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Insulin Lispro

Generic Name
Insulin Lispro
Brand Names
Admelog, Humalog, Humalog Mix, Humalog kwikpen, Liprolog, Lyumjev, Insulin lispro Sanofi, Lyumjev (previously Liumjev)
Drug Type
Biotech
CAS Number
133107-64-9
Unique Ingredient Identifier
GFX7QIS1II
Background

Insulin lispro is a rapid-acting form of insulin used for the treatment of hyperglycemia caused by Type 1 and Type 2 Diabetes. Insulin is 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. 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 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 lispro, 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 cause 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, and 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 Humalog, insulin lispro begins to exert its effects within 15 minutes of subcutaneous administration, while peak levels occur 30 to 90 minutes after administration. Due to its duration of action of around 5 hours, Humalog is considered "bolus insulin" as it provides high levels of insulin in a short period of time to mimic the release of endogenous insulin from the pancreas after meals. Bolus insulin is often combined with once daily, long-acting "basal insulin" such as Insulin detemir, Insulin degludec, or Insulin glargine to provide low concentrations of background insulin that can keep blood sugar stable between meals or overnight. 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 lispro is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli and was the first commercially available insulin analog. Formerly called LYSPRO from the chemical nomenclature LYS(B28), PRO(B29), insulin lispro differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. These biochemical changes result in a reduced tendency for self-association resulting in dissolution to a dimer and then to a monomer that is absorbed more rapidly after subcutaneous injection compared to endogenous human insulin.

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

本品尤其适用于下列情况:

1.经常发生低血糖的1型糖尿病者,使用本品可减少低血糖的发生率;

2.生活不规律,外出活动较多的用胰岛素治疗的糖尿病患者,本品快速、短效的特点有助于及时调整胰岛素的用量。

Associated Conditions
Diabetes Mellitus, Diabetic Ketoacidosis, Gestational Diabetes Mellitus (GDM)

Super-Bolus: Effects on Postprandial Glycemia After High Glycemic Index Meal

Phase 4
Completed
Conditions
Diabetes Mellitus, Type 1
Interventions
First Posted Date
2019-07-15
Last Posted Date
2023-11-30
Lead Sponsor
Medical University of Warsaw
Target Recruit Count
72
Registration Number
NCT04019821
Locations
🇵🇱

Department of Pediatric Diabetology and Pediatrics, Pediatric Teaching Clinical Hospital, Warsaw, Poland

A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 2 Diabetes

Phase 3
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2019-05-16
Last Posted Date
2022-02-08
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
628
Registration Number
NCT03952143
Locations
🇨🇳

Dalian Municipal Central Hospital Affiliated of Dalian Medical University, Dalian, Cn-21, China

🇨🇳

Shengjing Hospital of China Medical University, Shenyang, Cn-21, China

🇨🇳

Shanghai Putuo District Center Hospital, Shanghai, Cn-31, China

and more 38 locations

A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes

Phase 3
Completed
Conditions
Type 1 Diabetes Mellitus
Interventions
First Posted Date
2019-05-16
Last Posted Date
2023-02-08
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
354
Registration Number
NCT03952130
Locations
🇦🇷

Centro Médico Viamonte, Caba, Buenos Aires, Argentina

🇦🇷

Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC, Cordoba, Argentina

🇨🇳

Dongguan people's hospital, Dongguan, Guangdong, China

and more 27 locations

A Trial to Assess a Co-formulation of an Insulin Analog and Pramlintide in Subjects With Type 1 Diabetes Mellitus

Phase 1
Completed
Conditions
Type 1 Diabetes Mellitus
Interventions
Drug: ADO09 formulation
Drug: Placebo
First Posted Date
2019-04-16
Last Posted Date
2019-04-16
Lead Sponsor
Adocia
Target Recruit Count
24
Registration Number
NCT03916640
Locations
🇩🇪

Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany

A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes

Not Applicable
Completed
Conditions
Type 1 Diabetes Mellitus
Interventions
Device: AID System
First Posted Date
2019-03-26
Last Posted Date
2019-06-05
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
10
Registration Number
NCT03890003
Locations
🇺🇸

Sansum Diabetes Research Institute, Santa Barbara, California, United States

A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes Mellitus

Not Applicable
Completed
Conditions
Type 1 Diabetes Mellitus
Interventions
Device: AID System
First Posted Date
2019-02-21
Last Posted Date
2019-04-25
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
10
Registration Number
NCT03849612
Locations
🇺🇸

Diablo Clinical Research, Walnut Creek, California, United States

A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes Mellitus During Meal Challenges

Not Applicable
Completed
Conditions
Type 1 Diabetes Mellitus
Interventions
Device: AID System
First Posted Date
2019-02-21
Last Posted Date
2019-04-23
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
10
Registration Number
NCT03848767
Locations
🇺🇸

Rainier Clinical Research Center, Renton, Washington, United States

A Study Comparing LY900014 to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes Using Insulin Pump Therapy

Phase 3
Completed
Conditions
Type 1 Diabetes Mellitus
Interventions
Drug: Ultra-Rapid Lispro
First Posted Date
2019-02-05
Last Posted Date
2021-01-22
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
471
Registration Number
NCT03830281
Locations
🇺🇸

Marin Endocrine Associates, Greenbrae, California, United States

🇺🇸

Diabetes and Endocrine Associates, La Mesa, California, United States

🇺🇸

Barbara Davis Center for Childhood Diabetes, Aurora, Colorado, United States

and more 76 locations

A Study of LY900014 in a Medtronic Pump

Phase 2
Completed
Conditions
Type1 Diabetes Mellitus
Interventions
First Posted Date
2018-11-30
Last Posted Date
2020-10-29
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
42
Registration Number
NCT03760640
Locations
🇺🇸

Atlanta Diabetes Associates, Atlanta, Georgia, United States

🇺🇸

International Diabetes Center, Saint Louis Park, Minnesota, United States

A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes Mellitus (T1D)

Not Applicable
Completed
Conditions
Type 1 Diabetes Mellitus
Interventions
Device: AID System
First Posted Date
2018-11-16
Last Posted Date
2019-02-19
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
10
Registration Number
NCT03743285
Locations
🇺🇸

Rainier Clinical Research Center, Renton, Washington, United States

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