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

NCT02109029 | Completed Phase 1 Results DMC

• 2 other identifiers: 14873I2R-MC-BIDP
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

  Absolute concentration of ISF of insulin peglispro and human insulin.

  16, 20, 24, and 28 hours postdose

Study Arms (2)

Insulin Peglispro (LY2605541)

EXPERIMENTAL

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).

Drug: Insulin Peglispro

Human Insulin

ACTIVE COMPARATOR

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).

Drug: Human Insulin

Interventions

Insulin Peglispro DRUG

Administered IV

Also known as: LY2605541

Insulin Peglispro (LY2605541)

Human Insulin DRUG

Administered IV

Human Insulin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (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, 8036, Austria

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

basal insulin peglispro; LY2605541; Insulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2014
• First Posted: April 9, 2014
• Study Start: April 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 6, 2019
• Results First Posted: March 6, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)