Back to resultsA Study of Insulin Efsitora Alfa (LY3209590) Compared to Glargine in Adult Participants With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-1) (QWINT-1)
Primary Purpose
Type 2 Diabetes, T2D
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Insulin Efsitora Alfa
Insulin Glargine
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria: Have a diagnosis of T2D according to the World Health Organization criteria. Have an HbA1c of 7.0% to 10.0%, 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. Are insulin naive Exceptions: short-term insulin treatment for a maximum of 14 days, prior to screening, and prior insulin treatment for gestational diabetes. Exclusion Criteria: Have a diagnosis of type 1 diabetes (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
- Cahaba Research
- Syed Research Consultants Llc
- AMCR Institute
- Velocity Clinical Research, Gardena
- Velocity Clinical Research, Huntington Park
- Velocity Clinical Research, Westlake
- Diabetes Associates Medical Group
- Encompass Clinical Research
- Millennium Clinical Trials
- University Clinical Investigators, Inc.
- Diablo Clinical Research, Inc.
- University of Colorado Anschutz Medical Campus
- Chase Medical Research, LLC
- Clinical Research of West Florida, Inc. (Clearwater)
- Suncoast Research Group
- Clinical Research of West Florida
- Center for Advanced Research & Education
- Pacific Diabetes & Endocrine Center
- Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
- American Health Network of Indiana, LLC - Franklin
- American Health Network of Indiana, LLC - Muncie
- Iowa Diabetes and Endocrinology Research Center
- Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
- Clinvest Research LLC
- University Of Nebraska Medical Center
- Mid Hudson Medical Research
- Velocity Clinical Research, Vestal
- Alliance for Multispecialty Research, LLC
- Diabetes & Endocrinology Consultants of Pennsylvania, LLC
- Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
- WR-Clinsearch, LLC
- Private Practice - Dr. Osvaldo A. Brusco
- Velocity Clinical Research, Dallas
- Prime Revival Research Institute
- Endocrine Associates
- Endocrine Ips, Pllc
- North Hills Family Medicine/North Hills Medical Research
- Texas Valley Clinical Research
- Eastside Research Associates
- Centro de Investigaciones Metabólicas (CINME)
- Instituto de Investigaciones Clínicas Mar del Plata
- DIM Clínica Privada
- Go Centro Medico San Nicolás
- Asociación de Beneficencia Hospital Sirio Libanés
- Stat Research S.A.
- Centro Médico Viamonte
- Glenny Corp
- CEMEDIAB
- CIPREC
- Investigaciones Medicas Imoba Srl
- Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
- Centro Medico Privado San Vicente Diabetes
- Instituto Médico Río Cuarto
- CIPADI - Centro Integral de Prevencion y Atencion en Diabetes
- Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
- Clínica Mayo
- Fundación Respirar
- CENUDIAB
- Centro de Diagnóstico y Rehabilitación (CEDIR)
- Sanatorio Norte
- RM Pharma Specialists
- Instituto Jalisciense de Investigacion en Diabetes y Obesidad
- Diseno y Planeacion en Investigacion Medica
- Instituto de Diabetes, Obesidad y Nutricion
- Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
- Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
- Unidad Médica para la Salud Integral
- Medical Care and Research SA de CV
- Investigacion En Salud Y Metabolismo Sc
- Ponce Medical School Foundation Inc.
- Latin Clinical Trial Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Insulin Efsitora Alfa
Insulin Glargine
Arm Description
Participants will receive insulin efsitora alfa subcutaneously (SC) once weekly.
Participants will receive insulin glargine SC once daily.
Outcomes
Primary Outcome Measures
Change from Baseline in Hemoglobin A1c (HbA1c)
Demonstrate noninferiority of insulin efsitora alfa compared to insulin glargine
Secondary Outcome Measures
Change from Baseline in HbA1c
Demonstrate superiority of insulin efsitora alfa compared to insulin glargine
Change from Baseline in Fasting Glucose
Change from baseline in fasting glucose measured by self-monitoring blood glucose (SMBG)
Level 2 and 3 Hypoglycemia Event Rate of Composite and Incidence
Incidence and rate of composite of Level 2 and 3 hypoglycemia events during the treatment period.
Level 2 and 3 Nocturnal Hypoglycemia Event Rate of Composite and Incidence
Incidence and rate of composite of Level 2 and 3 hypoglycemia events during the treatment period.
Change from Baseline in Body Weight
Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ) in Overall Treatment Satisfaction
DTSQ assesses the overall treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia.
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 treatments.
Change from Baseline in Treatment Experience in Simplicity of Diabetes Treatment Questionnaire (SIM-Q) in Overall Simplicity and Complexity
SIM-Q assess the simplicity and complexity of treatment for type 2 diabetes (single medication).
Change from Baseline in Treatment Experience in Diabetes Injection Device Experience Questionnaire (DID-EQ) in Device Characteristics
DID-EQ assesses participants' perceptions of non-insulin diabetes injection delivery systems for type 2 diabetes.
Full Information
NCT ID
NCT05662332
First Posted
December 15, 2022
Last Updated
August 2, 2023
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT05662332
Brief Title
A Study of Insulin Efsitora Alfa (LY3209590) Compared to Glargine in Adult Participants With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-1)
Acronym
QWINT-1
Official Title
A Phase 3, Parallel-Design, Open-Label, Randomized Control Study to Evaluate the Efficacy and Safety of LY3209590 Administered Weekly Using a Fixed Dose Escalation Compared to Insulin Glargine in Insulin-Naïve Adults With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 14, 2023 (Actual)
Primary Completion Date
July 16, 2024 (Anticipated)
Study Completion Date
July 16, 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 determine the efficacy and safety of insulin efsitora alfa (LY3209590) administered weekly using a fixed dose escalation compared to insulin glargine in adults with type 2 diabetes (T2D) who are starting basal insulin therapy for the first time.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, T2D
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Sponsor will be blinded throughout the study.
Allocation
Randomized
Enrollment
796 (Actual)
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 Glargine
Arm Type
Active Comparator
Arm Description
Participants will receive insulin glargine 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 Glargine
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Change from Baseline in Hemoglobin A1c (HbA1c)
Description
Demonstrate noninferiority of insulin efsitora alfa compared to insulin glargine
Time Frame
Baseline, Week 52
Secondary Outcome Measure Information:
Title
Change from Baseline in HbA1c
Description
Demonstrate superiority of insulin efsitora alfa compared to insulin glargine
Time Frame
Baseline, 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
Level 2 and 3 Hypoglycemia Event Rate of Composite and Incidence
Description
Incidence and rate of composite of Level 2 and 3 hypoglycemia events during the treatment period.
Time Frame
Week 52
Title
Level 2 and 3 Nocturnal Hypoglycemia Event Rate of Composite and Incidence
Description
Incidence and rate of composite of Level 2 and 3 hypoglycemia events during the treatment period.
Time Frame
Week 52
Title
Change from Baseline in Body Weight
Time Frame
Baseline, Week 52
Title
Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ) in Overall Treatment Satisfaction
Description
DTSQ assesses the overall treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia.
Time Frame
Baseline, Week 52
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 treatments.
Time Frame
Baseline, Week 52
Title
Change from Baseline in Treatment Experience in Simplicity of Diabetes Treatment Questionnaire (SIM-Q) in Overall Simplicity and Complexity
Description
SIM-Q assess the simplicity and complexity of treatment for type 2 diabetes (single medication).
Time Frame
Baseline, Week 52
Title
Change from Baseline in Treatment Experience in Diabetes Injection Device Experience Questionnaire (DID-EQ) in Device Characteristics
Description
DID-EQ assesses participants' perceptions of non-insulin diabetes injection delivery systems for type 2 diabetes.
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 a diagnosis of T2D according to the World Health Organization criteria.
Have an HbA1c of 7.0% to 10.0%, 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.
Are insulin naive
Exceptions:
short-term insulin treatment for a maximum of 14 days, prior to screening, and
prior insulin treatment for gestational diabetes.
Exclusion Criteria:
Have a diagnosis of type 1 diabetes (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
Cahaba Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35242
Country
United States
Facility Name
Syed Research Consultants Llc
City
Sheffield
State/Province
Alabama
ZIP/Postal Code
35660
Country
United States
Facility Name
AMCR Institute
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Velocity Clinical Research, Gardena
City
Gardena
State/Province
California
ZIP/Postal Code
90247
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
Velocity Clinical Research, Westlake
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Diabetes Associates Medical Group
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Encompass Clinical Research
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Millennium Clinical Trials
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
University Clinical Investigators, Inc.
