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A Study of Tirzepatide Compared With Intensified Conventional Care in Adult Participants With Type 2 Diabetes (SURPASS-EARLY)

Primary Purpose

Type 2 Diabetes

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Tirzepatide
Antihyperglycemic medication
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 focused on measuring T2D, Diabetes

Eligibility Criteria

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

Inclusion Criteria:

  • Have, within the last 4 years, been diagnosed with T2D based on the World Health Organization classification or other locally applicable diagnostic standards.
  • Have HbA1c ≥7% to ≤9.5% as determined by the central laboratory.

  • Have been on a stable treatment of metformin only at least 90 days preceding baseline

    • with the minimum effective dose of ≥1500 mg/day, but not higher than the maximum approved dose per country-specific label, or
    • <1500 mg/day in case of intolerance of full therapeutic dose.

Exclusion Criteria:

  • Have type 1 diabetes mellitus
  • Have a history of chronic or acute pancreatitis any time prior to study entry

  • Have a history of

    • proliferative diabetic retinopathy
    • diabetic macular edema, or
    • no proliferative diabetic retinopathy requiring immediate or urgent treatment

  • Are at high risk for cardiovascular disease (CVD) in the investigator's opinion or have a history of any of these CV conditions prior to study entry

    • myocardial infarction
    • percutaneous coronary revascularization procedure
    • carotid stenting or surgical revascularization
    • nontraumatic amputation
    • peripheral vascular procedure (e.g., stenting or surgical revascularization)
    • cerebrovascular accident (stroke), or congestive heart failure
  • Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)
  • Have within 90 days prior to screening received treatment with medications intended to promote weight loss. This includes prescribed, over the counter, or alternative remedies
  • Have an estimated glomerular filtration rate (eGFR) <30 mL/minute/1.73 m2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label), calculated by chronic kidney disease-epidemiology equation as determined by central laboratory at screening.

  • Have been treated with any injectable glucagon-like peptide-1 (GLP-1) receptor agonists and insulin prior to screening.

    • Exception: use of insulin for gestational diabetes or short-term use (<14 days) for acute conditions such as acute illness, hospitalization, or elective surgery.

Sites / Locations

  • Cahaba Research - TrussvilleRecruiting
  • San Fernando Valley Health InstituteRecruiting
  • National Research Institute - Huntington ParkRecruiting
  • Velocity Clinical Research, San DiegoRecruiting
  • Clinical Trials ResearchRecruiting
  • National Research Institute - WilshireRecruiting
  • Catalina Research Institute, LLCRecruiting
  • Velocity Clinical Research, North HollywoodRecruiting
  • Velocity Clinical Research, Panorama CityRecruiting
  • Western University of Health SciencesRecruiting
  • Velocity Clinical Research, Santa AnaRecruiting
  • New England Research Associates, LLCRecruiting
  • Excel Medical Clinical TrialsRecruiting
  • Alliance for Multispecialty Research, LLCRecruiting
  • South Florida Clinical Research InstituteRecruiting
  • Emory University School of Medicine- Grady CampusRecruiting
  • Center for Advanced Research & EducationRecruiting
  • Qualmedica Research, LLCRecruiting
  • Iowa Diabetes and Endocrinology Research CenterRecruiting
  • Qualmedica ResearchRecruiting
  • Qualmedica Research, LLCRecruiting
  • NECCR PrimaCare ResearchRecruiting
  • SKY Integrative Medical Center/SKYCRNGRecruiting
  • StudyMetrix ResearchRecruiting
  • Clinvest Research LLCRecruiting
  • Research Foundation of SUNY - University of BuffaloRecruiting
  • Lucas Research, IncRecruiting
  • The Corvallis Clinic, P.C.Recruiting
  • Clinical Research of PhiladelphiaRecruiting
  • Preferred Primary Care PhysiciansRecruiting
  • Tribe Clinical Research, LLCRecruiting
  • VitaLink Research - SpartanburgRecruiting
  • Dallas Diabetes Research CenterRecruiting
  • Centro de Investigaciones Metabólicas (CINME)Recruiting
  • Instituto de Investigaciones Clínicas Mar del PlataRecruiting
  • Go Centro Medico San NicolásRecruiting
  • CIAD MoronRecruiting
  • Centro Médico ViamonteRecruiting
  • Bluewater Clinical Research Group Inc.
  • Stouffville Medical Centre
  • 9109-0126 Quebec Inc.
  • ClinPhenomics GmbH & Co KGRecruiting
  • Diabetes- und Stoffwechselpraxis Bochum
  • InnoDiab Forschung GmbhRecruiting
  • Zentrum für klinische StudienRecruiting
  • Private Practice - Dr. Christine KoschRecruiting
  • RED-Institut GmbHRecruiting
  • Diabetespraxis MergentheimRecruiting
  • Diabetes Zentrum Dr. TewsRecruiting
  • Edith Wolfson Medical CenterRecruiting
  • Rabin Medical CenterRecruiting
  • Kaplan Medical CenterRecruiting
  • Clalit Health Services - AtlitRecruiting
  • Bnai Zion Medical CenterRecruiting
  • Clalit Health Services - Sakhnin Community ClinicRecruiting
  • Linn Medical CenterRecruiting
  • University of Naples Federico IIRecruiting
  • Centro Cardiologico MonzinoRecruiting
  • Ospedale Civile Santa Croce Pronto SoccorsoRecruiting
  • A.O.U.C. Policlinico di BariRecruiting
  • Ospedale san Giovanni di Dio-DiabetologiaRecruiting
  • A.O.U. Policlinico Paolo GiacconeRecruiting
  • Azienda Ospedaliera Universitaria PisanaRecruiting
  • Azienda Ospedaliera Mater DominiRecruiting
  • Private Practice - Dr. Arechavaleta Granell Maria del RosarioRecruiting
  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"Recruiting
  • Investigacion En Salud Y Metabolismo ScRecruiting
  • San Juan Bautista School of Medicine - Clinical Research UnitRecruiting
  • Dorado Medical ComplexRecruiting
  • GCM Medical Group, PSC - Hato Rey SiteRecruiting
  • C.M.D.T.A. NeomedRecruiting
  • Centrul Medical NutriLifeRecruiting
  • Gama DiamedRecruiting
  • Diabmed Dr. Popescu AlexandrinaRecruiting
  • Milena SanteRecruiting
  • Clinica KorallRecruiting
  • MEDIKALSRecruiting
  • ProDia s.r.o.Recruiting
  • JALRecruiting
  • IRIDIARecruiting
  • Aberdeen Royal InfirmaryRecruiting
  • Ninewells Hospital and Medical SchoolRecruiting
  • Staploe Medical CentreRecruiting
  • Knowle House SurgeryRecruiting
  • Leicester General HospitalRecruiting
  • Wickersley Health Centre - Clifton Medical CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tirzepatide

