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).

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
Canada	8

Trials by US State

Trials by US State for Levemir
Location	Trials
New York	7
Texas	7
Washington	5
Georgia	5
Ohio	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
Unknown status	4
Terminated	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 of Yeshiva University	3

Sponsor Type

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

LEVEMIR (insulin detemir) Clinical Trials Update, Market Analysis, and Projection

Last updated: April 27, 2026

What is LEVEMIR and where does it sit in the insulin market?

LEVEMIR is insulin detemir, a long-acting basal insulin. In most developed markets, detemir is no longer the category leader; it competes in basal insulin with insulin glargine (including biosimilars) and insulin degludec (including biosimilars). Detemir’s commercial standing has been pressured by:

• Switching to once-daily ultralong basal insulins (especially degludec), and
• Biosimilar-driven price compression in glargine-heavy geographies.

From a market structure perspective, the long-acting basal segment is the center of gravity because it maps directly to chronic diabetes management patterns and payer formularies (basal-bolus regimens and basal intensification).

---

What does the clinical evidence base show for LEVEMIR?

Core efficacy and safety profile

Across major randomized clinical development programs, insulin detemir shows a consistent basal pattern:

• Lower or similar hypoglycemia vs comparator basal insulins in multiple head-to-head settings (with differences varying by regimen and study population).
• Glycemic efficacy comparable to other basal insulins in A1c reduction, with weight effects that are often reported as neutral to modestly favorable depending on regimen.

The pivotal point for current use is not “new efficacy” but how detemir performs against current payer-preferred basal options (glargine and degludec, including biosimilars) in real-world treatment pathways.

Regimen and label-relevant points

LEVEMIR is used as basal insulin with label-driven titration, typically:

• Once daily or twice daily dosing depending on glycemic targets and patient response.
• Ongoing use in insulin-treated diabetes populations, subject to local label details and regulatory updates.

---

Which trial updates matter now?

How to interpret “updates” for an established insulin

For mature products like LEVEMIR, trial “updates” usually come from:

• Post-marketing safety reporting and label revisions,
• Trials comparing basal insulin strategies (including treat-to-target designs),
• Real-world evidence and registry analyses,
• Biosimilar-era comparative effectiveness research.

Because the product is established and widely studied, the key decision-grade updates for business users typically relate to comparative hypoglycemia, weight, persistence (treatment duration), and hospitalization or acute-care outcomes, rather than novel A1c endpoints.

---

Clinical outcomes lens: what outcomes do payers optimize?

Across basal insulin purchasing, payers usually weigh:

• Hypoglycemia risk (especially severe and nocturnal events),
• Weight impact (affects adherence and downstream costs),
• Dosing simplicity (adherence and persistence),
• Acquisition cost driven by competitive pricing and biosimilars.

In that context, detemir’s competitive posture depends on local pricing and formulary positioning versus glargine and degludec.

---

What is the market status for LEVEMIR today?

Category reality

LEVEMIR is a “mature incumbent” in basal insulin. In most markets:

• Uptake has shifted toward biosimilar glargines and degludec-based options.
• Pricing pressure is structurally higher because insulin glargine is widely biosimilar-available in many regions, and degludec has captured share in multiple formularies.

Demand drivers

Detemir demand typically persists where:

• Patients are already stabilized and clinicians maintain continuity,
• Formularies keep detemir as a contracted option,
• Price reductions make detemir competitive relative to other basal insulins available on the same list.

---

Market analysis: where LEVEMIR wins and loses

Wins

LEVEMIR holds advantages when:

• Cost at net price is competitive in tendered settings,
• Switching risk (clinical or administrative) favors continuation,
• Patient-specific factors favor the dosing pattern and titration achieved on detemir.

Loses

LEVEMIR is pressured when:

• Once-daily ultralong basal insulins improve adherence or reduce visit burden,
• Biosimilar glargines depress payer willingness to pay for legacy basal insulins,
• Newer basal insulins have better formulary positioning or constrained copays.

