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A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin

Primary Purpose

Type 2 Diabetes

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Insulin Efsitora Alfa
Insulin Degludec
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

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

Inclusion Criteria:

  • Have been diagnosed with Type 2 diabetes according to the World Health Organization (WHO) criteria treated with basal insulin
  • Are receiving ≥10 units of basal insulin per day and ≤110 units per day at screening
  • Have HbA1c value of 6.5% - 10% inclusive, at screening
  • Have a Body mass index (BMI) less than or equal to 45 kilogram/square meter (kg/m²)

  • Have been treated with one of the following stable insulin regimens at least 90 days prior to screening:

    • once daily U100 or U200 of insulin degludec
    • once daily U100 or U300 of insulin glargine
    • once or twice daily U100 of insulin detemir, or
    • once or twice daily human insulin NPH

  • acceptable non insulin glucose lowering therapies may include 0 to up to 3 of the following:

    • dipeptidyl peptidase (DPP-4) IV inhibitors
    • SGLT2 inhibitors
    • metformin
    • alphaglucosidase inhibitors or,
    • Glucagon-Like Peptide-1 (GLP-1) receptor agonists
    • Participants must be willing to stay on stable dose throughout the study

Exclusion Criteria:

  • Have Type 1 diabetes mellitus
  • Have acute or chronic hepatitis, cirrhosis, or obvious clinical signs or symptoms of any other liver disease, except Nonalcoholic Fatty Liver Disease (NAFLD)
  • Estimated glomerular filtration rate (eGFR) <20 milliliters/minute/1.73 square meter (m²)
  • Have active or untreated malignancy
  • Are pregnant
  • Have a significant weight gain or loss the past 3 months

  • Have received anytime in the past 6 months, any of the following insulin therapies:

    • prandial insulin
    • insulin mixtures
    • inhaled insulin
    • U-500 insulin, or
    • continuous subcutaneous insulin infusion therapy

  • Have had any of New York Heart Association Class IV heart failure or any of the following CV conditions in the past 3 months:

    • acute myocardial infarctions
    • cerebrovascular accident (stroke), or
    • coronary bypass surgery
  • Gastrointestinal: have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery (Lap-Band) or sleeve gastrectomy within 1 year prior to screening

