A Study of LY2605541 (Insulin Peglispro) and Human Insulin Concentrations in Fat Tissue

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: Insulin Peglispro; Drug: Human Insulin

• Registration Number: NCT02109029
• Lead Sponsor: Eli Lilly and Company

Brief Summary

LY2605541 is an investigational drug being developed for the treatment of diabetes mellitus. This study is designed to understand how the body handles the investigational drug, and to measure the quantity of LY2605541 in fat tissue. The study has two parts. It involves intravenous (IV) infusion of the investigational drug and a procedure to measure concentrations in the fat tissue. Both parts of the study will be conducted in participants with type 1 diabetes mellitus (T1DM). Part A and B of the study might take up to 7 weeks to complete.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-07
• Study First Submitted QC: 2014-04-07
• Study First Posted: 2014-04-09
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Results First Submitted: 2018-03-17
• Status Verified: 2018-11
• Results First Submitted QC: 2018-11-06
• Last Update Submitted: 2018-11-06
• Results First Posted: 2019-03-06
• Last Update Posted: 2019-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) based on medical history for at least 1 year prior to enrollment
• Have a c-peptide value ≤0.3 nanomoles per liter (nmol/L) at screening
• Have a serum creatinine value within normal limits at screening
• Have a haemoglobin A1c (HbA1c) value ≤75 millimoles per mole (mmol/mol) (9.0%) at screening
• Have a body mass index (BMI) of 20.0-30.0 kilograms per meter squared (kg/m^2), inclusive, at screening

Exclusion Criteria

• Have known or suspected allergies or hypersensitivities to LY2605541, human insulin, sinistrin, related compounds or any components of the formulations
• Are women who are pregnant or lactating
• Have an abnormal blood pressure for the population as determined by the investigator
• Have renal insufficiency or major renal disorders
• Have proliferative retinopathy or maculopathy
• Have lipodystrophy
• Have any wound healing disorder or are prone to keloid or hypertrophic scar formation
• Have results of screening prothrombin time (PT) and international normalized ratio (INR) tests that are significantly prolonged
• Have a fasting triglycerides value > 4.52 millimoles per liter (mmol/L) (400 milligrams/deciliter (mg/dL))
• Are receiving chronic systemic or inhaled glucocorticoid or have received such therapy within the 4 weeks before dosing
• Have a total daily insulin dose greater than 1.2 units per kilogram (U/kg)
• Regular use or intended use of any over-the-counter or prescription medications or nutritional supplements that affect blood glucose or the body's sensitivity to insulin or that promote weight loss within 14 days prior to dosing
• Regular use or intended use of non-selective beta blockers
• Regular use or intended use of monoamine oxidase (MAO) inhibitors
• Are currently participating in a weight loss program or plan to do so during the course of the study
• Are unwilling to avoid excessive sun exposure, steam baths, saunas, and swimming during the study. Sun cream should be used during sun bathing for the 6-month period following the study
• Are unwilling to avoid extensive consumption of food containing inulin during the study and in the 48-hour period leading up to the clamp

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Insulin Peglispro (LY2605541)	Insulin Peglispro	Part A Cohort 1: (low dose) priming dose (PD) of 2.00 units (U), 0.92 U/hour (U/h) constant infusion of insulin peglispro Part A Cohort 1: (high dose) PD of 8.00 U, 4.50 U/h constant IV infusion of insulin peglispro Part A Cohort 2: (intermediate dose 1) PD of 4.00 U, 1.84/h constant IV infusion of insulin peglispro Part A Cohort 2: (intermediate dose 2) PD of 6.0 U, 2.76 U/h constant IV infusion of insulin peglispro Part B Insulin Peglispro: PD of 6.00 U, 2.76 constant IV infusion of insulin peglispro and a constant infusion of 6 pico moles per kilogram per minute (pmol/kg/min). IV infusion of sinistrin (250 mg/mL, SOC to achieve a steady state for up to 16 hours).
Human Insulin	Human Insulin	Constant IV infusion ( 6 pico moles per kilogram perminute \[pmol/kg/min\]) of human insulin for up to 36 hours. IV infusion of sinistrin (250 mg/mL, SOC to achieve a steady state for up to 16 hours).

Primary Outcome Measures

Name	Time	Method
Part B: Pharmacokinetics: Steady-State Concentrations in Adipose Tissue Interstitial Fluid (ISF)	16, 20, 24, and 28 hours postdose
Part B: Pharmacokinetics: ISF-to-Serum Concentrations	16, 20, 24, and 28 hours postdose	Absolute concentration of ISF of insulin peglispro and human insulin.

Trial Locations

Locations (1)

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.; 🇦🇹 Graz, Austria