Insulin detemir

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

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
Associated Therapies
-

Applications Site Reactions After Injection of Insulin Detemir and Saline in Subjects With Diabetes

Phase 4
Completed
Conditions
Interventions
First Posted Date
2008-02-06
Last Posted Date
2012-09-03
Lead Sponsor
Lise Tarnow
Target Recruit Count
40
Registration Number
NCT00607737
Locations
🇩🇰

Steno Diabetes Center, Gentofte, Denmark

Safety and Efficacy of Insulin Detemir in Combination With OAD in Type 2 Diabetes

Phase 3
Completed
Conditions
First Posted Date
2008-01-30
Last Posted Date
2017-01-27
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
477
Registration Number
NCT00604396
Locations
🇸🇪

Novo Nordisk Investigational Site, Umeå, Sweden

Efficacy and the Safety of Insulin Detemir in Subjects With Insulin Requiring Diabetes

Phase 3
Completed
Conditions
First Posted Date
2008-01-30
Last Posted Date
2017-01-27
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
401
Registration Number
NCT00604344
Locations
🇯🇵

Novo Nordisk Investigational Site, Tokyo, Japan

Efficacy and Safety of Insulin Detemir in Type 2 Diabetes Inadequately Controlled on OHA Therapy Alone

Phase 3
Completed
Conditions
First Posted Date
2008-01-30
Last Posted Date
2017-01-27
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
362
Registration Number
NCT00604253
Locations
🇯🇵

Novo Nordisk Investigational Site, Tokyo, Japan

Efficacy and Safety of Insulin Detemir in Combination With Insulin Aspart and Biphasic Insulin Aspart 30 in Type 2 Diabetes

Phase 3
Completed
Conditions
First Posted Date
2008-01-30
Last Posted Date
2017-06-27
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
719
Registration Number
NCT00605020
Locations
🇨🇭

Novo Nordisk Investigational Site, Zürich, Switzerland

Safety of Insulin Detemir in Children With Type 1 Diabetes

Phase 3
Completed
Conditions
First Posted Date
2008-01-30
Last Posted Date
2017-02-24
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
83
Registration Number
NCT00605137
Locations
🇯🇵

Novo Nordisk Investigational Site, Tokyo, Japan

Efficacy and Safety of Insulin Detemir in Type 1 Diabetes

Phase 3
Completed
Conditions
First Posted Date
2008-01-16
Last Posted Date
2017-02-24
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
114
Registration Number
NCT00595374
Locations
🇳🇱

Novo Nordisk Investigational Site, Zwolle, Netherlands

Safety and Efficacy of Insulin Detemir in Combination With OADs in Type 2 Diabetes

Phase 3
Completed
Conditions
First Posted Date
2008-01-14
Last Posted Date
2017-01-27
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
132
Registration Number
NCT00592527
Locations
🇮🇳

Novo Nordisk Investigational Site, Nagpur, India

Management of Diabetes in the Emergency Room: a Randomized Trial of an Insulin Protocol.

First Posted Date
2008-01-11
Last Posted Date
2022-02-07
Lead Sponsor
Rush University Medical Center
Target Recruit Count
176
Registration Number
NCT00591227
Locations
🇺🇸

Rush University Medical Center, Chicago, Illinois, United States

Basal Insulins - Pharmacodynamics

First Posted Date
2007-12-03
Last Posted Date
2007-12-03
Lead Sponsor
University of Aarhus
Target Recruit Count
10
Registration Number
NCT00566124
Locations
🇩🇰

Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Aarhus, DK, Denmark

© Copyright 2024. All Rights Reserved by MedPath