LEVEMIR (insulin detemir) · Novo Nordisk
Levemir is a long-acting insulin analog used to help both adults and children manage their blood sugar levels. It treats patients living with diabetes mellitus by providing consistent glycemic control. While it is effective for daily management, it is not used for patients experiencing diabetic ketoacidosis.
How LEVEMIR Works
This medication works by regulating glucose metabolism and lowering blood sugar levels. It encourages skeletal muscle and fat to absorb glucose while stopping the liver from producing it. It also helps the body build protein and prevents the breakdown of fats and proteins.
Details
- Status
- Prescription
- First Approved
- 2005-06-16
- Routes
- INJECTION, SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
LEVEMIR Approval History
What LEVEMIR Treats
1 indicationsLEVEMIR is approved for 1 conditions since its original approval in 2005. These indications span multiple therapeutic areas including oncology, immunology, and more.
LEVEMIR Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in LEVEMIR's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications LEVEMIR treats. First-in-class if their pivotal trials read out positive.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Novo Nordisk's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
37 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06685185 | NN1644-7794 2024-511808-17, U1111-1304-2544 | Ph 1 | completed | A Research Study of a New Medicine NNC0363-1063 in Healthy Participants and Participants With Type 1 Diabetes |
| NCT02048189 TRICIDIA | RUDONI PARI 2011 | Ph 4 | terminated | Treatment With Continuous Sub-cutaneous Insulin Infusion Via a Portable Pump Versus Discontinuous Insulin Infusion Via Multiple-injections in Type 2 Diabetes |
| NCT05124457 DETERMINE | DETERMINE | Ph 2 | recruiting | DETERMINE: Detemir vs NPH |
| NCT03377699 EXPECT results posted | NN1250-4300 U1111-1191-3018, 2017-000048-17 | Ph 3 | completed | Research Study Comparing Insulin Degludec to Insulin Detemir, Together With Insulin Aspart, in Pregnant Women With Type 1 Diabetes |
| NCT05134987 | NN1845-4886 U1111-1266-4162, 2021-003271-33 | Ph 1 | completed | A Multiple Dose Study Investigating Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0363-0845 in Participants With Type 1 Diabetes Pharmacokinetics and Pharmacodynamics: How Insulin NNC0363-0845 is Transported Throughout the Body and How It Works |
| NCT02967224 Reach-Control | LPS13931 2015-001831-18, U1111-1170-8104 | Ph 4 | completed | A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo Compared to "Standard of Care" Basal Insulins in Insulin Naïve Patients Initiating Insulin |
| NCT02967211 REGAIN CONTROL | LPS14060 2015-001832-39, U1111-1170-8132 | Ph 4 | completed | A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo Compared to "Standard of Care" Basal Insulin in Patients Already Using Basal Insulin |
| NCT00591227 results posted | 07070902 | Ph 4 | completed | Management of Diabetes in the Emergency Room: a Randomized Trial of an Insulin Protocol. |
| NCT01595646 SL120 results posted | IRB00023230 ZEN-10-173646US | Ph 2 | completed | Study of Nasal Insulin to Fight Forgetfulness - Long-acting Insulin Detemir - 120 Days (SL120) |
| NCT02451137 results posted | LPS14347 U1111-1168-0354 | Ph 4 | completed | A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo (ACHIEVE CONTROL REAL LIFE STUDY PROGRAM) |
| NCT01513473 BEGIN™ results posted | NN1250-3561 2011-003148-39, P/44/2010 | Ph 3 | completed | A Trial Investigating the Efficacy and Safety of Insulin Degludec in Children and Adolescents With Type 1 Diabetes Mellitus |
| NCT01831765 onset® 1 results posted | NN1218-3852 2010-024049-53, U1111-1118-2442 | Ph 3 | completed | Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes |
| NCT01835431 results posted | NN5401-3816 2012-003566-41, U1111-1133-0958 | Ph 3 | completed | A Trial Investigating the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily Plus Insulin Aspart for the Remaining Meals Versus Insulin Detemir Once or Twice Daily Plus Meal Time Insulin Aspart in Children and Adolescents With Type 1 Diabetes Mellitus |
| NCT02131272 iDEAt2 results posted | NN304-4093 2013-005500-33, U1111-1151-4056 | Ph 3 | terminated | A Trial Investigating the Efficacy and Safety of Insulin Detemir Versus Insulin NPH in Combination With Metformin and Diet/Exercise in Children and Adolescents With Type 2 Diabetes Insufficiently Controlled on Metformin With or Without Other Oral Antidiabetic Drug(s) With or Without Basal Insulin |
| NCT01232491 DIET™ results posted | NN304-3785 U1111-1116-2629, 2009-014894-42 | Ph 4 | completed | Impact of Dietary Intervention on Weight Change in Subjects With Type 2 Diabetes |
