Type 2 Diabetes MellitusPhase 3PRONTO-T2DNCT03214380
A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 Diabetes
A Phase 3 study testing LY900014, Insulin Lispro and Insulin Glargine in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 141 sites in 16 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- LY900014, Insulin Lispro and Insulin Glargine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 933 participants
- Where
- 141 sitesin 16 countries
- Study dates
- 14 Jul 2017to 13 Mar 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 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
Show all 13Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
141 sites in 16 countries.
141 sites in 16 countries
United States32 sites
Texas Diabetes and Endocrinology
Austin, Texas, 78731-4309
Texas Diabetes and Endocrinology-Austin South
Austin, Texas, 78749
Heritage Valley Medical Group, Inc.
Beaver, Pennsylvania, 15009
Elite Clinical Trials LLLP
Blackfoot, Idaho, 83221
Northwest Clinical Trials
Boise, Idaho, 83704
Progressive Clinical Research
Bountiful, Utah, 84010
Aventiv Research
Columbus, Ohio, 43213
ALL Medical Research, LLC
Cooper City, Florida, 33024
Dallas Diabetes Endocrine Center
Dallas, Texas, 75230
Private: Dr. Larry Stonesifer
Federal Way, Washington, 98003
The Center For Diabetes & Endocrine Care
Fort Lauderdale, Florida, 33312
Valley Research
Fresno, California, 93720
East West Medical Institute
Honolulu, Hawaii, 96814
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, 83404
East Coast Institute For Research
Jacksonville, Florida, 32216
University of Kansas Medical Center
Kansas City, Kansas, 66160
Cotton O'Neil Diabetes and Endocrinology Center
Kansas City, Kansas, 66606
Diabetes and Endocrine Associates
La Mesa, California, 91942
First Valley Medical Group
Lancaster, California, 93534
Palm Research Center
Las Vegas, Nevada, 89128
Palm Research Center
Las Vegas, Nevada, 89148
National Research Institute
Los Angeles, California, 90057
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
Care Access Research
Santa Clarita, California, 91321
Consano Clinical Research
Shavano Park, Texas, 78231
Encompass Clinical Research
Spring Valley, California, 91978
Prairie Education and Research Cooperative
Springfield, Illinois, 62711
University Clinical Investigators, Inc.
Tustin, California, 92780
Iderc, P.L.C.
West Des Moines, Iowa, 50265
Japan22 sites
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Chiba, 277-0825
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Fukuoka, 815-8555
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Fukuoka, 830-8543
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Hyōgo, 661-0002
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Kanagawa, 235-0045
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Kanagawa, 247-0056
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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, 530-0001
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Ōsaka, 534-0021
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Sapporo, 060-0001
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Sapporo, 060-0062
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Sasebo, 857-1195
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Sendai, 980-0021
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Tama, 206-0033
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Tokyo, 103-0027
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Tokyo, 1030002
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Tokyo, 143-0015
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Tokyo, 160 0022
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Yamato, 242-0004
South Korea14 sites
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Ansan-si, 15355
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Bucheon-si, Gyeonggi-do, 14647
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Daegu, 41931
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Daejeon, 35233
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Gangwon-do, 24289
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Gangwon-do, 26426
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Seoul, 01830
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Seoul, 02841
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Seoul, 03181
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Seoul, 05278
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Seoul, 06351
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Seoul, 06591
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Seoul, 07061
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Seoul, 08308
India12 sites
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Ahmedabad, Gujarat, 380015
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Ahmedabad, Gujarat, 380015
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Ahmedabad, Gujarat, 380016
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Bangalore, Karnataka, 560017
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Bangalore, Karnataka, 560054
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Chennai, Tamil Nadu, 600086
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Hyderabad, Telangana, 500012
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Hyderabad, Telangana, 500072
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Jaipur, Rajasthan, 302017
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Mumbai, Maharshtra, 400012
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Pune, Maharashtra, 411004
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Pune, Maharashtra, 411011
Germany9 sites
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Bad Mergentheim, Baden-Wurttemberg, 97980
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Falkensee, Brandenburg, 14612
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Hamburg, 22607
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Magdeburg, Saxony-Anhalt, 39120
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Mayen, Rhineland-Palatinate, 56727
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Münster, North Rhine-Westphalia, 48145
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Oldenburg in Holstein, Schleswig-Holstein, 23758
