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A Study of Insulin Efsitora Alfa (LY3209590) Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-2)

Primary Purpose

Diabetes, 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 Diabetes

Eligibility Criteria

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

Inclusion Criteria:

  • Have diagnosis of T2D according to the World Health Organization Criteria
  • Have an HbA1c of 7.0% - 10% inclusive, at screening
  • Are on a stable treatment of at least 1 antihyperglycemic medication, for at least 3 months prior to screening, and willing to continue the stable treatment for the duration of the study

Exclusion Criteria:

  • Have a diagnosis of T1D, latent autoimmune diabetes, or specific type of diabetes other than T2D, for example, monogenic diabetes, diseases of the exocrine pancreas, or drug induced or chemical-induced diabetes.
  • Have a history of >1 episode of ketoacidosis or hyperosmolar state or coma requiring hospitalization within 6 months prior to screening.
  • Have had severe hypoglycemia episodes within 6 months prior to screening.
  • Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.

  • Have had New York Heart Association Class IV heart failure or any of these cardiovascular conditions within 3 months prior to screening

    • acute myocardial infarction
    • cerebrovascular accident (stroke), or
    • coronary bypass surgery.
  • Have had gastric bypass (bariatric) surgery, restrictive bariatric surgery, for example Lap-Band, or sleeve gastrectomy within 1 year prior to screening
  • Have had significant weight gain or loss within 3 months prior to screening, for example, ≥5%.

Sites / Locations

  • Neighborhood Healthcare Institute of Health
  • Valley Research
  • NorCal Medical Research, Inc
  • Catalina Research Institute, LLC
  • Southern California Dermatology, Inc.
  • New West Physicians Clinical Research
  • New England Research Associates, LLC
  • East Coast Institute for Research, LLC
  • East Coast Institute for Research - Canton
  • Rophe Adult and Pediatric Medicine/SKYCRNG
  • Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
  • Qualmedica Research, LLC
  • Iowa Diabetes and Endocrinology Research Center
  • Qualmedica Research
  • Qualmedica Research, LLC
  • MedStar Health Research Institute (MedStar Physician Based Research Network)
  • Endocrine and Metabolic Consultants
  • SKY Integrative Medical Center/SKYCRNG
  • Clinvest Research LLC
  • Clarity Clinical Research
  • Great Lakes Medical Research, LLC
  • Monroe Biomedical Research
  • Lucas Research, Inc
  • Alliance for Multispecialty Research, LLC
  • Jefferson Clinical Research Institute (JCRI)
  • Tribe Clinical Research, LLC
  • Dallas Diabetes Research Center
  • Juno Research
  • Southern Endocrinology Associates
  • North Hills Family Medicine/North Hills Medical Research
  • Consano Clinical Research, LLC
  • Multicare Institute for Research and Innovation
  • CEDOES
  • CPCLIN
  • Centro de Pesquisa Sao Lucas
  • Hospital São Lucas de Copacabana
  • CPQuali Pesquisa Clínica
  • Hospital das Clinicas FMUSP
  • LMC Diabetes & Endocrinology
  • LMC Diabetes & Endocrinology
  • Aggarwal and Associates Limited
  • LMC Manna Research
  • Bluewater Clinical Research Group Inc.
  • Centricity Research Etobicoke Endocrinology
  • Fadia El Boreky Medicine
  • 9109-0126 Quebec Inc.
  • Beijing Pinggu District Hospital
  • Chongqing General Hospital
  • Hebei Medical University - Harrison International Peace Hospital
  • The First Hospital of Harbin Medical University
  • The First Affiliated Hospital of Henan University of Science &Technology
  • The Second Affiliated Hospital of Zhengzhou University
  • The Second Xiangya Hospital of Central South University
  • The First People's Hospital of Yueyang
  • Changzhou No.2 People's Hospital
  • Nanjing First Hospital
  • The Second Affiliated Hospital of Nanjing Medical University
  • Nanjing Medical University - Nanjing Jiangning Hospital
  • The First Affiliated Hospital of Soochow University
  • The Affiliated Jiangyin Hospital of Southeast University Medical College
  • Wuxi People's Hospital
  • The Third Hospital of Nanchang
  • Jinan Central Hospital
  • Shanghai Putuo District Center Hospital
  • West China Hospital of Sichuan University
  • Chengdu Fifth People's Hospital
  • Tianjin Medical University General Hospital
  • Tianjin Medical University Zhu Xianyi Memorial Hospital
  • Zhejiang Hospital
  • Ningbo First Hospital
  • INTENDIA klinika s.r.o.
  • MUDr. Alena Vachova
  • MUDr. Tomas Hrdina
  • MUDr. Tomas Edelsberger
  • Diahelp s.r.o
  • Milan Kvapil s.r.o., Diabetologicka ambulance
  • Diacentrum Brandys n.L. s.r.o.
  • Praxis Sauter & Sauter & Vorbach
  • InnoDiab Forschung Gmbh
  • Medizentrum Essen Borbeck
  • Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz
  • Zentrum für klinische Studien
  • Universitaetsklinikum Carl Gustav Carus Dresden
  • RED-Institut GmbH
  • Diabeteszentrum Hamburg West
  • Iatriko Paleou Falirou Medical Center
  • Alexandra Hospital
  • Thermi Clinic
  • Athens Euroclinic
  • Tosaki Clinic for Diabetes and Endocrinology
  • Kashiwa City Hospital
  • Tokuyama Clinic
  • Nippon Kokan Fukuyama Hospital
  • Hasegawa Medical Clinic
  • Manda Memorial Hospital
  • MinamiAkatsukaClinic
  • Nakakinen clinic
  • Hayashi Diabetes Internal Medicine Clinic
  • Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
  • Shimizu Clinic Fusa
  • Oyama East Clinic
  • Kumanomae Nishimura Clinic
  • Tokyo-Eki Center-building Clinic
  • Fukuwa Clinic
  • Hachioji Diabetes Clinic
  • Medical Corporation Sato Medical clinic
  • Tomonaga Clinic
  • Yoshimura Clinic
  • Jinnouchi Hospital
  • Abe Clinic
  • Kangwon National University Hospital
  • Hanyang University Guri Hospital
  • Severance Hospital, Yonsei University Health System
  • Investigacion En Salud Y Metabolismo Sc
  • Centro de Endocrinologia y Nutricion
  • Private Practice - Dr. Paola Mansilla-Letelier

