Clinical trial NCT03214380: A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 Diabetes
Official title: A Prospective, Randomized, Double-Blind Comparison of LY900014 to Insulin Lispro, Both in Combination With Insulin Glargine or Insulin Degludec in Adults With Type 2 Diabetes PRONTO-T2D
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2017-07-11
Enrollment: 933
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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.

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.

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26
timeFrame: Baseline, Week 26
Secondary outcomes:
measure: 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand
timeFrame: Week 26
measure: 2-hour PPG Excursion During MMTT Efficacy Estimand
timeFrame: Week 26
measure: Rate of Severe Hypoglycemia
timeFrame: Baseline through Week 26
measure: Rate of Documented Symptomatic Hypoglycemia
timeFrame: Baseline through Week 26
measure: Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in Insulin Dose at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) Regimen Inconvenience Domain Score at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in ITSQ Lifestyle Flexibility Domain Score at Week 26
timeFrame: Baseline, Week 26
measure: Number of Participants With HbA1c <7%
timeFrame: Week 26
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Valley Research
state: California
city: La Mesa
country: United States
facility: Diabetes and Endocrine Associates
state: California
city: Lancaster
country: United States
facility: First Valley Medical Group
state: California
city: Los Angeles
country: United States
facility: National Research Institute
state: California
city: Santa Clarita
country: United States
facility: Care Access Research
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Tustin
country: United States
facility: University Clinical Investigators, Inc.
state: California
city: Cooper City
country: United States
facility: ALL Medical Research, LLC
state: Florida
city: Fort Lauderdale
country: United States
facility: The Center For Diabetes & Endocrine Care
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute For Research
state: Florida
city: New Port Richey
country: United States
facility: Sun Coast Clinical Research, Inc
state: Florida
city: Honolulu
country: United States
facility: East West Medical Institute
state: Hawaii
city: Blackfoot
country: United States
facility: Elite Clinical Trials LLLP
state: Idaho
city: Boise
country: United States
facility: Northwest Clinical Trials
state: Idaho
city: Idaho Falls
country: United States
facility: Rocky Mountain Diabetes and Osteoporosis Center
state: Idaho
city: Springfield
country: United States
facility: Prairie Education and Research Cooperative
state: Illinois
city: West Des Moines
country: United States
facility: Iderc, P.L.C.
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Kansas City
country: United States
facility: Cotton O'Neil Diabetes and Endocrinology Center
state: Kansas
city: Las Vegas
country: United States
facility: Palm Research Center
state: Nevada
city: Las Vegas
country: United States
facility: Palm Research Center
state: Nevada
city: New York
country: United States
facility: Manhattan Medical Research
state: New York
city: Columbus
country: United States
facility: Aventiv Research
state: Ohio
city: Beaver
country: United States
facility: Heritage Valley Medical Group, Inc.
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Partners in Nephrology & Endocrinology
state: Pennsylvania
city: Austin
country: United States
facility: Texas Diabetes and Endocrinology
state: Texas
city: Austin
country: United States
facility: Texas Diabetes and Endocrinology-Austin South
state: Texas
city: Dallas
country: United States
facility: Dallas Diabetes Endocrine Center
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research
state: Texas
city: Bountiful
country: United States
facility: Progressive Clinical Research
state: Utah
city: Federal Way
country: United States
facility: Private: Dr. Larry Stonesifer
state: Washington
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
city: Caba
country: Argentina
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Buenos Aires
city: Caba
country: Argentina
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state: Buenos Aires
city: Caba
country: Argentina
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state: Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
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state: Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
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state: Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
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state: Buenos Aires
city: Mar del Plata
country: Argentina
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state: Buenos Aires
city: Keswick
country: Australia
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state: South Australia
city: Oaklands Park
country: Australia
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state: South Australia
city: Box Hill
country: Australia
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state: Victoria
city: Geelong
country: Australia
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state: Victoria
city: Fremantle
country: Australia
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state: Western Australia
city: Krnov
country: Czechia
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city: Pardubice
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city: Praha
country: Czechia
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city: Bad Mergentheim
country: Germany
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state: Baden-Württemberg
city: Falkensee
country: Germany
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state: Brandenburg
city: Pohlheim
country: Germany
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state: Hessen
city: Münster
country: Germany
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state: Nordrhein-Westfalen
city: Mayen
country: Germany
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state: Rheinland-Pfalz
city: Saint Ingbert-Oberwürzbach
country: Germany
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state: Saarland
city: Magdeburg
country: Germany
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state: Sachsen-Anhalt
city: Oldenburg
country: Germany
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state: Schleswig-Holstein
city: Hamburg
country: Germany
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city: Budapest
country: Hungary
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city: Budapest
country: Hungary
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city: Budapest
country: Hungary
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city: Nagykanizsa
country: Hungary
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city: Ahmedabad
