Clinical trial NCT02703337: A Study of LY900014 in Participants With Type 2 Diabetes on Insulin Injection Therapy
Official title: Pharmacokinetics, Glucodynamics, Safety, and Tolerability of LY900014 in Patients With Type 2 Diabetes Mellitus on Multiple Daily Insulin Injection Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2016-03-09
Enrollment: 30
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 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.


Eligibility criteria: 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* Have previously completed or withdrawn from this study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)

Primary outcomes:
measure: Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) (Part A)
timeFrame: 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
measure: Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) (Part B)
timeFrame: 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:
measure: 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)
timeFrame: 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
measure: 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)
timeFrame: 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
Other outcomes:
Locations:
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:
citation: Leohr J, Kazda C, Liu R, Reddy S, Dellva MA, Matzopoulos M, Loh MT, Hardy T, Klein O, Kapitza C. Ultra-rapid lispro shows faster pharmacokinetics and reduces postprandial glucose excursions versus Humalog(R) in patients with type 2 diabetes mellitus in a randomized, controlled crossover meal test early phase study. Diabetes Obes Metab. 2022 Feb;24(2):187-195. doi: 10.1111/dom.14561. Epub 2021 Oct 27.