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Insulin detemir

Generic Name
Insulin detemir
Brand Names
Levemir
Drug Type
Biotech
CAS Number
169148-63-4
Unique Ingredient Identifier
4FT78T86XV

Overview

Insulin detemir is a long-acting form of insulin used for the treatment of hyperglycemia caused by Type 1 and Type 2 Diabetes. Insulin is typically prescribed for the management of diabetes mellitus to mimic the activity of endogenously produced human insulin, a peptide hormone produced by beta cells of the pancreas that promotes glucose metabolism. Insulin is released from the pancreas following a meal to promote the uptake of glucose from the blood into internal organs and tissues such as the liver, fat cells, and skeletal muscle. The absorption of glucose into cells allows for its transformation into glycogen or fat for storage. Insulin also inhibits hepatic glucose production, enhances protein synthesis, and inhibits lipolysis and proteolysis among many other functions. Insulin is an important treatment in the management of Type 1 Diabetes (T1D) which is caused by an autoimmune reaction that destroys the beta cells of the pancreas, resulting in the body not being able to produce or synthesize the insulin needed to manage circulating blood sugar levels. As a result, people with T1D rely primarily on exogenous forms of insulin, such as insulin detemir, to lower glucose levels in the blood. Insulin is also used in the treatment of Type 2 Diabetes (T2D), another form of diabetes mellitus that is a slowly progressing metabolic disorder caused by a combination of genetic and lifestyle factors that promote chronically elevated blood sugar levels. Without treatment or improvement in non-pharmacological measures such as diet and exercise to lower blood glucose, high blood sugar eventually causes cellular resistance to endogenous insulin, and in the long term, damage to pancreatic islet cells. Insulin is typically prescribed later in the course of T2D, after several oral medications such as Metformin, Gliclazide, or Sitagliptin have been tried, when sufficient damage has been caused to pancreatic cells that the body is no longer able to produce insulin on its own. Marketed as the brand name product Levemir, insulin detemir has a duration of action of 16-24 hours allowing for once-daily dosing, typically at bedtime. Due to its duration of action, Levemir is considered "basal insulin" as it provides low concentrations of background insulin that can keep blood sugar stable between meals or overnight. Basal insulin is often combined with short-acting "bolus insulin" such as Insulin lispro, Insulin glulisine, and Insulin aspart to provide higher doses of insulin required following meals. Use of basal and bolus insulin together is intended to mimic the pancreas' production of endogenous insulin, with a goal of avoiding any periods of hypoglycemia. Insulin detemir is produced using recombinant DNA technology in yeast cells. This insulin analogue has a 14-C fatty acid, myristic acid, bound to the lysine amino acid at position B29. The myristoyl side chain increases self-association and albumin binding. This along with slow systemic absorption from the injection site prolongs distribution of the hormone into tissues and results in a long duration of action. Without an adequate supply of insulin to promote absorption of glucose from the bloodstream, blood sugar levels can climb to dangerously high levels and can result in symptoms such as fatigue, headache, blurred vision, and increased thirst. If left untreated, the body starts to break down fat, instead of glucose, for energy which results in a build-up of ketone acids in the blood and a syndrome called ketoacidosis, which is a life-threatening medical emergency. In the long term, elevated blood sugar levels increase the risk of heart attack, stroke, and diabetic neuropathy.

Indication

Insulin detemir is indicated to improve glycemic control in adults and children with diabetes mellitus.

Associated Conditions

  • Type 1 Diabetes Mellitus
  • Type 2 Diabetes Mellitus

Research Report

Published: Jul 18, 2025

Insulin Detemir (DB01307): A Comprehensive Monograph on its Molecular Design, Clinical Profile, and Therapeutic Standing

1.0 Introduction and Drug Profile

1.1 Overview of Basal Insulin Analogues in Diabetes Management

The management of diabetes mellitus aims to replicate the complex, dynamic secretion of insulin by a healthy pancreas. Physiologically, the pancreas provides a continuous, low-level (basal) secretion of insulin throughout the day and night. This basal insulin is critical for suppressing hepatic glucose production, thereby maintaining stable blood glucose levels between meals and during periods of fasting.[1] In individuals with diabetes, particularly type 1 diabetes (T1D) where pancreatic beta-cell function is absent, or in advanced type 2 diabetes (T2DM) where it is severely impaired, exogenous insulin therapy is required to replace this function.[1]

The therapeutic goal of basal insulin replacement is to establish a steady, peakless, and long-lasting insulin concentration in the bloodstream that mimics the natural physiological state.[1] For decades, Neutral Protamine Hagedorn (NPH) insulin served as the primary basal insulin. However, NPH has significant pharmacokinetic limitations, including a pronounced peak of action several hours after injection, a high degree of intra-patient variability in absorption, and a duration of action that is often insufficient to provide 24-hour coverage from a single injection. These characteristics contribute to an elevated risk of unpredictable hypoglycemia, especially nocturnal hypoglycemia, which is a major barrier to achieving optimal glycemic control.[3]

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2021/11/26
Phase 1
Completed
2021/11/18
Phase 2
Recruiting
2020/01/10
Phase 3
UNKNOWN
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
2019/05/23
N/A
Completed
2018/08/08
Phase 4
Completed
2017/12/19
Phase 3
Completed
2017/07/18
Phase 3
Completed
2016/11/18
Phase 4
Completed
2016/11/18
Phase 4
Completed
2015/07/14
Phase 2
Terminated

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
A-S Medication Solutions
50090-1475
SUBCUTANEOUS
100 [iU] in 1 mL
12/8/2022
Novo Nordisk
0169-6438
SUBCUTANEOUS
100 [iU] in 1 mL
12/8/2022
Dispensing Solutions, Inc.
68258-8977
SOFT TISSUE
14.2 mg in 1 mL
9/14/2011
A-S Medication Solutions
50090-6414
SUBCUTANEOUS
100 [iU] in 1 mL
12/8/2022
Novo Nordisk
0169-3687
SUBCUTANEOUS
100 [iU] in 1 mL
12/8/2022
Physicians Total Care, Inc.
54868-5883
SUBCUTANEOUS
14.2 mg in 1 mL
3/2/2012
Novo Nordisk
0169-6432
SUBCUTANEOUS
100 [iU] in 1 mL
12/8/2022
A-S Medication Solutions
50090-1276
SUBCUTANEOUS
100 [iU] in 1 mL
12/8/2022
A-S Medication Solutions
50090-6391
SUBCUTANEOUS
100 [iU] in 1 mL
12/8/2022

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
Authorised
6/1/2004

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
LEVEMIR FLEXPEN INJ 100U/ML
N/A
novo nordisk hong kong ltd.
N/A
N/A
8/1/2005

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
LEVEMIR PENFILL
Novo Nordisk Canada Inc
02271842
Solution - Subcutaneous
100 UNIT / ML
11/14/2005
LEVEMIR FLEXTOUCH
Novo Nordisk Canada Inc
02412829
Solution - Subcutaneous
100 UNIT / ML
11/25/2013

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
LEVEMIR FLEXPEN 100 U/ML SOLUCION INYECTABLE EN UNA PLUMA PRECARGADA
04278005
SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
LEVEMIR INNOLET 100 U/ML SOLUCION INYECTABLE EN UNA PLUMA PRECARGADA
04278008
SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Not Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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