Clinical trial NCT01688635: A Study to Compare LY2963016 and US-approved Lantus® After Single Dose Administration to Healthy Participants
Official title: Comparative Pharmacokinetics and Pharmacodynamics of LY2963016 and US-Approved Lantus® After Single-Dose Subcutaneous Administration to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Volunteers
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2012-09-20
Enrollment: 91
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to compare the pharmacokinetics and pharmacodynamics of LY2963016 and US-approved Lantus®. The study involves four single injections; two doses of LY2963016 and two doses of US-approved Lantus®. The study will have 4 periods. In each period, a single injection will be administered before undergoing a euglycemic clamp that lasts for 24 hours. There will be at least a 7 day washout between each period. Side effects will be documented. Study participation is expected to last up to 14 weeks.


Eligibility criteria: Inclusion Criteria:

* Are overtly healthy males or females
* Have body mass index between 18.5 and 29.9 kilograms per meter square (kg/m\^2)
* Are nonsmokers and have not smoked for at least 2 months prior to entering the study
* Have normal blood pressure and pulse rates at screening
* Have electrocardiograms (ECGs) at screening considered as within normal limits
* Have clinical laboratory test results within normal reference ranges

Exclusion Criteria:

* Are currently enrolled in or discontinued within the last 30 days from a clinical study involving an investigational drug or device or are concurrently enrolled in any other type of medical research
* Have known allergies to insulin, its excipients, or related drugs or have history of relevant allergic reactions of any origin
* Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
* Show evidence of significant active neuropsychiatric disease, including taking prescription medication for such diseases
* Show evidence of current use of known drugs of abuse or a history of use within the past year
* Have a history of first-degree relatives known to have diabetes mellitus
* Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies at screening
* Have positive hepatitis B surface antigen at screening
* Intend to use over-the-counter or prescription medication within 7 or 14 days, respectively, prior to dosing (apart from vitamin/mineral supplements, occasional paracetamol, thyroid replacement medication, or birth control methods)
* Have donated or had a blood loss of 450 milliliters (mL) within 3 months prior to study enrollment
* Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females) or are unwilling to stop alcohol consumption from 24 hours prior to each dosing until discharged from the clinical research unit (CRU)

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY2963016 and US-Approved Lantus
timeFrame: 30 minutes predose up to 24 hours postdose in all treatment periods
measure: Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2963016 and US-Approved Lantus
timeFrame: 30 minutes predose up to 24 hours postdose in all treatment periods
Secondary outcomes:
measure: Maximum Glucose Infusion Rate (Rmax)
timeFrame: 30 minutes predose up to 24 hours postdose in all treatment periods
measure: Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp Procedure
timeFrame: 30 minutes predose up to 24 hours postdose in all treatment periods
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 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: