A Study of LY900014 in Participants With Type 1 Diabetes
NCT ID: NCT03214367
Last Updated: 2020-05-01
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
1392 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-07-17
Study Completion Date
2019-08-22
Brief Summary
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The main purpose of this study is to evaluate the efficacy of the study drug LY900014 compared to insulin lispro, both in combination with insulin glargine or insulin degludec, in adults with type 1 diabetes (T1D).
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Detailed Description
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Conditions
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Type 1 Diabetes Mellitus
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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LY900014
LY900014 given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
Group Type
EXPERIMENTAL
LY900014
Intervention Type
DRUG
Administered SC
Insulin Glargine
Intervention Type
DRUG
Administered SC
Insulin Degludec
Intervention Type
DRUG
Administered SC
Insulin Lispro (Humalog)
Insulin lispro given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
Group Type
ACTIVE_COMPARATOR
Insulin Lispro
Intervention Type
DRUG
Administered SC
Insulin Glargine
Intervention Type
DRUG
Administered SC
Insulin Degludec
Intervention Type
DRUG
Administered SC
LY900014 Postmeal (Open Label)
LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
Group Type
EXPERIMENTAL
LY900014
Intervention Type
DRUG
Administered SC
Insulin Glargine
Intervention Type
DRUG
Administered SC
Insulin Degludec
Intervention Type
DRUG
Administered SC
LY900014 - Maximum Extended Enrollment (MEE)
LY900014 given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
Group Type
EXPERIMENTAL
LY900014
Intervention Type
DRUG
Administered SC
Insulin Glargine
Intervention Type
DRUG
Administered SC
Insulin Degludec
Intervention Type
DRUG
Administered SC
Insulin Lispro (Humalog)-MEE
Insulin lispro given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
Group Type
ACTIVE_COMPARATOR
Insulin Lispro
Intervention Type
DRUG
Administered SC
Insulin Glargine
Intervention Type
DRUG
Administered SC
Insulin Degludec
Intervention Type
DRUG
Administered SC
LY900014 Postmeal (Open Label)-MEE
LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
Group Type
EXPERIMENTAL
LY900014
Intervention Type
DRUG
Administered SC
Insulin Glargine
Intervention Type
DRUG
Administered SC
Insulin Degludec
Intervention Type
DRUG
Administered SC
Interventions
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LY900014
Administered SC
Intervention Type
DRUG
Insulin Lispro
Administered SC
Intervention Type
DRUG
Insulin Glargine
Administered SC
Intervention Type
DRUG
Insulin Degludec
Administered SC
Intervention Type
DRUG
Other Intervention Names
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Ultra-Rapid Lispro
Humalog
Eligibility Criteria
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Inclusion Criteria
* Have T1D for at least 1 year prior to screening and continuously using insulin for at least 1 year.
* HbA1c of ≥7.0 and ≤9.5%.
* Use insulin lispro, insulin aspart, or insulin glulisine as prandial insulin.
* Use insulin glargine, insulin detemir, insulin degludec, or neutral protamine Hagedorn (NPH) insulin as basal insulin.
* HbA1c of ≥7.0 and ≤9.5%.
* Use insulin lispro, insulin aspart, or insulin glulisine as prandial insulin.
* Use insulin glargine, insulin detemir, insulin degludec, or neutral protamine Hagedorn (NPH) insulin as basal insulin.
Exclusion Criteria
* Have used other antihyperglycemic medications or therapies (inhaled, oral or injectable) within 90-days of screening.
* Have had more than 1 severe hypoglycemic episode within 6 months of screening.
* Have had more than 1 hospitalization related to hyperglycemia or diabetic ketoacidosis within 6 months of screening.
* Have clinically significant gastrointestinal disease.
* Have had more than 1 severe hypoglycemic episode within 6 months of screening.
* Have had more than 1 hospitalization related to hyperglycemia or diabetic ketoacidosis within 6 months of screening.
* Have clinically significant gastrointestinal disease.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Internal Medicine Center LLC
Mobile, Alabama, United States
Site Status
John Muir Physician Network Clinical Research Center
Concord, California, United States
Site Status
AMCR Institute INC
Escondido, California, United States
Site Status
Valley Endocrine, Fresno
Fresno, California, United States
Site Status
Marin Endocrine Associates
Greenbrae, California, United States
Site Status
Diabetes and Endocrine Associates
La Mesa, California, United States
Site Status
University Clinical Investigators, Inc.