Intensified Conventional Care Dose

Arm Description

Participants will receive tirzepatide at the maximum tolerated dose subcutaneously (SC)

Participants will receive an antihyperglycemic medication

Outcomes

Primary Outcome Measures

Change from Baseline in Hemoglobin A1c (HbA1c)

Secondary Outcome Measures

Change from Baseline in HbA1c
Change from Baseline in Weight
Change from Baseline in Weight
Change from Baseline in Waist Circumference
Change from Baseline in Waist Circumference
Change from Baseline in Fasting Serum Glucose (FSG)
Change from Baseline in FSG
Change from Baseline in Lipids
Change from Baseline in Lipids
Percentage of Participants Achieving HbA1c <7.0%
Percentage of Participants Achieving HbA1c ≤6.5%
Percentage of Participants Achieving HbA1c <5.7%
Percentage of Participants Achieving HbA1c <7.0%
Percentage of Participants Achieving HbA1c ≤6.5%
Percentage of Participants Achieving HbA1c <5.7%
Change from Baseline in Weight loss of ≥5%,
Change from Baseline in Weight loss of ≥10%
Change from Baseline in Weight loss of ≥15%
Change from Baseline in Weight loss of ≥5%
Change from Baseline in Weight loss of ≥10%
Change from Baseline in Weight loss of ≥15%
A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia
A composite endpoint defined as HbA1c ≤ 6.5%, weight loss ≥10%, no hypoglycemia, defined as blood glucose (BG) <54 milligram/deciliter (mg/dL) <3.0 millimole/liter (mmol/L) and/or severe hypoglycemia
A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia
A composite endpoint defined as HbA1c ≤ 6.5%, weight loss ≥10%, no hypoglycemia, defined as BG <54 mg/dL (<3.0 mmol/L) and/or severe hypoglycemia
Change from Baseline in β-cell Glucose Sensitivity
β-cell Glucose Sensitivity assessed by Oral Glucose Tolerance Test (OGTT)
Change from Baseline in β-cell glucose sensitivity
Change from baseline in β-cell glucose sensitivity assessed by OGTT
Change from Baseline in Insulin Secretion Rate at a Fixed Glucose Concentration
Insulin Secretion Rate assessed by OGTT
Change from Baseline in Insulin Secretion Rate at a Fixed Glucose Concentration
Insulin Secretion Rate assessed by OGTT
Change from Baseline in Postprandial Insulin Sensitivity Indices
Postprandial Insulin Sensitivity Indices assessed by OGTT
Change from Baseline in Postprandial Insulin Sensitivity Indices
Postprandial Insulin Sensitivity Indices assessed by OGTT
Change from Baseline in Fasting and Post-challenge Glucose [total and incremental AUC(₀-₂₄₀min)]
Fasting and Post-challenge Glucose [total and incremental AUC(₀-₂₄₀min)] assessed by OGTT
Change from Baseline in Fasting and Post-challenge Glucose [total and incremental (AUC₀-₂₄₀min)]
Fasting and Post-challenge Glucose [total and incremental AUC(₀-₂₄₀min)] assessed by OGTT
Change from Baseline in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) - Physical Functioning Domain
Change from Baseline in the IWQOL-Lite-CT - Physical Functioning Domain

