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
-

Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes

Phase 3
Completed
Conditions
First Posted Date
2006-04-07
Last Posted Date
2017-01-27
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
325
Registration Number
NCT00312104
Locations
🇿🇦

Novo Nordisk Investigational Site, Cape Town, Western Cape, South Africa

Comparison of Efficacy and Safety of Insulin Detemir and NPH Insulin in Children and Adolescents With Type 1 Diabetes

Phase 3
Completed
Conditions
First Posted Date
2006-04-07
Last Posted Date
2017-01-27
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
347
Registration Number
NCT00312156
Locations
🇬🇧

Novo Nordisk Investigational Site, Stirling, United Kingdom

Comparison of Insulin Detemir or Insulin Glargine as Add on to Oral Antidiabetic Drugs in Type 2 Diabetes

Phase 3
Completed
Conditions
First Posted Date
2006-01-30
Last Posted Date
2017-01-27
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
583
Registration Number
NCT00283751
Locations
🇬🇧

Novo Nordisk Investigational Site, Swansea, United Kingdom

Efficacy and Safety of a Fixed or a Flexible Supplementary Insulin Therapy in Type 2 Diabetes

Phase 4
Completed
Conditions
First Posted Date
2006-01-10
Last Posted Date
2014-11-21
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
373
Registration Number
NCT00274274

Comparison of Self Adjustment Versus Standard of Care Treatment in Subjects With Type 2 Diabetes

Phase 4
Completed
Conditions
First Posted Date
2005-12-13
Last Posted Date
2017-01-31
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
5652
Registration Number
NCT00264901
Locations
🇺🇸

Novo Nordisk Investigational Site, Plainsboro, New Jersey, United States

Comparison of Insulin Detemir and Insulin Semilente®MC in Type 1 Diabetes

Phase 3
Completed
Conditions
First Posted Date
2005-09-16
Last Posted Date
2017-02-24
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
71
Registration Number
NCT00184639
Locations
🇩🇪

Novo Nordisk Investigational Site, Hannover, Germany

Comparison of Insulin Detemir With NPH Insulin in Type 1 Diabetes

Phase 3
Completed
Conditions
First Posted Date
2005-09-16
Last Posted Date
2017-01-27
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
501
Registration Number
NCT00184665
Locations
🇹🇷

Novo Nordisk Investigational Site, Istanbul, Turkey

Comparison of Insulin Detemir, Insulin Aspart and Biphasic Insulin Aspart 30 With OAD Treatment in Type 2 Diabetes

First Posted Date
2005-09-16
Last Posted Date
2017-03-09
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
708
Registration Number
NCT00184600
Locations
🇬🇧

Novo Nordisk Investigational Site, Wirral, Merseyside, United Kingdom

Hospital In-Patient Insulin Study

Phase 4
Terminated
Conditions
First Posted Date
2005-08-25
Last Posted Date
2007-05-01
Lead Sponsor
The Royal Bournemouth Hospital
Target Recruit Count
41
Registration Number
NCT00135070
Locations
🇬🇧

The Royal Bournemouth Hospital, Bournemouth, Dorset, United Kingdom

Comparison of Insulin Detemir Given Once or Twice Daily in Type 1 Diabetes

Phase 4
Completed
Conditions
First Posted Date
2005-07-08
Last Posted Date
2017-06-02
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
520
Registration Number
NCT00117780
Locations
🇱🇺

Novo Nordisk Investigational Site, Luxembourg, Luxembourg

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