Sites / Locations

  • Medical Investigations
  • John Muir Physician Network Research Center
  • AMCR Institute
  • Valley Research
  • Velocity Clinical Research, Huntington Park
  • Scripps Whittier Diabetes Institute
  • Diabetes Associates Medical Group
  • University Clinical Investigators, Inc.
  • Chase Medical Research, LLC
  • Encore Medical Research
  • New Horizon Research Center
  • Suncoast Clinical Research, Inc.
  • West Orange Endocrinology
  • Balanced Life Health Care Solutions/SKYCRNG
  • Rocky Mountain Clinical Research
  • American Health Network of Indiana, LLC - Avon
  • Iowa Diabetes and Endocrinology Research Center
  • L-MARC Research Center
  • Endocrine and Metabolic Consultants
  • Joslin Diabetes Center
  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
  • HealthPartners Institute dba International Diabetes Center
  • SKY Clinical Research Network Group - Hall
  • Clinvest Research LLC
  • Palm Research Center Tenaya
  • Albany Medical College, Division of Community Endocrinology
  • NYC Research
  • Lillestol Research
  • Aventiv Research Inc
  • Alliance for Multispecialty Research, LLC
  • Heritage Valley Medical Group, Inc.
  • Jefferson Clinical Research Institute (JCRI)
  • Preferred Primary Care Physicians
  • Gadolin Research
  • Velocity Clinical Research, Dallas
  • Juno Research
  • Biopharma Informatic, LLC
  • Southern Endocrinology Associates
  • Texas Diabetes & Endocrinology, P.A.
  • Consano Clinical Research, LLC
  • Rainier Clinical Research Center
  • Centro de Investigaciones Metabólicas (CINME)
  • Instituto de Investigaciones Clínicas Mar del Plata
  • Go Centro Medico San Nicolás
  • Consultorio de Investigación Clínica EMO SRL
  • Stat Research S.A.
  • Centro Médico Viamonte
  • Mautalen Salud e Investigación
  • Instituto Centenario
  • Centro Medico Privado CEMAIC
  • CIPADI - Centro Integral de Prevencion y Atencion en Diabetes
  • Instituto Médico Catamarca IMEC
  • CEMEDIC
  • CENUDIAB
  • Centro Diabetológico Dr. Waitman
  • DRC Gyógyszervizsgáló Központ
  • Kanizsai Dorottya Korhaz
  • Zala Megyei Szent Rafael Kórház
  • Szent Margit Rendelointézet
  • Szent János Kórház
  • Strazsahegy Medicina Bt.
  • Tokuyama Clinic
  • Yuri Ono Clinic
  • Nakamoto Internal Medicine Clinic
  • Kozawa Eye Hospital and Diabetes Center
  • Noritake Clinic
  • Matoba Internal Medicine Clinic
  • Takai Internal Medicine Clinic
  • Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
  • Shiraiwa Medical Clinic
  • Takatsuki Red Cross Hospital
  • Shimizu Clinic Fusa
  • Oyama East Clinic
  • The Institute of Medical Science, Asahi Life Foundation
  • Tokyo-Eki Center-building Clinic
  • Medical Corporation Chiseikai Tokyo Center Clinic
  • Fukuwa Clinic
  • Jinnouchi Hospital
  • Heiwadai Hospital
  • Abe Clinic
  • AMC Nishiumeda Clinic
  • Kangwon National University Hospital
  • Wonju Severance Christian Hospital
  • Korea University Ansan Hospital
  • Hanyang University Guri Hospital
  • Yeungnam Univeristy Medical Center
  • Inje University Sanggye Paik Hospital
  • Asan Medical Center
  • Hallym University Kangnam Sacred Heart Hospital
  • Kyung Hee University Hospital at Gangdong
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Ulsan University Hospital
  • CenterMed Lublin NZOZ
  • Gabinety TERPA
  • NZOZ Medica
  • Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
  • Centrum Zdrowia Tuchów
  • Centrum Badan Klinicznych PI-House sp. z o.o.
  • OMEDICA Medical Center
  • Gaja Poradnie Lekarskie Maciej Wiza
  • Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
  • IRMED
  • NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
  • Mgcendo Llc
  • GCM Medical Group, PSC - Hato Rey Site
  • MediVet s.r.o.
  • Human Care s.r.o.
  • Areteus s.r.o.
  • MEDI-DIA s.r.o.
  • Diacrin .s.ro.
  • DIA-MED CENTRUM s.r.o.
  • ENDIAMED s.r.o
  • CHUAC-Complejo Hospitalario Universitario A Coruña
  • Centro Periférico de Especialidades Bola Azul
  • Hospital Universitario Virgen de la Victoria
  • Hospital Quiron Infanta Luisa
  • Clínica Juaneda
  • Hospital Universitari Vall d'Hebron
  • Hospital Universitario Marqués de Valdecilla
  • Vithas Hospital Sevilla
  • Hospital Universitario de La Ribera
  • Hospital General Universitario de Valencia
  • Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
  • Chung Shan Medical University Hospital
  • Taichung Veterans General Hospital
  • Chi Mei Medical Center
  • Fu Jen Catholic University Hospital
  • National Cheng Kung University Hospital
  • Taipei Veterans General 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 be given insulin efsitora alfa subcutaneously (SC).

Participants with be given insulin degludec SC.

Outcomes

Primary Outcome Measures

Change from Baseline in Hemoglobin A1c (HbA1c)
Change from Baseline in HbA1c of insulin efsitora alfa compared to insulin degludec on glycemic control in participants with type 2 diabetes currently on basal insulin.

