A Study Comparing LY900014 to Insulin Lispro (Humalog) in Children and Adolescents With Type 1 Diabetes



Status:Not yet recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:1 - 17
Updated:4/5/2019
Start Date:April 22, 2019
End Date:January 2, 2021
Contact:There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Email:clinicaltrials.gov@lilly.com
Phone:1-317-615-4559

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A Prospective, Randomized, Double-Blind Comparison of LY900014 to Humalog With an Open-Label Postprandial LY900014 Treatment Group in Children and Adolescents With Type 1 Diabetes

The reason for this study is to compare the study drug LY900014 to insulin lispro (Humalog)
in children and adolescents with type 1 diabetes (T1D).


Inclusion Criteria:

- T1D for at least 6 months at the screening visit.

- Have been treated with only one of the following rapid-acting insulin analogs as part
of an multiple daily injection regimen for at least the last 90 days prior to the
screening visit:

- insulin lispro U-100, or

- insulin aspart

- insulin glulisine or

- fast acting insulin aspart

- Have been treated with only one of the following basal insulins for at least the last
90 days prior to the screening visit:

- insulin glargine U-100 (once a day [QD] or twice a day [BID]), or

- insulin detemir U-100 (QD or BID), or

- insulin degludec U-100 (QD)

- Have a HbA1c value ≥6.5% and ≤9.5% at the screening visit.

Exclusion Criteria:

- Have current hypoglycemic unawareness or have had more than 1 episode of severe
hypoglycemia within 6 months prior to the screening visit.

- Have had more than 1 emergency room visit or hospitalization due to poor glucose
control within 6 months prior to the screening visit.

- Have been on a treatment regimen that includes regular human insulin, neutral
protamine Hagedorn (NPH), Afrezza® (insulin human) inhalation powder, any premixed
insulins or use of diluted insulins within 90 days prior to the screening visit.
We found this trial at
26
sites
4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
Principal Investigator: Henry Rodriguez
Phone: 813-396-2580
University of South Florida The University of South Florida is a high-impact, global research university...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Mary Lauren Scott
Phone: 2059969569
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Principal Investigator: Nicole Sheanon
Phone: 513-636-4744
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Cincinnati, OH
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Principal Investigator: Mark A Clements
Phone: 816-855-1769
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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Kansas City, MO
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Steven Willi
Phone: 215-426-7037
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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3020 Childrens way
San Diego, California 92123
(858) 576-1700
Principal Investigator: Michael E Gottschalk
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
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San Diego, CA
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Atlanta, Georgia 30318
Principal Investigator: Quentin VanMeter
Phone: 678-961-2100
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Aurora, Colorado 80010
Principal Investigator: Raj P Wadwa
Phone: 303-724-6719
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Baltimore, Maryland 21229
Principal Investigator: Barry Reiner
Phone: 410-646-4009
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6400 Perkins Rd
Baton Rouge, Louisiana 70808
(225) 763-2500
Principal Investigator: Daniel Hsia
Phone: 225-763-2831
Pennington Biomedical Research Center Unlike other medical research facilities where science occurs in separate labs...
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Baton Rouge, LA
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Boise, Idaho 83712
Principal Investigator: Daniel Flynn
Phone: 208-381-7340
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Boise, ID
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One Joslin Place
Boston, Massachusetts 02215
617-309-2400
Principal Investigator: Lori M Laffel
Phone: 617-732-2603
Joslin Diabetes Center Joslin Diabetes Center, located in Boston, Massachusetts, is the world's largest diabetes...
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Boston, MA
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Buffalo, New York 14203
Principal Investigator: Kathleen Bethin
Phone: 716-323-0170
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Graz, Steiermark
Principal Investigator: Elke Fröhlich-Reiterer
Phone: 4331638580562
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Idaho Falls, Idaho 83404
Principal Investigator: Joshua Smith
Phone: 208-523-1122
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Indianapolis, Indiana 46202
Principal Investigator: Linda DiMeglio
Phone: 317-944-3889
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Indianapolis, IN
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Los Angeles, California 90027
Principal Investigator: Roshanak Monzavi
Phone: 323-631-7040
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Lufkin, Texas 75904
Principal Investigator: Lance Sloan
Phone: 936-632-4282
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Principal Investigator: Jennifer L Sherr
Phone: 203-737-5831
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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Orlando, Florida 32803
Principal Investigator: Konda Reddy
Phone: 407-896-2901
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Palo Alto, California 94304
Principal Investigator: BRUCE BUCKINGHAM
Phone: 650-725-6549
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Sacramento, California 98521
Principal Investigator: Gnanagurudasan Prakasam
Phone: 916-426-1902
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Syracuse, New York 13210
Principal Investigator: Ruth S Weinstock
Phone: 315-464-9006
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Tacoma, Washington 98405
Principal Investigator: Gadi B. Kletter
Phone: 253-403-7250
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Tucson, Arizona 85721
(520) 621-2211
Principal Investigator: Mark Wheeler
Phone: 520-626-6077
University of Arizona The University of Arizona is a premier, public research university. Established in...
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1031 Office Park Road
West Des Moines, Iowa 50265
Principal Investigator: Anuj Bhargava
Phone: 515-329-6800
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