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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)

A Study Evaluating the Bioequivalence of VIAject®7 Compared to VIAject®25 and Comparing the Pharmacokinetic and Pharmacodynamic Properties of VIAject®7 to Insulin Lispro in Subjects With Type 1 Diabetes Mellitus

Phase 1
Completed
Conditions
Diabetes Mellitus
Interventions
Drug: VIAject®25
Drug: VIAject®7
First Posted Date
2010-11-05
Last Posted Date
2015-07-29
Lead Sponsor
Biodel
Target Recruit Count
43
Registration Number
NCT01235039
Locations
🇩🇪

Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany

Study of Insulin Lispro in Participants With Inadequately Controlled Type 2 Diabetes

Phase 4
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2010-10-07
Last Posted Date
2014-04-23
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
1117
Registration Number
NCT01215955
Locations
🇿🇦

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Somerset West, South Africa

PK/PD Study of Intranasal Insulin in Type I Diabetes

Phase 1
Conditions
Type 1 Diabetes
Interventions
First Posted Date
2010-09-14
Last Posted Date
2011-06-17
Lead Sponsor
Hompesch, Marcus, M.D.
Target Recruit Count
20
Registration Number
NCT01201278
Locations
🇺🇸

Profil Institute for Clinical Research, Chula Vista, California, United States

Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Patients With Type 2 Diabetes Mellitus

First Posted Date
2010-09-02
Last Posted Date
2014-08-20
Lead Sponsor
Halozyme Therapeutics
Target Recruit Count
132
Registration Number
NCT01194258
Locations
🇺🇸

Mercury Street Medical, Butte, Montana, United States

🇺🇸

UT Southwestern Medical Center at Dallas, Dallas, Texas, United States

🇺🇸

John Muir Physician Network Clinical Research Center, Concord, California, United States

and more 19 locations

Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Participants With Type 1 Diabetes Mellitus

First Posted Date
2010-09-02
Last Posted Date
2019-02-26
Lead Sponsor
Halozyme Therapeutics
Target Recruit Count
135
Registration Number
NCT01194245
Locations
🇺🇸

Mercury Street Medical, Butte, Montana, United States

🇺🇸

Mid-America Diabetes Associates, Wichita, Kansas, United States

🇺🇸

Rocky Mountain Diabetes and Osteoporosis Center, Idaho Falls, Idaho, United States

and more 16 locations

A Study in Participants With Type 2 Diabetes Mellitus (AWARD-4)

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2010-08-30
Last Posted Date
2014-10-08
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
884
Registration Number
NCT01191268
Locations
🇨🇳

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Yong Kang City, Taiwan

A Study Comparing Insulin Intensification Therapies in Patients With Type 2 Diabetes Mellitus

Phase 4
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2010-08-05
Last Posted Date
2013-12-18
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
402
Registration Number
NCT01175811
Locations
🇨🇳

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Yong Kung City, Taiwan

Hospital Management of Hyperglycemia Study of Insulin Glargine Plus Insulin Lispro Versus Human Regular Insulin

Phase 3
Terminated
Conditions
Hyperglycemia
Interventions
First Posted Date
2010-06-03
Last Posted Date
2012-11-13
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
16
Registration Number
NCT01136746
Locations
🇺🇸

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Memphis, Tennessee, United States

A Randomized Control Trial Comparing Linjeta Versus Humalog in Pumps: Effect on Postprandial Blood Sugars.

Phase 2
Withdrawn
Conditions
Diabetes Mellitus
Interventions
Drug: LINjeta U-100 Insulin
First Posted Date
2010-02-11
Last Posted Date
2017-02-10
Lead Sponsor
Stanford University
Registration Number
NCT01067118
Locations
🇺🇸

Stanford University School of Medicine, Stanford, California, United States

🇺🇸

University of Colorado Denver School of Medicine Barbara Davis Center, Denver, Colorado, United States

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Insulin (IN-105) in Type 1 Diabetes Patients

Phase 1
Terminated
Conditions
Type 1 Diabetes Mellitus
Interventions
First Posted Date
2009-12-21
Last Posted Date
2018-01-23
Lead Sponsor
Biocon Limited
Target Recruit Count
20
Registration Number
NCT01035801
Locations
🇮🇳

Bharti Research Institute of Diabetes and Endocrinology, Karnal, Hariyana, India

🇮🇳

Bangalore Diabetes Hospital, Bangalore, Karnataka, India

🇮🇳

Care Hospital, Hyderabad, Andhra Pradesh, India

and more 2 locations
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