Secondary Outcome Measures

Nocturnal Hypoglycemia Event Rate
The event rate of participant-reported clinically significant nocturnal hypoglycemia (<54 milligram/deciliter (mg/dL) or severe) measured during treatment phase up to Week 78.
Time in Range
Time in glucose range between 70 and 180 mg/dL inclusive measured by continued glucose monitoring (CGM) during a 4-week CGM session.
Change from Baseline in Fasting Glucose
Fasting glucose measured by Self-Monitoring of Blood Glucose (SMBG).
Weekly Insulin dose
The weekly insulin dose calculated based on participant entry of daily or weekly insulin dose in an electronic diary.
Level 2 or Level 3 Nocturnal Hypoglycemia Event Rate
The event rate of participant-reported clinically significant nocturnal hypoglycemia (<54 milligram/deciliter (mg/dL) or severe) measured during treatment phase.
Change from Baseline in Body Weight
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 during the CGM session.
Time in Hyperglycemia Range
Time in hyperglycemia range defined as time in hyperglycemia with glucose >180 mg/dL measured during the CGM session.
Change from Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D)
TRIM-D assesses the impact of diabetes treatment on participants' functioning and well-being across available diabetes treatment.
Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ)
DTSQ assesses the overall treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia.
Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ)
DTSQ assesses the overall treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia.

Full Information

First Posted
March 3, 2022
Last Updated
April 12, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT05275400
Brief Title
A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin
Official Title
A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Trial to Evaluate the Efficacy and Safety of LY3209590 Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin (QWINT-3)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 8, 2022 (Actual)
Primary Completion Date
May 14, 2024 (Anticipated)
Study Completion Date
May 14, 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 reason for this study is to see if the study drug insulin efsitora alfa (LY3209590) is safe and effective in participants with Type 2 diabetes that have already been treated with basal insulin. The study consists of a 3-week screening/lead-in period, a 78-week treatment period and a 5-week safety follow-up period. The study will last up to 86 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
986 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insulin Efsitora Alfa
Arm Type
Experimental
Arm Description
Participants will be given insulin efsitora alfa subcutaneously (SC).
Arm Title
Insulin Degludec
Arm Type
Active Comparator
Arm Description
Participants with be given 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)
Description
Change from Baseline in HbA1c of insulin efsitora alfa compared to insulin degludec on glycemic control in participants with type 2 diabetes currently on basal insulin.
Time Frame
Baseline, Week 26
Secondary Outcome Measure Information:
Title
Nocturnal Hypoglycemia Event Rate
Description
The event rate of participant-reported clinically significant nocturnal hypoglycemia (<54 milligram/deciliter (mg/dL) or severe) measured during treatment phase up to Week 78.
Time Frame
Baseline to Week 78
Title
Time in Range
Description
Time in glucose range between 70 and 180 mg/dL inclusive measured by continued glucose monitoring (CGM) during a 4-week CGM session.
Time Frame
Week 22 to Week 26
Title
Change from Baseline in Fasting Glucose
Description
Fasting glucose measured by Self-Monitoring of Blood Glucose (SMBG).
Time Frame
Baseline, Week 26
Title
Weekly Insulin dose
Description
The weekly insulin dose calculated based on participant entry of daily or weekly insulin dose in an electronic diary.
Time Frame
Week 26
Title
Level 2 or Level 3 Nocturnal Hypoglycemia Event Rate
Description
The event rate of participant-reported clinically significant nocturnal hypoglycemia (<54 milligram/deciliter (mg/dL) or severe) measured during treatment phase.
Time Frame
Baseline to Week 78
Title
Change from Baseline in Body Weight
Description
Change from baseline in body weight
Time Frame
Baseline, Week 78
Title
Time in Hypoglycemia Range
Description
Time in hypoglycemia range defined as time in hypoglycemia with glucose <54 mg/dL measured during the CGM session.
Time Frame
Week 22 to Week 26
Title
Time in Hyperglycemia Range
Description
Time in hyperglycemia range defined as time in hyperglycemia with glucose >180 mg/dL measured during the CGM session.
Time Frame
Week 22 to Week 26
Title
Change from Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D)
Description
TRIM-D assesses the impact of diabetes treatment on participants' functioning and well-being across available diabetes treatment.
Time Frame
Baseline, Week 26
Title
Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ)
Description
DTSQ assesses the overall treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia.
Time Frame
Baseline, Week 26
Title
Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ)
Description
DTSQ assesses the overall treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia.
Time Frame
Baseline, Week 78

