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
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.
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
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.

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
Hyperglycemia	1
Post-Transplant Glucocorticoid Induced Diabetes	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
Stroke	1

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

Trials by Country

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Trials by Country for Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant
Location	Trials
Bangladesh	1
Spain	1
United Kingdom	1
Japan	1
Australia	1

Trials by US State

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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

Insulin Aspart: Clinical Trials, Market Analysis, and Projections

Introduction to Insulin Aspart

Insulin aspart, a rapid-acting human insulin analog, is designed to lower postprandial blood glucose levels. It is effective when administered immediately before a meal and is characterized by its rapid onset and shorter duration of action compared to traditional human insulin[5].

Clinical Trials and Efficacy

Pharmacokinetic and Pharmacodynamic Properties

Clinical trials have shown that insulin aspart has a faster absorption profile compared to human insulin. The substitution of proline with aspartic acid at position B28 reduces the tendency to form hexamers, leading to quicker dissociation into active monomers. This results in a faster onset of action, typically within 10-20 minutes, and a maximum effect between 1-4 hours after injection. The duration of action can last up to 24 hours[1].

Comparative Studies

In clinical trials, insulin aspart has been compared to biphasic human insulin. These studies have shown that insulin aspart can achieve lower postprandial glucose increases and fewer hypoglycemic episodes. However, the overall rates of hypoglycemia did not differ significantly between insulin aspart and human insulin. Additionally, insulin aspart demonstrated equal control of glycosylated hemoglobin (HbA1c) compared to biphasic human insulin in some trials, although other studies showed slightly higher HbA1c levels with insulin aspart[1].

Pediatric and Special Populations

The pharmacokinetics of insulin aspart have been investigated in children and adolescents with type 1 diabetes, showing rapid absorption similar to adults, but with varying maximum concentrations (Cmax) that highlight the need for individual titration. However, the pharmacokinetics in elderly patients or those with impaired renal or liver function have not been extensively studied[1].

Market Analysis

Global Market Trends

The global rapid-acting insulin market, which includes insulin aspart, is projected to grow significantly. By 2032, the market is expected to reach $11.17 billion from $7.36 billion in 2023, growing at a CAGR of 4.75%. This growth is driven by the increasing prevalence of diabetes worldwide, technological advancements in insulin delivery systems, and improved diabetes management strategies[3].

China Market

In China, the market for rapid-acting insulins like insulin aspart is particularly robust. The number of diabetic patients in China exceeded 1.13 billion by the end of 2020, with 30-40% of type 2 diabetes patients eventually becoming insulin-dependent. The sales value of recombinant lispro insulin, a similar rapid-acting insulin, has increased from less than CNY 7 million in 2005 to CNY 254 million in 2020. Eli Lilly's Humalog and Gan & Lee Pharmaceuticals' Prandilin are the dominant players in this market, though other domestic companies are entering the scene[2].

Market Share and Competition

The market is dominated by a few key players, including Eli Lilly and Novo Nordisk, the manufacturer of Novolog (insulin aspart). These companies are focusing on product development and innovation to address the growing healthcare needs of diabetic patients. The introduction of biosimilar insulin products is also expected to enhance access to diabetes care and improve patient outcomes[3].

Market Projections

Future Growth

The rapid-acting insulin market, including insulin aspart, is expected to continue growing due to several factors:

• Increasing Diabetes Prevalence: The global rise in diabetes cases is a significant driver.
• Technological Advancements: Improvements in insulin delivery systems and personalized treatment regimens are enhancing patient care and adherence.
• Government Initiatives: In regions like China, government efforts to improve healthcare standards are boosting the market[3].

Regional Growth

China is emerging as a key market for rapid-acting insulins, driven by a large diabetic population and government initiatives. Despite challenges in patient education and healthcare infrastructure, the potential for growth in this region is substantial[3].

Product Development

New product approvals and the introduction of biosimilar insulins are expected to further drive the market. Companies are investing heavily in research and development to offer enhanced therapeutic options and improve patient outcomes[3].

Key Takeaways

• Rapid Onset and Action: Insulin aspart has a faster onset and shorter duration of action compared to traditional human insulin.
• Clinical Efficacy: It has shown equal or superior control of postprandial glucose levels and HbA1c in various clinical trials.
• Market Growth: The global rapid-acting insulin market is projected to grow significantly, driven by increasing diabetes prevalence and technological advancements.
• China Market Potential: China is a key growth region due to its large diabetic population and government healthcare initiatives.
• Competitive Landscape: The market is dominated by a few key players, with a focus on innovation and product development.

FAQs

What is insulin aspart, and how does it differ from human insulin?

Insulin aspart is a rapid-acting human insulin analog with a faster onset and shorter duration of action compared to traditional human insulin. It is engineered with an aspartate at position B28, which reduces the formation of hexamers, leading to quicker absorption[5].

What are the key clinical benefits of insulin aspart?

Insulin aspart offers lower postprandial glucose increases, fewer hypoglycemic episodes, and equal or superior control of HbA1c compared to biphasic human insulin in some studies[1].

How is the global market for rapid-acting insulins projected to grow?

The global rapid-acting insulin market is expected to reach $11.17 billion by 2032, growing at a CAGR of 4.75% from $7.36 billion in 2023, driven by increasing diabetes prevalence and technological advancements[3].

Who are the major players in the insulin aspart market?

Eli Lilly and Novo Nordisk are among the dominant players in the market, with other companies like Gan & Lee Pharmaceuticals also playing significant roles, especially in regions like China[2][3].

What are the challenges and opportunities in the Chinese market for insulin aspart?

The Chinese market faces challenges such as patient education and healthcare infrastructure, but it also offers significant growth opportunities due to a large diabetic population and government healthcare initiatives[2][3].

How does insulin aspart compare to other rapid-acting insulins like lispro insulin?

Insulin aspart and lispro insulin are both rapid-acting insulins with similar pharmacokinetic profiles, but they have different amino acid substitutions. Insulin aspart has an aspartate at position B28, while lispro insulin has a lysine and proline swap at positions B28 and B29. Both are effective in lowering postprandial glucose levels but may have slightly different clinical profiles[5][2].