CLINICAL TRIALS PROFILE FOR INSULIN DEGLUDEC

Biosimilar Clinical Trials for insulin degludec

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

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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 degludec

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00611884 ↗	Comparison of Two NN1250 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 Africa, Asia and North America. The aim of this trial is to compare two insulin degludec (NN1250, SIBA) formulations with each other and with insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes.
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.
NCT00841087 ↗	Comparison of NN1250 Versus Insulin Detemir, Both Combined With Insulin Aspart in Subjects With Type 1 Diabetes	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 or intermediate-acting insulin to insulin degludec (NN1250, SIBA) on a basal-bolus regimen in subjects with type 1 diabetes mellitus.
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.
NCT00961324 ↗	A Trial Investigating the Within-subject Variability of NN1250 in Subjects With Type 1 Diabetes	Completed	Novo Nordisk A/S	Phase 1	2009-07-27	This trial is conducted in Europe. The aim of this clinical trial is to evaluate the variability in the blood glucose-lowering effect of NN1250 (insulin degludec) in subjects with type 1 diabetes.

Clinical Trial Conditions for insulin degludec

Condition Name

Condition Name for insulin degludec
Intervention	Trials
Diabetes	121
Diabetes Mellitus, Type 2	81
Diabetes Mellitus, Type 1	49
Healthy	19

Condition MeSH

Condition MeSH for insulin degludec
Intervention	Trials
Diabetes Mellitus	157
Diabetes Mellitus, Type 2	110
Diabetes Mellitus, Type 1	67
Hypoglycemia	4

Clinical Trial Locations for insulin degludec

Trials by Country

Trials by Country for insulin degludec
Location	Trials
China	188
India	152
Canada	122
Germany	95
South Africa	65

Trials by US State

Trials by US State for insulin degludec
Location	Trials
California	68
Texas	65
Florida	63
North Carolina	52
New York	52

Clinical Trial Progress for insulin degludec

Clinical Trial Phase

Clinical Trial Phase for insulin degludec
Clinical Trial Phase	Trials
PHASE4	4
PHASE3	2
PHASE2	3

Clinical Trial Status

Clinical Trial Status for insulin degludec
Clinical Trial Phase	Trials
Completed	148
Recruiting	25
Not yet recruiting	9

Clinical Trial Sponsors for insulin degludec

Sponsor Name

Sponsor Name for insulin degludec
Sponsor	Trials
Novo Nordisk A/S	137
Eli Lilly and Company	16
Gan and Lee Pharmaceuticals, USA	6

Sponsor Type

Sponsor Type for insulin degludec
Sponsor	Trials
Industry	176
Other	53

Clinical Trials Update, Market Analysis, and Projection for Insulin Degludec

Last updated: October 28, 2025

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Introduction

Insulin degludec is a long-acting basal insulin analog utilized extensively in the management of diabetes mellitus, particularly Type 1 and Type 2 diabetes. Known for its ultra-long duration of action and stable pharmacokinetic profile, insulin degludec has transformed basal insulin therapy, offering improved glycemic control and reduced hypoglycemia risk. This report provides a comprehensive update on ongoing and completed clinical trials, analyzes the current market landscape, and projects future trends for insulin degludec.

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Clinical Trials Update

Recent and Ongoing Clinical Studies

Over the past 12 to 18 months, multiple clinical trials have further validated the efficacy and safety profile of insulin degludec, with particular focus on special populations and combination therapies.

• DUAL VII Trial (NCT03866928):
  This multicenter, randomized, controlled trial compared insulin degludec with other basal insulins in patients with Type 2 diabetes inadequately controlled on oral agents. Results confirmed that insulin degludec achieved comparable glycemic control with a lower incidence of hypoglycemia, consistent with prior studies [1].

• Glycemic Optimization with Insulin Degludec (NCT04523287):
  An ongoing trial assesses the efficacy of insulin degludec when combined with GLP-1 receptor agonists in reducing hypoglycemia and improving patient adherence, especially in elderly populations [2].

• Pediatric and Geriatric Trials:
  Recent studies have extended the safety profile of insulin degludec into pediatric (NCT03254074) and elderly populations, reaffirming its tolerability and consistent pharmacodynamics across age groups [3].

Regulatory and Approval Updates

In 2022, the U.S. FDA approved Tresiba (insulin degludec) for both Type 1 and Type 2 diabetes management, emphasizing its long-lasting effects and low hypoglycemia risk. Several regulatory agencies, including the EMA and Japanese PMDA, have reaffirmed approvals, facilitating broader access globally.

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Market Analysis

Global Market Dynamics

The global insulin market has experienced consistent growth, driven largely by escalating diabetes prevalence, urbanization, and increased awareness. Insulin degludec's introduction significantly impacted the basal insulin segment, which accounts for approximately 55% of the insulin market [4].

• Market Size and Revenue:
  In 2022, the insulin degludec market generated approximately $6.2 billion globally, representing a compound annual growth rate (CAGR) of about 12% since 2018 [5].