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have been diagnosed with Type 2 diabetes according to the World Health Organization (WHO) criteria treated with basal insulin Are receiving ≥10 units of basal insulin per day and ≤110 units per day at screening Have HbA1c value of 6.5% - 10% inclusive, at screening Have a Body mass index (BMI) less than or equal to 45 kilogram/square meter (kg/m²) Have been treated with one of the following stable insulin regimens at least 90 days prior to screening: once daily U100 or U200 of insulin degludec once daily U100 or U300 of insulin glargine once or twice daily U100 of insulin detemir, or once or twice daily human insulin NPH acceptable non insulin glucose lowering therapies may include 0 to up to 3 of the following: dipeptidyl peptidase (DPP-4) IV inhibitors SGLT2 inhibitors metformin alphaglucosidase inhibitors or, Glucagon-Like Peptide-1 (GLP-1) receptor agonists Participants must be willing to stay on stable dose throughout the study Exclusion Criteria: Have Type 1 diabetes mellitus Have acute or chronic hepatitis, cirrhosis, or obvious clinical signs or symptoms of any other liver disease, except Nonalcoholic Fatty Liver Disease (NAFLD) Estimated glomerular filtration rate (eGFR) <20 milliliters/minute/1.73 square meter (m²) Have active or untreated malignancy Are pregnant Have a significant weight gain or loss the past 3 months Have received anytime in the past 6 months, any of the following insulin therapies: prandial insulin insulin mixtures inhaled insulin U-500 insulin, or continuous subcutaneous insulin infusion therapy Have had any of New York Heart Association Class IV heart failure or any of the following CV conditions in the past 3 months: acute myocardial infarctions cerebrovascular accident (stroke), or coronary bypass surgery Gastrointestinal: have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery (Lap-Band) or sleeve gastrectomy within 1 year 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
Medical Investigations
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
John Muir Physician Network Research Center
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
AMCR Institute
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Valley Research
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Velocity Clinical Research, Huntington Park
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
Scripps Whittier Diabetes Institute
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Diabetes Associates Medical Group
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University Clinical Investigators, Inc.
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Chase Medical Research, LLC
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Encore Medical Research
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
New Horizon Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
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
West Orange Endocrinology
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Balanced Life Health Care Solutions/SKYCRNG
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Rocky Mountain Clinical Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
American Health Network of Indiana, LLC - Avon
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
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
L-MARC Research Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Endocrine and Metabolic Consultants
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Joslin Diabetes Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
HealthPartners Institute dba International Diabetes Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
SKY Clinical Research Network Group - Hall
City
Fayette
State/Province
Mississippi
ZIP/Postal Code
39069
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
Albany Medical College, Division of Community Endocrinology
City
Albany
State/Province
New York
ZIP/Postal Code
12203
Country
United States
Facility Name
NYC Research
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Lillestol Research
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Aventiv Research Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Heritage Valley Medical Group, Inc.
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Facility Name
Jefferson Clinical Research Institute (JCRI)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Preferred Primary Care Physicians
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
Gadolin Research
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Facility Name
Velocity Clinical Research, Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Juno Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77040
