A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 Diabetes

NCT03214380 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: 16314I8B-MC-ITRN2015-005357-12
• Study Type: interventional
• Target: 933
• Locations: 16 countries
• Sites: 141

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).

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 26

Secondary Outcomes (10)

• 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand

  Week 26

• 2-hour PPG Excursion During MMTT Efficacy Estimand

  Week 26

• Rate of Severe Hypoglycemia

  Baseline through Week 26

• Rate of Documented Symptomatic Hypoglycemia

  Baseline through Week 26

• Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26

  Baseline, Week 26

Study Arms (4)

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.

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.

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.

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.

Drug: Insulin Lispro; Drug: Insulin Glargine; Drug: Insulin Degludec; Drug: Metformin; Drug: SGLT2 inhibitor

Interventions

LY900014 DRUG

Administered SC

Also known as: Ultra-Rapid Lispro

LY900014; LY900014 Maximum Extended Enrollment (MEE)

Insulin Lispro DRUG

Administered SC

Also known as: Humalog

Insulin Lispro (Humalog); Insulin Lispro (Humalog) MEE

Insulin Glargine DRUG

Administered SC

Insulin Lispro (Humalog); Insulin Lispro (Humalog) MEE; LY900014; LY900014 Maximum Extended Enrollment (MEE)

Insulin Degludec DRUG

Administered SC

Insulin Lispro (Humalog); Insulin Lispro (Humalog) MEE; LY900014; LY900014 Maximum Extended Enrollment (MEE)

Metformin DRUG

Administered orally.

Insulin Lispro (Humalog); Insulin Lispro (Humalog) MEE; LY900014; LY900014 Maximum Extended Enrollment (MEE)

SGLT2 inhibitor DRUG

Administered orally.

Insulin Lispro (Humalog); Insulin Lispro (Humalog) MEE; LY900014; LY900014 Maximum Extended Enrollment (MEE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (141)

Valley Research

Fresno, California, 93720, United States

Location

Diabetes and Endocrine Associates

La Mesa, California, 91942, United States

Location

First Valley Medical Group

Lancaster, California, 93534, United States

Location

National Research Institute

Los Angeles, California, 90057, United States

Location

Care Access Research

Santa Clarita, California, 91321, United States

Location

Encompass Clinical Research

Spring Valley, California, 91978, United States

Location

University Clinical Investigators, Inc.

Tustin, California, 92780, United States

Location

ALL Medical Research, LLC

Cooper City, Florida, 33024, United States

Location

The Center For Diabetes & Endocrine Care

Fort Lauderdale, Florida, 33312, United States

Location

East Coast Institute For Research

Jacksonville, Florida, 32216, United States

Location

Sun Coast Clinical Research, Inc

New Port Richey, Florida, 34652, United States

Location

East West Medical Institute

Honolulu, Hawaii, 96814, United States

Location

Elite Clinical Trials LLLP

Blackfoot, Idaho, 83221, United States

Location

Northwest Clinical Trials

Boise, Idaho, 83704, United States

Location

Rocky Mountain Diabetes and Osteoporosis Center

Idaho Falls, Idaho, 83404, United States

Location

Prairie Education and Research Cooperative

Springfield, Illinois, 62711, United States

Location

Iderc, P.L.C.

West Des Moines, Iowa, 50265, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Cotton O'Neil Diabetes and Endocrinology Center

Kansas City, Kansas, 66606, United States

Location

Palm Research Center

Las Vegas, Nevada, 89128, United States

Location

Palm Research Center

Las Vegas, Nevada, 89148, United States

Location

Manhattan Medical Research

New York, New York, 10016, United States

Location

Aventiv Research

Columbus, Ohio, 43213, United States

Location

Heritage Valley Medical Group, Inc.

