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
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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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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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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Tampa, FL
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Atlanta, Georgia 30318
Principal Investigator: Quentin VanMeter
Phone: 678-961-2100
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Atlanta, GA
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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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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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Los Angeles, CA
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Lufkin, Texas 75904
Principal Investigator: Lance Sloan
Phone: 936-632-4282
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Lufkin, TX
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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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Orlando, FL
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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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