NCT01133392

Brief Summary

This study will compare how the body treats 2 different forms of insulin lispro and how they affect blood sugar levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started May 2010

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

May 1, 2010

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 28, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

December 30, 2014

Completed
Last Updated

December 30, 2014

Status Verified

December 1, 2014

Enrollment Period

3 months

First QC Date

May 27, 2010

Results QC Date

October 10, 2014

Last Update Submit

December 29, 2014

Conditions

Healthy Volunteers

Keywords

insulinlispro

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration [AUC0-tlast]

    Primary outcome measure is based on the pharmacokinetic area under the concentration-time curve from time 0 to the last time point with a measurable concentration.

    0 up to 8 hours post dose

Secondary Outcomes (4)

  • Pharmacokinetic Parameter: Maximum Serum Insulin Concentration [Cmax]

    0 to 8 hours post dose

  • Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax)

    0 to 8 hours post dose

  • Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax)

    0 to 8 hours post dose

  • Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot)

    0 to 8 hours post dose

Study Arms (2)

Insulin Lispro A

EXPERIMENTAL

20 units (U) subcutaneously (SC)

Drug: Insulin lispro A

Insulin lispro B

ACTIVE COMPARATOR

20 units (U) subcutaneously (SC)

Drug: Insulin lispro B

Interventions

Insulin lispro ADRUG

20 units (U) subcutaneously (SC).

Also known as: LY275585
Insulin Lispro A
Insulin lispro BDRUG

20 U subcutaneously (SC).

Also known as: LY275585
Insulin lispro B

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Are healthy males or females.
  • Body mass index (BMI) between 18.5 and 29.9 kilograms per meter squared (kg/m\^2)
  • Are nonsmokers.
  • Have normal blood pressure and pulse rate, a normal electrocardiogram (ECG), and clinical laboratory test results within normal reference range at screening.

You may not qualify if:

  • History of first-degree relatives known to have diabetes mellitus.
  • Evidence of significant active neuropsychiatric disease.
  • Evidence of an acute infection with fever or infectious disease.
  • Intend to use over-the-counter or prescription medication (apart from vitamin/mineral supplements, occasional paracetamol, or birth control methods).
  • Have used systemic glucocorticoids within 3 months prior to entry into the study.
  • Have donated blood of 1 unit or more within the last 3 months prior to study entry.
  • Excessive alcohol intake
  • Have a fasting venous blood glucose (FBG, plasma) \>6 millimoles/liter (mmol/L) at screening.
  • Have positive hepatitis B surface antigen.

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

Insulin Resistance

Interventions

Insulin Lispro

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-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

May 27, 2010

First Posted

May 28, 2010

Study Start

May 1, 2010

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

December 30, 2014

Results First Posted

December 30, 2014

Record last verified: 2014-12

Locations

SG(1)