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Pohlheim, Hesse, 35415
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Saint Ingbert-Oberwürzbach, Saarland, 66386
Argentina7 sites
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CABA, Buenos Aires, 1425
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CABA, Buenos Aires, C1013AAB
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CABA, Buenos Aires, C1179AAB
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Ciudad Autonoma de Buenos Aire, Buenos Aires, 1408
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Ciudad Autonoma de Buenos Aire, Buenos Aires, C1056ABJ
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Ciudad Autonoma de Buenos Aire, Buenos Aires, C1204AAD
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Mar del Plata, Buenos Aires, B7600FZN
Russia6 sites
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Arkhangelsk, 163045
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Kursk, 305014
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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
Australia5 sites
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Box Hill, Victoria, 3128
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Fremantle, Western Australia, 6959
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Geelong, Victoria, 3220
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Keswick, South Australia, 5035
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Oaklands Park, South Australia, 5046
Czechia5 sites
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Krnov, 79401
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Pardubice, 53002
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Prague, 104 00
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Prague, 149 00
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Prague, 181 00
Puerto Rico5 sites
Centro de Endocrinologia y Nutricion del Turabo
Caguas, 00726
Manati Center for Clinical Research Inc
Manati, 00674
Ponce School of Medicine CAIMED Center
Ponce, 00716
Research and Cardiovascular Corp.
Ponce, 00717-1332
GCM Medical Group PSC
San Juan, 00917
Slovakia5 sites
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Košice, Slovak Republic, 04012
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Malacky, 90101
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Nové Mesto nad Váhom, 91501
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Púchov, 02001
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Rožňava, 048 01
Taiwan5 sites
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Taichung, 40201
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Taipei, 10507
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Taipei, 11031
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Taipei, 23148
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Yongkang District, 71004
Hungary4 sites
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Budapest, 1089
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Budapest, 1139
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Budapest, 1213
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Nagykanizsa, 8800
Mexico4 sites
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Jalisco, 44650
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Monterrey, 64460
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Zapopan, 45030
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Zapopan, 45116
Spain4 sites
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Lleida, 25198
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Málaga, 29006
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Seville, 41003
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Seville, 41010
Italy2 sites
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Palmero, 90127
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Sesto San Giovanni, 20099
About this study
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
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).
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- LY900014, Insulin Lispro, Insulin Glargine, Insulin Degludec, Metformin
- Medical subject headings
- Diabetes Mellitus, Type 2
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
MetforminDrug
Administered orally.
SGLT2 inhibitorDrug
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| LY900014 | Experimental | 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. Receives: Drug: LY900014; Drug: Insulin Glargine; Drug: Insulin Degludec; Drug: Metformin; Drug: SGLT2 inhibitor |
| Insulin Lispro (Humalog) | Active comparator | 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. Receives: Drug: Insulin Lispro; Drug: Insulin Glargine; Drug: Insulin Degludec; Drug: Metformin; Drug: SGLT2 inhibitor |
| LY900014 Maximum Extended Enrollment (MEE) | Experimental | 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. Receives: Drug: LY900014; Drug: Insulin Glargine; Drug: Insulin Degludec; Drug: Metformin; Drug: SGLT2 inhibitor |
| Insulin Lispro (Humalog) MEE | Active comparator | 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. Receives: Drug: Insulin Lispro; Drug: Insulin Glargine; Drug: Insulin Degludec; Drug: Metformin; Drug: SGLT2 inhibitor |
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
Change from baseline in HbA1c was performed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, 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 were available prior to permanent discontinuation of study drug.
Measured: Baseline, Week 26
Secondary outcomes (10)
1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand
1-hour PPG excursion during MMTT uses the analysis of covariance (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 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: Week 26
2-hour PPG Excursion During MMTT Efficacy Estimand
2-hour PPG excursion during MMTT uses 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 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: Week 26
Rate of Severe Hypoglycemia
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. 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 com with or without seizures, and may require parenteral therapy.
