A Study Comparing LY900014 to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes Using Insulin Pump Therapy
NCT ID: NCT03830281
Last Updated: 2021-01-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
471 participants
INTERVENTIONAL
2019-02-14
2020-01-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of LY900014 Versus Insulin Lispro (Humalog) on High Blood Sugar in Participants With Type 1 Diabetes Who Use Insulin Pumps
NCT04276207
A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes
NCT03952130
A Study Comparing LY900014 to Insulin Lispro (Humalog) in Children and Adolescents With Type 1 Diabetes
NCT03740919
A Study of LY900014 in Participants With Type 1 Diabetes Mellitus
NCT03465878
A Comparative Study of LY900014 to Insulin Lispro (Humalog) in Healthy Participants
NCT03286751
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Insulin Lispro (Humalog)
Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
Insulin Lispro
Administered SC
Ultra-Rapid Lispro
Participants received individual dose of 100 units per milliliter (U/mL) ultra rapid lispro by continuous subcutaneous insulin infusion (CSII); where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
Ultra-Rapid Lispro
Administered SC
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ultra-Rapid Lispro
Administered SC
Insulin Lispro
Administered SC
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Have been using CSII therapy for a minimum of 6 months
* Currently treated with \<100 Units of one of following rapid-acting analog insulin via CSII for at least the past 30 days: insulin lispro U-100, insulin aspart, fast-acting insulin aspart, insulin glulisine
* Must be using a MiniMed 530G (US), Paradigm Revel (US), or MiniMed 630G (US and Canada), MiniMed 640G or Paradigm Veo (select countries outside the US), insulin pump for at least the past 90 days
Exclusion Criteria
* Have had more than 1 episode of severe hypoglycemia within 6 months prior to screening
* Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within 6 months prior to screening
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eli Lilly and Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
John Muir Physician Network Clinical Research Center
Concord, California, United States
Valley Research
Fresno, California, United States
Marin Endocrine Associates
Greenbrae, California, United States
Diabetes and Endocrine Associates
La Mesa, California, United States
First Valley Medical Group
Lancaster, California, United States
Center of Excellence in Diabetes & Endocrinology
Sacramento, California, United States
University Clinical Investigators, Inc.
Tustin, California, United States
Coastal Metabolic Research Centre
Ventura, California, United States
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States
ALL Medical Research, LLC
Cooper City, Florida, United States
Sun Coast Clinical Research, Inc
New Port Richey, Florida, United States
Metabolic Research Institute Inc.
West Palm Beach, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, United States
East West Medical Institute
Honolulu, Hawaii, United States
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, United States
Northwestern Feinberg School of Medicine
Chicago, Illinois, United States
Prairie Education and Research Cooperative
Springfield, Illinois, United States
Iderc, P.L.C.
West Des Moines, Iowa, United States
Kentucky Diabetes Endocrinology Center
Lexington, Kentucky, United States
Endocrine and Metabolic Consultants
Rockville, Maryland, United States
Palm Research Center
Las Vegas, Nevada, United States
Palm Research Center
Las Vegas, Nevada, United States
Southern New Hampshire Diabetes and Endocrinology
Nashua, New Hampshire, United States
Physicians East
Greenville, North Carolina, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Texas Diabetes and Endocrinology-Austin South
Austin, Texas, United States
Dallas Diabetes Endocrine Center
Dallas, Texas, United States
Texas Diabetes and Endocrinology, P.A.
Round Rock, Texas, United States
Private: Dr. Larry Stonesifer
Federal Way, Washington, United States
Rainier Clinical Research Center
Renton, Washington, United States
Tacoma Center for Arthritis Research, PS
Tacoma, Washington, United States
The AIM Centre
Merewether, New South Wales, Australia
GP Plus Marion
Oaklands Park, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Barwon Health - The Geelong Hospital
Geelong, Victoria, Australia
Fremantle Hospital
Fremantle, Western Australia, Australia
Universitätsklinikum Graz
Graz, Styria, Austria
VIVIT Institut am LKH Feldkirch
Feldkirch, Vorarlberg, Austria
Universitätsklinikum Salzburg
Salzburg, , Austria
KA Rudolfstiftung
Vienna, , Austria
LMC Endocrinology Centres Ltd.
Barrie, Ontario, Canada
LMC Endocrinology Centres Ltd.
Concord, Ontario, Canada
LMC Endocrinology Centres
Oakville, Ontario, Canada
LMC Endocrinology Centres Ltd.
Toronto, Ontario, Canada
IRCM
Montreal, Quebec, Canada
LMC Endocrinology Centres Ltd.
Saint-Laurent, Quebec, Canada
CHU Toulouse Hopital de Rangueil
Toulouse, Cedex 9, France
Clinique Hotel Dieu
Le Creusot, , France
Centre hospitalier universitaire Lapeyronie
Montpellier, , France
Hopital Cochin
Paris, , France
Hôpital de HautePierre
Strasbourg, , France
Groupe hospitalier mutualiste Les Portes du sud
Vénissieux, , France
Arztpraxis Dr. Cornelia Marck
Pohlheim, Hesse, Germany
Institut für Diabetesforschung Münster GmbH
Münster, North Rhine-Westphalia, Germany
Praxis Dr. Kempe - Dr. Stemler
Ludwigshafen am Rhein, Rhineland-Palatinate, Germany
Schwerpunktpraxis Diabetes
Saint Ingbert-Oberwürzbach, Saarland, Germany
RED-Institut GmbH
Oldenburg in Holstein, Schleswig-Holstein, Germany
Diabetespraxis Prenzlauer Allee
Berlin, , Germany
Diabetologische Schwerpunktpraxis B. Scholz/Dr. B. Paschen
Hamburg, , Germany
Gemeinschaftspraxis für innere Medizin und Diabetologie
Hamburg, , Germany
Budai Irgalmasrendi Korhaz
Budapest, , Hungary
ClinDiab Kft.
Budapest, , Hungary
UNO Medical Trials Kft.
Budapest, , Hungary
TRANTOR 99 Bt.
Budapest, , Hungary
Soroka Medical Center - Pediatric Outpatient Clinic
Beersheba, , Israel
Rambam Health Care Campus
Haifa, , Israel
Hadassah Medical Center
Jerusalem, , Israel
Schneider Medical Center
Petah Tikva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, , Italy
IRCCS Ospedale San Raffaele
Milan, , Italy
Ospedale San Giovanni di Dio
Olbia, , Italy
Ospedale Santa Maria delle Croci
Ravenna, , Italy
Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza
Roma, , Italy
Advanced Clinical Research, LLC
Bayamón, PR, Puerto Rico
Centro de Endocrinologia Alcantara Gonzalez
Lomas Verdes, , Puerto Rico
Corporació Sanitaria Parc Tauli
Sabadell, Barcelona, Spain
Hospital Universitari Arnau de Vilanova
Lleida, Catalonia, Spain
Hospital Clinic I Provincial
Barcelona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
A Study Comparing LY900014 to Insulin Lispro in Adults With Type 1 Diabetes Using Insulin Pump Therapy
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
I8B-MC-ITRO
Identifier Type: OTHER
Identifier Source: secondary_id
2015-005358-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16315
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.