A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 Diabetes
NCT ID: NCT03214380
Last Updated: 2020-03-27
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
933 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-07-14
Study Completion Date
2019-03-13
Brief Summary
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The purpose of this study is to compare LY900014 to insulin lispro, both in combination with insulin glargine or insulin degludec, in participants with type 2 diabetes (T2D).
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Detailed Description
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Conditions
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Type 2 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) with each meal with either 100 U/mL (U-100) basal insulin glargine given SC once or twice daily or U-100 or 200 U/mL (U-200) 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
Metformin
Intervention Type
DRUG
Administered orally.
SGLT2 inhibitor
Intervention Type
DRUG
Administered orally.
Insulin Lispro (Humalog)
Insulin lispro given SC with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 insulin degludec given SC once daily. Prandial 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
Metformin
Intervention Type
DRUG
Administered orally.
SGLT2 inhibitor
Intervention Type
DRUG
Administered orally.
LY900014 Maximum Extended Enrollment (MEE)
LY900014 given subcutaneously (SC) with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 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
Metformin
Intervention Type
DRUG
Administered orally.
SGLT2 inhibitor
Intervention Type
DRUG
Administered orally.
Insulin Lispro (Humalog) MEE
Insulin lispro given SC with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 insulin degludec given SC once daily. Prandial 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
Metformin
Intervention Type
DRUG
Administered orally.
SGLT2 inhibitor
Intervention Type
DRUG
Administered orally.
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
Metformin
Administered orally.
Intervention Type
DRUG
SGLT2 inhibitor
Administered orally.
Intervention Type
DRUG
Other Intervention Names
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Ultra-Rapid Lispro
Humalog
Eligibility Criteria
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Inclusion Criteria
* Have been diagnosed (clinically) with T2D, based on the World Health Organization (WHO) classification for at least 1 year prior to screening.
* Have been treated for at least 90 days prior to screening with:
* Basal insulin (insulin glargine U-100 \[Basaglar/Abasaglar or LANTUS\] or U-300, insulin detemir, insulin degludec U-100 or U-200, or neutral protamine Hagedorn \[NPH\] insulin) in combination with at least 1 prandial injection of bolus insulin (insulin lispro U-100 or U-200, insulin aspart, insulin glulisine, or regular insulin) Or
* Premixed analog or human insulin regimens with any basal and bolus insulin combination injected at least twice daily
* Participants may be treated with up to 3 of the following oral antihyperglycemic medications (OAMs) in accordance with local regulations:
* Metformin
* Dipeptidyl peptidase-4 (DPP-4) inhibitor
* Sodium glucose cotransporter 2 (SGLT2) inhibitor
* Sulfonylurea
* Meglitinide
* Alpha-glucoside inhibitor
* Have an HbA1c value between ≥7.0 and ≤10.0%, according to the central laboratory at the time of screening.
* Have a body mass index (BMI) of ≤45.0 kilograms per meter squared at screening.
* Have been treated for at least 90 days prior to screening with:
* Basal insulin (insulin glargine U-100 \[Basaglar/Abasaglar or LANTUS\] or U-300, insulin detemir, insulin degludec U-100 or U-200, or neutral protamine Hagedorn \[NPH\] insulin) in combination with at least 1 prandial injection of bolus insulin (insulin lispro U-100 or U-200, insulin aspart, insulin glulisine, or regular insulin) Or
* Premixed analog or human insulin regimens with any basal and bolus insulin combination injected at least twice daily
* Participants may be treated with up to 3 of the following oral antihyperglycemic medications (OAMs) in accordance with local regulations:
* Metformin
* Dipeptidyl peptidase-4 (DPP-4) inhibitor
* Sodium glucose cotransporter 2 (SGLT2) inhibitor
* Sulfonylurea
* Meglitinide
* Alpha-glucoside inhibitor
* Have an HbA1c value between ≥7.0 and ≤10.0%, according to the central laboratory at the time of screening.
* Have a body mass index (BMI) of ≤45.0 kilograms per meter squared at screening.
Exclusion Criteria
* Have been diagnosed, at any time, with type 1 diabetes (T1D) or Latent Autoimmune Diabetes in Adults.
* Have hypoglycemia unawareness as judged by the investigator.
* Have had any episode of severe hypoglycemia within the 6 months prior to screening.
* Have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening.
* Have used thiazolidinediones, Glucagon-Like Peptide 1 (GLP-1) receptor agonist, or pramlintide within 90 days prior to screening.
* Have hypoglycemia unawareness as judged by the investigator.
* Have had any episode of severe hypoglycemia within the 6 months prior to screening.
* Have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening.
* Have used thiazolidinediones, Glucagon-Like Peptide 1 (GLP-1) receptor agonist, or pramlintide within 90 days prior to screening.
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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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
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Valley Research
Fresno, California, United States
Site Status
Diabetes and Endocrine Associates
La Mesa, California, United States
Site Status
First Valley Medical Group
Lancaster, California, United States
Site Status
National Research Institute
Los Angeles, California, United States
Site Status
Care Access Research
Santa Clarita, California, United States
Site Status
Encompass Clinical Research
Spring Valley, California, United States
Site Status
University Clinical Investigators, Inc.
