Clinical trial NCT03341312: A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 2 Diabetes Mellitus (T2DM)
Official title: A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Compared to Humalog® in Patients With T2DM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2017-11-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which is a drug that lowers blood sugar. The study will look at how the body processes LY900014, and the effect of LY900014 on blood sugar levels following a standard meal. For each participant, the study will consist of 4 periods and will last approximately 12 weeks from screening to final study follow up.


Eligibility criteria: Inclusion Criteria:

* Have a body mass index (BMI) of 18.5 kilogram per meter square (kg/m²) to 40.0 kg/m²
* Have a glycated hemoglobin (HbA1c) less than or equal to (≤)9.0%
* Have a fasting C-peptide ≤1.0 nanomole per liter (nmol/L)
* Are on stable prandial insulin and basal insulin (neutral protamine Hagedorn \[NPH\] insulin, insulin glargine or insulin detemir) with or without a stable dose of metformin for at least 3 months before screening

Exclusion Criteria:

* Are currently enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research
* Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate in the study
* Have donated blood of more than 450 millilitre (mL) or more in the last 3 months or provided any blood donation within the last month before screening
* Any significant changes in insulin regimen and/or unstable blood glucose control within the past 3 months prior to screening as assessed by the investigator
* Are treated with a CSII (insulin pump)
* Require daily insulin treatment greater than (\>)1.2 units per kilogram per body weight (U/kg/body weight)

Primary outcomes:
measure: Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve Zero to Seven Hours (AUC0-7hr)
timeFrame: Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes (7 hours) postdose
Secondary outcomes:
measure: Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Curve (BGΔAUC) for Each Treatment Arm
timeFrame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, and 300 minutes post-meal
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: 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.
city: Neuss
country: Germany
facility: 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.
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: