Clinical trial NCT02109029: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2014-04-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Part B: Pharmacokinetics: Steady-State Concentrations in Adipose Tissue Interstitial Fluid (ISF)
timeFrame: 16, 20, 24, and 28 hours postdose
measure: Part B: Pharmacokinetics: ISF-to-Serum Concentrations
timeFrame: 16, 20, 24, and 28 hours postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: