Back to resultsA Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy (QWINT-5)
Primary Purpose
Type 1 Diabetes, Diabetes
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Insulin Efsitora Alfa
Insulin Degludec
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 Diabetes (T1D)
Eligibility Criteria
Inclusion Criteria:
- Have a clinical diagnosis of type 1 diabetes for at least 1 year prior to screening
- Have received treatment with basal-bolus insulin analog multiple daily injection therapy according to the local product label for at least 90 days prior to screening
- Have an HbA1c value of 7.0% to 10.0%, inclusive, as determined by the central laboratory at screening.
- Have a body mass index of ≤35 kilogram/square meter (kg/m²)
Exclusion Criteria:
- Have a diagnosis of type 2 diabetes, latent autoimmune diabetes, or specific types of diabetes other than type 1 diabetes
- Have a history of more than 1 episode of severe hypoglycemia, within the 6 months prior to screening.
- Have a history of more than 1 episode of diabetic ketoacidosis or hyperosmolar state or coma requiring hospitalization within the 6 months prior to screening.
Sites / Locations
- John Muir Physician Network Research Center
- Valley Research
- Catalina Research Institute, LLC
- Sansum Diabetes Research Institute
- University Clinical Investigators, Inc.
- University of Colorado Anschutz Medical Campus
- Northeast Research Institute (NERI)
- Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care
- Suncoast Clinical Research, Inc.
- Hanson Clinical Research Center
- East Coast Institute for Research, LLC
- East-West Medical Research Institute
- Rocky Mountain Clinical Research
- Iowa Diabetes and Endocrinology Research Center
- Cotton O'Neil Clinical Research Center
- MedStar Health Research Institute (MedStar Physician Based Research Network)
- Endocrine and Metabolic Consultants
- Clinvest Research LLC
- Palm Research Center Tenaya
- Palm Research Center Sunset
- Research Foundation of SUNY - University of Buffalo
- NYU Langone Hospital - Long Island
- NYC Research
- SUNY Upstate Medical University
- Thomas Jefferson University - Clinical Research Institute
- Texas Diabetes & Endocrinology, P.A.
- Velocity Clinical Research, Dallas
- North Texas Endocrine Center
- Research Institute of Dallas
- Biopharma Informatic, LLC
- Amir A Hassan, MD, PA
- Southern Endocrinology Associates
- Texas Diabetes & Endocrinology, P.A.
- Rainier Clinical Research Center
- CEDIC
- Centro de Investigaciones Metabólicas (CINME)
- Consultorio de Investigación Clínica EMO SRL
- CIAD Moron
- Mautalen Salud e Investigación
- Investigaciones Medicas Imoba Srl
- Centro Medico Privado CEMAIC
- Centro Medico Privado San Vicente Diabetes
- Centro de Salud e Investigaciones Médicas
- CIPADI - Centro Integral de Prevencion y Atencion en Diabetes
- Centro de Investigaciones Médicas Tucuman
- Clínica Mayo
- Instituto Médico Especializado (IME)
- Centro Diabetológico Dr. Waitman
- Nirmal Hospital Pvt Ltd.
- Victoria Hospital, Bangalore Medical College And Research Institute
- Kumudini Devi Diabetes Research Center
- Tosaki Clinic for Diabetes and Endocrinology
- Yuri Ono Clinic
- Manda Memorial Hospital
- MinamiAkatsukaClinic
- Nakakinen clinic
- Noritake Clinic
- Takai Internal Medicine Clinic
- Takatsuki Red Cross Hospital
- Shimizu Clinic Fusa
- The Institute of Medical Science, Asahi Life Foundation
- Hachioji Diabetes Clinic
- Clinic Masae Minami
- Jinnouchi Hospital
- Heiwadai Hospital
- Abe Clinic
- Gabinety TERPA
- NZOZ Przychodnia Specjalistyczna Medica
- Centrum Medyczne "Diabetika"
- Centralny Szpital Kliniczny MSWiA w Warszawie
- NBR Polska
- Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
- SN ZOZ Lege Artis Poradnia Diabetologiczna
- NZOZ Specjalistyczny Ośrodek Internistyczno-Diabetologiczny
- Centrum Badan Klinicznych PI-House sp. z o.o.
- Private Practice - Dr. Janusz Gumprecht
- Advanced Clinical Research, LLC
- Mgcendo Llc
- Tatratrial s.r.o.
- FUNKYSTUFF s.r.o.
- ENDIAMED s.r.o
- Changhua Christian Hospital
- Chung Shan Medical University Hospital
- Taichung Veterans General Hospital
- Chi Mei Medical Center
- Taipei Veterans General Hospital
- National Cheng Kung University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Insulin Efsitora Alfa
Insulin Degludec
Arm Description
Participants will receive insulin efsitora alfa by subcutaneously (SC)
Participants will receive insulin degludec SC
Outcomes
Primary Outcome Measures
Change from Baseline in Hemoglobin A1c (HbA1c)
Secondary Outcome Measures
Time in Glucose Range
Time in glucose range between 70 and 180 milligram/deciliter (mg/dL) [3.9 and 10.0 millimole/liter (mmol/L)] inclusive, measured by continued glucose monitoring (CGM) 4 weeks prior to week 26
Nocturnal Hypoglycemia Event Rate
The event rate of participant-reported clinically significant nocturnal hypoglycemia (<54 mg/dL or severe) measured during treatment phase up to week 52.
Change from Baseline in Fasting Glucose
Change from baseline in fasting glucose measured by self-monitoring of blood glucose (SMBG).
Glucose Variability
Glucose variability measured by CGM 4 weeks prior to week 26
Basal Insulin Dose
Bolus Insulin Dose
Total Insulin Dose
Rate of Composite Level 2 and 3 Hypoglycemia Events
Change from Baseline in Body Weight
Time in Hypoglycemia Range
Time in hypoglycemia range defined as time in hypoglycemia with glucose <54 mg/dL, measured by CGM 4 weeks prior to week 26.
Time in Hyperglycemia Range
Time in hyperglycemia range defined as glucose >180 mg/dL, measured by CGM 4 weeks prior to week 26.
Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ)
DTSQ consists of 8 items and assesses the overall treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia.
Change from Baseline in Short Form-36 Version 2 (SF-36 v2) Acute Form Domain Scores
SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05463744
Brief Title
A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy
Acronym
QWINT-5
Official Title
A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 12, 2022 (Actual)
Primary Completion Date
May 6, 2024 (Anticipated)
Study Completion Date
May 6, 2024 (Anticipated)
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
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The main purpose of this study is to measure the safety and efficacy of insulin efsitora alfa (LY3209590) compared with insulin degludec in participants with type 1 diabetes treated with multiple daily injection therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Diabetes
Keywords
Type 1 Diabetes (T1D)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
692 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Insulin Efsitora Alfa
Arm Type
Experimental
Arm Description
Participants will receive insulin efsitora alfa by subcutaneously (SC)
Arm Title
Insulin Degludec
Arm Type
Active Comparator
Arm Description
Participants will receive insulin degludec SC
Intervention Type
Drug
Intervention Name(s)
Insulin Efsitora Alfa
Other Intervention Name(s)
LY3209590 and Basal Insulin-FC
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)
Time Frame
Baseline, Week 26
Secondary Outcome Measure Information:
Title
Time in Glucose Range
Description
Time in glucose range between 70 and 180 milligram/deciliter (mg/dL) [3.9 and 10.0 millimole/liter (mmol/L)] inclusive, measured by continued glucose monitoring (CGM) 4 weeks prior to week 26
Time Frame
Week 22 to Week 26
Title
Nocturnal Hypoglycemia Event Rate
Description
The event rate of participant-reported clinically significant nocturnal hypoglycemia (<54 mg/dL or severe) measured during treatment phase up to week 52.
Time Frame
Baseline to Week 52
Title
Change from Baseline in Fasting Glucose
Description
Change from baseline in fasting glucose measured by self-monitoring of blood glucose (SMBG).
Time Frame
Baseline, Week 26
Title
Glucose Variability
Description
Glucose variability measured by CGM 4 weeks prior to week 26
Time Frame
Week 22 to Week 26
Title
Basal Insulin Dose
Time Frame
Week 26
Title
Bolus Insulin Dose
Time Frame
Week 26
Title
Total Insulin Dose
Time Frame
Week 26
Title
Rate of Composite Level 2 and 3 Hypoglycemia Events
Time Frame
Baseline to Week 52
Title
Change from Baseline in Body Weight
Time Frame
Baseline, Week 26
Title
Time in Hypoglycemia Range
Description
Time in hypoglycemia range defined as time in hypoglycemia with glucose <54 mg/dL, measured by CGM 4 weeks prior to week 26.
Time Frame
Week 22 to Week 26
Title
Time in Hyperglycemia Range
Description
Time in hyperglycemia range defined as glucose >180 mg/dL, measured by CGM 4 weeks prior to week 26.
Time Frame
Week 22 to Week 26
Title
Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ)
Description
DTSQ consists of 8 items and assesses the overall treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia.
Time Frame
Baseline, Week 26
Title
Change from Baseline in Short Form-36 Version 2 (SF-36 v2) Acute Form Domain Scores
Description
SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality.
