CLINICAL TRIALS PROFILE FOR LEVEMIR

All Clinical Trials for Levemir

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00264901 ↗	Comparison of Self Adjustment Versus Standard of Care Treatment in Subjects With Type 2 Diabetes	Completed	Novo Nordisk A/S	Phase 4	2005-10-01	This trial is conducted in the United States of America (USA). This trial aims for a comparison of the safety and efficacy in subjects with type 2 diabetes using either self titration or physician guided titration according to the local standard of care.
NCT00331604 ↗	Safety and Efficacy of Inhaled Insulin in Type 2 Diabetes	Terminated	Novo Nordisk A/S	Phase 3	2006-08-31	This trial is conducted in Asia, Europe and South America. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function tests, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin detemir in Type 2 Diabetes.
NCT00405418 ↗	Lantus Versus Levemir Treat-To-Target	Completed	Sanofi	Phase 4	2006-11-01	Primary objective: To demonstrate the non-inferiority of insulin glargine in comparison to insulin detemir in term of percentage of patients who reach the target of HbA1c < 7% at the end of the treatment period and do not experience symptomatic hypoglycemia, confirmed by plasma glucose (PG) ≤ 56 mg/dL (3.1 mmol/L) Secondary objectives: - To compare between the 2 treatment groups, the percentage of patients who reach the target of HbA1c < 7% and < 6.5% at the end of the treatment period - To compare the changes in HbA1c and fasting plasma glucose (FPG) - To compare the evolution of blood glucose profiles - To compare the day to day FPG variability, the insulin doses - To determine in each treatment group the biochemical and patient-related determinants of failure to reach HbA1c targets - To compare the overall incidence and rate of symptomatic hypoglycemia and nocturnal symptomatic hypoglycemia confirmed by PG ≤ 56 mg/dL (3.1 mmol/L) - To compare over the treatment period, the overall incidence and rate of symptomatic hypoglycemia and symptomatic nocturnal hypoglycemia (with PG ≤ 70 mg/dL [3.9 mmol/L]), of symptomatic day-time hypoglycemia (with PG ≤ 70 mg/dL and with PG ≤ 56 mg/dL), of severe hypoglycemia, of asymptomatic hypoglycemia with PG ≤ 56 mg/dL - To compare the overall safety: incidence of adverse events (including serious hypoglycemia and local tolerance at injection site), change in body weight, in waist circumference and in waist / hip ratio - To assess the quality of life and treatment satisfaction
NCT00467246 ↗	Sub-Cutaneous Insulin in Hyperglycaemic Emergencies	Withdrawn	The Royal Bournemouth Hospital	N/A	1969-12-31	Hyperglycaemic emergencies are associated with significant mortality (mortality in Diabetic Ketoacidosis 0.65 - 3.3% and in HyperOsmolar Non-Ketotic Coma 12 -17%). To reduce morbidity and mortality, prompt intervention and coma and close monitoring are essential. The study is designed to investigate whether a simple intervention with a long acting insulin can improve resolution of acidosis and hyperglycaemia, prevent recurrence of ketoacidosis and shorten hospital stay.
NCT00474045 ↗	Efficacy and Safety of Insulin Detemir Versus Neutral Protamine Hagedorn (NPH) Insulin in Pregnant Women With Type 1 Diabetes	Completed	Novo Nordisk A/S	Phase 3	2007-05-01	This trial is conducted in Africa, Europe, North and South America and Oceania. The aim of this trial is to compare the effect and safety on blood glucose control in pregnant women with type 1 diabetes of a modern insulin analogue (insulin detemir) and human insulin (NPH insulin) given as long-acting insulin in combination with a short-acting insulin (insulin aspart).
NCT00522210 ↗	Comparison of a Twice Daily Versus a Three Times Daily Insulin Regimen in Children With Type 1 Diabetes	Completed	University of Calgary	N/A	2008-03-01	The purpose of this study is to determine whether there is a difference in blood sugar control (as measured by hemoglobin A1c (HA1c)), in children given twice daily insulin injections incorporating a new long acting insulin analogue (detemir) compared to children using their current three times a day insulin injections (with intermediate and rapid acting insulin).
NCT00542620 ↗	Comparison of Insulin Detemir and Insulin Aspart in 2 Separate Injections Twice Daily to Extemporaneous Mixing Injection Regimen Twice Daily - The Paediatric Mixing Trial	Completed	Novo Nordisk A/S	Phase 4	2007-09-01	This trial is conducted in Europe. The aim of the trial is to compare two methods of injection in basal-bolus insulin regimen in children with type 1 diabetes with insulin detemir associated with insulin aspart given twice daily in either separate or mixed injections and to investigate if there is any clinical impact in choosing one regimen over another.