Country
United States
Facility Name
Biopharma Informatic, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77043
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
Consano Clinical Research, LLC
City
Shavano Park
State/Province
Texas
ZIP/Postal Code
78231
Country
United States
Facility Name
Rainier Clinical Research Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
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
Instituto de Investigaciones Clínicas Mar del Plata
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
7600
Country
Argentina
Facility Name
Go Centro Medico San Nicolás
City
San Nicolas
State/Province
Buenos Aires
ZIP/Postal Code
2900
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
Stat Research S.A.
City
Ciudad Autónoma de Buenos Aire
State/Province
Buenos Air
ZIP/Postal Code
C1023AAB
Country
Argentina
Facility Name
Centro Médico Viamonte
City
Buenos Aires
State/Province
Ciudad Aut
ZIP/Postal Code
C1120AAC
Country
Argentina
Facility Name
Mautalen Salud e Investigación
City
Buenos Aires
State/Province
Ciudad Aut
ZIP/Postal Code
C1128AAF
Country
Argentina
Facility Name
Instituto Centenario
City
Caba
State/Province
Ciudad Autónoma De Buenos Aire
ZIP/Postal Code
1204
Country
Argentina
Facility Name
Centro Medico Privado CEMAIC
City
Capital
State/Province
Córdoba
ZIP/Postal Code
X5008HHW
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
Instituto Médico Catamarca IMEC
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
CEMEDIC
City
Buenos Aires
ZIP/Postal Code
1407
Country
Argentina
Facility Name
CENUDIAB
City
Ciudad Autónoma de Buenos Aire
ZIP/Postal Code
C1440AAD
Country
Argentina
Facility Name
Centro Diabetológico Dr. Waitman
City
Córdoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
DRC Gyógyszervizsgáló Központ
City
Balatonfüred
State/Province
Veszprém
ZIP/Postal Code
8230
Country
Hungary
Facility Name
Kanizsai Dorottya Korhaz
City
Nagykanizsa
State/Province
Zala
ZIP/Postal Code
8800
Country
Hungary
Facility Name
Zala Megyei Szent Rafael Kórház
City
Zalaegerszeg
State/Province
Zala
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Szent Margit Rendelointézet
City
Budapest
ZIP/Postal Code
1032
Country
Hungary
Facility Name
Szent János Kórház
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Strazsahegy Medicina Bt.
City
Budapest
ZIP/Postal Code
H1171
Country
Hungary
Facility Name
Tokuyama Clinic
City
Mihama-ku,Chiba City
State/Province
Chiba
ZIP/Postal Code
261-0004
Country
Japan
Facility Name
Yuri Ono Clinic
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0001
Country
Japan
Facility Name
Nakamoto Internal Medicine Clinic
City
Mito
State/Province
Ibaraki
ZIP/Postal Code
310-0826
Country
Japan
Facility Name
Kozawa Eye Hospital and Diabetes Center
City
Mito
State/Province
Ibaraki
ZIP/Postal Code
310-0845
Country
Japan
Facility Name
Noritake Clinic
City
Ushiku
State/Province
Ibaraki
ZIP/Postal Code
300-1207
Country
Japan
Facility Name
Matoba Internal Medicine Clinic
City
Ebina
State/Province
Kanagawa
ZIP/Postal Code
243-0432
Country
Japan
Facility Name
Takai Internal Medicine Clinic
City
Kamakura-shi
State/Province
Kanagawa
ZIP/Postal Code
247-0056
Country
Japan
Facility Name
Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
City
Yamato-shi
State/Province
Kanagawa
ZIP/Postal Code
242-0004
Country
Japan
Facility Name
Shiraiwa Medical Clinic
City
Kashiwara
State/Province
Osaka
ZIP/Postal Code
582-0005
Country
Japan
Facility Name
Takatsuki Red Cross Hospital
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-1045
Country
Japan
Facility Name
Shimizu Clinic Fusa
City
Saitama-shi
State/Province
Saitama
ZIP/Postal Code
336-0967
Country
Japan
Facility Name
Oyama East Clinic
City
Oyama
State/Province
Tochigi
ZIP/Postal Code
323-0022
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
Tokyo-Eki Center-building Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0027
Country
Japan
Facility Name
Medical Corporation Chiseikai Tokyo Center Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0028
Country
Japan
Facility Name
Fukuwa Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0031
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
AMC Nishiumeda Clinic
City
Osaka
ZIP/Postal Code
530-0001
Country
Japan
Facility Name
Kangwon National University Hospital
City
Chuncheon-si
State/Province
Kang-won-do
ZIP/Postal Code
24289
Country
Korea, Republic of
Facility Name
Wonju Severance Christian Hospital
City
Wonju
State/Province
Kang-won-do
ZIP/Postal Code
26426
Country
Korea, Republic of
Facility Name
Korea University Ansan Hospital
City
Ansan-si
State/Province
Kyǒnggi-do
ZIP/Postal Code
15355
Country
Korea, Republic of
Facility Name
Hanyang University Guri Hospital
City
Guri-si
