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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

LY900014

Insulin Lispro

Insulin Glargine

Insulin Degludec

Metformin

SGLT2 inhibitor

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Have been diagnosed (clinically) with T2D, based on the World Health Organization (WHO) classification for at least 1 year prior to screening.
Have been treated for at least 90 days prior to screening with:
- Basal insulin (insulin glargine U-100 [Basaglar/Abasaglar or LANTUS] or U-300, insulin detemir, insulin degludec U-100 or U-200, or neutral protamine Hagedorn [NPH] insulin) in combination with at least 1 prandial injection of bolus insulin (insulin lispro U-100 or U-200, insulin aspart, insulin glulisine, or regular insulin) Or
- Premixed analog or human insulin regimens with any basal and bolus insulin combination injected at least twice daily
Participants may be treated with up to 3 of the following oral antihyperglycemic medications (OAMs) in accordance with local regulations:
- Metformin
- Dipeptidyl peptidase-4 (DPP-4) inhibitor
- Sodium glucose cotransporter 2 (SGLT2) inhibitor
- Sulfonylurea
- Meglitinide
- Alpha-glucoside inhibitor
Have an HbA1c value between ≥7.0 and ≤10.0%, according to the central laboratory at the time of screening.
Have a body mass index (BMI) of ≤45.0 kilograms per meter squared at screening.

Exclusion Criteria:

Have been diagnosed, at any time, with type 1 diabetes (T1D) or Latent Autoimmune Diabetes in Adults.
Have hypoglycemia unawareness as judged by the investigator.
Have had any episode of severe hypoglycemia within the 6 months prior to screening.
Have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening.
Have used thiazolidinediones, Glucagon-Like Peptide 1 (GLP-1) receptor agonist, or pramlintide within 90 days prior to screening.

Sites / Locations

Valley Research
Diabetes and Endocrine Associates
First Valley Medical Group
National Research Institute
Care Access Research
Encompass Clinical Research
University Clinical Investigators, Inc.
ALL Medical Research, LLC
The Center For Diabetes & Endocrine Care
East Coast Institute For Research
Sun Coast Clinical Research, Inc
East West Medical Institute
Elite Clinical Trials LLLP
Northwest Clinical Trials
Rocky Mountain Diabetes and Osteoporosis Center
Prairie Education and Research Cooperative
Iderc, P.L.C.
University of Kansas Medical Center
Cotton O'Neil Diabetes and Endocrinology Center
Palm Research Center
Palm Research Center
Manhattan Medical Research
Aventiv Research
Heritage Valley Medical Group, Inc.
Partners in Nephrology & Endocrinology
Texas Diabetes and Endocrinology
Texas Diabetes and Endocrinology-Austin South
Dallas Diabetes Endocrine Center
Consano Clinical Research
Progressive Clinical Research
Private: Dr. Larry Stonesifer
Rainier Clinical Research Center
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Centro de Endocrinologia y Nutricion del Turabo
Manati Center for Clinical Research Inc
Ponce School of Medicine CAIMED Center
Research and Cardiovascular Corp.
GCM Medical Group PSC
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

LY900014

Insulin Lispro (Humalog)

LY900014 Maximum Extended Enrollment (MEE)

Insulin Lispro (Humalog) MEE

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

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.

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.

Number of Participants With HbA1c <7%

Number of participants with HbA1c <7% at Week 26.

Full Information

NCT ID

NCT03214380

First Posted

July 10, 2017

Last Updated

March 12, 2020

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT03214380

Brief Title

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

Acronym

PRONTO-T2D

Official Title

A Prospective, Randomized, Double-Blind Comparison of LY900014 to Insulin Lispro, Both in Combination With Insulin Glargine or Insulin Degludec in Adults With Type 2 Diabetes PRONTO-T2D

Study Type

Interventional

2. Study Status

Record Verification Date

August 15, 2019

Overall Recruitment Status

Completed

Study Start Date

July 14, 2017 (Actual)

Primary Completion Date

August 14, 2018 (Actual)

Study Completion Date

March 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

933 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LY900014

Arm Type

Experimental

Arm Description

Arm Title

Insulin Lispro (Humalog)

Arm Type

Active Comparator

Arm Description

Arm Title

LY900014 Maximum Extended Enrollment (MEE)

Arm Type

Experimental

Arm Description

Arm Title

Insulin Lispro (Humalog) MEE

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

LY900014

Other Intervention Name(s)

Ultra-Rapid Lispro

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

Insulin Lispro

Other Intervention Name(s)

Humalog

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

Insulin Glargine

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

Insulin Degludec

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

Administered orally.

