Clinical trial NCT03305822: A Study of LY900014 in Participants With Type 2 Diabetes Mellitus
Official title: A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Compared to Humalog Following a Single Dose 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: 2017-10-10
Enrollment: 38
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 compare LY900014 with insulin lispro (Humalog) in participants with type 2 diabetes mellitus. 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 compared to insulin lispro (Humalog).

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 and 8 weeks.


Eligibility criteria: Inclusion Criteria:

* Are male or female participants with Type 2 Diabetes Mellitus (T2DM) for at least 1 year
* Have a body mass index (BMI) of 18.5 to 35.0 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 T2DM), 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

Primary outcomes:
measure: Pharmacokinetics (PK): Insulin Lispro Area Under the Plasma Concentration Curve Zero to 10 Hours (AUC[0-10) Following Each Treatment Arm
timeFrame: Predose, 5 minutes (mn), 10mn, 15mn, 20mn, 25mn, 30mn, 35mn, 40mn,45 mn,50mn, 55mn, 60mn, 70mn, 90mn, 120mn, 150mn, 180mn, 240mn, 300mn, 360mn, 420mn, 480mn, 540mn, and 600 minutes(10 hours) postdose
Secondary outcomes:
measure: Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) Over Duration of Clamp for Each Treatment Arm
timeFrame: Predose, every minute starting from run-in and throughout the duration of the 10 hours
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.
state: Nordrhein-Westfalen
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, Dellva MA, Carter K, LaBell E, Linnebjerg H. Ultra Rapid Lispro (URLi) Accelerates Insulin Lispro Absorption and Insulin Action vs Humalog(R) Consistently Across Study Populations: A Pooled Analysis of Pharmacokinetic and Glucodynamic Data. Clin Pharmacokinet. 2021 Nov;60(11):1423-1434. doi: 10.1007/s40262-021-01030-0. Epub 2021 May 27.
citation: Leohr J, Dellva MA, Coutant DE, LaBell E, Heise T, Andersen G, Zijlstra E, Hermanski L, Nosek L, Linnebjerg H. Pharmacokinetics and Glucodynamics of Ultra Rapid Lispro (URLi) versus Humalog(R) (Lispro) in Patients with Type 2 Diabetes Mellitus: A Phase I Randomised, Crossover Study. Clin Pharmacokinet. 2020 Dec;59(12):1601-1610. doi: 10.1007/s40262-020-00901-2.