Beaver, Pennsylvania, 15009, United States

Location

Partners in Nephrology & Endocrinology

Pittsburgh, Pennsylvania, 15224, United States

Location

Texas Diabetes and Endocrinology

Austin, Texas, 78731-4309, United States

Location

Texas Diabetes and Endocrinology-Austin South

Austin, Texas, 78749, United States

Location

Dallas Diabetes Endocrine Center

Dallas, Texas, 75230, United States

Location

Consano Clinical Research

Shavano Park, Texas, 78231, United States

Location

Progressive Clinical Research

Bountiful, Utah, 84010, United States

Location

Private: Dr. Larry Stonesifer

Federal Way, Washington, 98003, United States

Location

Rainier Clinical Research Center

Renton, Washington, 98057, United States

Location

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CABA, Buenos Aires, 1425, Argentina

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CABA, Buenos Aires, C1013AAB, Argentina

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CABA, Buenos Aires, C1179AAB, Argentina

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Ciudad Autonoma de Buenos Aire, Buenos Aires, 1408, Argentina

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Ciudad Autonoma de Buenos Aire, Buenos Aires, C1056ABJ, Argentina

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Ciudad Autonoma de Buenos Aire, Buenos Aires, C1204AAD, Argentina

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Mar del Plata, Buenos Aires, B7600FZN, Argentina

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Keswick, South Australia, 5035, Australia

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Oaklands Park, South Australia, 5046, Australia

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Box Hill, Victoria, 3128, Australia

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Geelong, Victoria, 3220, Australia

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Fremantle, Western Australia, 6959, Australia

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Krnov, 79401, Czechia

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Pardubice, 53002, Czechia

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Prague, 104 00, Czechia

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Prague, 149 00, Czechia

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Prague, 181 00, Czechia

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Bad Mergentheim, Baden-Wurttemberg, 97980, Germany

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Falkensee, Brandenburg, 14612, Germany

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Pohlheim, Hesse, 35415, Germany

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Münster, North Rhine-Westphalia, 48145, Germany

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Mayen, Rhineland-Palatinate, 56727, Germany

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Saint Ingbert-Oberwürzbach, Saarland, 66386, Germany

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Magdeburg, Saxony-Anhalt, 39120, Germany

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Oldenburg in Holstein, Schleswig-Holstein, 23758, Germany

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Hamburg, 22607, Germany

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Budapest, 1089, Hungary

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Budapest, 1139, Hungary

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Budapest, 1213, Hungary

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Nagykanizsa, 8800, Hungary

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Ahmedabad, Gujarat, 380015, India

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Ahmedabad, Gujarat, 380015, India

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Ahmedabad, Gujarat, 380016, India

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Bangalore, Karnataka, 560017, India

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Bangalore, Karnataka, 560054, India

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Pune, Maharashtra, 411004, India

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Pune, Maharashtra, 411011, India

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Mumbai, Maharshtra, 400012, India

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Chennai, Tamil Nadu, 600086, India

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Hyderabad, Telangana, 500012, India

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Palmero, 90127, Italy

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Sesto San Giovanni, 20099, Italy

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Chiba, 277-0825, Japan

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Fukuoka, 815-8555, Japan

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Fukuoka, 830-8543, Japan

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Hyōgo, 661-0002, Japan

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Kanagawa, 235-0045, Japan

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Kanagawa, 247-0056, Japan

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Kumamoto, 862-0976, Japan

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Miyazaki, 880-0034, Japan

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Naka, 311-0113, Japan

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Ōita, 870-0039, Japan

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Ōsaka, 530-0001, Japan

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Ōsaka, 534-0021, Japan

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Sapporo, 060-0001, Japan

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Sapporo, 060-0062, Japan

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Sasebo, 857-1195, Japan

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Sendai, 980-0021, Japan

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Tama, 206-0033, Japan

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Tokyo, 103-0027, Japan

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Tokyo, 1030002, Japan

Location

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Tokyo, 143-0015, Japan

Location

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Tokyo, 160 0022, Japan

Location

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Yamato, 242-0004, Japan

Location

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Jalisco, 44650, Mexico

Location

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Monterrey, 64460, Mexico

Location

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Zapopan, 45030, Mexico

Location

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Zapopan, 45116, Mexico

Location

Centro de Endocrinologia y Nutricion del Turabo

Caguas, 00726, Puerto Rico

Location

Manati Center for Clinical Research Inc

Manatí, 00674, Puerto Rico

Location

Ponce School of Medicine CAIMED Center

Ponce, 00716, Puerto Rico

Location

Research and Cardiovascular Corp.

