A Study of LY900014 in Participants With Type 1 Diabetes
PRONTO-T1D
A Prospective, Randomized, Double-Blind Comparison of LY900014 to Insulin Lispro With an Open-Label Postprandial LY900014 Treatment Group, in Combination With Insulin Glargine or Insulin Degludec, in Adults With Type 1 Diabetes PRONTO-T1D
3 other identifiers
interventional
1,392
19 countries
168
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2017
168 active sites
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
First Submitted
Initial submission to the registry
July 10, 2017
CompletedFirst Posted
Study publicly available on registry
July 11, 2017
CompletedStudy Start
First participant enrolled
July 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 6, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 22, 2019
CompletedResults Posted
Study results publicly available
May 1, 2020
CompletedMay 1, 2020
September 1, 2019
1.1 years
July 10, 2017
April 17, 2020
April 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with strata (pooled country, type of basal insulin, prandial insulin dosing plan, and HbA1c stratum) and treatment as fixed effects and baseline as a covariate. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.
Baseline, Week 26
Secondary Outcomes (11)
Change From Baseline in 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 26
Baseline, Week 26
Change From Baseline in 2-hour PPG Excursion During MMTT Efficacy Estimand at Week 26
Baseline, Week 26
Rate of Severe Hypoglycemia at Week 26
Baseline through Week 26
Rate of Documented Symptomatic Hypoglycemia at Week 26
Baseline through Week 26
Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26
Baseline, Week 26
- +6 more secondary outcomes
Study Arms (6)
LY900014
EXPERIMENTALLY900014 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.
Insulin Lispro (Humalog)
ACTIVE COMPARATORInsulin 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.
LY900014 Postmeal (Open Label)
EXPERIMENTALLY900014 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.
LY900014 - Maximum Extended Enrollment (MEE)
EXPERIMENTALLY900014 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.
Insulin Lispro (Humalog)-MEE
ACTIVE COMPARATORInsulin 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.
LY900014 Postmeal (Open Label)-MEE
EXPERIMENTALLY900014 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.
Interventions
Administered SC
Administered SC
Administered SC
Administered SC
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (172)
Internal Medicine Center LLC
Mobile, Alabama, 36608, United States
John Muir Physician Network Clinical Research Center
Concord, California, 94520, United States
AMCR Institute INC
Escondido, California, 92025, United States
Valley Endocrine, Fresno
Fresno, California, 93720, United States
Marin Endocrine Associates
Greenbrae, California, 94904, United States
Diabetes and Endocrine Associates
La Mesa, California, 91942, United States
University Clinical Investigators, Inc.
Tustin, California, 92780, United States
Coastal Metabolic Research Centre
Ventura, California, 93003, United States
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045, United States
The Center For Diabetes & Endocrine Care
Fort Lauderdale, Florida, 33312, United States
East Coast Institute For Research
Jacksonville, Florida, 32204, United States
Sun Coast Clinical Research, Inc
New Port Richey, Florida, 34652, United States
Metabolic Research Institute Inc.
West Palm Beach, Florida, 33401, United States
Atlanta Diabetes Associates
Atlanta, Georgia, 30318, United States
East Coast Institute For Research
Macon, Georgia, 31210, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, 30076, United States
East West Medical Institute
Honolulu, Hawaii, 96814, United States
Northwest Clinical Trials
Boise, Idaho, 83704, United States
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, 83404, United States
Prairie Education and Research Cooperative
Springfield, Illinois, 62711, United States
Iderc, P.L.C.
West Des Moines, Iowa, 50265, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Cotton O'Neil Diabetes and Endocrinology Center
Topeka, Kansas, 66606, United States
Kentucky Diabetes Endocrinology Center
Lexington, Kentucky, 40503, United States
MassResearch
Waltham, Massachusetts, 02453, United States
Palm Research Center
Las Vegas, Nevada, 89128, United States
Palm Research Center
Las Vegas, Nevada, 89148, United States
Southern New Hampshire Diabetes and Endocrinology
Nashua, New Hampshire, 03063, United States
Manhattan Medical Research
New York, New York, 10016, United States
Physicians East
Greenville, North Carolina, 27843, United States
Diabetes & Endocrinology Consultants PC
Morehead City, North Carolina, 28557, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401, United States
Your Diabetes Endocrine Nutrition Group PC
Mentor, Ohio, 44060, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
Partners in Nephrology & Endocrinology
Pittsburgh, Pennsylvania, 15224, United States
Sudir Bansal M.D. Inc.
Warwick, Rhode Island, 02886, United States
University Diabetes and Endocrine Consultants
Chattanooga, Tennessee, 37411, United States
Texas Diabetes and Endocrinology
Austin, Texas, 78731-4309, United States
Dallas Diabetes Endocrine Center
Dallas, Texas, 75230, United States
Texas Diabetes and Endocrinology, P.A.