---

Projection: what is the likely trajectory for LEVEMIR revenues and volume?

Short-to-medium term (1 to 3 years)

The most likely trajectory is continued share erosion in regions where biosimilar glargine and degludec gain further formulary penetration. The product can retain revenue via:

• Stabilized patient pools,
• Local tender wins when detemir pricing undercuts competitors,
• Contracting in certain national formularies.

Medium term (3 to 7 years)

Detemir is unlikely to regain category leadership. Expected dynamics:

• Continued volume decline from relative positioning against ultralong basal options and biosimilars,
• Revenue resilience only if pricing remains supported by contracting or tender mechanisms.

Long term (7+ years)

In mature geographies, LEVEMIR becomes increasingly dependent on:

• Substitution limits in payer structures,
• Ongoing contracted access,
• Biosimilar and competitive pricing equilibrium.

---

Competitive set and how it frames LEVEMIR projections

Basal insulin competition relevant for projections:

• Insulin glargine (including biosimilars)
• Insulin degludec (including biosimilars)
• Other long-acting/adjunct basal strategies depending on geography

Detemir’s projection is most sensitive to two variables:

• Net price relative to glargine and degludec biosimilars,
• Formulary tier placement that determines switching rates.

---

Regulatory and lifecycle signals

LEVEMIR is no longer a “launch phase” asset, so its future is driven by:

• Label lifecycle maintenance and safety reporting obligations,
• Competitive replacement cycles,
• Local policy shifts on insulin reimbursement and formulary tendering.

From a portfolio strategy standpoint, detemir behaves like an incumbent basal: stable but declining unless it wins pricing through contracting.

---

What commercial outcomes should investors or R&D leaders model?

Model inputs that typically control outcomes

1. Formulary placement probability by geography (tier level and restriction rules)
2. Switching elasticity from competitor basal insulins
3. Net price trend after biosimilar market expansion
4. Persistence rate among stabilized patients
5. Hypoglycemia and weight-related switching criteria used by clinicians and payers

Base-case directional view

• Volume: downward trend in most major markets.
• Revenue: declines slower than volume if net price stabilizes through contracting; otherwise faster.
• Share: persistent erosion versus glargine biosimilars and degludec.

---

Key Takeaways

• LEVEMIR (insulin detemir) is an established basal insulin competing in a market now dominated by biosimilar glargines and ultralong degludec.
• Clinical evidence supports a consistent basal efficacy and safety profile, but the commercial story is driven by payer economics and formulary choice, not new clinical differentiation.
• Near-term outcomes depend on local net pricing and tender access; absent favorable pricing, the base-case is continued volume share erosion.
• The projection framework should model formulary position, switching elasticity, persistence, and net price trend against glargine and degludec competitors.

---

FAQs

1. Is LEVEMIR considered a first-line basal insulin in most formularies today?
   Generally, it is an incumbent option rather than the default preferred basal in regions where biosimilar glargine and degludec dominate.

2. What endpoints matter most for payer decisions in basal insulin?
   Hypoglycemia rates, weight impact, dosing simplicity, and net acquisition cost under formulary rules.

3. What drives LEVEMIR demand when competition increases?
   Patient persistence on stable therapy, contracting, and restrictions that limit switching.

4. How should LEVEMIR be projected versus glargine and degludec?
   Expect market-share pressure as biosimilars and ultralong basals expand, with revenue resilience only if net price remains supported.

5. Does clinical efficacy alone typically reverse incumbent insulin share loss?
   In basal insulin, formulary economics and competitive net pricing usually dominate unless clinical differentiation translates into demonstrable payer-friendly outcomes.

---

References

[1] European Medicines Agency (EMA). Levemir: EPAR - Product Information.
[2] U.S. Food and Drug Administration (FDA). Levemir (insulin detemir) prescribing information.
[3] International Diabetes Federation (IDF). Diabetes Atlas (global diabetes epidemiology and treatment context).
[4] American Diabetes Association (ADA). Standards of Care in Diabetes (basal insulin positioning and hypoglycemia considerations).