Tustin, California, United States
Site Status
Coastal Metabolic Research Centre
Ventura, California, United States
Site Status
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States
Site Status
The Center For Diabetes & Endocrine Care
Fort Lauderdale, Florida, United States
Site Status
East Coast Institute For Research
Jacksonville, Florida, United States
Site Status
Sun Coast Clinical Research, Inc
New Port Richey, Florida, United States
Site Status
Metabolic Research Institute Inc.
West Palm Beach, Florida, United States
Site Status
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Site Status
East Coast Institute For Research
Macon, Georgia, United States
Site Status
Endocrine Research Solutions, Inc.
Roswell, Georgia, United States
Site Status
East West Medical Institute
Honolulu, Hawaii, United States
Site Status
Northwest Clinical Trials
Boise, Idaho, United States
Site Status
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, United States
Site Status
Prairie Education and Research Cooperative
Springfield, Illinois, United States
Site Status
Iderc, P.L.C.
West Des Moines, Iowa, United States
Site Status
University of Kansas Medical Center
Kansas City, Kansas, United States
Site Status
Cotton O'Neil Diabetes and Endocrinology Center
Topeka, Kansas, United States
Site Status
Kentucky Diabetes Endocrinology Center
Lexington, Kentucky, United States
Site Status
MassResearch
Waltham, Massachusetts, United States
Site Status
Palm Research Center
Las Vegas, Nevada, United States
Site Status
Palm Research Center
Las Vegas, Nevada, United States
Site Status
Southern New Hampshire Diabetes and Endocrinology
Nashua, New Hampshire, United States
Site Status
Manhattan Medical Research
New York, New York, United States
Site Status
Physicians East
Greenville, North Carolina, United States
Site Status
Diabetes & Endocrinology Consultants PC
Morehead City, North Carolina, United States
Site Status
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
Site Status
Your Diabetes Endocrine Nutrition Group PC
Mentor, Ohio, United States
Site Status
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Site Status
Partners in Nephrology & Endocrinology
Pittsburgh, Pennsylvania, United States
Site Status
Sudir Bansal M.D. Inc.
Warwick, Rhode Island, United States
Site Status
University Diabetes and Endocrine Consultants
Chattanooga, Tennessee, United States
Site Status
Texas Diabetes and Endocrinology
Austin, Texas, United States
Site Status
Dallas Diabetes Endocrine Center
Dallas, Texas, United States
Site Status
Texas Diabetes and Endocrinology, P.A.
Round Rock, Texas, United States
Site Status
Consano Clinical Research
Shavano Park, Texas, United States
Site Status
Progressive Clinical Research
Bountiful, Utah, United States
Site Status
Private: Dr. Larry Stonesifer
Federal Way, Washington, United States
Site Status
Rainier Clinical Research Center
Renton, Washington, United States
Site Status
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Caba, , Argentina
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Caba, , Argentina
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Ciudad Autonoma de Buenos Aire, , Argentina
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Ciudad Autonoma de Buenos Aire, , Argentina
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Córdoba, , Argentina
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Córdoba, , Argentina
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Mar del Plata, , Argentina
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Box Hill, , Australia
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Geelong, , Australia
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Merewether, , Australia
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Oaklands Park, , Australia
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Graz, , Austria
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Graz, , Austria
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Vienna, , Austria
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São Paulo, , Brazil
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Bad Mergentheim, , Germany
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Falkensee, , Germany
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Hamburg, , Germany
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Hessen, , Germany
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Magdeburg, , Germany
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Mayen, , Germany
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Münster, , Germany
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Oldenburg, , Germany
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Rheine, , Germany
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Saterland, , Germany
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Ampelokipoi, , Greece
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Athens, , Greece
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Athens, , Greece
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Larissa, , Greece
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Thermi, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Ahmedabad, , India
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Hyderabad, , India
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Hyderabad, , India
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Hyderabad, , India
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Indore, , India
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Pune, , India
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Secunderabad, , India
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Visakhapatnam, , India
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Milan, , Italy
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Ravenna, , Italy
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Roma, , Italy
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Siena, , Italy
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Amagasaki, , Japan
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Fukuoka, , Japan
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Fukuoka, , Japan
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Kamakura, , Japan
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Kanagawa, , Japan
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Kumamoto, , Japan
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Miyazaki, , Japan
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Naka, , Japan
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Ōita, , Japan
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Ōsaka, , Japan
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Ōsaka, , Japan
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Sapporo, , Japan
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Sapporo, , Japan
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Sasebo, , Japan
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Shinjuku, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Guadalajara, , Mexico
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Monterrey, , Mexico
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Monterrey, , Mexico
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Zapopan, , Mexico
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Takapuna, Auckland, New Zealand
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Auckland, , New Zealand
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Christchurch, , New Zealand
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Wellington, , New Zealand
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Gdansk, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Lublin, , Poland
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Ruda Śląska, , Poland
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Szczecin, , Poland
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Szczecin, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
Site Status
Dr Altagracia Aurora Alcantara Gonzalez
Bayamón, , Puerto Rico
Site Status
Advanced Clinical Research, LLC
Bayamón, , Puerto Rico
Site Status
Manati Center for Clinical Research Inc
Manatí, , Puerto Rico
Site Status
Martha Gomez Cuellar M.D.
