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

Primary Purpose

Diabetes Mellitus, Type 1

Status

Completed

Phase

Phase 1

Locations

Austria

Study Type

Interventional

Intervention

Insulin Peglispro

Human Insulin

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / 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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Insulin Peglispro (LY2605541)

Human Insulin

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Part B: Pharmacokinetics: Steady-State Concentrations in Adipose Tissue Interstitial Fluid (ISF)

Part B: Pharmacokinetics: ISF-to-Serum Concentrations

Absolute concentration of ISF of insulin peglispro and human insulin.

Secondary Outcome Measures

Full Information

NCT ID

NCT02109029

First Posted

April 7, 2014

Last Updated

November 6, 2018

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT02109029

Brief Title

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

Official Title

Use of Open-Flow Microperfusion to Measure LY2605541 and Human Insulin Concentrations in Adipose Tissue Interstitial Fluid

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

April 2014 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Insulin Peglispro (LY2605541)

Arm Type

Experimental

Arm Description

Arm Title

Human Insulin

Arm Type

Active Comparator

Arm Description

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).

Intervention Type

Drug

Intervention Name(s)

Insulin Peglispro

Other Intervention Name(s)

LY2605541

Intervention Description

Administered IV

Intervention Type

Drug

Intervention Name(s)

Human Insulin

Intervention Description

Administered IV

Primary Outcome Measure Information:

Title

Part B: Pharmacokinetics: Steady-State Concentrations in Adipose Tissue Interstitial Fluid (ISF)

Time Frame

16, 20, 24, and 28 hours postdose

Title

Part B: Pharmacokinetics: ISF-to-Serum Concentrations

Description

Absolute concentration of ISF of insulin peglispro and human insulin.

Time Frame

16, 20, 24, and 28 hours postdose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Graz

ZIP/Postal Code

8036

Country

Austria

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

Learn more about this trial

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

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