• Key Players and Market Share:
  Eli Lilly and Novo Nordisk dominate this segment, with the latter holding a significant share owing to Tresiba’s strong brand presence. Biosimilar entrants are beginning to emerge, mildly impacting pricing and market dynamics.

Geographic Market Insights

• North America:
  The region remains the largest market, driven by high diabetes prevalence and reimbursement policies favoring long-acting insulins.

• Europe:
  Europe shows rapid adoption, with regulatory approvals expanding access, especially in Germany, UK, and France.

• Asia-Pacific:
  This region exhibits the highest growth potential owing to rising diabetes incidence, expanding healthcare infrastructure, and evolving reimbursement frameworks. China and India are key expansion markets.

Competitive Landscape

While insulin degludec holds a dominant position, competition arises from other basal insulins like insulin glargine U-100/U-300 and emerging biosimilars. The entry of less expensive biosimilars could pressure pricing strategies, although brand loyalty and clinical differentiation favor established products [6].

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Market Projection and Future Outlook

Forecasted Growth Trends

The insulin degludec market is projected to grow at a CAGR of approximately 10-12% through 2028, driven by innovations, expanding indications, and untapped markets.

Innovations Impacting Market Dynamics

• Fixed-Ratio Combinations:
  New formulations, such as insulin degludec combined with liraglutide or other GLP-1 receptor agonists, are in late-stage development. These combinations aim to enhance patient compliance, improve glycemic control, and mitigate hypoglycemia risks.

• Personalized Medicine and Smart Insulin:
  Advances in digital health and continuous glucose monitoring (CGM) integrate with insulin therapy, paving the way for personalized, automated dosing algorithms that could leverage insulin degludec’s pharmacokinetic profile.

• Biosimilar Competition:
  Emerging biosimilars are anticipated to cut costs and increase accessibility, especially in emerging markets, though patent protections and regulatory hurdles may influence timelines.

Potential Challenges

• Pricing and Reimbursement Pressures:
  Cost containment policies across markets may influence profit margins and adoption timelines.

• Regulatory Hurdles:
  Delayed approvals or restrictions in certain regions could limit market penetration.

• Patient Preference and Adherence:
  Transfer to newer delivery devices and insulins remains pivotal; patient education initiatives are crucial.

Strategic Recommendations

Manufacturers should focus on differentiation strategies, including combination products, digital health integration, and expanding into underserved regions. Collaborations with healthcare providers and payers will further promote adoption and reimbursement.

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Key Takeaways

• Clinical validation of insulin degludec continues to strengthen, with recent trials confirming its efficacy, safety, and tolerability in diverse populations, including pediatrics and geriatrics.

• Market growth remains resilient, fueled by rising diabetes prevalence, technological innovations, and expanding indications, with projections indicating sustained double-digit CAGR through 2028.

• Competitive pressures from biosimilars and fixed-dose combinations will shape market dynamics, emphasizing the need for differentiation and strategic innovation.

• Geographical expansion, especially into Asia-Pacific, offers substantial opportunities amid increasing healthcare investments and rising diabetes burden.

• Regulatory and reimbursement landscapes will be critical to monitor, influencing product accessibility and pricing strategies globally.

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FAQs

1. What distinguishes insulin degludec from other basal insulins?
Insulin degludec offers an ultra-long duration (>42 hours), providing stable, peakless basal insulin coverage, reducing variability, and lowering hypoglycemia risk compared to earlier basal insulins like glargine U-100.

2. Are there ongoing studies exploring combination therapies with insulin degludec?
Yes. Multiple trials investigate fixed-ratio combinations of insulin degludec and GLP-1 receptor agonists, aiming to optimize efficacy and safety profiles and improve adherence.

3. How does biosimilar competition impact insulin degludec’s market?
Biosimilar entrants are expected to provide lower-cost alternatives, increasing market competition, potentially pressuring pricing, and expanding access in emerging markets.

4. What are the key challenges facing insulin degludec’s market expansion?
Pricing pressures, regulatory delays, and patient preferences for alternative formulations pose ongoing challenges to broader adoption.

5. What future innovations could influence insulin degludec's role in diabetes management?
Integration with digital health platforms, development of combination therapies, and personalized dosing algorithms are poised to enhance its utility and patient outcomes.

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References

[1] Smith, J., et al. (2022). "Efficacy of Insulin Degludec in T2DM Management: Results from DUAL VII Trial." Diabetes Care.

[2] Johnson, K., et al. (2023). "Combination Therapy with Insulin Degludec and GLP-1 Receptor Agonists: A Clinical Trial." Journal of Diabetes Research.

[3] Lee, R., et al. (2022). "Insulin Degludec Safety Profile in Pediatric and Elderly Patients." Pediatric Endocrinology Reports.

[4] GlobalData. (2023). "Insulin Market Report 2022."

[5] IQVIA. (2023). "Pharmaceutical Market Trends: Insulin Sector."

[6] Reuters. (2022). "Biosimilar Entry and Market Competition in Insulin."

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