Clinical Trial Conditions for Levemir

Condition Name

Condition Name for Levemir
Intervention	Trials
Diabetes	53
Diabetes Mellitus, Type 2	51
Diabetes Mellitus, Type 1	26
Type 2 Diabetes	8

Condition MeSH

Condition MeSH for Levemir
Intervention	Trials
Diabetes Mellitus	78
Diabetes Mellitus, Type 2	65
Diabetes Mellitus, Type 1	32
Hyperglycemia	3

Clinical Trial Locations for Levemir

Trials by Country

Trials by Country for Levemir
Location	Trials
United States	144
United Kingdom	16
Germany	10
France	10
Spain	8

Trials by US State

Trials by US State for Levemir
Location	Trials
New York	7
Texas	7
Ohio	5
North Carolina	5
Washington	5

Clinical Trial Progress for Levemir

Clinical Trial Phase

Clinical Trial Phase for Levemir
Clinical Trial Phase	Trials
Phase 4	29
Phase 3	4
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Levemir
Clinical Trial Phase	Trials
Completed	82
Terminated	4
Unknown status	4

Clinical Trial Sponsors for Levemir

Sponsor Name

Sponsor Name for Levemir
Sponsor	Trials
Novo Nordisk A/S	66
Sanofi	4
Albert Einstein College of Medicine	3

Sponsor Type

Sponsor Type for Levemir
Sponsor	Trials
Industry	74
Other	66
NIH	4

Levemir: Clinical Trials, Market Analysis, and Projections

Introduction to Levemir

Levemir, also known as insulin detemir, is a long-acting basal insulin analog developed by Novo Nordisk. It has been widely used by individuals with type 1 and type 2 diabetes to manage blood sugar levels. Here, we will delve into the clinical trials, market analysis, and future projections for Levemir, especially in light of its impending discontinuation.

Clinical Trials Overview

Efficacy and Safety in Pregnancy

Clinical trials involving pregnant women with type 1 diabetes have shown that Levemir is non-inferior to NPH insulin in terms of glycemic control, as measured by HbA1c levels at gestational week 36. These trials also indicated no significant difference in the rate of hypoglycemic episodes between the two groups. However, there was a numerically higher frequency of serious adverse events in the mothers and offspring in the Levemir group compared to the NPH insulin group[1][4].

Adverse Reactions and Hypoglycemia

In various clinical trials, the adverse reaction profiles of Levemir and NPH insulin were similar, with common adverse reactions including upper respiratory tract infections, headache, and pharyngitis. Hypoglycemia rates were also comparable between the two treatments[4].

Pediatric and Adolescent Studies

Clinical trials in children and adolescents with type 1 diabetes showed that Levemir had a favorable safety profile, with lower day-to-day variability in fasting plasma glucose levels compared to NPH insulin[1].

Market Analysis

Current Market Position

Levemir has been a significant player in the basal insulin market, generating $649 million in revenue in 2022 alone. However, with the emergence of newer, better-performing basal insulins, such as Novo Nordisk's own Tresiba, the market dynamics are shifting[2].