Measured: Baseline through Week 26
Rate of Documented Symptomatic Hypoglycemia
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
Change from baseline in 1,5-AG 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 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
Change from baseline in 10-point SMBG values 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
Change from baseline in insulin dose 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.
Change from baseline in ITSQ regimen inconvenience domain score 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.
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.
Change from baseline in ITSQ lifestyle flexibility domain score 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.
Measured: Baseline, Week 26
Number of Participants With HbA1c <7%
Number of participants with HbA1c <7% at Week 26.
Measured: Week 26
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 start14 Jul 2017
- Primary completion14 Aug 2018
- Study completion13 Mar 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 2 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
- 933 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
- NCT03214380
- Sponsor's protocol ID
- 16314
- Other IDs
- I8B-MC-ITRN, 2015-005357-12, 2015
- Acronym
- PRONTO-T2D
- Status last verified
- 15 Aug 2019
- First submitted
- 10 Jul 2017
- Last updated
- 27 Mar 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 38035641Zhang 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.
PubMed 35781789Jinnouchi 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.
PubMed 32728833Blevins 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.
PubMed 32616612
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 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, Both in Combination With Insulin Glargine or Insulin Degludec in Adults With Type 2 Diabetes PRONTO-T2D
- ClinicalTrials.gov ID
- NCT03214380
- Acronym / sponsor ID
- PRONTO-T2D / 16314
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 933 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2017 (actual)
- Primary completion
- 14 Aug 2018 (actual)
- Study completion
- 13 Mar 2019 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Posted 27 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LY900014 | Experimental | Drug: LY900014, Drug: Insulin Glargine, Drug: Insulin Degludec, Drug: Metformin, Drug: SGLT2 inhibitorLY900014 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. |
| Insulin Lispro (Humalog) | Active comparator | Drug: Insulin Lispro, Drug: Insulin Glargine, Drug: Insulin Degludec, Drug: Metformin, Drug: SGLT2 inhibitorInsulin 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. |
| LY900014 Maximum Extended Enrollment (MEE) | Experimental | Drug: LY900014, Drug: Insulin Glargine, Drug: Insulin Degludec, Drug: Metformin, Drug: SGLT2 inhibitorLY900014 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. |
| Insulin Lispro (Humalog) MEE | Active comparator | Drug: Insulin Lispro, Drug: Insulin Glargine, Drug: Insulin Degludec, Drug: Metformin, Drug: SGLT2 inhibitorInsulin 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- Participants may be treated with up to 3 of the following oral antihyperglycemic medications (OAMs) in accordance with local regulations:
- 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.
Key exclusion criteria (5 listed)
- 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.
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) |
| 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) |
| Insulin DegludecAdministered SC | Drug | Insulin Lispro (Humalog), Insulin Lispro (Humalog) MEE, LY900014, LY900014 Maximum Extended Enrollment (MEE) |
| MetforminAdministered orally. | Drug | Insulin Lispro (Humalog), Insulin Lispro (Humalog) MEE, LY900014, LY900014 Maximum Extended Enrollment (MEE) |
| SGLT2 inhibitorAdministered orally. | Drug | Insulin Lispro (Humalog), Insulin Lispro (Humalog) MEE, LY900014, LY900014 Maximum Extended Enrollment (MEE) |
Primary outcome
Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26
Time frame: Baseline, Week 26
Change from baseline in HbA1c was performed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, 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 were available prior to permanent discontinuation of study drug.
10 secondary outcomes
1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand
Time frame: Week 26
2-hour PPG Excursion During MMTT Efficacy Estimand
Time frame: Week 26
Rate of Severe Hypoglycemia
Time frame: Baseline through Week 26
Rate of Documented Symptomatic Hypoglycemia
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
Number of Participants With HbA1c <7%
Time frame: Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 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 35781789Zhang 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.
- Derived from this study: PubMed 32728833Jinnouchi 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.
- Derived from this study: PubMed 32616612Blevins 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.
- A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 Diabetes (PRONTO-T2D)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
141 sites in 16 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 2 Diabetes Mellitus, run by Eli Lilly and Company at 141 sites in 16 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 13 inclusion and 5 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 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 141 sites in United States, Japan, South Korea, India, Germany and 11 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 27 Mar 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 NCT03214380, 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 27 Mar 2020.