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 subcutaneously (SC) once weekly.

Participants will receive insulin degludec SC once daily

Outcomes

Primary Outcome Measures

Change from Baseline in Hemoglobin A1c (HbA1c)
Change from Baseline in HbA1c of insulin efsitora alfa (LY3209590) compared to insulin degludec for the treatment of type 2 diabetes (T2D) in adults.

Secondary Outcome Measures

Change from Baseline in HbA1c
Change from Baseline in HbA1c of insulin efsitora alfa (LY3209590) compared to insulin degludec for participants using glucagon-like peptide-1 (GLP-1) receptor agonists
Change from Baseline in HbA1c
Change from Baseline in HbA1c of insulin efsitora alfa (LY3209590) compared to insulin degludec for participants not using GLP-1 receptor agonists
Time in Glucose Range
Time in glucose range between 70 and 180 milligram/deciliter inclusive, collected during the continued glucose monitoring session prior to week 52.
Change from Baseline in Fasting Glucose
Change from baseline in fasting glucose measured by self-monitoring 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 Events
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 with glucose <54 mg/dL
Time in hypoglycemia with glucose <54 mg/dL measurements collected during continuous glucose monitoring (CGM) sessions collected prior to Week 52
Time in Hyperglycemia range with glucose >180 mg/dL
Time in hypoglycemia with glucose >180 mg/dL measurements collected during CGM sessions collected prior to Week 52
Change from Baseline in Treatment-Related IMPACT Measures-Diabetes (TRIM-D)
TRIM-D assesses the impact of diabetes treatment on participants' functioning and well-being across available diabetes treatments. Each of the 28 items is assessed on a 5-point scale, where higher scores indicate a better health state.
Change from Baseline in Short Form-36 Version 2 Health Survey Acute Form (SF-36)
SF-36 v2 Health Survey Acute form is a participant self-administered measure designed to assess these 8 domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health. Each domain is scored individually. Scoring of each domain and both summary scores, physical and mental component scores, are norm based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10. Higher scores indicate better levels of function and/or better health.
Change from Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L)
EQ-5D-5L assesses 5 dimensions of health mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. The 5L version scores each dimension at 5 levels, no problems, slight problems, moderate problems, severe problems, and unable to perform or extreme problems. Each domain score ranges between less than 0 to 1, where negative values are valued as worse than dead, 0 is a health state equivalent to death, and 1 represents perfect health.

