Clinical trial NCT01374178: A Comparison of LY2963016 to a Basal Insulin After a Single Dose in Healthy Subjects
Official title: Relative Bioavailability of LY2963016 to LANTUS® After Single Dose Subcutaneous Administration to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2011-06-15
Enrollment: 16
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purposes of this study are to determine the pharmacokinetics and pharmacodynamics of LY2963016 compared to those of basal insulin. The study will also gather information on the safety and tolerability of LY2963016 in healthy subjects. The study is approximately 12 weeks.


Eligibility criteria: Inclusion Criteria:

* Are overtly healthy males or females
* Have a body mass index (BMI) between 18.5 and 29.9 kilogram per square meter (kg/m\^2)
* Are nonsmokers
* Have normal blood pressure and pulse rate
* Have an electrocardiogram (ECG) considered as within normal limits
* Have clinical laboratory test results within normal reference range

Exclusion Criteria:

* Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device
* Have known allergies to insulin or its excipients
* Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
* Show evidence of significant active neuropsychiatric disease
* Have a history of first-degree relatives known to have diabetes mellitus
* Have a fasting venous blood glucose \>6.0 millimoles per liter (mmol/L)
* Intend to use over-the-counter or prescription medication
* Have donated or had a blood loss of 450 milliliters (mL) or more in the past 3 months
* Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females)

Primary outcomes:
measure: Pharmacokinetics: Area Under the Concentration-Time Curve (AUC)
timeFrame: Periods 1 and 2: Baseline up to 24 hours
Secondary outcomes:
measure: Pharmacokinetics: Maximum Concentration (Cmax)
timeFrame: Periods 1 and 2: Baseline up to 24 hours
measure: Maximum Glucose Infusion Rate (Rmax)
timeFrame: Periods 1 and 2: Baseline up to 24 hours
measure: Total Glucose Infused (Gtot)
timeFrame: Periods 1 and 2: Baseline up to 24 hours
measure: Time of Maximum Glucose Infusion Rate (tRmax)
timeFrame: Periods 1 and 2: Baseline up to 24 hours
measure: Number of Participants With Clinically Significant Effects
timeFrame: Baseline up to 30 days
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: