Type 1 Diabetes MellitusPhase 3PRONTO-T1DNCT03214367
A Study of LY900014 in Participants With Type 1 Diabetes
A Phase 3 study testing LY900014, Insulin Lispro and Insulin Glargine in people with Type 1 Diabetes Mellitus, run by Eli Lilly and Company at 172 sites in 20 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- LY900014, Insulin Lispro and Insulin Glargine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,392 participants
- Where
- 172 sitesin 20 countries
- Study dates
- 17 Jul 2017to 22 Aug 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
172 sites in 20 countries.
172 sites in 20 countries
United States44 sites
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045
Texas Diabetes and Endocrinology
Austin, Texas, 78731-4309
Northwest Clinical Trials
Boise, Idaho, 83704
Progressive Clinical Research
Bountiful, Utah, 84010
University Diabetes and Endocrine Consultants
Chattanooga, Tennessee, 37411
John Muir Physician Network Clinical Research Center
Concord, California, 94520
Dallas Diabetes Endocrine Center
Dallas, Texas, 75230
AMCR Institute INC
Escondido, California, 92025
Private: Dr. Larry Stonesifer
Federal Way, Washington, 98003
The Center For Diabetes & Endocrine Care
Fort Lauderdale, Florida, 33312
Valley Endocrine, Fresno
Fresno, California, 93720
Marin Endocrine Associates
Greenbrae, California, 94904
Physicians East
Greenville, North Carolina, 27843
East West Medical Institute
Honolulu, Hawaii, 96814
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, 83404
East Coast Institute For Research
Jacksonville, Florida, 32204
University of Kansas Medical Center
Kansas City, Kansas, 66160
Diabetes and Endocrine Associates
La Mesa, California, 91942
Palm Research Center
Las Vegas, Nevada, 89128
Palm Research Center
Las Vegas, Nevada, 89148
Kentucky Diabetes Endocrinology Center
Lexington, Kentucky, 40503
East Coast Institute For Research
Macon, Georgia, 31210
Your Diabetes Endocrine Nutrition Group PC
Mentor, Ohio, 44060
Internal Medicine Center LLC
Mobile, Alabama, 36608
Diabetes & Endocrinology Consultants PC
Morehead City, North Carolina, 28557
Southern New Hampshire Diabetes and Endocrinology
Nashua, New Hampshire, 03063
Sun Coast Clinical Research, Inc
New Port Richey, Florida, 34652
Manhattan Medical Research
New York, New York, 10016
Partners in Nephrology & Endocrinology
Pittsburgh, Pennsylvania, 15224
Rainier Clinical Research Center
Renton, Washington, 98057
Endocrine Research Solutions, Inc.
Roswell, Georgia, 30076
Texas Diabetes and Endocrinology, P.A.
Round Rock, Texas, 78681
Consano Clinical Research
Shavano Park, Texas, 78231
Prairie Education and Research Cooperative
Springfield, Illinois, 62711
Cotton O'Neil Diabetes and Endocrinology Center
Topeka, Kansas, 66606
University Clinical Investigators, Inc.
Tustin, California, 92780
Coastal Metabolic Research Centre
Ventura, California, 93003
MassResearch
Waltham, Massachusetts, 02453
Sudir Bansal M.D. Inc.
Warwick, Rhode Island, 02886
Iderc, P.L.C.
West Des Moines, Iowa, 50265
Metabolic Research Institute Inc.
West Palm Beach, Florida, 33401
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401
Japan19 sites
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Amagasaki, 661
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Fukuoka, 815-0071
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Fukuoka, 815-8555
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Kamakura, 247-0056
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Kanagawa, 235-0045
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Kumamoto, 862-0976
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Miyazaki, 880-0034
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Naka, 311-0113
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Ōita, 870-0039
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Ōsaka, 569-1096
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Sapporo, 060-0001
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Sasebo, 857-1195
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Tokyo, 1030002
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Tokyo, 143-0015
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Tokyo, 160 0022
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Tokyo, 206-0033
Poland11 sites
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Gdansk, 80-546
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Krakow, 31-500
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Lodz, 90-132
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Lublin, 20-333
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Lublin, 20-538
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Ruda Śląska, 41-709
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Szczecin, 70-376
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Szczecin, 70-506
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Warsaw, 01-518
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Warsaw, 02-507
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Wroclaw, 50-403
Germany10 sites
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Bad Mergentheim, 97980
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Falkensee, 14612
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Hamburg, 22607
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Hessen, 35415
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Magdeburg, 39112
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Mayen, 56727
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Münster, 48145
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Oldenburg, 23758
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Rheine, 67059
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Saterland, 66386
Romania10 sites
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Bacau, 600164
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Brasov, 500283
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Bucharest, 013682
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Lasi, 700547
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Oradea, 410025
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Ploieşti, 100163
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Ploieşti, 100342
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Satu Mare, 440055
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Târgu Mureş, 540098
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Timișoara, 300456
Argentina9 sites
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Buenos Aires, C1013AAB
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Buenos Aires, C1056ABJ
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Caba, C1179AAB
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Caba, C1180AAX
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Ciudad Autonoma de Buenos Aire, 1408
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Ciudad Autonoma de Buenos Aire, C1128AAF
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Córdoba, 5000
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Córdoba, 5006
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Mar del Plata, B7600FZN
Greece8 sites
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Ampelokipoi, 11527
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Athens, 11527
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Athens, 17562
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Larissa, 41110
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Thermi, 57001
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Thessaloniki, 54642
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Thessaloniki, 54645
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Thessaloniki, 57010
India8 sites
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Ahmedabad, 380015
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Hyderabad, 500001
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Hyderabad, 500035
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Hyderabad, 500072
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Indore, 452002
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Pune, 411001
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Secunderabad, 500033
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Visakhapatnam, 530002
Russia7 sites
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Arkhangelsk, 163045
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Kursk, 305014
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Moscow, 117036
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Moscow, 119435
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Moscow, 123182
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Saint Petersburg, 195257
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Saratov, 410053
Spain7 sites
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Alzira, Valencia, 46600
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Málaga, 29006
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Sabadell, Barcelona, 08208
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Seville, 41003
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Seville, 41010
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Seville, 41071
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Teruel, 44002
Taiwan6 sites
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Chang-hua, 500
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Taichung, 40201
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Taichung, 40447
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Tainan, 704
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Taipei, 10507
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Yongkang District, 71004
Puerto Rico5 sites
Dr Altagracia Aurora Alcantara Gonzalez
Bayamón, 00956
Advanced Clinical Research, LLC
Bayamón, 00961
Manati Center for Clinical Research Inc
Manati, 00674
Martha Gomez Cuellar M.D.
San Juan, 00921
Centro de Endocrinologia del Este
Yabucoa, 00767
Australia4 sites
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Box Hill, 3128
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Geelong, 3220
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Merewether, 2291
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Oaklands Park, 5046
Italy4 sites
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Milan, 20132
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Ravenna, 48121
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Roma, 00161
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Siena, 53100
Mexico4 sites
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Guadalajara, 44650
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Monterrey, 64460
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Monterrey, 64710
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Zapopan, 45116
New Zealand4 sites
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Auckland, 2025
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Christchurch, 8011
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Takapuna, Auckland, 0620
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Wellington, 6021
Slovakia4 sites
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Košice, 04012
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Malacky, 90101
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Nové Mesto nad Váhom, 91501
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Rožňava, 048 01
Sweden4 sites
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Gothenburg, 41345
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Linköping, 581 85
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Lund, 22185
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Stockholm, 14186
Austria3 sites
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Graz, 1060
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Graz, 8036
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Vienna, 1030
Brazil1 site
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São Paulo, 01244-030
About this study
Official title: 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
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).
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- LY900014, Insulin Lispro, Insulin Glargine, Insulin Degludec
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY900014Drug
Also called Ultra-Rapid Lispro
Administered SC
Insulin LisproDrug
Also called Humalog
Administered SC
Insulin GlargineDrug
Administered SC
Insulin DegludecDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| LY900014 | Experimental | 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. Receives: Drug: LY900014; Drug: Insulin Glargine; Drug: Insulin Degludec |
| Insulin Lispro (Humalog) | Active comparator | 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. Receives: Drug: Insulin Lispro; Drug: Insulin Glargine; Drug: Insulin Degludec |
| LY900014 Postmeal (Open Label) | Experimental | 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. Receives: Drug: LY900014; Drug: Insulin Glargine; Drug: Insulin Degludec |
| LY900014 - Maximum Extended Enrollment (MEE) | Experimental | 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. Receives: Drug: LY900014; Drug: Insulin Glargine; Drug: Insulin Degludec |
| Insulin Lispro (Humalog)-MEE | Active comparator | 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. Receives: Drug: Insulin Lispro; Drug: Insulin Glargine; Drug: Insulin Degludec |
| LY900014 Postmeal (Open Label)-MEE | Experimental | 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. Receives: Drug: LY900014; Drug: Insulin Glargine; Drug: Insulin Degludec |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 1-hour timepoint after the start of meal minus fasting serum glucose. 1-hour PPG excursion during MMTT uses the ANCOVA 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.
Measured: Baseline, Week 26
Change From Baseline in 2-hour PPG Excursion During MMTT Efficacy Estimand at Week 26
A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 2-hour timepoint after the start of meal minus fasting serum glucose. 2-hour PPG excursion during MMTT uses the ANCOVA 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.
Measured: Baseline, Week 26
Rate of Severe Hypoglycemia at Week 26
Severe hypoglycemia is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. During these episodes, the participant has an altered mental status and cannot assist in his or her own care, or may be semiconscious or unconscious, or experience coma with or without seizures, and may require parenteral therapy. Rate of severe hypoglycemia events per 100 years during a defined period was calculated by total number of severe hypoglycemia episodes within the period divided by the cumulative days on treatment from all participants within a treatment group *36525.
Measured: Baseline through Week 26
Rate of Documented Symptomatic Hypoglycemia at Week 26
Documented symptomatic hypoglycemia is an event during which typical symptoms of hypoglycemia are accompanied by blood glucose (BG) of <54 mg/dL [3.0 millimole per liter (mmol/L)]. The rate of documented symptomatic hypoglycemia was estimated by negative binomial model: number of episodes = treatment with log (treatment exposure in days/365.25) as an offset variable.
Measured: Baseline through Week 26
Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26
1,5-anhydroglucitol (1,5-AG) is a marker of short-term glycemic control especially postprandial hyperglycemia. 1,5-AG accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. LS Mean was calculated using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The analysis included data collected prior to permanent discontinuation of study drug.
Measured: Baseline, Week 26
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 26
SMBG 10-point profiles were measured at fasting, 1-hour post morning meal, 2-hours post morning meal, pre midday meal, 1-hour post midday meal, 2-hours post midday meal, pre evening meal, 1-hour post evening meal, 2-hours post evening meal, and bedtime. LS Mean was analyzed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The efficacy estimand included participant data when baseline and at least one post-baseline measurement prior to permanent discontinuation of study drug.
Measured: Baseline, Week 26
Change From Baseline in Insulin Dose at Week 26
LS Mean was analyzed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The analysis included data prior to permanent discontinuation of study drug.
Measured: Baseline, Week 26
Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) Regimen Inconvenience Domain Score at Week 26
ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction. LS Mean was calculated using the ANCOVA model with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum), and treatment as fixed effects and baseline as covariate. The analysis included data prior to permanent discontinuation of study drug. The analysis included data prior to permanent discontinuation of study drug.
Measured: Baseline, Week 26
Change From Baseline in ITSQ Lifestyle Flexibility Domain Score at Week 26
ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction. LS Mean was calculated using the analysis of covariance (ANCOVA) with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum), and treatment as fixed effects and baseline as covariate. The analysis included data prior to permanent discontinuation of study drug. The analysis included data prior to permanent discontinuation of study drug.
Measured: Baseline, Week 26
Percentage of Participants With HbA1c <7%
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Measured: Week 26
Change From Baseline in HbA1c at Week 52
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 MMRM model with variables of baseline, pooled country, type of basal insulin during lead-in, prandial Insulin Dosing Plan, treatment (Type III sum of squares) as fixed factors. The analysis included data prior to permanent discontinuation of study drug.
Measured: Baseline, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start17 Jul 2017
- Primary completion6 Sep 2018
- Study completion22 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214367
- Sponsor's protocol ID
- 16313
- Other IDs
- I8B-MC-ITRM, 2015-005356-99, 2015
- Acronym
- PRONTO-T1D
- Status last verified
- Sep 2019
- First submitted
- 10 Jul 2017
- Last updated
- 1 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 38035641Miura 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.
PubMed 34347267Bue-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.
PubMed 33458803Miura 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.
PubMed 32728832
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03214367
- Acronym / sponsor ID
- PRONTO-T1D / 16313
- Conditions
- Type 1 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,392 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2017 (actual)
- Primary completion
- 6 Sep 2018 (actual)
- Study completion
- 22 Aug 2019 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Posted 1 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| LY900014 | Experimental | Drug: LY900014, Drug: Insulin Glargine, Drug: Insulin DegludecLY900014 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 comparator | Drug: Insulin Lispro, Drug: Insulin Glargine, Drug: Insulin DegludecInsulin 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) | Experimental | Drug: LY900014, Drug: Insulin Glargine, Drug: Insulin DegludecLY900014 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) | Experimental | Drug: LY900014, Drug: Insulin Glargine, Drug: Insulin DegludecLY900014 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 comparator | Drug: Insulin Lispro, Drug: Insulin Glargine, Drug: Insulin DegludecInsulin 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 | Experimental | Drug: LY900014, Drug: Insulin Glargine, Drug: Insulin DegludecLY900014 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY900014Also: Ultra-Rapid LisproAdministered SC | Drug | LY900014, LY900014 - Maximum Extended Enrollment (MEE), LY900014 Postmeal (Open Label), LY900014 Postmeal (Open Label)-MEE |
| Insulin LisproAlso: HumalogAdministered SC | Drug | Insulin Lispro (Humalog), Insulin Lispro (Humalog)-MEE |
| Insulin GlargineAdministered SC | Drug | Insulin Lispro (Humalog), Insulin Lispro (Humalog)-MEE, LY900014, LY900014 - Maximum Extended Enrollment (MEE), LY900014 Postmeal (Open Label), LY900014 Postmeal (Open Label)-MEE |
| Insulin DegludecAdministered SC | Drug | Insulin Lispro (Humalog), Insulin Lispro (Humalog)-MEE, LY900014, LY900014 - Maximum Extended Enrollment (MEE), LY900014 Postmeal (Open Label), LY900014 Postmeal (Open Label)-MEE |
Primary outcome
Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26
Time frame: Baseline, 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.
11 secondary outcomes
Change From Baseline in 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 26
Time frame: Baseline, Week 26
Change From Baseline in 2-hour PPG Excursion During MMTT Efficacy Estimand at Week 26
Time frame: Baseline, Week 26
Rate of Severe Hypoglycemia at Week 26
Time frame: Baseline through Week 26
Rate of Documented Symptomatic Hypoglycemia at Week 26
Time frame: Baseline through Week 26
Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26
Time frame: Baseline, Week 26
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 26
Time frame: Baseline, Week 26
Change From Baseline in Insulin Dose at Week 26
Time frame: Baseline, Week 26
Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) Regimen Inconvenience Domain Score at Week 26
Time frame: Baseline, Week 26
Change From Baseline in ITSQ Lifestyle Flexibility Domain Score at Week 26
Time frame: Baseline, Week 26
Percentage of Participants With HbA1c <7%
Time frame: Week 26
Change From Baseline in HbA1c at Week 52
Time frame: Baseline, Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38035641Piras 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.
- Derived from this study: PubMed 34347267Miura 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.
- Derived from this study: PubMed 33458803Bue-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.
- Derived from this study: PubMed 32728832Miura 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.
- A Study of LY900014 in Participants With Type 1 Diabetes (PRONTO-T1D)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
172 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LY900014, Insulin Lispro and Insulin Glargine in people with Type 1 Diabetes Mellitus, run by Eli Lilly and Company at 172 sites in 20 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 172 sites in United States, Japan, Poland, Germany, Romania and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26 (time frame: Baseline, Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03214367, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2020.