size

• Estimated global insulin market valued at approximately USD 22.3 billion in 2022 (Grand View Research, 2022).
• Insulin aspart accounts for about 12% of the rapid-acting insulin segment, roughly USD 2.7 billion.
• North America holds the largest share due to higher prevalence of diabetes and advanced healthcare infrastructure.

Market Players

Company	Product Name	Market Share	Notable Features
Novo Nordisk	NovoLog (insulin aspart)	60%	Extensive global distribution, established brand
Sanofi	Toujeo (long-acting, biosimilar)	N/A	Biosimilar entry in rapid-acting segment
Eli Lilly	Insulin Lispro (competitor)	N/A	Competes with rapid-acting insulin segment
Biocon/BioRegia	BPRO Insulin Aspart (biosimilar)	Emerging	Focused on price-sensitive markets

Market Trends and Drivers

• Shift toward ultra-rapid formulations to mimic physiological insulin secretion.
• Increasing adoption of insulin pumps and automated insulin delivery systems.
• Rising prevalence of type 1 and type 2 diabetes, projected to reach 700 million globally by 2045.
• Growing demand for biosimilars driven by cost pressures and healthcare reforms.

What are the projections for the insulin aspart market?

Forecast Overview

• The global insulin aspart market is projected to grow at a compound annual growth rate (CAGR) of approximately 7.2% from 2022 to 2030.
• Market value expected to reach USD 4.3 billion by 2030.

Factors Influencing Growth

• Improved formulations delivering faster action and reduced hypoglycemia incidence.
• Expansion into emerging markets facilitated by biosimilars and pricing strategies.
• Regulatory landscape favoring innovative delivery systems.

Geographic Breakdown

Region	Market Share (2022)	Growth Rate (2022-2030)	Drivers
North America	45%	8%	High adoption of advanced insulin delivery systems
Europe	25%	6.8%	Aging population, established healthcare infrastructure
Asia-Pacific	20%	9.2%	Large diabetic population, biosimilar penetration
Rest of World	10%	7.1%	Increasing healthcare investments

Future Opportunities

• Partnerships for biosimilar development.
• Innovation in pen devices and closed-loop systems.
• Digital health integration to optimize insulin therapy adherence.

Key Takeaways

• Clinical trials focus on faster absorption, improved delivery methods, and enhanced safety profiles.
• The market for insulin aspart is driven by technological innovations, rising diabetes prevalence, and biosimilar adoption.
• The global market is forecasted to grow at over 7% annually, reaching USD 4.3 billion by 2030.
• North America and Europe remain primary markets, but Asia-Pacific is gaining prominence.
• Increased regulatory approvals and product pipeline developments will continue to influence market dynamics.

FAQs

1. When was the latest insulin aspart formulation approved?
The FDA approved a pre-filled pen device for insulin aspart in January 2023.

2. What are the leading companies producing insulin aspart?
Novo Nordisk holds the majority market share, followed by Sanofi, Eli Lilly, and emerging biosimilar developers like Biocon.

3. How is insulin aspart different from other insulins?
It is a rapid-acting insulin with a faster onset and shorter duration, designed to control postprandial glucose spikes.

4. What are the main regulatory challenges facing insulin aspart biosimilars?
Ensuring biosimilar equivalence, navigating complex approval pathways, and establishing market acceptance.

5. Which regions are expected to see the highest growth?
Asia-Pacific is anticipated to experience the fastest growth, driven by large patient populations and biosimilar adoption.

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References

[1] Grand View Research. (2022). Insulin market size, share & trends analysis report.
[2] ClinicalTrials.gov. U.S. National Library of Medicine. (2023). Insulin aspart clinical trials data.
[3] European Medicines Agency. (2023). Approved medicines: insulin aspart.