Insulin peglispro
Also known as: Basal Insulin Peglispro, BIL, Insulin peglispro, LY2605541, PEGylated insulin lispro
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Summary
Insulin peglispro (LY2605541) is a PEGylated basal insulin analog developed for once‑daily subcutaneous administration in diabetes. Development was halted after Phase III trials showed concerns about hepatic steatosis and altered lipid profiles, and it has never received regulatory approval.
Mechanism of Action
Agonist of the insulin receptor with prolonged subcutaneous absorption due to PEGylation, providing basal glucose‑lowering activity
Routes of Administration
Goals & Uses
- Weight neutral profileMetabolicLow
- Weight management in insulin-treated diabetesMetabolic / EndocrineLow
- Glycemic controlDiabetesModerate
- Reduced nocturnal hypoglycemiaSafetyModerate
- Basal glycemic controlDiabetes ManagementModerate
- Reduction of nocturnal hypoglycemiaSafety / TolerabilityModerate
- Glycemic control in type 2 diabetesMetabolicModerate
- Glycemic control in type 1 diabetesMetabolic / EndocrineModerate
Contraindications
- Severe hypoglycemiaMetabolicHigh
- Hypersensitivity to insulin peglispro or PEG excipientsImmunologicHigh
- Hypersensitivity to insulin or PEGAllergyHigh
- Pre-existing hepatic diseaseHepaticHigh
- Active liver diseaseHepaticModerate
Adverse Effects
- Increased hepatic fat (steatosis)HepaticUncommon
- HypoglycemiaMetabolicCommonAbnormally low blood glucose
- Injection site reactionsLocalUncommon
- Hepatic steatosis (increased liver fat content)HepaticCommon
- Increased triglyceridesLipidUncommon
- Triglyceride elevationMetabolicUncommon
- Elevated liver enzymes (ALT/AST)HepaticCommon
- Injection‑site reactionsLocalCommon
- LipohypertrophyDermatologicUncommon
- Weight gainMetabolicCommonIncrease in body weight
- Elevated liver enzymesHepaticUncommonIncrease in AST/ALT or other hepatic markers
Drug Interactions
- Beta‑blockersModerate
- Beta-blockersModerate
- CorticosteroidsModerate
- Other insulinsHigh
- Other insulin productsHigh
- Oral antidiabetic agentsModerate
- SulfonylureasModerateMay increase risk of low blood sugar
- Hepatotoxic drugsHigh
Population Constraints
- PregnancyReproductive SafetyRelative
- Patients with hepatic impairment or liver diseaseHepaticAbsolute
- Elderly with renal impairmentRenalRelative
- Pediatric patientsAgeAbsolute
- Pregnant womenReproductiveRelative
- Pediatrics (<2 years)AgeAbsolute
- Patients with hypertriglyceridemiaMetabolicRelative
Regulatory Status
- European UnionUnapprovedNo marketing authorization; withdrawn from development.
- United StatesUnapprovedInvestigational; development discontinued.
- United KingdomUnapprovedNever submitted for approval; development halted.
Development discontinued in 2015; no approvals in US, EU, or UK.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Insulin peglispro?
Insulin peglispro (LY2605541) is a PEGylated basal insulin analog developed for once‑daily subcutaneous administration in diabetes. Development was halted after Phase III trials showed concerns about hepatic steatosis and altered lipid profiles, and it has never received regulatory approval.
What is Insulin peglispro used for?
Insulin peglispro is educationally associated with: Weight neutral profile, Weight management in insulin-treated diabetes, Glycemic control, Reduced nocturnal hypoglycemia, Basal glycemic control, Reduction of nocturnal hypoglycemia, Glycemic control in type 2 diabetes, Glycemic control in type 1 diabetes. Educational only — not medical advice.
How is Insulin peglispro administered?
Recorded routes of administration: Subcutaneous.
What are the potential side effects of Insulin peglispro?
Reported adverse effects include: Increased hepatic fat (steatosis), Hypoglycemia, Injection site reactions, Hepatic steatosis (increased liver fat content), Increased triglycerides, Triglyceride elevation, Elevated liver enzymes (ALT/AST), Injection‑site reactions, Lipohypertrophy, Weight gain, Elevated liver enzymes. This list is not exhaustive — consult a qualified clinician.
Who should avoid Insulin peglispro?
Recorded contraindications: Severe hypoglycemia, Hypersensitivity to insulin peglispro or PEG excipients, Hypersensitivity to insulin or PEG, Pre-existing hepatic disease, Active liver disease. Consult a qualified clinician before use.