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	119
Diabetes Mellitus, Type 2	77
Diabetes Mellitus, Type 1	47
Healthy	17

Condition MeSH

Condition MeSH for insulin degludec
Intervention	Trials
Diabetes Mellitus	155
Diabetes Mellitus, Type 2	102
Diabetes Mellitus, Type 1	63
Hypoglycemia	3

Clinical Trial Locations for insulin degludec

Trials by Country

Trials by Country for insulin degludec
Location	Trials
China	177
India	152
Canada	115
Germany	90
South Africa	65

Trials by US State

Trials by US State for insulin degludec
Location	Trials
California	67
Texas	64
Florida	62
North Carolina	51
New York	51

Clinical Trial Progress for insulin degludec

Clinical Trial Phase

Clinical Trial Phase for insulin degludec
Clinical Trial Phase	Trials
Phase 4	20
Phase 3	77
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for insulin degludec
Clinical Trial Phase	Trials
Completed	144
Recruiting	18
Not yet recruiting	9

Clinical Trial Sponsors for insulin degludec

Sponsor Name

Sponsor Name for insulin degludec
Sponsor	Trials
Novo Nordisk A/S	134
Eli Lilly and Company	15
Sanofi	5

Sponsor Type

Sponsor Type for insulin degludec
Sponsor	Trials
Industry	161
Other	50

Insulin degludec Market Analysis and Financial Projection

Insulin Degludec: Clinical Trials, Market Analysis, and Projections

Introduction to Insulin Degludec

Insulin degludec, marketed under the brand name Tresiba, is a long-acting insulin analogue designed for the management of type 1 and type 2 diabetes. It is characterized by its slow release and consistent baseline insulin levels over an extended period, typically up to 42 hours.

Clinical Trials Update

Efficacy and Safety in Type 1 and Type 2 Diabetes

Several clinical trials have evaluated the efficacy and safety of insulin degludec. In a phase 3a trial, insulin degludec was compared to once-weekly insulin icodec in patients with type 1 diabetes. The trial, part of the ONWARDS clinical development program, showed that insulin degludec, when combined with insulin aspart, provided effective glycemic control with a similar risk of hypoglycemia compared to once-weekly icodec[1].

For type 2 diabetes, multiple trials within the ONWARDS program have demonstrated that insulin degludec is either statistically superior or non-inferior to other long-acting insulins like glargine U100 in reducing glycated hemoglobin (HbA1c) levels. These trials also highlighted low rates of combined clinically significant or severe hypoglycemia[1].

Comparative Studies

A meta-analysis and several clinical trials have compared insulin degludec to other long-acting insulins. For instance, a 26-week phase 3 trial compared degludec to liraglutide and a fixed-ratio combination of the two (IDegLira). This study, replicated using in-silico models, showed that degludec effectively lowered HbA1c and fasting plasma glucose levels, with results consistent between the clinical trial and simulations[4].

Cardiovascular Risk Assessment

The DEVOTE trial, which compared the cardiovascular risk of degludec to glargine in adults with type 2 diabetes, found that degludec did not increase the risk of major adverse cardiovascular events (MACE) compared to glargine. This was crucial in establishing the safety profile of insulin degludec[3].

Market Analysis

Global Insulin Market

The global insulin market is expected to grow significantly due to the rising prevalence of diabetes. According to the International Diabetic Federation (IDF), the number of individuals living with diabetes is projected to reach 643 million by 2030 and 783 million by 2045. This increase in diabetes cases is a key driver of the insulin market, which is estimated to reach USD 33.81 billion by 2029, growing at a CAGR of 3.87% during the forecast period[2].

Long-acting Insulin Segment

Long-acting insulins, such as insulin degludec, are expected to record significant growth. These insulins ensure a consistent baseline insulin level over an extended period, reducing the frequency of insulin injections and improving patient compliance. The approval of biosimilar long-acting insulins, like the unbranded biologic insulin degludec approved by the FDA in 2022, further supports this growth[2].

Market Projections

US Insulin Drugs and Delivery Devices Market

In the United States, the insulin drugs and delivery devices market is projected to reach USD 23.11 billion by 2030, growing from USD 20.23 billion in 2025. Insulin pumps, which offer continuous insulin administration, are expected to grow with a CAGR of more than 6.5% during the forecast period due to their preference over traditional injection methods[5].

Global Market Outlook

The global insulin market, driven by the increasing prevalence of diabetes and the launch of novel insulin products, is expected to continue its upward trend. Insulin degludec, with its established efficacy and safety profile, is poised to remain a significant player in this market. The market size is estimated to reach USD 35.11 billion by 2030, growing at a CAGR of 3.87% from 2024 to 2029[2].

Patient Compliance and Technological Advancements

Patient compliance is a critical factor in the success of insulin therapy. Long-acting insulins like degludec, which reduce the frequency of injections, are expected to drive market growth. Additionally, technological advancements in insulin delivery devices, such as insulin pumps and remote-controlled systems, are enhancing the convenience and accuracy of insulin administration, further boosting the market[5].

Key Takeaways

• Clinical Efficacy: Insulin degludec has demonstrated effective glycemic control with a similar risk of hypoglycemia compared to other long-acting insulins in clinical trials.
• Market Growth: The global insulin market is expected to grow significantly due to the rising prevalence of diabetes and the launch of novel insulin products.
• Long-acting Insulins: This segment is expected to record significant growth due to improved patient compliance and technological advancements.
• US Market: The US insulin drugs and delivery devices market is projected to grow, driven by the preference for continuous insulin administration via insulin pumps.

FAQs

What is insulin degludec, and how does it work?

Insulin degludec is a long-acting insulin analogue that provides a consistent baseline insulin level over an extended period, typically up to 42 hours, by precipitating when injected subcutaneously.

What are the key findings from clinical trials of insulin degludec?

Clinical trials have shown that insulin degludec provides effective glycemic control with a similar risk of hypoglycemia compared to other long-acting insulins. It has also been found to be non-inferior or superior in reducing HbA1c levels in various studies.

How is the global insulin market expected to grow?

The global insulin market is expected to reach USD 35.11 billion by 2030, growing at a CAGR of 3.87% from 2024 to 2029, driven by the rising prevalence of diabetes and the launch of novel insulin products.

What role do long-acting insulins play in the market?

Long-acting insulins, such as insulin degludec, are expected to record significant growth due to their ability to reduce the frequency of insulin injections and improve patient compliance.

How are technological advancements impacting the insulin market?

Technological advancements in insulin delivery devices, such as insulin pumps and remote-controlled systems, are enhancing the convenience and accuracy of insulin administration, further boosting the market.

Sources

1. The Lancet: "Once-weekly insulin icodec versus once-daily insulin degludec as add-on to insulin aspart in adults with type 1 diabetes: a 52-week, randomised, open-label, treat-to-target, phase 3a trial"[1].
2. Mordor Intelligence: "Insulin Market - Size, Share, Growth & Trends"[2].
3. FDA: "203313Orig1s000 203314Orig1s000 - Tresiba and Ryzodeg 70/30"[3].
4. Diabetes Journal: "75-OR: In-Silico Replay of Insulin Degludec and Liraglutide Clinical Trials"[4].
5. Mordor Intelligence: "US Insulin Drugs & Delivery Devices Market - Size, Share & Analysis"[5].