Time Frame
Baseline, Week 26
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a clinical diagnosis of type 1 diabetes for at least 1 year prior to screening
Have received treatment with basal-bolus insulin analog multiple daily injection therapy according to the local product label for at least 90 days prior to screening
Have an HbA1c value of 7.0% to 10.0%, inclusive, as determined by the central laboratory at screening.
Have a body mass index of ≤35 kilogram/square meter (kg/m²)
Exclusion Criteria:
Have a diagnosis of type 2 diabetes, latent autoimmune diabetes, or specific types of diabetes other than type 1 diabetes
Have a history of more than 1 episode of severe hypoglycemia, within the 6 months prior to screening.
Have a history of more than 1 episode of diabetic ketoacidosis or hyperosmolar state or coma requiring hospitalization within the 6 months 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 Chair
Facility Information:
Facility Name
John Muir Physician Network Research Center
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Valley Research
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Catalina Research Institute, LLC
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Facility Name
Sansum Diabetes Research Institute
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
University Clinical Investigators, Inc.
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Northeast Research Institute (NERI)
City
Fleming Island
State/Province
Florida
ZIP/Postal Code
32003
Country
United States
Facility Name
Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33312
Country
United States
Facility Name
Suncoast Clinical Research, Inc.
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Hanson Clinical Research Center
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
East Coast Institute for Research, LLC
City
Macon
State/Province
Georgia
ZIP/Postal Code
31210
Country
United States
Facility Name
East-West Medical Research Institute
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Rocky Mountain Clinical Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Iowa Diabetes and Endocrinology Research Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Cotton O'Neil Clinical Research Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
MedStar Health Research Institute (MedStar Physician Based Research Network)
City
Hyattsville
State/Province
Maryland
ZIP/Postal Code
20782
Country
United States
Facility Name
Endocrine and Metabolic Consultants
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Clinvest Research LLC
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Palm Research Center Tenaya
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Palm Research Center Sunset
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Research Foundation of SUNY - University of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
NYU Langone Hospital - Long Island
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
NYC Research
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Thomas Jefferson University - Clinical Research Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Texas Diabetes & Endocrinology, P.A.
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Velocity Clinical Research, Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
North Texas Endocrine Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Research Institute of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Biopharma Informatic, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77043
Country
United States
Facility Name
Amir A Hassan, MD, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Facility Name
Southern Endocrinology Associates
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Facility Name
Texas Diabetes & Endocrinology, P.A.
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Rainier Clinical Research Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
CEDIC
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1060ABN
Country
Argentina
Facility Name
Centro de Investigaciones Metabólicas (CINME)
City
Ciudad Autónoma de Buenos Aire
State/Province
Buenos Aires
ZIP/Postal Code
1056
Country
Argentina
Facility Name
Consultorio de Investigación Clínica EMO SRL
City
Ciudad Autonoma de Buenos Aire
State/Province
Buenos Air
ZIP/Postal Code
C1405BUB
Country
Argentina
Facility Name
CIAD Moron
City
Moron
State/Province
Buenos Air
ZIP/Postal Code
B1708EPE
Country
Argentina
Facility Name
Mautalen Salud e Investigación
City
Buenos Aires
State/Province
Ciudad Autónoma De Buenos Aire
ZIP/Postal Code
C1128AAF
Country
Argentina
Facility Name
Investigaciones Medicas Imoba Srl
City
Buenos Aires
State/Province
Ciudad Autónoma De Buenos Aire
ZIP/Postal Code
C1179AAB
Country
Argentina
Facility Name
Centro Medico Privado CEMAIC
City
Capital
State/Province
Córdoba
ZIP/Postal Code
X5008HHW
Country
Argentina
Facility Name
Centro Medico Privado San Vicente Diabetes
City
Cordoba
State/Province
Córdoba
ZIP/Postal Code
5006
Country
Argentina
Facility Name
Centro de Salud e Investigaciones Médicas
City
Santa Rosa
State/Province
La Pampa
ZIP/Postal Code
6300
Country
Argentina
Facility Name
CIPADI - Centro Integral de Prevencion y Atencion en Diabetes
City
Godoy Cruz
State/Province
Mendoza
ZIP/Postal Code
M5501ARP
Country
Argentina
Facility Name
Centro de Investigaciones Médicas Tucuman
City
SAN M. DE Tucuman
State/Province
Tucumán
ZIP/Postal Code
T4000AXL
Country
Argentina
Facility Name
Clínica Mayo
City
San Miguel de Tucuman
State/Province
Tucumán
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Instituto Médico Especializado (IME)
City
Buenos Aires
ZIP/Postal Code
1405
Country
Argentina
Facility Name
Centro Diabetológico Dr. Waitman
City
Córdoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Nirmal Hospital Pvt Ltd.