Full Information

First Posted
May 2, 2022
Last Updated
October 19, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT05362058
Brief Title
A Study of Insulin Efsitora Alfa (LY3209590) Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time
Acronym
QWINT-2
Official Title
A Phase 3, Parallel-Design, Open-Label, Randomized Control Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared to Insulin Degludec in Insulin Naïve Adults With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 3, 2022 (Actual)
Primary Completion Date
April 14, 2024 (Anticipated)
Study Completion Date
April 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 purpose of this study is to determine the effect and safety of insulin efsitora alfa (LY3209590) compared to degludec in adult participants with type 2 diabetes who are starting basal insulin for the first time. Additional participants will continue to be enrolled in a maximum extended enrollment cohort.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, 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
912 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Insulin Efsitora Alfa
Arm Type
Experimental
Arm Description
Participants will receive insulin efsitora alfa subcutaneously (SC) once weekly.
Arm Title
Insulin Degludec
Arm Type
Active Comparator
Arm Description
Participants will receive insulin degludec SC once daily
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 (LY3209590) compared to insulin degludec for the treatment of type 2 diabetes (T2D) in adults.
Time Frame
Baseline, Week 52
Secondary Outcome Measure Information:
Title
Change from Baseline in HbA1c
Description
Change from Baseline in HbA1c of insulin efsitora alfa (LY3209590) compared to insulin degludec for participants using glucagon-like peptide-1 (GLP-1) receptor agonists
Time Frame
Baseline, Week 52
Title
Change from Baseline in HbA1c
Description
Change from Baseline in HbA1c of insulin efsitora alfa (LY3209590) compared to insulin degludec for participants not using GLP-1 receptor agonists
Time Frame
Baseline, Week 52
Title
Time in Glucose Range
Description
Time in glucose range between 70 and 180 milligram/deciliter inclusive, collected during the continued glucose monitoring session prior to week 52.
Time Frame
Week 48 to Week 52
Title
Change from Baseline in Fasting Glucose
Description
Change from baseline in fasting glucose measured by self-monitoring blood glucose (SMBG)
Time Frame
Baseline, Week 52
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
Baseline, Week 52
Title
Level 2 or Level 3 Nocturnal Hypoglycemia Events
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 52
Title
Change from Baseline in Body Weight
Description
Change from baseline in body weight
Time Frame
Baseline, Week 52
Title
Time in hypoglycemia range with glucose <54 mg/dL
Description
Time in hypoglycemia with glucose <54 mg/dL measurements collected during continuous glucose monitoring (CGM) sessions collected prior to Week 52
Time Frame
Week 48 to Week 52
Title
Time in Hyperglycemia range with glucose >180 mg/dL
Description
Time in hypoglycemia with glucose >180 mg/dL measurements collected during CGM sessions collected prior to Week 52
Time Frame
Week 48 to Week 52
Title
Change from Baseline in Treatment-Related IMPACT Measures-Diabetes (TRIM-D)
Description
TRIM-D assesses the impact of diabetes treatment on participants' functioning and well-being across available diabetes treatments. Each of the 28 items is assessed on a 5-point scale, where higher scores indicate a better health state.
Time Frame
Baseline, Week 52
Title
Change from Baseline in Short Form-36 Version 2 Health Survey Acute Form (SF-36)
Description
SF-36 v2 Health Survey Acute form is a participant self-administered measure designed to assess these 8 domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health. Each domain is scored individually. Scoring of each domain and both summary scores, physical and mental component scores, are norm based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10. Higher scores indicate better levels of function and/or better health.
Time Frame
Baseline, Week 52
Title
Change from Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L)
Description
