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

NCT ID: NCT02109029

Last Updated: 2019-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-03-31

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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Insulin Peglispro (LY2605541)

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).

Group Type: EXPERIMENTAL

Insulin Peglispro

Intervention Type: DRUG

Administered IV

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).

Group Type: ACTIVE_COMPARATOR

Human Insulin

Intervention Type: DRUG

Administered IV

Interventions

Insulin Peglispro

Administered IV

Intervention Type: DRUG

Human Insulin

Administered IV

Intervention Type: DRUG

Other Intervention Names

LY2605541

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

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.

Graz, , Austria

Countries

Austria

Other Identifiers

I2R-MC-BIDP

Identifier Type: OTHER

Identifier Source: secondary_id

14873

Identifier Type: -

Identifier Source: org_study_id