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Diablo Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
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
Chase Medical Research, LLC
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Clinical Research of West Florida, Inc. (Clearwater)
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Suncoast Research Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Clinical Research of West Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Center for Advanced Research & Education
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Pacific Diabetes & Endocrine Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
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
American Health Network of Indiana, LLC - Franklin
City
Franklin
State/Province
Indiana
ZIP/Postal Code
46131
Country
United States
Facility Name
American Health Network of Indiana, LLC - Muncie
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47304
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
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Clinvest Research LLC
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
University Of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-4130
Country
United States
Facility Name
Mid Hudson Medical Research
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Facility Name
Velocity Clinical Research, Vestal
City
Vestal
State/Province
New York
ZIP/Postal Code
13850
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Diabetes & Endocrinology Consultants of Pennsylvania, LLC
City
Feasterville-Trevose
State/Province
Pennsylvania
ZIP/Postal Code
19053
Country
United States
Facility Name
Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
WR-Clinsearch, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Private Practice - Dr. Osvaldo A. Brusco
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78414
Country
United States
Facility Name
Velocity Clinical Research, Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Prime Revival Research Institute
City
Flower Mound
State/Province
Texas
ZIP/Postal Code
75028
Country
United States
Facility Name
Endocrine Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Endocrine Ips, Pllc
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
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
Texas Valley Clinical Research
City
Weslaco
State/Province
Texas
ZIP/Postal Code
78596
Country
United States
Facility Name
Eastside Research Associates
City
Redmond
State/Province
Washington
ZIP/Postal Code
98052
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
DIM Clínica Privada
City
Ramos Mejía
State/Province
Buenos Aires
ZIP/Postal Code
B1704ETD
Country
Argentina
Facility Name
Go Centro Medico San Nicolás
City
San Nicolas
State/Province
Buenos Aires
ZIP/Postal Code
2900
Country
Argentina
Facility Name
Asociación de Beneficencia Hospital Sirio Libanés
City
Buenos Aires
State/Province
Buenos Air
ZIP/Postal Code
C1419AHN
Country
Argentina
Facility Name
Stat Research S.A.
City
Buenos Aires
State/Province
Ciudad Aut
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
Glenny Corp
City
Buenos Aires
State/Province
Ciudad Aut
ZIP/Postal Code
C1430CKE
Country
Argentina
Facility Name
CEMEDIAB
City
C.a.b.a.
State/Province
Ciudad Aut
ZIP/Postal Code
C1205AAO
Country
Argentina
Facility Name
CIPREC
City
Buenos Aires
State/Province
Ciudad Autónoma De Buenos Aire
ZIP/Postal Code
C1061AAS
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 Dra. Laura Maffei- Investigacion Clinica Aplicada
City
Ciudad Autonoma de Buenos Aire
State/Province
Ciudad Autónoma De Buenos Aire
ZIP/Postal Code
C1425AGC
Country
Argentina
Facility Name
Centro Medico Privado San Vicente Diabetes
City
Cordoba
State/Province
Córdoba
ZIP/Postal Code
5006
Country
Argentina
Facility Name
Instituto Médico Río Cuarto
City
Río Cuarto
State/Province
Córdoba
ZIP/Postal Code
X5800AEV
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 Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Clínica Mayo
City
San Miguel de Tucuman
State/Province
Tucumán
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Fundación Respirar
City
Buenos Aires
ZIP/Postal Code
C1426ABP
Country
Argentina
Facility Name
CENUDIAB
City
Ciudad Autónoma de Buenos Aire
ZIP/Postal Code
C1440AAD
Country
Argentina
Facility Name
Centro de Diagnóstico y Rehabilitación (CEDIR)
City
Santa Fe
ZIP/Postal Code
3000
Country
Argentina
Facility Name
Sanatorio Norte
City
Santiago del Estero
ZIP/Postal Code
4200
Country
Argentina
Facility Name
RM Pharma Specialists
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
03100
Country
Mexico
Facility Name
Instituto Jalisciense de Investigacion en Diabetes y Obesidad
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
04460
Country
Mexico
Facility Name
Diseno y Planeacion en Investigacion Medica
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44130
Country
Mexico
Facility Name
Instituto de Diabetes, Obesidad y Nutricion
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62250
Country
Mexico
Facility Name
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
66460
Country
Mexico
Facility Name
Unidad Médica para la Salud Integral
City
San Nicolás de los Garza
State/Province
Nuevo León
ZIP/Postal Code
66465
Country
Mexico
Facility Name
Medical Care and Research SA de CV
City
Merida
State/Province
Yucatán
ZIP/Postal Code
97070
Country
Mexico
Facility Name
Investigacion En Salud Y Metabolismo Sc
City
Chihuahua
ZIP/Postal Code
31217
Country
Mexico
Facility Name
Ponce Medical School Foundation Inc.
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Facility Name
Latin Clinical Trial Center
City
San Juan
ZIP/Postal Code
00909
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 United States (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.lilly.com/en-US/trial/379581
Description
A Study of LY3209590 Compared to Glargine in Adult Participants With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-1)
Learn more about this trial
A Study of Insulin Efsitora Alfa (LY3209590) Compared to Glargine in Adult Participants With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-1)
We'll reach out to this number within 24 hrs