Full Information

First Posted
June 22, 2022
Last Updated
October 18, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT05433584
Brief Title
A Study of Tirzepatide Compared With Intensified Conventional Care in Adult Participants With Type 2 Diabetes
Acronym
SURPASS-EARLY
Official Title
A Randomized, Open-Label, Parallel-Group, Two-Arm, Phase 4 Study to Evaluate the Long-Term Efficacy and Safety of Tirzepatide Compared With Intensified Conventional Care in Adults When Initiating Treatment Early in the Course of Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
October 30, 2025 (Anticipated)
Study Completion Date
November 29, 2027 (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
No

5. Study Description

Brief Summary
This study aims to investigate the efficacy and safety of tirzepatide in participants with type 2 diabetes (T2D) compared to other existing treatment options when treatment is initiated early.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
T2D, Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
780 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tirzepatide
Arm Type
Experimental
Arm Description
Participants will receive tirzepatide at the maximum tolerated dose subcutaneously (SC)
Arm Title
Intensified Conventional Care Dose
Arm Type
Active Comparator
Arm Description
Participants will receive an antihyperglycemic medication
Intervention Type
Drug
Intervention Name(s)
Tirzepatide
Other Intervention Name(s)
LY3298176
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Antihyperglycemic medication
Intervention Description
As prescribed
Primary Outcome Measure Information:
Title
Change from Baseline in Hemoglobin A1c (HbA1c)
Time Frame
Baseline, Week 104
Secondary Outcome Measure Information:
Title
Change from Baseline in HbA1c
Time Frame
Baseline, Week 208
Title
Change from Baseline in Weight
Time Frame
Baseline, Week 104
Title
Change from Baseline in Weight
Time Frame
Baseline, Week 208
Title
Change from Baseline in Waist Circumference
Time Frame
Baseline, Week 104
Title
Change from Baseline in Waist Circumference
Time Frame
Baseline, Week 208
Title
Change from Baseline in Fasting Serum Glucose (FSG)
Time Frame
Baseline, Week 104
Title
Change from Baseline in FSG
Time Frame
Baseline, Week 208
Title
Change from Baseline in Lipids
Time Frame
Baseline, Week 104
Title
Change from Baseline in Lipids
Time Frame
Baseline, Week 208
Title
Percentage of Participants Achieving HbA1c <7.0%
Time Frame
Week 104
Title
Percentage of Participants Achieving HbA1c ≤6.5%
Time Frame
Week 104
Title
Percentage of Participants Achieving HbA1c <5.7%
Time Frame
Week 104
Title
Percentage of Participants Achieving HbA1c <7.0%
Time Frame
Week 208
Title
Percentage of Participants Achieving HbA1c ≤6.5%
Time Frame
Week 208
Title
Percentage of Participants Achieving HbA1c <5.7%
Time Frame
Week 208
Title
Change from Baseline in Weight loss of ≥5%,
Time Frame
Baseline, Week 104
Title
Change from Baseline in Weight loss of ≥10%
Time Frame
Baseline, Week 104
Title
Change from Baseline in Weight loss of ≥15%
Time Frame
Baseline, Week 104
Title
Change from Baseline in Weight loss of ≥5%
Time Frame
Baseline, Week 208
Title
Change from Baseline in Weight loss of ≥10%
Time Frame
Baseline, Week 208
Title
Change from Baseline in Weight loss of ≥15%
Time Frame
Baseline, Week 208
Title
A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia
Description
A composite endpoint defined as HbA1c ≤ 6.5%, weight loss ≥10%, no hypoglycemia, defined as blood glucose (BG) <54 milligram/deciliter (mg/dL) <3.0 millimole/liter (mmol/L) and/or severe hypoglycemia
Time Frame
Week 104
Title
A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia
Description
A composite endpoint defined as HbA1c ≤ 6.5%, weight loss ≥10%, no hypoglycemia, defined as BG <54 mg/dL (<3.0 mmol/L) and/or severe hypoglycemia
Time Frame
Week 208
Title
Change from Baseline in β-cell Glucose Sensitivity
Description
β-cell Glucose Sensitivity assessed by Oral Glucose Tolerance Test (OGTT)
Time Frame
Baseline, Week 104
Title
Change from Baseline in β-cell glucose sensitivity
Description
Change from baseline in β-cell glucose sensitivity assessed by OGTT
Time Frame
Baseline, Week 208
Title
Change from Baseline in Insulin Secretion Rate at a Fixed Glucose Concentration
Description
Insulin Secretion Rate assessed by OGTT
Time Frame
Baseline, Week 104
Title
Change from Baseline in Insulin Secretion Rate at a Fixed Glucose Concentration
Description
Insulin Secretion Rate assessed by OGTT
Time Frame
Baseline, Week 208
Title
Change from Baseline in Postprandial Insulin Sensitivity Indices
Description
Postprandial Insulin Sensitivity Indices assessed by OGTT
Time Frame
Baseline, Week 104
Title
Change from Baseline in Postprandial Insulin Sensitivity Indices
Description
Postprandial Insulin Sensitivity Indices assessed by OGTT
Time Frame
Baseline, Week 208
Title
Change from Baseline in Fasting and Post-challenge Glucose [total and incremental AUC(₀-₂₄₀min)]
Description
Fasting and Post-challenge Glucose [total and incremental AUC(₀-₂₄₀min)] assessed by OGTT
Time Frame
Baseline through Week 104
Title
Change from Baseline in Fasting and Post-challenge Glucose [total and incremental (AUC₀-₂₄₀min)]
Description
Fasting and Post-challenge Glucose [total and incremental AUC(₀-₂₄₀min)] assessed by OGTT
Time Frame
Baseline through Week 208
Title
Change from Baseline in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) - Physical Functioning Domain
Time Frame
Baseline, Week 104
Title
Change from Baseline in the IWQOL-Lite-CT - Physical Functioning Domain
Time Frame
Baseline, Week 208

