NCT01374178

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 diabetes-mellitus

Timeline
Completed

Started Jun 2011

Shorter than P25 for phase_1 diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2011

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

October 7, 2014

Completed
Last Updated

October 7, 2014

Status Verified

October 1, 2014

Enrollment Period

1 month

First QC Date

June 13, 2011

Results QC Date

October 3, 2014

Last Update Submit

October 3, 2014

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

    Baseline up to 30 days

Study Arms (2)

LY2963016

EXPERIMENTAL

A single 0.5-unit per kilogram (U/kg) dose of LY2963016 will be administered subcutaneously.

Drug: LY2963016

Lantus

ACTIVE COMPARATOR

A single 0.5-U/kg dose of Lantus will be administered subcutaneously.

Drug: Lantus

Interventions

LY2963016DRUG

Administered subcutaneously

LY2963016
LantusDRUG

Administered subcutaneously

Also known as: Insulin Glargine
Lantus

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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, Singapore

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

LY2963016 insulin glargineInsulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

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
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2011

First Posted

June 15, 2011

Study Start

June 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

October 7, 2014

Results First Posted

October 7, 2014

Record last verified: 2014-10

Locations

SG(1)