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A Study of LY900014 in Participants With Type 1 Diabetes (PRONTO-T1D)

Primary Purpose

Type 1 Diabetes Mellitus

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

LY900014

Insulin Lispro

Insulin Glargine

Insulin Degludec

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus

Eligibility Criteria

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

Inclusion Criteria:

Have T1D for at least 1 year prior to screening and continuously using insulin for at least 1 year.
HbA1c of ≥7.0 and ≤9.5%.
Use insulin lispro, insulin aspart, or insulin glulisine as prandial insulin.
Use insulin glargine, insulin detemir, insulin degludec, or neutral protamine Hagedorn (NPH) insulin as basal insulin.

Exclusion Criteria:

Have used other antihyperglycemic medications or therapies (inhaled, oral or injectable) within 90-days of screening.
Have had more than 1 severe hypoglycemic episode within 6 months of screening.
Have had more than 1 hospitalization related to hyperglycemia or diabetic ketoacidosis within 6 months of screening.
Have clinically significant gastrointestinal disease.

Sites / Locations

Internal Medicine Center LLC
John Muir Physician Network Clinical Research Center
AMCR Institute INC
Valley Endocrine, Fresno
Marin Endocrine Associates
Diabetes and Endocrine Associates
University Clinical Investigators, Inc.
Coastal Metabolic Research Centre
Barbara Davis Center for Childhood Diabetes
The Center For Diabetes & Endocrine Care
East Coast Institute For Research
Sun Coast Clinical Research, Inc
Metabolic Research Institute Inc.
Atlanta Diabetes Associates
East Coast Institute For Research
Endocrine Research Solutions, Inc.
East West Medical Institute
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
Kentucky Diabetes Endocrinology Center
MassResearch
Palm Research Center
Palm Research Center
Southern New Hampshire Diabetes and Endocrinology
Manhattan Medical Research
Physicians East
Diabetes & Endocrinology Consultants PC
PMG Research of Wilmington, LLC
Your Diabetes Endocrine Nutrition Group PC
Lehigh Valley Hospital
Partners in Nephrology & Endocrinology
Sudir Bansal M.D. Inc.
University Diabetes and Endocrine Consultants
Texas Diabetes and Endocrinology
Dallas Diabetes Endocrine Center
Texas Diabetes and Endocrinology, P.A.
Consano Clinical Research
Progressive Clinical Research
Private: Dr. Larry Stonesifer
Rainier Clinical Research Center
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Dr Altagracia Aurora Alcantara Gonzalez
Advanced Clinical Research, LLC
Manati Center for Clinical Research Inc
Martha Gomez Cuellar M.D.
Centro de Endocrinologia del Este
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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.
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.
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.
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.
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.
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.
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 5

Arm 6

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

LY900014

Insulin Lispro (Humalog)

LY900014 Postmeal (Open Label)

LY900014 - Maximum Extended Enrollment (MEE)

Insulin Lispro (Humalog)-MEE

LY900014 Postmeal (Open Label)-MEE

Arm Description

LY900014 given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.

Insulin lispro given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.

LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.

Outcomes

Primary Outcome Measures

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

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with strata (pooled country, type of basal insulin, prandial insulin dosing plan, and HbA1c stratum) and treatment as fixed effects and baseline as a covariate. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.

Secondary Outcome Measures

Change From Baseline in 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 26

A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 1-hour timepoint after the start of meal minus fasting serum glucose. 1-hour PPG excursion during MMTT uses the ANCOVA model with strata (pooled country, type of basal insulin, prandial insulin dosing plan, and HbA1c stratum) and treatment as fixed effects and baseline as a covariate. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.

Change From Baseline in 2-hour PPG Excursion During MMTT Efficacy Estimand at Week 26

A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 2-hour timepoint after the start of meal minus fasting serum glucose. 2-hour PPG excursion during MMTT uses the ANCOVA model with strata (pooled country, type of basal insulin, prandial insulin dosing plan, and HbA1c stratum) and treatment as fixed effects and baseline as a covariate. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.