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395002
Country
India
Facility Name
Victoria Hospital, Bangalore Medical College And Research Institute
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560002
Country
India
Facility Name
Kumudini Devi Diabetes Research Center
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500072
Country
India
Facility Name
Tosaki Clinic for Diabetes and Endocrinology
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
468-0009
Country
Japan
Facility Name
Yuri Ono Clinic
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0001
Country
Japan
Facility Name
Manda Memorial Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0062
Country
Japan
Facility Name
MinamiAkatsukaClinic
City
Mito
State/Province
Ibaraki
ZIP/Postal Code
311-4153
Country
Japan
Facility Name
Nakakinen clinic
City
Naka
State/Province
Ibaraki
ZIP/Postal Code
311-0113
Country
Japan
Facility Name
Noritake Clinic
City
Ushiku
State/Province
Ibaraki
ZIP/Postal Code
300-1207
Country
Japan
Facility Name
Takai Internal Medicine Clinic
City
Kamakura-shi
State/Province
Kanagawa
ZIP/Postal Code
247-0056
Country
Japan
Facility Name
Takatsuki Red Cross Hospital
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-1096
Country
Japan
Facility Name
Shimizu Clinic Fusa
City
Saitama-shi
State/Province
Saitama
ZIP/Postal Code
336-0967
Country
Japan
Facility Name
The Institute of Medical Science, Asahi Life Foundation
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0002
Country
Japan
Facility Name
Hachioji Diabetes Clinic
City
Hachioji-shi
State/Province
Tokyo
ZIP/Postal Code
192-0083
Country
Japan
Facility Name
Clinic Masae Minami
City
Fukuoka
ZIP/Postal Code
815-0071
Country
Japan
Facility Name
Jinnouchi Hospital
City
Kumamoto
ZIP/Postal Code
862-0976
Country
Japan
Facility Name
Heiwadai Hospital
City
Miyazaki
ZIP/Postal Code
880-0034
Country
Japan
Facility Name
Abe Clinic
City
Oita
ZIP/Postal Code
870-0039
Country
Japan
Facility Name
Gabinety TERPA
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-333
Country
Poland
Facility Name
NZOZ Przychodnia Specjalistyczna Medica
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-538
Country
Poland
Facility Name
Centrum Medyczne "Diabetika"
City
Radom
State/Province
Mazowieckie
ZIP/Postal Code
26-600
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSWiA w Warszawie
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-507
Country
Poland
Facility Name
NBR Polska
City
Warszawa
State/Province
Mazowiecki
ZIP/Postal Code
00-710
Country
Poland
Facility Name
Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
City
Krakow
State/Province
Małopolskie
ZIP/Postal Code
31-261
Country
Poland
Facility Name
SN ZOZ Lege Artis Poradnia Diabetologiczna
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-404
Country
Poland
Facility Name
NZOZ Specjalistyczny Ośrodek Internistyczno-Diabetologiczny
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-435
Country
Poland
Facility Name
Centrum Badan Klinicznych PI-House sp. z o.o.
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-546
Country
Poland
Facility Name
Private Practice - Dr. Janusz Gumprecht
City
Zabrze
State/Province
Śląskie
ZIP/Postal Code
41-800
Country
Poland
Facility Name
Advanced Clinical Research, LLC
City
Bayamon
ZIP/Postal Code
00960
Country
Puerto Rico
Facility Name
Mgcendo Llc
City
San Juan
ZIP/Postal Code
00921
Country
Puerto Rico
Facility Name
Tatratrial s.r.o.
City
Rožňava
State/Province
Košický Kraj
ZIP/Postal Code
04801
Country
Slovakia
Facility Name
FUNKYSTUFF s.r.o.
City
Nove Zamky
State/Province
Nitriansky Kraj
ZIP/Postal Code
940 02
Country
Slovakia
Facility Name
ENDIAMED s.r.o
City
Dolny Kubin
State/Province
Žilinský Kraj
ZIP/Postal Code
026 01
Country
Slovakia
Facility Name
Changhua Christian Hospital
City
Changhua County
State/Province
Changhua
ZIP/Postal Code
50006
Country
Taiwan
Facility Name
Chung Shan Medical University Hospital
City
Taichung City
State/Province
Taichung
ZIP/Postal Code
402
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung City
State/Province
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Chi Mei Medical Center
City
Tainan City
State/Province
Tainan
ZIP/Postal Code
71004
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei City
State/Province
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual participant 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
http://vivli.org/
Links:
URL
https://trials.lilly.com/en-US/trial/351115
Description
A Study of LY3209590 Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy (QWINT-5)
Learn more about this trial
A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy
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