country: India
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state: Gujarat
city: Ahmedabad
country: India
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state: Gujarat
city: Ahmedabad
country: India
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state: Gujarat
city: Bangalore
country: India
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state: Karnataka
city: Bangalore
country: India
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state: Karnataka
city: Pune
country: India
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state: Maharashtra
city: Pune
country: India
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state: Maharashtra
city: Mumbai
country: India
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state: Maharshtra
city: Jaipur
country: India
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state: Rajasthan
city: Chennai
country: India
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state: Tamil Nadu
city: Hyderabad
country: India
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state: Telangana
city: Hyderabad
country: India
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state: Telangana
city: Palmero
country: Italy
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city: Sesto San Giovanni
country: Italy
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city: Chiba
country: Japan
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city: Fukuoka
country: Japan
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city: Fukuoka
country: Japan
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city: Hyōgo
country: Japan
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city: Kanagawa
country: Japan
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city: Kanagawa
country: Japan
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city: Kumamoto
country: Japan
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city: Miyazaki
country: Japan
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city: Naka
country: Japan
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city: Sapporo
country: Japan
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city: Sapporo
country: Japan
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city: Sasebo
country: Japan
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city: Sendai
country: Japan
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city: Tama
country: Japan
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city: Tokyo
country: Japan
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city: Tokyo
country: Japan
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city: Tokyo
country: Japan
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city: Tokyo
country: Japan
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city: Yamato
country: Japan
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city: Ōita
country: Japan
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city: Ōsaka
country: Japan
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city: Ōsaka
country: Japan
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city: Bucheon
country: Korea, Republic of
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state: Gyeonggi-do
city: Ansan-si
country: Korea, Republic of
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city: Daegu
country: Korea, Republic of
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Daejeon
country: Korea, Republic of
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Gangwon-do
country: Korea, Republic of
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Gangwon-do
country: Korea, Republic of
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Seoul
country: Korea, Republic of
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Seoul
country: Korea, Republic of
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Seoul
country: Korea, Republic of
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Seoul
country: Korea, Republic of
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Seoul
country: Korea, Republic of
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Seoul
country: Korea, Republic of
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Seoul
country: Korea, Republic of
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Seoul
country: Korea, Republic of
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Jalisco
country: Mexico
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Monterrey
country: Mexico
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Zapopan
country: Mexico
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Zapopan
country: Mexico
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Caguas
country: Puerto Rico
facility: Centro de Endocrinologia y Nutricion del Turabo
city: Manati
country: Puerto Rico
facility: Manati Center for Clinical Research Inc
city: Ponce
country: Puerto Rico
facility: Ponce School of Medicine CAIMED Center
city: Ponce
country: Puerto Rico
facility: Research and Cardiovascular Corp.
city: San Juan
country: Puerto Rico
facility: GCM Medical Group PSC
city: Arkhangel'sk
country: Russian Federation
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Kursk
country: Russian Federation
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Moscow
country: Russian Federation
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Moscow
country: Russian Federation
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Saint Petersburg
country: Russian Federation
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Saratov
country: Russian Federation
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Košice
country: Slovakia
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Slovak Republic
city: Malacky
country: Slovakia
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Nove Mesto nad Vahom
country: Slovakia
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Púchov
country: Slovakia
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Rožňava
country: Slovakia
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Lleida
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Málaga
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Sevilla
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Sevilla
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Taichung
country: Taiwan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Taipei
country: Taiwan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Taipei
country: Taiwan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Taipei
country: Taiwan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Yongkang
country: Taiwan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: 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
References:
citation: 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.
citation: 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.
citation: 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.