Rate of Severe Hypoglycemia at Week 26

Severe hypoglycemia is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. During these episodes, the participant has an altered mental status and cannot assist in his or her own care, or may be semiconscious or unconscious, or experience coma with or without seizures, and may require parenteral therapy. Rate of severe hypoglycemia events per 100 years during a defined period was calculated by total number of severe hypoglycemia episodes within the period divided by the cumulative days on treatment from all participants within a treatment group *36525.

Rate of Documented Symptomatic Hypoglycemia at Week 26

Documented symptomatic hypoglycemia is an event during which typical symptoms of hypoglycemia are accompanied by blood glucose (BG) of <54 mg/dL [3.0 millimole per liter (mmol/L)]. The rate of documented symptomatic hypoglycemia was estimated by negative binomial model: number of episodes = treatment with log (treatment exposure in days/365.25) as an offset variable.

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

1,5-anhydroglucitol (1,5-AG) is a marker of short-term glycemic control especially postprandial hyperglycemia. 1,5-AG accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. LS Mean was calculated using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The analysis included data collected prior to permanent discontinuation of study drug.

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

SMBG 10-point profiles were measured at fasting, 1-hour post morning meal, 2-hours post morning meal, pre midday meal, 1-hour post midday meal, 2-hours post midday meal, pre evening meal, 1-hour post evening meal, 2-hours post evening meal, and bedtime. LS Mean was analyzed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The efficacy estimand included participant data when baseline and at least one post-baseline measurement prior to permanent discontinuation of study drug.

Change From Baseline in Insulin Dose at Week 26

LS Mean was analyzed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The analysis included data prior to permanent discontinuation of study drug.

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

ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction. LS Mean was calculated using the ANCOVA model with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum), and treatment as fixed effects and baseline as covariate. The analysis included data prior to permanent discontinuation of study drug. The analysis included data prior to permanent discontinuation of study drug.

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

ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction. LS Mean was calculated using the analysis of covariance (ANCOVA) with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum), and treatment as fixed effects and baseline as covariate. The analysis included data prior to permanent discontinuation of study drug. The analysis included data prior to permanent discontinuation of study drug.

Percentage of Participants With HbA1c <7%

Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

Change From Baseline in HbA1c at Week 52

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by MMRM model with variables of baseline, pooled country, type of basal insulin during lead-in, prandial Insulin Dosing Plan, treatment (Type III sum of squares) as fixed factors. The analysis included data prior to permanent discontinuation of study drug.

Full Information

NCT ID

NCT03214367

First Posted

July 10, 2017

Last Updated

April 17, 2020

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT03214367

Brief Title

A Study of LY900014 in Participants With Type 1 Diabetes

Acronym

PRONTO-T1D

Official Title

A Prospective, Randomized, Double-Blind Comparison of LY900014 to Insulin Lispro With an Open-Label Postprandial LY900014 Treatment Group, in Combination With Insulin Glargine or Insulin Degludec, in Adults With Type 1 Diabetes PRONTO-T1D

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

July 17, 2017 (Actual)

Primary Completion Date

September 6, 2018 (Actual)

Study Completion Date

August 22, 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 main purpose of this study is to evaluate the efficacy of the study drug LY900014 compared to insulin lispro, both in combination with insulin glargine or insulin degludec, in adults with type 1 diabetes (T1D).

6. Conditions and Keywords

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

Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1392 (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 Postmeal (Open Label)

Arm Type

Experimental

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

Arm Title

LY900014 Postmeal (Open Label)-MEE

Arm Type

Experimental

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

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

Change From Baseline in 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 26

Description

Time Frame

Baseline, Week 26

Title

Change From Baseline in 2-hour PPG Excursion During MMTT Efficacy Estimand at Week 26

Description

Time Frame

Baseline, Week 26

Title

Rate of Severe Hypoglycemia at Week 26

Description

Time Frame

Baseline through Week 26

Title

Rate of Documented Symptomatic Hypoglycemia at Week 26

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. LS Mean was calculated using the analysis of covariance (ANCOVA) with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum), and treatment as fixed effects and baseline as covariate. The analysis included data prior to permanent discontinuation of study drug. The analysis included data prior to permanent discontinuation of study drug.

