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OpenTrials
Completed

NCT Number: NCT02109029

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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, 8036, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin Peglispro

Drug

Administered IV

Other names: LY2605541

human insulin

Drug

Administered IV

Primary outcomes

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

    Time frame: 16, 20, 24, and 28 hours postdose

  2. Part B: Pharmacokinetics: ISF-to-Serum Concentrations

    Time frame: 16, 20, 24, and 28 hours postdose

    Absolute concentration of ISF of insulin peglispro and human insulin.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 9, 2014
Registry last updated
Mar 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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