State/Province
Kyǒnggi-do
ZIP/Postal Code
11923
Country
Korea, Republic of
Facility Name
Yeungnam Univeristy Medical Center
City
Gyeongsan-si
State/Province
Kyǒngsangbuk-do
ZIP/Postal Code
42415
Country
Korea, Republic of
Facility Name
Inje University Sanggye Paik Hospital
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
01757
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Hallym University Kangnam Sacred Heart Hospital
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
07441
Country
Korea, Republic of
Facility Name
Kyung Hee University Hospital at Gangdong
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
134-090
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
3080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
State/Province
Seoul-teuk
ZIP/Postal Code
3722
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
State/Province
Ulsan-Kwangyǒkshi
ZIP/Postal Code
44033
Country
Korea, Republic of
Facility Name
CenterMed Lublin NZOZ
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-044
Country
Poland
Facility Name
Gabinety TERPA
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-333
Country
Poland
Facility Name
NZOZ Medica
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-538
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
Centrum Zdrowia Tuchów
City
Wierzchosławice
State/Province
Małopolskie
ZIP/Postal Code
33-122
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
OMEDICA Medical Center
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-111
Country
Poland
Facility Name
Gaja Poradnie Lekarskie Maciej Wiza
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
61-251
Country
Poland
Facility Name
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
City
Lodz
State/Province
Łódzkie
ZIP/Postal Code
90338
Country
Poland
Facility Name
IRMED
City
Piotrkow Trybunalski
State/Province
Łódzkie
ZIP/Postal Code
97-300
Country
Poland
Facility Name
NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
City
Ruda Slaska
State/Province
Śląskie
ZIP/Postal Code
41-709
Country
Poland
Facility Name
Mgcendo Llc
City
San Juan
ZIP/Postal Code
00921
Country
Puerto Rico
Facility Name
GCM Medical Group, PSC - Hato Rey Site
City
San Juan
ZIP/Postal Code
917
Country
Puerto Rico
Facility Name
MediVet s.r.o.
City
Malacky
State/Province
Bratislavský Kraj
ZIP/Postal Code
901 01
Country
Slovakia
Facility Name
Human Care s.r.o.
City
Kosice
State/Province
Košický Kraj
ZIP/Postal Code
04001
Country
Slovakia
Facility Name
Areteus s.r.o.
City
Trebisov
State/Province
Košický Kraj
ZIP/Postal Code
075 01
Country
Slovakia
Facility Name
MEDI-DIA s.r.o.
City
Sabinov
State/Province
Prešovský Kraj
ZIP/Postal Code
083 01
Country
Slovakia
Facility Name
Diacrin .s.ro.
City
Bratislava
ZIP/Postal Code
84102
Country
Slovakia
Facility Name
DIA-MED CENTRUM s.r.o.
City
Puchov
ZIP/Postal Code
020 01
Country
Slovakia
Facility Name
ENDIAMED s.r.o
City
Dolny Kubin
State/Province
Žilinský Kraj
ZIP/Postal Code
026 01
Country
Slovakia
Facility Name
CHUAC-Complejo Hospitalario Universitario A Coruña
City
A Coruña
State/Province
A Coruña [La Coruña]
ZIP/Postal Code
15006
Country
Spain
Facility Name
Centro Periférico de Especialidades Bola Azul
City
Almeria
State/Province
Almería
ZIP/Postal Code
04009
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria
City
Malaga
State/Province
Andalucía
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Quiron Infanta Luisa
City
Sevilla
State/Province
Andalucía
ZIP/Postal Code
41010
Country
Spain
Facility Name
Clínica Juaneda
City
Palma de Mallorca
State/Province
Balears [Baleares]
ZIP/Postal Code
07014
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Vithas Hospital Sevilla
City
Seville
State/Province
Sevilla
ZIP/Postal Code
41950
Country
Spain
Facility Name
Hospital Universitario de La Ribera
City
Alzira
State/Province
Valenciana, Comunitat
ZIP/Postal Code
46600
Country
Spain
Facility Name
Hospital General Universitario de Valencia
City
Valencia
State/Province
Valenciana, Comunitat
ZIP/Postal Code
46014
Country
Spain
Facility Name
Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
City
Sevilla
ZIP/Postal Code
41003
Country
Spain
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
Fu Jen Catholic University Hospital
City
New Taipei
ZIP/Postal Code
24352
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
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 European Union (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.lillytrialguide.com/en-US/trial/2r9JxzEnerVifDDkc8VETS
Description
A Study of LY3209590 Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin

Learn more about this trial

A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin

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