Time Frame

Baseline, Week 26

Title

Percentage of Participants With HbA1c <7%

Description

Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

Time Frame

Week 26

Title

Change From Baseline in HbA1c at Week 52

Description

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by MMRM model with variables of baseline, pooled country, type of basal insulin during lead-in, prandial Insulin Dosing Plan, treatment (Type III sum of squares) as fixed factors. The analysis included data prior to permanent discontinuation of study drug.

Time Frame

Baseline, Week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have T1D for at least 1 year prior to screening and continuously using insulin for at least 1 year. HbA1c of ≥7.0 and ≤9.5%. Use insulin lispro, insulin aspart, or insulin glulisine as prandial insulin. Use insulin glargine, insulin detemir, insulin degludec, or neutral protamine Hagedorn (NPH) insulin as basal insulin. Exclusion Criteria: Have used other antihyperglycemic medications or therapies (inhaled, oral or injectable) within 90-days of screening. Have had more than 1 severe hypoglycemic episode within 6 months of screening. Have had more than 1 hospitalization related to hyperglycemia or diabetic ketoacidosis within 6 months of screening. Have clinically significant gastrointestinal disease.

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

Internal Medicine Center LLC

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

John Muir Physician Network Clinical Research Center

City

Concord

State/Province

California

ZIP/Postal Code

94520

Country

United States

Facility Name

AMCR Institute INC

City

Escondido

State/Province

California

ZIP/Postal Code

92025

Country

United States

Facility Name

Valley Endocrine, Fresno

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

Marin Endocrine Associates

City

Greenbrae

State/Province

California

ZIP/Postal Code

94904

Country

United States

Facility Name

Diabetes and Endocrine Associates

City

La Mesa

State/Province

California

ZIP/Postal Code

91942

Country

United States

Facility Name

University Clinical Investigators, Inc.

City

Tustin

State/Province

California

ZIP/Postal Code

92780

Country

United States

Facility Name

Coastal Metabolic Research Centre

City

Ventura

State/Province

California

ZIP/Postal Code

93003

Country

United States

Facility Name

Barbara Davis Center for Childhood Diabetes

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

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

32204

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

Metabolic Research Institute Inc.

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33401

Country

United States

Facility Name

Atlanta Diabetes Associates

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30318

Country

United States

Facility Name

East Coast Institute For Research

City

Macon

State/Province

Georgia

ZIP/Postal Code

31210

Country

United States

Facility Name

Endocrine Research Solutions, Inc.

City

Roswell

State/Province

Georgia

ZIP/Postal Code

30076

Country

United States

Facility Name

East West Medical Institute

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96814

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

Topeka

State/Province

Kansas

ZIP/Postal Code

66606

Country

United States

Facility Name

Kentucky Diabetes Endocrinology Center

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40503

Country

United States

Facility Name

MassResearch

City

Waltham

State/Province

Massachusetts

ZIP/Postal Code

02453

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

Southern New Hampshire Diabetes and Endocrinology

City

Nashua

State/Province

New Hampshire

ZIP/Postal Code

03063

Country

United States

Facility Name

Manhattan Medical Research

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Physicians East

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27843

Country

United States

Facility Name

Diabetes & Endocrinology Consultants PC

City

Morehead City

State/Province

North Carolina

ZIP/Postal Code

28557

Country

United States

Facility Name

PMG Research of Wilmington, LLC

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Your Diabetes Endocrine Nutrition Group PC

City

Mentor

State/Province

Ohio

ZIP/Postal Code

44060

Country

United States

Facility Name

Lehigh Valley Hospital

City

Allentown

State/Province

Pennsylvania

ZIP/Postal Code

18103

Country

United States

Facility Name

Partners in Nephrology & Endocrinology

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15224

Country

United States

Facility Name

Sudir Bansal M.D. Inc.