San Juan, , Puerto Rico
Site Status
Centro de Endocrinologia del Este
Yabucoa, , Puerto Rico
Site Status
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Bacau, , Romania
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Brasov, , Romania
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Bucharest, , Romania
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Lasi, , Romania
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Oradea, , Romania
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Ploieşti, , Romania
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Ploieşti, , Romania
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Satu Mare, , Romania
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Târgu Mureş, , Romania
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Timișoara, , Romania
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Arkhangelsk, , Russia
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Kursk, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saratov, , Russia
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Košice, , Slovakia
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Malacky, , Slovakia
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Nové Mesto nad Váhom, , Slovakia
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Rožňava, , Slovakia
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Sabadell, Barcelona, Spain
Site Status
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Alzira, Valencia, Spain
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Málaga, , Spain
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Seville, , Spain
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Seville, , Spain
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Seville, , Spain
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Teruel, , Spain
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Gothenburg, , Sweden
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Linköping, , Sweden
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Lund, , Sweden
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Stockholm, , Sweden
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Chang-hua, , Taiwan
Site Status
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Taichung, , Taiwan
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Taichung, , Taiwan
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Tainan City, , Taiwan
Site Status
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Taipei, , Taiwan
Site Status
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Yongkang District, , Taiwan
Site Status
Countries
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United States
Argentina
Australia
Austria
Brazil
Germany
Greece
India
Italy
Japan
Mexico
New Zealand
Poland
Puerto Rico
Romania
Russia
Slovakia
Spain
Sweden
Taiwan
References
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Piras de Oliveira C, Dellva MA, Bue-Valleskey J, Chang AM, Liao B. Fasting and postprandial plasma glucose contributions to hemoglobin A1c and time in range in people with diabetes on multiple daily injection insulin therapy: Results from the PRONTO-T1D and PRONTO-T2D clinical trials. J Diabetes Complications. 2024 Jan;38(1):108648. doi: 10.1016/j.jdiacomp.2023.108648. Epub 2023 Nov 16.
Reference Type
DERIVED
Miura J, Nishiyama H, Imori M. Long-term Efficacy and Safety of Ultra Rapid Lispro in Japanese Patients With Type 1 Diabetes: Subpopulation Analysis of the 52-Week PRONTO-T1D Study. Diabetes Ther. 2021 Sep;12(9):2471-2484. doi: 10.1007/s13300-021-01124-9. Epub 2021 Aug 4.
Reference Type
DERIVED
Bue-Valleskey J, Klaff L, Cho JI, Dellva MA, Schloot NC, Tobian J, Miura J, Dahl D. Long-Term Efficacy and Safety of Ultra Rapid Lispro (URLi) in Adults with Type 1 Diabetes: The PRONTO-T1D Extension. Diabetes Ther. 2021 Feb;12(2):569-580. doi: 10.1007/s13300-020-00987-8. Epub 2021 Jan 17.
Reference Type
DERIVED
Miura J, Imori M, Nishiyama H, Imaoka T. Ultra-Rapid Lispro Efficacy and Safety Compared to Humalog(R) in Japanese Patients with Type 1 Diabetes: PRONTO-T1D Subpopulation Analysis. Diabetes Ther. 2020 Sep;11(9):2089-2104. doi: 10.1007/s13300-020-00892-0. Epub 2020 Jul 29.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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https://www.lillytrialguide.com/en-US/studies/type-1-diabetes/ITRM#?postal=
A Study of LY900014 in Participants With Type 1 Diabetes (PRONTO-T1D)
Other Identifiers
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I8B-MC-ITRM
Identifier Type: OTHER
Identifier Source: secondary_id
2015-005356-99
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16313
Identifier Type: -
Identifier Source: org_study_id
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