A Comparison of LY2963016 to a Basal Insulin After a Single Dose in Healthy Subjects

Relative Bioavailability of LY2963016 to LANTUS® After Single Dose Subcutaneous Administration to Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Drug: LY2963016; Drug: Lantus

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY2963016; A single 0.5-unit per kilogram (U/kg) dose of LY2963016 will be administered subcutaneously.	Drug: LY2963016; Administered subcutaneously
Active Comparator: Lantus; A single 0.5-U/kg dose of Lantus will be administered subcutaneously.	Drug: Lantus; Administered subcutaneously; Other Names: Insulin Glargine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC)	AUC from time zero to 24 hours (AUC0-24) is reported for this outcome measure.	Periods 1 and 2: Baseline up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics: Maximum Concentration (Cmax)		Periods 1 and 2: Baseline up to 24 hours
Maximum Glucose Infusion Rate (Rmax)		Periods 1 and 2: Baseline up to 24 hours
Total Glucose Infused (Gtot)		Periods 1 and 2: Baseline up to 24 hours
Time of Maximum Glucose Infusion Rate (tRmax)		Periods 1 and 2: Baseline up to 24 hours
Number of Participants With Clinically Significant Effects	Clinically significant effects were defined as serious and nonserious adverse events. A summary of serious and all other nonserious adverse events is located in the Reported Adverse Event module.	Baseline up to 30 days

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: June 13, 2011
• First Submitted That Met QC Criteria: June 14, 2011
• First Posted (Estimate): June 15, 2011

Study Record Updates

• Last Update Posted (Estimate): October 7, 2014
• Last Update Submitted That Met QC Criteria: October 3, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Glargine
• Other Study ID Numbers: 14094; I4L-MC-ABEI (Other Identifier: Eli Lilly and Company)