A Study of LY900014 in Elderly and Younger Adult Participants With Type 1 Diabetes Mellitus

Eli Lilly and Company80 enrolled

Overview

The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in elderly and younger adults with type 1 diabetes mellitus. Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be between 3 to 8 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Diabetes Mellitus, Type 1

Interventions

LY900014DRUG

Administered SC

Insulin LisproDRUG

Administered SC

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Are male or female participants with Type 1 Diabetes Mellitus (T1DM) * Have a body mass index (BMI) of 18.5 to 30.0 kilogram per meter square (kg/m²) * Have a glycated hemoglobin (HbA1c) less than (\<)9.0 percent (%) * Have had no episodes of severe hypoglycaemia in the last 6 months Exclusion Criteria: * Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from T1DM), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data * Have a history of renal impairment * Have a history of deep vein thrombosis of the leg or repeated episodes of deep leg vein thrombosis in first-degree relatives * Have proliferative retinopathy or maculopathy and/or severe neuropathy

Locations (2)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Mainz, Germany

Neuss, Germany

Outcomes

Primary Outcomes

Pharmacokinetics: Insulin Lispro Area Under the Concentration Versus Time Curve (AUC) for Each Treatment Arm

Pharmacokinetics: Insulin lispro AUC from time zero to 10 hours postdose \[AUC(0-10h)\] for each treatment arm.

Time frame: Day 1: Pre-dose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose

Secondary Outcomes

Total Amount of Glucose Infused (Gtot) Over Duration of Clamp for Each Treatment Arm

Glucodynamics: Gtot is the total glucose infusion over the clamp duration (10 hours) and is used to measure the study drug action over time as measured by the euglycemic clamp procedure.

Time frame: Every minute starting from the pre-dose and throughout the duration of the clamp until 10 hours post-dose

Data from ClinicalTrials.gov

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