City

Warwick

State/Province

Rhode Island

ZIP/Postal Code

02886

Country

United States

Facility Name

University Diabetes and Endocrine Consultants

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37411

Country

United States

Facility Name

Texas Diabetes and Endocrinology

City

Austin

State/Province

Texas

ZIP/Postal Code

78731-4309

Country

United States

Facility Name

Dallas Diabetes Endocrine Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Texas Diabetes and Endocrinology, P.A.

City

Round Rock

State/Province

Texas

ZIP/Postal Code

78681

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 1-888-545-5972 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

Buenos Aires

ZIP/Postal Code

C1013AAB

Country

Argentina

Facility Name

City

Buenos Aires

ZIP/Postal Code

C1056ABJ

Country

Argentina

Facility Name

City

Caba

ZIP/Postal Code

C1179AAB

Country

Argentina

Facility Name

City

Caba

ZIP/Postal Code

C1180AAX

Country

Argentina

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

Ciudad Autonoma de Buenos Aire

ZIP/Postal Code

1408

Country

Argentina

Facility Name

City

Ciudad Autonoma de Buenos Aire

ZIP/Postal Code

C1128AAF

Country

Argentina

Facility Name

City

Córdoba

ZIP/Postal Code

5000

Country

Argentina

Facility Name

City

Córdoba

ZIP/Postal Code

5006

Country

Argentina

Facility Name

City

Mar del Plata

ZIP/Postal Code

B7600FZN

Country

Argentina

Facility Name

City

Box Hill

ZIP/Postal Code

3128

Country

Australia

Facility Name

City

Geelong

ZIP/Postal Code

3220

Country

Australia

Facility Name

City

Merewether

ZIP/Postal Code

2291

Country

Australia

Facility Name

City

Oaklands Park

ZIP/Postal Code

5046

Country

Australia

Facility Name

City

Graz

ZIP/Postal Code

1060

Country

Austria

Facility Name

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

City

Wien

ZIP/Postal Code

1030

Country

Austria

Facility Name

City

São Paulo

ZIP/Postal Code

01244-030

Country

Brazil

Facility Name

City

Bad Mergentheim

ZIP/Postal Code

97980

Country

Germany

Facility Name

City

Falkensee

ZIP/Postal Code

14612

Country

Germany

Facility Name

City

Hamburg

ZIP/Postal Code

22607

Country

Germany

Facility Name

City

Hessen

ZIP/Postal Code

35415

Country

Germany

Facility Name

City

Magdeburg

ZIP/Postal Code

39112

Country

Germany

Facility Name

City

Mayen

ZIP/Postal Code

56727

Country

Germany

Facility Name

City

Münster

ZIP/Postal Code

48145

Country

Germany

Facility Name

City

Oldenburg

ZIP/Postal Code

23758

Country

Germany

Facility Name

City

Rheine

ZIP/Postal Code

67059

Country

Germany

Facility Name

City

Saterland

ZIP/Postal Code

66386

Country

Germany

Facility Name

City

Ampelókipoi

ZIP/Postal Code

11527

Country

Greece

Facility Name

City

Athens

ZIP/Postal Code

11527

Country

Greece

Facility Name

City

Athens

ZIP/Postal Code

17562

Country

Greece

Facility Name

City

Lárisa

ZIP/Postal Code

41110

Country

Greece

Facility Name

City

Thessaloníki

ZIP/Postal Code

54642

Country

Greece

Facility Name

City

Thessaloníki

ZIP/Postal Code

54645

Country

Greece

Facility Name

City

Thessaloníki

ZIP/Postal Code

57010

Country

Greece

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

Thérmi

ZIP/Postal Code

57001

Country

Greece

Facility Name

City

Ahmedabad