Ponce, 00717-1332, Puerto Rico

Location

GCM Medical Group PSC

San Juan, 00917, Puerto Rico

Location

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Arkhangelsk, 163045, Russia

Location

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Kursk, 305014, Russia

Location

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Moscow, 119435, Russia

Location

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Moscow, 123182, Russia

Location

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Saint Petersburg, 195257, Russia

Location

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Saratov, 410053, Russia

Location

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Košice, Slovak Republic, 04012, Slovakia

Location

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Malacky, 90101, Slovakia

Location

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Nové Mesto nad Váhom, 91501, Slovakia

Location

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Púchov, 02001, Slovakia

Location

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Rožňava, 048 01, Slovakia

Location

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Bucheon-si, Gyeonggi-do, 14647, South Korea

Location

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Ansan-si, 15355, South Korea

Location

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Daegu, 41931, South Korea

Location

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Daejeon, 35233, South Korea

Location

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Gangwon-do, 24289, South Korea

Location

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Gangwon-do, 26426, South Korea

Location

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Seoul, 01830, South Korea

Location

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Seoul, 02841, South Korea

Location

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Seoul, 03181, South Korea

Location

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Seoul, 05278, South Korea

Location

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Seoul, 06351, South Korea

Location

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Seoul, 06591, South Korea

Location

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Seoul, 07061, South Korea

Location

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Seoul, 08308, South Korea

Location

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Lleida, 25198, Spain

Location

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Málaga, 29006, Spain

Location

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Seville, 41003, Spain

Location

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Seville, 41010, Spain

Location

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Taichung, 40201, Taiwan

Location

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Taipei, 10507, Taiwan

Location

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Taipei, 11031, Taiwan

Location

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Taipei, 23148, Taiwan

Location

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Yongkang District, 71004, Taiwan

Location

Related Publications (4)

• Piras de Oliveira C, Dellva MA, Bue-Valleskey J, Chang AM, Liao B. Fasting and postprandial plasma glucose contributions to hemoglobin A1c and time in range in people with diabetes on multiple daily injection insulin therapy: Results from the PRONTO-T1D and PRONTO-T2D clinical trials. J Diabetes Complications. 2024 Jan;38(1):108648. doi: 10.1016/j.jdiacomp.2023.108648. Epub 2023 Nov 16.

  PMID: 38035641 DERIVED

• Zhang Q, Chigutsa F, Chang AM. Efficacy and Safety of Ultra-Rapid Lispro in Younger and Older Patients with Type 2 Diabetes: Randomized Double-Blind PRONTO-T2D Study. Diabetes Ther. 2022 Aug;13(8):1547-1557. doi: 10.1007/s13300-022-01290-4. Epub 2022 Jul 4.

  PMID: 35781789 DERIVED

• Jinnouchi H, Imori M, Nishiyama H, Imaoka T. Ultra-Rapid Lispro Efficacy and Safety Compared to Humalog(R) in Japanese Patients With Type 2 Diabetes: PRONTO-T2D Subpopulation Analysis. Diabetes Ther. 2020 Sep;11(9):2075-2088. doi: 10.1007/s13300-020-00890-2. Epub 2020 Jul 29.

  PMID: 32728833 DERIVED

• Blevins T, Zhang Q, Frias JP, Jinnouchi H, Chang AM; PRONTO-T2D Investigators. Randomized Double-Blind Clinical Trial Comparing Ultra Rapid Lispro With Lispro in a Basal-Bolus Regimen in Patients With Type 2 Diabetes: PRONTO-T2D. Diabetes Care. 2020 Dec;43(12):2991-2998. doi: 10.2337/dc19-2550. Epub 2020 Jul 2.

  PMID: 32616612 DERIVED

Related Links

• A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 Diabetes (PRONTO-T2D)

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Lispro; Insulin Glargine; insulin degludec; Metformin; Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Long-Acting; Biguanides; Guanidines; Amidines; Organic Chemicals; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Limitations and Caveats

As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2017
• First Posted: July 11, 2017
• Study Start: July 14, 2017
• Primary Completion: August 14, 2018
• Study Completion: March 13, 2019
• Last Updated: March 27, 2020
• Results First Posted: March 27, 2020

Record last verified: 2019-08-15

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

RU (6); CZ (5); IN (12); JP (22); HU (4); AR (7); KR (14); DE (9); AU (5); TW (5); IT (2); SL (5); PR (5); ES (4); US (32); ME (4)