Intervention Type

Drug

Intervention Name(s)

SGLT2 inhibitor

Intervention Description

Administered orally.

Primary Outcome Measure Information:

Title

Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26

Description

Time Frame

Baseline, Week 26

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Week 26

Title

2-hour PPG Excursion During MMTT Efficacy Estimand

Description

Time Frame

Week 26

Title

Rate of Severe Hypoglycemia

Description

Time Frame

Baseline through Week 26

Title

Rate of Documented Symptomatic Hypoglycemia

Description

Time Frame

Baseline through Week 26

Title

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

Description

Time Frame

Baseline, Week 26

Title

Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 26

Description

Time Frame

Baseline, Week 26

Title

Change From Baseline in Insulin Dose at Week 26

Description

Time Frame

Baseline, Week 26

Title

Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) Regimen Inconvenience Domain Score at Week 26

Description

Time Frame

Baseline, Week 26

Title

Change From Baseline in ITSQ Lifestyle Flexibility Domain Score at Week 26

Description

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.

Time Frame

Baseline, Week 26

Title

Number of Participants With HbA1c <7%

Description

Number of participants with HbA1c <7% at Week 26.

Time Frame

Week 26

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have been diagnosed (clinically) with T2D, based on the World Health Organization (WHO) classification for at least 1 year prior to screening. Have been treated for at least 90 days prior to screening with: Basal insulin (insulin glargine U-100 [Basaglar/Abasaglar or LANTUS] or U-300, insulin detemir, insulin degludec U-100 or U-200, or neutral protamine Hagedorn [NPH] insulin) in combination with at least 1 prandial injection of bolus insulin (insulin lispro U-100 or U-200, insulin aspart, insulin glulisine, or regular insulin) Or Premixed analog or human insulin regimens with any basal and bolus insulin combination injected at least twice daily Participants may be treated with up to 3 of the following oral antihyperglycemic medications (OAMs) in accordance with local regulations: Metformin Dipeptidyl peptidase-4 (DPP-4) inhibitor Sodium glucose cotransporter 2 (SGLT2) inhibitor Sulfonylurea Meglitinide Alpha-glucoside inhibitor Have an HbA1c value between ≥7.0 and ≤10.0%, according to the central laboratory at the time of screening. Have a body mass index (BMI) of ≤45.0 kilograms per meter squared at screening. Exclusion Criteria: Have been diagnosed, at any time, with type 1 diabetes (T1D) or Latent Autoimmune Diabetes in Adults. Have hypoglycemia unawareness as judged by the investigator. Have had any episode of severe hypoglycemia within the 6 months prior to screening. Have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening. Have used thiazolidinediones, Glucagon-Like Peptide 1 (GLP-1) receptor agonist, or pramlintide within 90 days prior to screening.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Valley Research

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

Diabetes and Endocrine Associates

City

La Mesa

State/Province

California

ZIP/Postal Code

91942

Country

United States

Facility Name

First Valley Medical Group

City

Lancaster

State/Province

California

ZIP/Postal Code

93534

Country

United States

Facility Name

National Research Institute

City

Los Angeles

State/Province

California

ZIP/Postal Code

90057

Country

United States

Facility Name

Care Access Research

City

Santa Clarita

State/Province

California

ZIP/Postal Code

91321

Country

United States

Facility Name

Encompass Clinical Research

City

Spring Valley

State/Province

California

ZIP/Postal Code

91978

Country

United States

Facility Name

University Clinical Investigators, Inc.