ZIP/Postal Code

380015

Country

India

Facility Name

City

Hyderabad

ZIP/Postal Code

500001

Country

India

Facility Name

City

Hyderabad

ZIP/Postal Code

500035

Country

India

Facility Name

City

Hyderabad

ZIP/Postal Code

500072

Country

India

Facility Name

City

Indore

ZIP/Postal Code

452002

Country

India

Facility Name

City

Pune

ZIP/Postal Code

411001

Country

India

Facility Name

City

Secunderabad

ZIP/Postal Code

500033

Country

India

Facility Name

City

Visakhapatnam

ZIP/Postal Code

530002

Country

India

Facility Name

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

City

Ravenna

ZIP/Postal Code

48121

Country

Italy

Facility Name

City

Roma

ZIP/Postal Code

00161

Country

Italy

Facility Name

City

Siena

ZIP/Postal Code

53100

Country

Italy

Facility Name

City

Amagasaki

ZIP/Postal Code

661

Country

Japan

Facility Name

City

Fukuoka

ZIP/Postal Code

815-0071

Country

Japan

Facility Name

City

Fukuoka

ZIP/Postal Code

815-8555

Country

Japan

Facility Name

City

Kamakura

ZIP/Postal Code

247-0056

Country

Japan

Facility Name

City

Kanagawa

ZIP/Postal Code

235-0045

Country

Japan

Facility Name

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

Shinjuku

ZIP/Postal Code

162-8666

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

Tokyo

ZIP/Postal Code

206-0033

Country

Japan

Facility Name

City

Ōita

ZIP/Postal Code

870-0039

Country

Japan

Facility Name

City

Ōsaka

ZIP/Postal Code

545-8586

Country

Japan

Facility Name

City

Ōsaka

ZIP/Postal Code

569-1096

Country

Japan

Facility Name

City

Guadalajara

ZIP/Postal Code

44650

Country

Mexico

Facility Name

City

Monterrey

ZIP/Postal Code

64460

Country

Mexico

Facility Name

City

Monterrey

ZIP/Postal Code

64710

Country

Mexico

Facility Name

City

Zapopan

ZIP/Postal Code

45116

Country

Mexico

Facility Name

City

Takapuna

State/Province

Auckland

ZIP/Postal Code

0620

Country

New Zealand

Facility Name

City

Auckland

ZIP/Postal Code

2025

Country

New Zealand

Facility Name

City

Christchurch

ZIP/Postal Code

8011

Country

New Zealand

Facility Name

City

Wellington

ZIP/Postal Code

6021

Country

New Zealand

Facility Name

City

Gdańsk

ZIP/Postal Code

80-546

Country

Poland

Facility Name

City

Kraków

ZIP/Postal Code

31-500

Country

Poland

Facility Name

City

Lublin

ZIP/Postal Code

20-333

Country

Poland

Facility Name

City

Lublin

ZIP/Postal Code

20-538

Country

Poland

Facility Name

City

Ruda Śląska

ZIP/Postal Code

41-709

Country

Poland

Facility Name

City

Szczecin

ZIP/Postal Code

70-376

Country

Poland

Facility Name

City

Szczecin

ZIP/Postal Code

70-506

Country

Poland

Facility Name

City

Warsaw

ZIP/Postal Code

01-518

Country

Poland

Facility Name

City

Warszawa

ZIP/Postal Code

02-507

Country

Poland

Facility Name

City

Wrocław

ZIP/Postal Code

50-403

Country

Poland

Facility Name

City

Łódź

ZIP/Postal Code

90-132

Country

Poland

Facility Name

Dr Altagracia Aurora Alcantara Gonzalez

City

Bayamon

ZIP/Postal Code

00956

Country

Puerto Rico

Facility Name

Advanced Clinical Research, LLC

City

Bayamon

ZIP/Postal Code

00961

Country

Puerto Rico

Facility Name

Manati Center for Clinical Research Inc

City

Manati

ZIP/Postal Code

00674

Country

Puerto Rico

Facility Name

Martha Gomez Cuellar M.D.