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have, within the last 4 years, been diagnosed with T2D based on the World Health Organization classification or other locally applicable diagnostic standards. Have HbA1c ≥7% to ≤9.5% as determined by the central laboratory. Have been on a stable treatment of metformin only at least 90 days preceding baseline with the minimum effective dose of ≥1500 mg/day, but not higher than the maximum approved dose per country-specific label, or <1500 mg/day in case of intolerance of full therapeutic dose. Exclusion Criteria: Have type 1 diabetes mellitus Have a history of chronic or acute pancreatitis any time prior to study entry Have a history of proliferative diabetic retinopathy diabetic macular edema, or no proliferative diabetic retinopathy requiring immediate or urgent treatment Are at high risk for cardiovascular disease (CVD) in the investigator's opinion or have a history of any of these CV conditions prior to study entry myocardial infarction percutaneous coronary revascularization procedure carotid stenting or surgical revascularization nontraumatic amputation peripheral vascular procedure (e.g., stenting or surgical revascularization) cerebrovascular accident (stroke), or congestive heart failure Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2) Have within 90 days prior to screening received treatment with medications intended to promote weight loss. This includes prescribed, over the counter, or alternative remedies Have an estimated glomerular filtration rate (eGFR) <30 mL/minute/1.73 m2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label), calculated by chronic kidney disease-epidemiology equation as determined by central laboratory at screening. Have been treated with any injectable glucagon-like peptide-1 (GLP-1) receptor agonists and insulin prior to screening. Exception: use of insulin for gestational diabetes or short-term use (<14 days) for acute conditions such as acute illness, hospitalization, or elective surgery.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CT LILLY (1-877-285-4559) or
Phone
: 1-317-615-4559
Email
ClinicalTrials.gov@lilly.com
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 - Trussville
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
205-408-4134
First Name & Middle Initial & Last Name & Degree
Song Yu
Facility Name
San Fernando Valley Health Institute
City
Canoga Park
State/Province
California
ZIP/Postal Code
91304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
818-222-6868
First Name & Middle Initial & Last Name & Degree
Jeffrey London
Facility Name
National Research Institute - Huntington Park
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
323-588-1990
First Name & Middle Initial & Last Name & Degree
Stanley H. Hsia
Facility Name
Velocity Clinical Research, San Diego
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
6195671550
First Name & Middle Initial & Last Name & Degree
J. Scott Overcash
Facility Name
Clinical Trials Research
City
Lincoln
State/Province
California
ZIP/Postal Code
95648
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey D Wayne
Facility Name
National Research Institute - Wilshire
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
213-483-1800
First Name & Middle Initial & Last Name & Degree
David Guzman
Facility Name
Catalina Research Institute, LLC
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
909-590-8409
First Name & Middle Initial & Last Name & Degree
Rizwana H Mohseni
Facility Name
Velocity Clinical Research, North Hollywood
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samuel Penziner
Facility Name
Velocity Clinical Research, Panorama City
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
8185326880
First Name & Middle Initial & Last Name & Degree
Robert Allen Jenders
Facility Name
Western University of Health Sciences
City
Pomona
State/Province
California
ZIP/Postal Code
91766
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
909-469-8626
First Name & Middle Initial & Last Name & Degree
Airani Sathananthan
Facility Name
Velocity Clinical Research, Santa Ana
City
Santa Ana
State/Province
California
ZIP/Postal Code
92704
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
424-551-7316
First Name & Middle Initial & Last Name & Degree
Mark T. Leibowitz
Facility Name