EQ-5D-5L assesses 5 dimensions of health mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. The 5L version scores each dimension at 5 levels, no problems, slight problems, moderate problems, severe problems, and unable to perform or extreme problems. Each domain score ranges between less than 0 to 1, where negative values are valued as worse than dead, 0 is a health state equivalent to death, and 1 represents perfect health.
Time Frame
Baseline, Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have diagnosis of T2D according to the World Health Organization Criteria Have an HbA1c of 7.0% - 10% inclusive, at screening Are on a stable treatment of at least 1 antihyperglycemic medication, for at least 3 months prior to screening, and willing to continue the stable treatment for the duration of the study Exclusion Criteria: Have a diagnosis of T1D, latent autoimmune diabetes, or specific type of diabetes other than T2D, for example, monogenic diabetes, diseases of the exocrine pancreas, or drug induced or chemical-induced diabetes. Have a history of >1 episode of ketoacidosis or hyperosmolar state or coma requiring hospitalization within 6 months prior to screening. Have had severe hypoglycemia episodes within 6 months prior to screening. Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c. Have had New York Heart Association Class IV heart failure or any of these cardiovascular conditions within 3 months prior to screening acute myocardial infarction cerebrovascular accident (stroke), or coronary bypass surgery. Have had gastric bypass (bariatric) surgery, restrictive bariatric surgery, for example Lap-Band, or sleeve gastrectomy within 1 year prior to screening Have had significant weight gain or loss within 3 months prior to screening, for example, ≥5%.
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
Neighborhood Healthcare Institute of Health
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
NorCal Medical Research, Inc
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Catalina Research Institute, LLC
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Facility Name
Southern California Dermatology, Inc.
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
New West Physicians Clinical Research
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
New England Research Associates, LLC
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
East Coast Institute for Research, LLC
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
East Coast Institute for Research - Canton
City
Canton
State/Province
Georgia
ZIP/Postal Code
30114
Country
United States
Facility Name
Rophe Adult and Pediatric Medicine/SKYCRNG
City
Union City
State/Province
Georgia
ZIP/Postal Code
30291
Country
United States
Facility Name
Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62711
Country
United States
Facility Name
Qualmedica Research, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47715
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
Qualmedica Research
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Facility Name
Qualmedica Research, LLC
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
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
SKY Integrative Medical Center/SKYCRNG
City
Ridgeland
State/Province
Mississippi
ZIP/Postal Code
39157
Country
United States
Facility Name
Clinvest Research LLC
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Clarity Clinical Research
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
Great Lakes Medical Research, LLC
City
Westfield
State/Province
New York
ZIP/Postal Code
14787
Country
United States
Facility Name
Monroe Biomedical Research
City
Monroe
State/Province
North Carolina
ZIP/Postal Code
28112
Country
United States
Facility Name
Lucas Research, Inc
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Jefferson Clinical Research Institute (JCRI)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Tribe Clinical Research, LLC
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Dallas Diabetes Research Center
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
Southern Endocrinology Associates
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Facility Name
North Hills Family Medicine/North Hills Medical Research
City
North Richland Hills
State/Province
Texas
ZIP/Postal Code
76180
Country
United States
Facility Name
Consano Clinical Research, LLC
City
Shavano Park
State/Province
Texas
ZIP/Postal Code
78231
Country
United States
Facility Name
Multicare Institute for Research and Innovation
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
CEDOES