City

Tustin

State/Province

California

ZIP/Postal Code

92780

Country

United States

Facility Name

ALL Medical Research, LLC

City

Cooper City

State/Province

Florida

ZIP/Postal Code

33024

Country

United States

Facility Name

The Center For Diabetes & Endocrine Care

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33312

Country

United States

Facility Name

East Coast Institute For Research

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

Sun Coast Clinical Research, Inc

City

New Port Richey

State/Province

Florida

ZIP/Postal Code

34652

Country

United States

Facility Name

East West Medical Institute

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96814

Country

United States

Facility Name

Elite Clinical Trials LLLP

City

Blackfoot

State/Province

Idaho

ZIP/Postal Code

83221

Country

United States

Facility Name

Northwest Clinical Trials

City

Boise

State/Province

Idaho

ZIP/Postal Code

83704

Country

United States

Facility Name

Rocky Mountain Diabetes and Osteoporosis Center

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

Facility Name

Prairie Education and Research Cooperative

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62711

Country

United States

Facility Name

Iderc, P.L.C.

City

West Des Moines

State/Province

Iowa

ZIP/Postal Code

50265

Country

United States

Facility Name

University of Kansas Medical Center

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Facility Name

Cotton O'Neil Diabetes and Endocrinology Center

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66606

Country

United States

Facility Name

Palm Research Center

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89128

Country

United States

Facility Name

Palm Research Center

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89148

Country

United States

Facility Name

Manhattan Medical Research

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Aventiv Research

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43213

Country

United States

Facility Name

Heritage Valley Medical Group, Inc.

City

Beaver

State/Province

Pennsylvania

ZIP/Postal Code

15009

Country

United States

Facility Name

Partners in Nephrology & Endocrinology

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15224

Country

United States

Facility Name

Texas Diabetes and Endocrinology

City

Austin

State/Province

Texas

ZIP/Postal Code

78731-4309

Country

United States

Facility Name

Texas Diabetes and Endocrinology-Austin South

City

Austin

State/Province

Texas

ZIP/Postal Code

78749

Country

United States

Facility Name

Dallas Diabetes Endocrine Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Consano Clinical Research

