A Study of LY900014 in Participants With Type 2 Diabetes on Insulin Injection Therapy

Eli Lilly and Company30 enrolled

Overview

The study will be conducted in participants with type 2 diabetes on insulin injection therapy to investigate how the body processes LY900014 and the effect of LY900014 on blood sugar levels. Side effects and tolerability will be documented. The study will be conducted in two parts (Part A and Part B) to achieve its objectives. Participants are expected to enroll in both parts.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

LY900014DRUG

Administered subcutaneously (SC)

Insulin LisproDRUG

Administered SC

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Are male or female participants with Type 2 Diabetes Mellitus (T2DM) on a stable multiple daily injection regimen with a short-acting as well as a long-acting insulin * Have a body mass index (BMI) ranging from 18.5 to 33.0 kilogram per square meter (kg/m²), inclusive, at screening * Have blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results acceptable for the study * Have had no episodes of severe hypoglycemia in the past 6 months (requiring assistance in treatment by a second party) * Have venous access sufficient to allow for blood sampling * Have provided written consent and are willing to follow study procedures and commit to the study duration Exclusion Criteria: * Are currently enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research judged to be incompatible with this study * Have previously completed or withdrawn from this study * Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate in the study * Had blood loss of more than 500 milliliters (mL) within the last month * Are treated with a continuous subcutaneous insulin infusion (insulin pump)

Locations (1)

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.

Neuss, Germany

Outcomes

Primary Outcomes

Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) (Part A)

PK: Insulin Lispro AUC(0-5h) (Part A)

Time frame: Day 1: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150,180, 240, 300 minutes post dose for each treatment

Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) (Part B)

PK: Insulin Lispro AUC(0-5h) (Part B)

Time frame: Days 1 and 14: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150,180, 240, 300 minutes post dose for each treatment

Secondary Outcomes

Pharmacodynamics (PD): Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT) (Part A)

PD: AUC(0-5h) of Glucose Relative to a MMTT (Part A)

Time frame: Day 1: -30, -15, 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, 300 minutes

Pharmacodynamics (PD): Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT) (Part B)

PD: AUC(0-5h) of Glucose Relative to a MMTT (Part B)

Time frame: Days 1 and 14: Day 1: -30, -15, 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, 300 minutes in each study period

Data from ClinicalTrials.gov

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