Tustin, California, United States
Site Status
ALL Medical Research, LLC
Cooper City, Florida, 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
East West Medical Institute
Honolulu, Hawaii, United States
Site Status
Elite Clinical Trials LLLP
Blackfoot, Idaho, 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
Kansas City, Kansas, United States
Site Status
Palm Research Center
Las Vegas, Nevada, United States
Site Status
Palm Research Center
Las Vegas, Nevada, United States
Site Status
Manhattan Medical Research
New York, New York, United States
Site Status
Aventiv Research
Columbus, Ohio, United States
Site Status
Heritage Valley Medical Group, Inc.
Beaver, Pennsylvania, United States
Site Status
Partners in Nephrology & Endocrinology
Pittsburgh, Pennsylvania, United States
Site Status
Texas Diabetes and Endocrinology
Austin, Texas, United States
Site Status
Texas Diabetes and Endocrinology-Austin South
Austin, Texas, United States
Site Status
Dallas Diabetes Endocrine Center
Dallas, 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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CABA, Buenos Aires, Argentina
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CABA, Buenos Aires, Argentina
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CABA, Buenos Aires, Argentina
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Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
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Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
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Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Keswick, South Australia, Australia
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Oaklands Park, South Australia, Australia
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Box Hill, Victoria, Australia
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Geelong, Victoria, Australia
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Fremantle, Western Australia, Australia
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Krnov, , Czechia
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Pardubice, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Bad Mergentheim, Baden-Wurttemberg, Germany
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Falkensee, Brandenburg, Germany
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Pohlheim, Hesse, Germany
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Münster, North Rhine-Westphalia, Germany
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Mayen, Rhineland-Palatinate, Germany
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Saint Ingbert-Oberwürzbach, Saarland, Germany
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Magdeburg, Saxony-Anhalt, Germany
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Oldenburg in Holstein, Schleswig-Holstein, Germany
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Hamburg, , Germany
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Nagykanizsa, , Hungary
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Ahmedabad, Gujarat, India
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Ahmedabad, Gujarat, India
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Ahmedabad, Gujarat, India
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Bangalore, Karnataka, India
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Bangalore, Karnataka, India
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Pune, Maharashtra, India
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Pune, Maharashtra, India
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Mumbai, Maharshtra, India
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Jaipur, Rajasthan, India
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Chennai, Tamil Nadu, India
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Hyderabad, Telangana, India
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Hyderabad, Telangana, India
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Palmero, , Italy
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Sesto San Giovanni, , Italy
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Chiba, , Japan
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Fukuoka, , Japan
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Fukuoka, , Japan
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Hyōgo, , Japan
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Kanagawa, , 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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Sendai, , Japan
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Tama, , 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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Yamato, , Japan
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Jalisco, , Mexico
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Monterrey, , Mexico
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Zapopan, , Mexico
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Zapopan, , Mexico
Site Status
Centro de Endocrinologia y Nutricion del Turabo
Caguas, , Puerto Rico
Site Status
Manati Center for Clinical Research Inc
Manatí, , Puerto Rico
Site Status
Ponce School of Medicine CAIMED Center
Ponce, , Puerto Rico
Site Status
Research and Cardiovascular Corp.
Ponce, , Puerto Rico
Site Status
GCM Medical Group PSC
San Juan, , Puerto Rico
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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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Saint Petersburg, , Russia
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Saratov, , Russia
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Košice, Slovak Republic, Slovakia
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Malacky, , Slovakia
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Nové Mesto nad Váhom, , Slovakia
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Púchov, , Slovakia
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Rožňava, , Slovakia
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Bucheon-si, Gyeonggi-do, South Korea
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Ansan-si, , South Korea
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Daegu, , South Korea
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Daejeon, , South Korea
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Gangwon-do, , South Korea
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Gangwon-do, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Lleida, , Spain
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Málaga, , Spain
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Seville, , Spain
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Seville, , Spain
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Yongkang District, , Taiwan
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Countries
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United States
Argentina
Australia
Czechia
Germany
Hungary
India
Italy
Japan
Mexico
Puerto Rico
Russia
Slovakia
South Korea
Spain
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
Zhang Q, Chigutsa F, Chang AM. Efficacy and Safety of Ultra-Rapid Lispro in Younger and Older Patients with Type 2 Diabetes: Randomized Double-Blind PRONTO-T2D Study. Diabetes Ther. 2022 Aug;13(8):1547-1557. doi: 10.1007/s13300-022-01290-4. Epub 2022 Jul 4.
Reference Type
DERIVED
Jinnouchi H, Imori M, Nishiyama H, Imaoka T. Ultra-Rapid Lispro Efficacy and Safety Compared to Humalog(R) in Japanese Patients With Type 2 Diabetes: PRONTO-T2D Subpopulation Analysis. Diabetes Ther. 2020 Sep;11(9):2075-2088. doi: 10.1007/s13300-020-00890-2. Epub 2020 Jul 29.
Reference Type
DERIVED
Blevins T, Zhang Q, Frias JP, Jinnouchi H, Chang AM; PRONTO-T2D Investigators. Randomized Double-Blind Clinical Trial Comparing Ultra Rapid Lispro With Lispro in a Basal-Bolus Regimen in Patients With Type 2 Diabetes: PRONTO-T2D. Diabetes Care. 2020 Dec;43(12):2991-2998. doi: 10.2337/dc19-2550. Epub 2020 Jul 2.
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-2-diabetes/ITRN#?postal=
A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 Diabetes (PRONTO-T2D)
Other Identifiers
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I8B-MC-ITRN
Identifier Type: OTHER
Identifier Source: secondary_id
2015-005357-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16314
Identifier Type: -
Identifier Source: org_study_id
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