City

San Juan

ZIP/Postal Code

00921

Country

Puerto Rico

Facility Name

Centro de Endocrinologia del Este

City

Yabucoa

ZIP/Postal Code

00767

Country

Puerto Rico

Facility Name

City

Bacău

ZIP/Postal Code

600164

Country

Romania

Facility Name

City

Braşov

ZIP/Postal Code

500283

Country

Romania

Facility Name

City

Bucuresti

ZIP/Postal Code

013682

Country

Romania

Facility Name

City

Lasi

ZIP/Postal Code

700547

Country

Romania

Facility Name

City

Oradea

ZIP/Postal Code

410025

Country

Romania

Facility Name

City

Ploieşti

ZIP/Postal Code

100163

Country

Romania

Facility Name

City

Ploieşti

ZIP/Postal Code

100342

Country

Romania

Facility Name

City

Satu Mare

ZIP/Postal Code

440055

Country

Romania

Facility Name

City

Timişoara

ZIP/Postal Code

300456

Country

Romania

Facility Name

City

Târgu-Mureş

ZIP/Postal Code

540098

Country

Romania

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

117036

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

ZIP/Postal Code

04012

Country

Slovakia

Facility Name

City

Malacky

ZIP/Postal Code

90101

Country

Slovakia

Facility Name

City

Nové Mesto nad Váhom

ZIP/Postal Code

91501

Country

Slovakia

Facility Name

City

Rožňava

ZIP/Postal Code

048 01

Country

Slovakia

Facility Name

City

Sabadell

State/Province

Barcelona

ZIP/Postal Code

08208

Country

Spain

Facility Name

City

Alcira

State/Province

Valencia

ZIP/Postal Code

46600

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

Sevilla

ZIP/Postal Code

41071

Country

Spain

Facility Name

City

Teruel

ZIP/Postal Code

44002

Country

Spain

Facility Name

City

Göteborg

ZIP/Postal Code

41345

Country

Sweden

Facility Name

City

Linköping

ZIP/Postal Code

581 85

Country

Sweden

Facility Name

City

Lund

ZIP/Postal Code

22185

Country

Sweden

Facility Name

City

Stockholm

ZIP/Postal Code

14186

Country

Sweden

Facility Name

City

Chang-hua

ZIP/Postal Code

500

Country

Taiwan

Facility Name

City

Taichung

ZIP/Postal Code

40201

Country

Taiwan

Facility Name

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

Facility Name

City

Taipei

ZIP/Postal Code

10507

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

34347267

Citation

Miura J, Nishiyama H, Imori M. Long-term Efficacy and Safety of Ultra Rapid Lispro in Japanese Patients With Type 1 Diabetes: Subpopulation Analysis of the 52-Week PRONTO-T1D Study. Diabetes Ther. 2021 Sep;12(9):2471-2484. doi: 10.1007/s13300-021-01124-9. Epub 2021 Aug 4.

Results Reference

derived

PubMed Identifier

33458803

Citation

Bue-Valleskey J, Klaff L, Cho JI, Dellva MA, Schloot NC, Tobian J, Miura J, Dahl D. Long-Term Efficacy and Safety of Ultra Rapid Lispro (URLi) in Adults with Type 1 Diabetes: The PRONTO-T1D Extension. Diabetes Ther. 2021 Feb;12(2):569-580. doi: 10.1007/s13300-020-00987-8. Epub 2021 Jan 17.

Results Reference

derived

PubMed Identifier

32728832

Citation

Miura J, Imori M, Nishiyama H, Imaoka T. Ultra-Rapid Lispro Efficacy and Safety Compared to Humalog(R) in Japanese Patients with Type 1 Diabetes: PRONTO-T1D Subpopulation Analysis. Diabetes Ther. 2020 Sep;11(9):2089-2104. doi: 10.1007/s13300-020-00892-0. Epub 2020 Jul 29.

Results Reference

derived

Links:

URL

https://www.lillytrialguide.com/en-US/studies/type-1-diabetes/ITRM#?postal=

Description

A Study of LY900014 in Participants With Type 1 Diabetes (PRONTO-T1D)

Learn more about this trial

A Study of LY900014 in Participants With Type 1 Diabetes

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