| NCT00978627 BOOST™ results posted | NN5401-3594 2008-005769-71, U1111-1111-8943 | Ph 3 | completed | Comparison of NN5401 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes |
| NCT01486966 results posted | NN304-3954 U1111-1123-7088 | Ph 4 | terminated | Comparing Efficacy and Safety of Insulin Detemir Plus Insulin Aspart and NPH Insulin Plus Human Soluble Insulin With or Without Metformin in Chinese Patients With Type 2 Diabetes |
| NCT00789191 results posted | NN304-3511 2008-001050-40 | Ph 3 | completed | Effect of Detemir and Sitagliptin on Blood Glucose Control in Type 2 Diabetes |
| NCT00634842 TITRATE™ results posted | NN304-3502 | Ph 4 | completed | Effect of Two Different Fasting Blood Glucose Targets on Glucose Control in Patients With Type 2 Diabetes Using Insulin Detemir Once Daily |
| NCT00909480 EFFICACY results posted | NN304-1768 | Ph 4 | completed | Effect of Insulin Detemir and Insulin Glargine on Blood Glucose Control in Subjects With Type 2 Diabetes |
| NCT00856986 results posted | NN2211-1842 2007-005317-19 | Ph 3 | completed | The Effect of Insulin Detemir in Combination With Liraglutide and Metformin Compared to Liraglutide and Metformin in Subjects With Type 2 Diabetes |
| NCT01074268 BEGIN™ results posted | NN1250-3585 2009-011672-29, U1111-1111-7249 | Ph 3 | completed | Comparison of NN1250 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes |
| NCT00841087 results posted | NN1250-3569 JapicCTI-090711 | Ph 2 | completed | Comparison of NN1250 Versus Insulin Detemir, Both Combined With Insulin Aspart in Subjects With Type 1 Diabetes |
| NCT01868542 results posted | NN304-3994 U1111-1132-9267 | Ph 4 | completed | A Trial Comparing the Glycaemic Control of Levemir® Administered Once Daily According to Two Insulin Detemir Titration Algorithms After 20 Weeks in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Treatment With or Without Other Anti-diabetic Drugs (OADs) |
| NCT01165684 Full STEP™ results posted | ANA-3786 2010-018974-19, U1111-1116-0908 | Ph 4 | completed | Efficacy and Safety of Basal-bolus Therapy, Comparing Stepwise Addition of Insulin Aspart Versus Complete Basal-bolus Regimen |
| NCT00873223 | NN2211-3673 | Ph 1 | completed | Examination of the Effects of Liraglutide on the Mode of Action of Insulin Detemir |
| NCT01043510 | NN1250-3762 U1111-1112-6185 | Ph 1 | completed | The Effect of NN1250 in Subjects With Type 2 Diabetes of Different Race and/or Ethnic Origin |
| NCT01135927 | NN1250-1996 U1111-1113-6722, JapicCTI-101158 | Ph 1 | completed | A Trial Investigating the Effect of NN1250 in Japanese Subjects With Type 1 Diabetes |
| NCT01068652 results posted | INS-3782 U1111-1112-6407 | Ph 4 | completed | Effect of Different Insulin Administrations, All in Combination With Metformin, on Glycaemic Control in Subjects With Type 2 Diabetes Inadequately Controlled by Oral Anti-diabetic Drugs |
| NCT00623194 results posted | NN304-1690 2006-002478-23 | Ph 3 | completed | Safety Follow-up on Children and Adolescents With Type 1 Diabetes Treated With Insulin Detemir. An Extension to Trial NN304-1689 |
| NCT00795600 results posted | NN304-3614 2008-003739-19 | Ph 4 | completed | Comparison of the Change in Fat Distribution in Overweight and Obese Subjects With Type 2 Diabetes After Insulin Treatment |
| NCT01003184 results posted | H8O-EW-GWDL | Ph 3 | completed | Efficacy of Once-Weekly Exenatide Versus Once or Twice Daily Insulin Detemir in Patients With Type 2 Diabetes |
| NCT00657943 CIMT | EudraCT 2007-006665-33 | Ph 4 | completed | The Copenhagen Insulin and Metformin Therapy Trial |
| NCT01547169 SNIFF-LONG 21 | 39683-A 2P50AG005136-27 | Ph 2 | completed | Study of Nasal Insulin to Fight Forgetfulness - Long-acting Insulin Detemir - 21 Days |
| NCT00607737 APPLY | APPLY EudraCT 2007-005677-59 | Ph 4 | completed | Applications Site Reactions After Injection of Insulin Detemir and Saline in Subjects With Diabetes |
| NCT00941148 | LANT_001 EudraCT Number: 2007-006109-26 | Ph 4 | completed | Beta-Cell Function of Insulin Glargine Compared to Neutral Protamine Hagedorn (NPH) Insuline and to Insulin Detemir in Combination With Metformin |
| NCT00810589 ENM-HS-001 | ENM-HS-001 | Ph 1 | completed | A Randomised, Single Centre, Double-Blind, Two-Period Crossover, Glucose Clamp Trial |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LEVEMIR FDA Label Details
Indications & Usage
FDA Label (PDF)LEVEMIR is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use LEVEMIR is not recommended for the treatment of diabetic ketoacidosis. LEVEMIR is a long-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus . Limitations of Use: Not recommended for the treatment of diabetic ketoacidosis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.