City
Vitória
State/Province
Espírito Santo
ZIP/Postal Code
29055450
Country
Brazil
Facility Name
CPCLIN
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59025-050
Country
Brazil
Facility Name
Centro de Pesquisa Sao Lucas
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13060-803
Country
Brazil
Facility Name
Hospital São Lucas de Copacabana
City
Rio de Janeiro
ZIP/Postal Code
22061-080
Country
Brazil
Facility Name
CPQuali Pesquisa Clínica
City
São Paulo
ZIP/Postal Code
01228-000
Country
Brazil
Facility Name
Hospital das Clinicas FMUSP
City
São Paulo
ZIP/Postal Code
04266-010
Country
Brazil
Facility Name
LMC Diabetes & Endocrinology
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2H 2G4
Country
Canada
Facility Name
LMC Diabetes & Endocrinology
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6S 0C6
Country
Canada
Facility Name
Aggarwal and Associates Limited
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 0G1
Country
Canada
Facility Name
LMC Manna Research
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2J 0V2
Country
Canada
Facility Name
Bluewater Clinical Research Group Inc.
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
Centricity Research Etobicoke Endocrinology
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9R 4E1
Country
Canada
Facility Name
Fadia El Boreky Medicine
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
9109-0126 Quebec Inc.
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4N 2W2
Country
Canada
Facility Name
Beijing Pinggu District Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101200
Country
China
Facility Name
Chongqing General Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400014
Country
China
Facility Name
Hebei Medical University - Harrison International Peace Hospital
City
Hengshui Shi
State/Province
Hebei
ZIP/Postal Code
053000
Country
China
Facility Name
The First Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Facility Name
The First Affiliated Hospital of Henan University of Science &Technology
City
Luoyang Shi
State/Province
Henan
ZIP/Postal Code
471003
Country
China
Facility Name
The Second Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450014
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Facility Name
The First People's Hospital of Yueyang
City
Yueyang
State/Province
Hunan
ZIP/Postal Code
414000
Country
China
Facility Name
Changzhou No.2 People's Hospital
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213000
Country
China
Facility Name
Nanjing First Hospital
City
Nanjing Shi
State/Province
Jiangsu
ZIP/Postal Code
210012
Country
China
Facility Name
The Second Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210011
Country
China
Facility Name
Nanjing Medical University - Nanjing Jiangning Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
211100
Country
China
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Facility Name
The Affiliated Jiangyin Hospital of Southeast University Medical College
City
Wuxi Shi
State/Province
Jiangsu
ZIP/Postal Code
214400
Country
China
Facility Name
Wuxi People's Hospital
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214003
Country
China
Facility Name
The Third Hospital of Nanchang
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330009
Country
China
Facility Name
Jinan Central Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Facility Name
Shanghai Putuo District Center Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200062
Country
China
Facility Name
West China Hospital of Sichuan University
City
Cheng Du
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Chengdu Fifth People's Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
611130
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Tianjin Medical University Zhu Xianyi Memorial Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
Zhejiang Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310013
Country
China
Facility Name
Ningbo First Hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315010
Country
China
Facility Name
INTENDIA klinika s.r.o.
City
Chrudim III
State/Province
Chrudim
ZIP/Postal Code
537 01
Country
Czechia
Facility Name
MUDr. Alena Vachova
City
Ceske Budejovice
State/Province
Jihočeský
ZIP/Postal Code
37011
Country
Czechia
Facility Name
MUDr. Tomas Hrdina
City
Opocno
State/Province
Královéhradecký Kraj
ZIP/Postal Code
517 73
Country
Czechia
Facility Name
MUDr. Tomas Edelsberger
City
Krnov
State/Province