City

Shavano Park

State/Province

Texas

ZIP/Postal Code

78231

Country

United States

Facility Name

Progressive Clinical Research

City

Bountiful

State/Province

Utah

ZIP/Postal Code

84010

Country

United States

Facility Name

Private: Dr. Larry Stonesifer

City

Federal Way

State/Province

Washington

ZIP/Postal Code

98003

Country

United States

Facility Name

Rainier Clinical Research Center

City

Renton

State/Province

Washington

ZIP/Postal Code

98057

Country

United States

Facility Name

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

1425

Country

Argentina

Facility Name

For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1013AAB

Country

Argentina

Facility Name

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1179AAB

Country

Argentina

Facility Name

City

Ciudad Autonoma de Buenos Aire

State/Province

Buenos Aires

ZIP/Postal Code

1408

Country

Argentina

Facility Name

City

Ciudad Autonoma de Buenos Aire

State/Province

Buenos Aires

ZIP/Postal Code

C1056ABJ

Country

Argentina

Facility Name

City

Ciudad Autonoma de Buenos Aire

State/Province

Buenos Aires

ZIP/Postal Code

C1204AAD

Country

Argentina

Facility Name

City

Mar del Plata

State/Province

Buenos Aires

ZIP/Postal Code

B7600FZN

Country

Argentina

Facility Name

City

Keswick

State/Province

South Australia

ZIP/Postal Code

5035

Country

Australia

Facility Name

City

Oaklands Park

State/Province

South Australia

ZIP/Postal Code

5046

Country

Australia

Facility Name

City

Box Hill

State/Province

Victoria

ZIP/Postal Code

3128

Country

Australia

Facility Name

City

Geelong

State/Province

Victoria

ZIP/Postal Code

3220

Country

Australia

Facility Name

City

Fremantle

State/Province

Western Australia

ZIP/Postal Code

6959

Country

Australia

Facility Name

City

Krnov

ZIP/Postal Code

79401

Country

Czechia

Facility Name

City

Pardubice

ZIP/Postal Code

53002

Country

Czechia

Facility Name

City

Praha

ZIP/Postal Code

104 00

Country

Czechia

Facility Name

City

Praha

ZIP/Postal Code

149 00

Country

Czechia

Facility Name

City

Praha

ZIP/Postal Code

181 00

Country

Czechia

Facility Name

City

Bad Mergentheim

State/Province

Baden-Württemberg

ZIP/Postal Code

97980

Country

Germany

Facility Name

City

Falkensee

State/Province

Brandenburg

ZIP/Postal Code

14612

Country

Germany

Facility Name

City

Pohlheim

State/Province

Hessen

ZIP/Postal Code

35415

Country

Germany

Facility Name

City

Münster

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

48145

Country

Germany

Facility Name

City

Mayen

State/Province

Rheinland-Pfalz

ZIP/Postal Code

56727

Country

Germany

Facility Name

City

Saint Ingbert-Oberwürzbach

State/Province

Saarland

ZIP/Postal Code

66386

Country

Germany

Facility Name

City

Magdeburg

State/Province

Sachsen-Anhalt

ZIP/Postal Code

39120

Country

Germany

Facility Name

City

Oldenburg

State/Province

Schleswig-Holstein

ZIP/Postal Code

23758

Country

Germany

Facility Name

City

Hamburg

ZIP/Postal Code

22607

Country

Germany

Facility Name

City

Budapest

ZIP/Postal Code

1089

Country

Hungary

Facility Name

City

Budapest

ZIP/Postal Code

1139

Country

Hungary

Facility Name

City

Budapest

ZIP/Postal Code

1213

Country

Hungary

Facility Name

City

Nagykanizsa

ZIP/Postal Code

8800

Country

Hungary

Facility Name

City

Ahmedabad

State/Province

Gujarat

ZIP/Postal Code

380015

Country

India

Facility Name

City

Ahmedabad

State/Province

Gujarat

ZIP/Postal Code

380015

Country

India

Facility Name

City

Ahmedabad

State/Province

Gujarat

ZIP/Postal Code

380016

Country

India

Facility Name

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560017

Country

India

Facility Name

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560054

Country

India

Facility Name

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411004

Country

India

Facility Name

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411011

Country

India

Facility Name

City

Mumbai

State/Province

Maharshtra

ZIP/Postal Code

400012

Country

India

Facility Name

City

Jaipur

State/Province

Rajasthan

ZIP/Postal Code

302017

Country

India

Facility Name

City

Chennai

State/Province

Tamil Nadu

ZIP/Postal Code

600086

Country

India

Facility Name

City

Hyderabad

State/Province

Telangana

ZIP/Postal Code

500012

Country

India

Facility Name

City

Hyderabad

State/Province

Telangana

ZIP/Postal Code

500072

Country

India

Facility Name

City

Palmero

ZIP/Postal Code

90127

Country

Italy

Facility Name

City

Sesto San Giovanni

ZIP/Postal Code

20099

Country

Italy

Facility Name

City

Chiba

ZIP/Postal Code

277-0825

Country

Japan

Facility Name

City

Fukuoka

ZIP/Postal Code

815-8555

Country

Japan

Facility Name

City

Fukuoka

ZIP/Postal Code

830-8543

Country

Japan

Facility Name

City

Hyōgo

ZIP/Postal Code

661-0002

Country

Japan

Facility Name

City

Kanagawa

ZIP/Postal Code

235-0045

Country

Japan

Facility Name

City

Kanagawa

ZIP/Postal Code

247-0056

Country

Japan

Facility Name

"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician."

