A Study to Compare LY2963016 and US-approved Lantus® After Single Dose Administration to Healthy Participants

NCT01688635 | Completed Phase 1 Results

• 2 other identifiers: 14973I4L-MC-ABEO
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Volunteers

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY2963016 and US-Approved Lantus

  The AUC from time 0 to 24 hours (AUC0-24) of LY2963016 and US-Approved Lantus was measured.

  30 minutes predose up to 24 hours postdose in all treatment periods

• Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2963016 and US-Approved Lantus

  30 minutes predose up to 24 hours postdose in all treatment periods

Secondary Outcomes (2)

• Maximum Glucose Infusion Rate (Rmax)

  30 minutes predose up to 24 hours postdose in all treatment periods

• Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp Procedure

  30 minutes predose up to 24 hours postdose in all treatment periods

Study Arms (2)

LY2963016

EXPERIMENTAL

Single 0.5 units per kilogram (U/kg) dose of LY2963016 administered subcutaneously, twice during the study

Drug: LY2963016

US-approved Lantus

EXPERIMENTAL

Single 0.5 U/kg dose of US-approved Lantus administered subcutaneously, twice during the study

Drug: US Approved Lantus

Interventions

LY2963016 DRUG

Administered subcutaneously

LY2963016

US Approved Lantus DRUG

Administered subcutaneously

US-approved Lantus

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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.

Singapore, 117597, Singapore

Location

MeSH Terms

Interventions

LY2963016 insulin glargine

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2012
• First Posted: September 20, 2012
• Study Start: September 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: October 7, 2014
• Results First Posted: October 7, 2014

Record last verified: 2014-10

Locations

SG (1)