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

Phase 1

Completed

Brief Summary: 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.

Recruitment & Eligibility

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Have previously completed or withdrawn from this study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)

Arm && Interventions

Group	Intervention	Description
LY900014 (Part A)	LY900014	Individualized doses of LY900014 administered by injection under the skin once in each of 3 periods
LY900014 (Part B)	LY900014	Individualized doses of LY900014 administered by injection under the skin with each meal for 14 days
Insulin Lispro - Reference (Part B)	Insulin Lispro	Individualized doses of insulin lispro reference formulation administered by injection under the skin with each meal for 14 days
Insulin Lispro - Reference (Part A)	Insulin Lispro	Individualized doses of insulin lispro reference formulation administered by injection under the skin once in each of 3 periods

Primary Outcome Measures

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

Secondary Outcome Measures

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

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