City

Kumamoto

ZIP/Postal Code

862-0976

Country

Japan

Facility Name

City

Miyazaki

ZIP/Postal Code

880-0034

Country

Japan

Facility Name

City

Naka

ZIP/Postal Code

311-0113

Country

Japan

Facility Name

City

Sapporo

ZIP/Postal Code

060-0001

Country

Japan

Facility Name

City

Sapporo

ZIP/Postal Code

060-0062

Country

Japan

Facility Name

City

Sasebo

ZIP/Postal Code

857-1195

Country

Japan

Facility Name

City

Sendai

ZIP/Postal Code

980-0021

Country

Japan

Facility Name

City

Tama

ZIP/Postal Code

206-0033

Country

Japan

Facility Name

City

Tokyo

ZIP/Postal Code

103-0027

Country

Japan

Facility Name

City

Tokyo

ZIP/Postal Code

1030002

Country

Japan

Facility Name

City

Tokyo

ZIP/Postal Code

143-0015

Country

Japan

Facility Name

City

Tokyo

ZIP/Postal Code

160 0022

Country

Japan

Facility Name

City

Yamato

ZIP/Postal Code

242-0004

Country

Japan

Facility Name

City

Ōita

ZIP/Postal Code

870-0039

Country

Japan

Facility Name

City

Ōsaka

ZIP/Postal Code

530-0001

Country

Japan

Facility Name

City

Ōsaka

ZIP/Postal Code

534-0021

Country

Japan

Facility Name

City

Bucheon

State/Province

Gyeonggi-do

ZIP/Postal Code

14647

Country

Korea, Republic of

Facility Name

City

Ansan-si

ZIP/Postal Code

15355

Country

Korea, Republic of

Facility Name

City

Daegu

ZIP/Postal Code

41931

Country

Korea, Republic of

Facility Name

City

Daejeon

ZIP/Postal Code

35233

Country

Korea, Republic of

Facility Name

City

Gangwon-do

ZIP/Postal Code

24289

Country

Korea, Republic of

Facility Name

City

Gangwon-do

ZIP/Postal Code

26426

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

01830

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

02841

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

03181

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

05278

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

07061

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

08308

Country

Korea, Republic of

Facility Name

City

Jalisco

ZIP/Postal Code

44650

Country

Mexico

Facility Name

City

Monterrey

ZIP/Postal Code

64460

Country

Mexico

Facility Name

City

Zapopan

ZIP/Postal Code

45030

Country

Mexico

Facility Name

City

Zapopan

ZIP/Postal Code

45116

Country

Mexico

Facility Name

Centro de Endocrinologia y Nutricion del Turabo

City

Caguas

ZIP/Postal Code

00726

Country

Puerto Rico

Facility Name

Manati Center for Clinical Research Inc

City

Manati

ZIP/Postal Code

00674

Country

Puerto Rico

Facility Name

Ponce School of Medicine CAIMED Center

City

Ponce

ZIP/Postal Code

00716

Country

Puerto Rico

Facility Name

Research and Cardiovascular Corp.

City

Ponce

ZIP/Postal Code

00717-1332

Country

Puerto Rico

Facility Name

GCM Medical Group PSC

City

San Juan

ZIP/Postal Code

00917

Country

Puerto Rico

Facility Name

City

Arkhangel'sk

ZIP/Postal Code

163045

Country

Russian Federation

Facility Name

City

Kursk

ZIP/Postal Code

305014

Country

Russian Federation

Facility Name

City

Moscow

ZIP/Postal Code

119435

Country

Russian Federation

Facility Name

City

Moscow

ZIP/Postal Code

123182

Country

Russian Federation

Facility Name

City

Saint Petersburg

ZIP/Postal Code

195257

Country

Russian Federation

Facility Name

City

Saratov

ZIP/Postal Code

410053

Country

Russian Federation

Facility Name

City

Košice

State/Province

Slovak Republic

ZIP/Postal Code

04012

Country

Slovakia

Facility Name

City

Malacky

ZIP/Postal Code

90101

Country

Slovakia

Facility Name

City

Nove Mesto nad Vahom

ZIP/Postal Code

91501

Country

Slovakia

Facility Name

City

Púchov

ZIP/Postal Code

02001

Country

Slovakia

Facility Name

City

Rožňava

ZIP/Postal Code

048 01

Country

Slovakia

Facility Name

City

Lleida

ZIP/Postal Code

25198

Country

Spain

Facility Name

City

Málaga

ZIP/Postal Code

29006

Country

Spain

Facility Name

City

Sevilla

ZIP/Postal Code

41003

Country

Spain

Facility Name

City

Sevilla

ZIP/Postal Code

41010

Country

Spain

Facility Name

City

Taichung

ZIP/Postal Code

40201

Country

Taiwan

Facility Name

City

Taipei

ZIP/Postal Code

10507

Country

Taiwan

Facility Name

City

Taipei

ZIP/Postal Code

11031

Country

Taiwan

Facility Name

City

Taipei

ZIP/Postal Code

23148

Country

Taiwan

Facility Name

City

Yongkang

ZIP/Postal Code

71004

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing URL

https://vivli.org/

Citations:

PubMed Identifier

35781789

Citation

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

Results Reference

derived

PubMed Identifier

32728833

Citation

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

Results Reference

derived

PubMed Identifier

32616612

Citation

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

Results Reference

derived

Links:

URL

https://www.lillytrialguide.com/en-US/studies/type-2-diabetes/ITRN#?postal=

Description

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

Learn more about this trial

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

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