Round Rock, Texas, 78681, United States
Consano Clinical Research
Shavano Park, Texas, 78231, United States
Progressive Clinical Research
Bountiful, Utah, 84010, United States
Private: Dr. Larry Stonesifer
Federal Way, Washington, 98003, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
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Buenos Aires, C1013AAB, Argentina
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Buenos Aires, C1056ABJ, Argentina
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Caba, C1179AAB, Argentina
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Caba, C1180AAX, Argentina
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Ciudad Autonoma de Buenos Aire, 1408, Argentina
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Ciudad Autonoma de Buenos Aire, C1128AAF, Argentina
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Córdoba, 5006, Argentina
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Mar del Plata, B7600FZN, Argentina
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Box Hill, 3128, Australia
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Geelong, 3220, Australia
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Merewether, 2291, Australia
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Oaklands Park, 5046, Australia
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Graz, 1060, Austria
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Graz, 8036, Austria
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Vienna, 1030, Austria
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São Paulo, 01244-030, Brazil
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Bad Mergentheim, 97980, Germany
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Falkensee, 14612, Germany
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Hamburg, 22607, Germany
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Hessen, 35415, Germany
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Magdeburg, 39112, Germany
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Mayen, 56727, Germany
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Münster, 48145, Germany
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Oldenburg, 23758, Germany
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Rheine, 67059, Germany
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Saterland, 66386, Germany
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Ampelokipoi, 11527, Greece
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Athens, 11527, Greece
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Athens, 17562, Greece
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Larissa, 41110, Greece
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Thermi, 57001, Greece
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Thessaloniki, 54642, Greece
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Thessaloniki, 54645, Greece
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Thessaloniki, 57010, Greece
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Ahmedabad, 380015, India
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Hyderabad, 500001, India
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Hyderabad, 500035, India
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Hyderabad, 500072, India
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Indore, 452002, India
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Pune, 411001, India
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Secunderabad, 500033, India
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Visakhapatnam, 530002, India
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Milan, 20132, Italy
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Ravenna, 48121, Italy
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Roma, 00161, Italy
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Siena, 53100, Italy
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Amagasaki, 661, Japan
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Fukuoka, 815-0071, Japan
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Fukuoka, 815-8555, Japan
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Kamakura, 247-0056, Japan
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Kanagawa, 235-0045, Japan
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Kumamoto, 862-0976, Japan
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Miyazaki, 880-0034, Japan
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Naka, 311-0113, Japan
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Ōita, 870-0039, Japan
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Ōsaka, 545-8586, Japan
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Ōsaka, 569-1096, Japan
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Sapporo, 060-0001, Japan
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Sapporo, 060-0062, Japan
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Sasebo, 857-1195, Japan
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Shinjuku, 162-8666, Japan
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Tokyo, 1030002, Japan
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Tokyo, 143-0015, Japan
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Tokyo, 160 0022, Japan
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Tokyo, 206-0033, Japan
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Guadalajara, 44650, Mexico
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Monterrey, 64460, Mexico
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Monterrey, 64710, Mexico
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Zapopan, 45116, Mexico
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Takapuna, Auckland, 0620, New Zealand
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Auckland, 2025, New Zealand
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Christchurch, 8011, New Zealand
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Wellington, 6021, New Zealand
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Gdansk, 80-546, Poland
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Krakow, 31-500, Poland
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Lodz, 90-132, Poland
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Lublin, 20-333, Poland
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Lublin, 20-538, Poland
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Ruda Śląska, 41-709, Poland
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Szczecin, 70-376, Poland
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Szczecin, 70-506, Poland
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Warsaw, 01-518, Poland
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Warsaw, 02-507, Poland
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Wroclaw, 50-403, Poland
Dr Altagracia Aurora Alcantara Gonzalez
Bayamón, 00956, Puerto Rico
Advanced Clinical Research, LLC
Bayamón, 00961, Puerto Rico
Manati Center for Clinical Research Inc
Manatí, 00674, Puerto Rico
Martha Gomez Cuellar M.D.
San Juan, 00921, Puerto Rico
Centro de Endocrinologia del Este
Yabucoa, 00767, Puerto Rico
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Bacau, 600164, Romania
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Brasov, 500283, Romania
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Bucharest, 013682, Romania
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Lasi, 700547, Romania
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Oradea, 410025, Romania
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Ploieşti, 100163, Romania
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Ploieşti, 100342, Romania
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Satu Mare, 440055, Romania
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Târgu Mureş, 540098, Romania
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Timișoara, 300456, Romania
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Arkhangelsk, 163045, Russia
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Kursk, 305014, Russia
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Moscow, 117036, Russia
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Moscow, 119435, Russia
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Moscow, 123182, Russia
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Saint Petersburg, 195257, Russia
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Saratov, 410053, Russia
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Košice, 04012, Slovakia
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Malacky, 90101, Slovakia
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Nové Mesto nad Váhom, 91501, Slovakia
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Rožňava, 048 01, Slovakia
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Sabadell, Barcelona, 08208, Spain
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Alzira, Valencia, 46600, Spain
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Málaga, 29006, Spain
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Seville, 41003, Spain
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Seville, 41010, Spain
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Seville, 41071, Spain
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Teruel, 44002, Spain
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Gothenburg, 41345, Sweden
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Linköping, 581 85, Sweden
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Lund, 22185, Sweden
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Stockholm, 14186, Sweden
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Chang-hua, 500, Taiwan
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Taichung, 40201, Taiwan
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Taichung, 40447, Taiwan
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Tainan, 704, Taiwan
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Taipei, 10507, Taiwan
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Yongkang District, 71004, Taiwan
Related Publications (4)
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.
PMID: 38035641DERIVEDMiura 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.
PMID: 34347267DERIVEDBue-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.
PMID: 33458803DERIVEDMiura 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.
PMID: 32728832DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2017
First Posted
July 11, 2017
Study Start
July 17, 2017
Primary Completion
September 6, 2018
Study Completion
August 22, 2019
Last Updated
May 1, 2020
Results First Posted
May 1, 2020
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.