Moravskosl
ZIP/Postal Code
79401
Country
Czechia
Facility Name
Diahelp s.r.o
City
Pardubice V
State/Province
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Facility Name
Milan Kvapil s.r.o., Diabetologicka ambulance
City
Praha
State/Province
Praha 4
ZIP/Postal Code
14900
Country
Czechia
Facility Name
Diacentrum Brandys n.L. s.r.o.
City
Brandys nad Labem
State/Province
Praha-vých
ZIP/Postal Code
25001
Country
Czechia
Facility Name
Praxis Sauter & Sauter & Vorbach
City
Wangen im Allgäu
State/Province
Baden-Württemberg
ZIP/Postal Code
88239
Country
Germany
Facility Name
InnoDiab Forschung Gmbh
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Medizentrum Essen Borbeck
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45355
Country
Germany
Facility Name
Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz
City
Ludwigshafen am Rhein
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67059
Country
Germany
Facility Name
Zentrum für klinische Studien
City
Saint Ingbert
State/Province
Saarland
ZIP/Postal Code
66386
Country
Germany
Facility Name
Universitaetsklinikum Carl Gustav Carus Dresden
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
RED-Institut GmbH
City
Oldenburg
State/Province
Schleswig-Holstein
ZIP/Postal Code
23758
Country
Germany
Facility Name
Diabeteszentrum Hamburg West
City
Hamburg
ZIP/Postal Code
22607
Country
Germany
Facility Name
Iatriko Paleou Falirou Medical Center
City
Paleo Faliro
State/Province
Attikí (Region)
ZIP/Postal Code
17562
Country
Greece
Facility Name
Alexandra Hospital
City
Athens
State/Province
Attikí
ZIP/Postal Code
11528
Country
Greece
Facility Name
Thermi Clinic
City
Thessaloniki
State/Province
Thessaloníki
ZIP/Postal Code
570 01
Country
Greece
Facility Name
Athens Euroclinic
City
Athens
ZIP/Postal Code
115 21
Country
Greece
Facility Name
Tosaki Clinic for Diabetes and Endocrinology
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
468-0009
Country
Japan
Facility Name
Kashiwa City Hospital
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-0825
Country
Japan
Facility Name
Tokuyama Clinic
City
Mihama-ku,Chiba City
State/Province
Chiba
ZIP/Postal Code
261-0004
Country
Japan
Facility Name
Nippon Kokan Fukuyama Hospital
City
Fukuyama-shi
State/Province
Hiroshima
ZIP/Postal Code
721-0927
Country
Japan
Facility Name
Hasegawa Medical Clinic
City
Chitose
State/Province
Hokkaido
ZIP/Postal Code
066-0032
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
Hayashi Diabetes Internal Medicine Clinic
City
Chigasaki
State/Province
Kanagawa
ZIP/Postal Code
253-0044
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
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
Kumanomae Nishimura Clinic
City
Arakawa-ku
State/Province
Tokyo
ZIP/Postal Code
116-0012
Country
Japan
Facility Name
Tokyo-Eki Center-building Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0027
Country
Japan
Facility Name
Fukuwa Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0031
Country
Japan
Facility Name
Hachioji Diabetes Clinic
City
Hachioji-shi
State/Province
Tokyo
ZIP/Postal Code
192-0083
Country
Japan
Facility Name
Medical Corporation Sato Medical clinic
City
Ootaku
State/Province
Tokyo
ZIP/Postal Code
143-0015
Country
Japan
Facility Name
Tomonaga Clinic
City
Shinjuku
State/Province
Tokyo
ZIP/Postal Code
160-0022
Country
Japan
Facility Name
Yoshimura Clinic
City
Kumamoto
ZIP/Postal Code
861-8039
Country
Japan
Facility Name
Jinnouchi Hospital
City
Kumamoto
ZIP/Postal Code
862-0976
Country
Japan
Facility Name
Abe Clinic
City
Oita
ZIP/Postal Code
870-0039
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
Hanyang University Guri Hospital
City
Guri-si
State/Province
Kyǒnggi-do
ZIP/Postal Code
11923
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
Investigacion En Salud Y Metabolismo Sc
City
Chihuahua
ZIP/Postal Code
31217
Country
Mexico
Facility Name
Centro de Endocrinologia y Nutricion
City
Caguas
ZIP/Postal Code
00725
Country
Puerto Rico
Facility Name
Private Practice - Dr. Paola Mansilla-Letelier
City
Guaynabo
ZIP/Postal Code
00970
Country
Puerto Rico

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/7lHZ0WNetEMo9OIZqscbDa
Description
A Study of LY3209590 Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-2)

Learn more about this trial

A Study of Insulin Efsitora Alfa (LY3209590) Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time

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