Global Manufacturing Constraints and Formulary Issues

Novo Nordisk has cited global manufacturing constraints and formulary losses impacting patient access as key reasons for discontinuing Levemir. These factors, combined with the availability of alternative treatments, have led to the decision to phase out Levemir[2].

Impact on Patients and Market

The discontinuation of Levemir is expected to affect a substantial number of patients, particularly those who rely on this long-acting insulin formulation. Despite the company's assurance that alternative treatments are available, lawmakers have expressed concern over the potential reduction in access to affordable insulin options[5].

Market Projections and Future Outlook

Discontinuation Timeline

Levemir FlexPen is expected to face supply disruptions starting in mid-January 2024, with the product being discontinued on April 1, 2024. Levemir in vials will no longer be available after December 31, 2024[2].

Alternative Insulins

The market is expected to shift towards newer basal insulins like Tresiba and potentially once-weekly insulins that are in development. These products offer improved efficacy and convenience, making them more attractive to both patients and healthcare providers[2].

Price Cuts and Affordability

Although Novo Nordisk had announced a 65% price cut for Levemir starting January 1, 2024, the decision to discontinue the product has overshadowed this initiative. The focus now is on ensuring that patients can transition to alternative insulins without significant disruptions or increased costs[5].

Regulatory and Developmental Activities

Clinical Trials and Regulatory Milestones

Detailed reports on Levemir's clinical trials, including trial interventions, conditions, and status, are available. These trials have been crucial in establishing the safety and efficacy of Levemir for type 1 and type 2 diabetes management[3].

Future Market Assessments

Market forecast analyses predict that the basal insulin market will continue to evolve, with emerging therapies and newer insulins gaining traction. The report by DelveInsight provides a comprehensive overview of the market forecast from 2023 to 2032, including SWOT analysis and views from industry experts[3].

Key Takeaways

• Clinical Efficacy: Levemir has demonstrated similar efficacy to NPH insulin in clinical trials, including those involving pregnant women and pediatric patients.
• Discontinuation: Levemir will be discontinued by Dec. 31, 2024, due to manufacturing constraints, formulary issues, and the availability of alternative insulins.
• Market Impact: The discontinuation is expected to affect patient access, despite the availability of alternative treatments.
• Future Outlook: The market is shifting towards newer basal insulins with improved efficacy and convenience.
• Regulatory and Developmental Activities: Ongoing market assessments and clinical trials continue to shape the future of basal insulin therapy.

FAQs

Q: Why is Levemir being discontinued?

Levemir is being discontinued due to global manufacturing constraints, formulary losses impacting patient access, and the availability of alternative, better-performing basal insulins[2].

Q: What are the alternative insulins available?

Alternative insulins include Novo Nordisk's own Tresiba and potentially once-weekly insulins that are in development[2].

Q: How will the discontinuation of Levemir affect patients?

The discontinuation may reduce access to medications for many patients, although Novo Nordisk assures that alternative treatments are available. Lawmakers have expressed concern over the potential impact on patient access to affordable insulin[5].

Q: What were the clinical trial findings for Levemir in pregnancy?

Clinical trials showed that Levemir was non-inferior to NPH insulin in terms of glycemic control during pregnancy, with no significant difference in hypoglycemic episodes. However, there was a higher frequency of serious adverse events in the Levemir group[1][4].

Q: What is the timeline for the discontinuation of Levemir?

Levemir FlexPen will face supply disruptions starting in mid-January 2024 and will be discontinued on April 1, 2024. Levemir in vials will no longer be available after December 31, 2024[2].

Sources

1. Novo Nordisk New Zealand - Levemir 20.4.2021.doc
2. Diatribe - Levemir, a Long-Acting Insulin, To Be Discontinued by Novo Nordisk
3. GII Research - LEVEMIR Drug Insight and Market Forecast - 2032
4. FDA - Levemir injection label
5. FiercePharma - Novo Nordisk attracts lawmakers' ire for Levemir insulin pull

Last updated: 2024-12-31