New England Research Associates, LLC
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
203-374-9816
First Name & Middle Initial & Last Name & Degree
Ilja Hulinsky
Facility Name
Excel Medical Clinical Trials
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33434
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
561-756-8206
First Name & Middle Initial & Last Name & Degree
Rasha Youssef
Facility Name
Alliance for Multispecialty Research, LLC
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erick Juarez
Facility Name
South Florida Clinical Research Institute
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
954-582-7007
First Name & Middle Initial & Last Name & Degree
Juan Loy
Facility Name
Emory University School of Medicine- Grady Campus
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
404-251-8959
First Name & Middle Initial & Last Name & Degree
Guillermo Umpierrez
Facility Name
Center for Advanced Research & Education
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
7705345154
First Name & Middle Initial & Last Name & Degree
Angela Dawn Ritter
Facility Name
Qualmedica Research, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47715
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Earl Schultz
Facility Name
Iowa Diabetes and Endocrinology Research Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
515-329-6800
First Name & Middle Initial & Last Name & Degree
Anuj Bhargava
Facility Name
Qualmedica Research
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
2709044334
First Name & Middle Initial & Last Name & Degree
Paul Anthony Kniery
Facility Name
Qualmedica Research, LLC
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
270-685-4589
First Name & Middle Initial & Last Name & Degree
J Christopher Christopher Sartore
Facility Name
NECCR PrimaCare Research
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02721
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
508-672-7450
First Name & Middle Initial & Last Name & Degree
Ehab Sorial
Facility Name
SKY Integrative Medical Center/SKYCRNG
City
Ridgeland
State/Province
Mississippi
ZIP/Postal Code
39157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
601-617-7717
First Name & Middle Initial & Last Name & Degree
Michael Livingston
Facility Name
StudyMetrix Research
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
636-387-5100
First Name & Middle Initial & Last Name & Degree
Timothy R Smith
Facility Name
Clinvest Research LLC
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
4178837889
First Name & Middle Initial & Last Name & Degree
David Gregory True
Facility Name
Research Foundation of SUNY - University of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
716-535-1850
First Name & Middle Initial & Last Name & Degree
Ajay Chaudhuri
Facility Name
Lucas Research, Inc
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
2522225700
First Name & Middle Initial & Last Name & Degree
Kathryn Jean Lucas
Facility Name
The Corvallis Clinic, P.C.
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
541-754-1398
First Name & Middle Initial & Last Name & Degree
Brian Curtis
Facility Name
Clinical Research of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
215-676-6696
First Name & Middle Initial & Last Name & Degree
Donna M Gavarone
Facility Name
Preferred Primary Care Physicians
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
724-912-0033
First Name & Middle Initial & Last Name & Degree
Paul A. Hartley
Facility Name
Tribe Clinical Research, LLC
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
864-334-0141
First Name & Middle Initial & Last Name & Degree
Ronald Mayfield
Facility Name
VitaLink Research - Spartanburg
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
864-515-0092
First Name & Middle Initial & Last Name & Degree
Farhan Siddiqui
Facility Name
Dallas Diabetes Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
972-566-7799
First Name & Middle Initial & Last Name & Degree
Julio Rosenstock
Facility Name
Centro de Investigaciones Metabólicas (CINME)
City
Ciudad Autónoma de Buenos Aire
State/Province
Buenos Aires
ZIP/Postal Code
1056
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
00541139842826
First Name & Middle Initial & Last Name & Degree
Federico C. Perez Manghi
Facility Name
Instituto de Investigaciones Clínicas Mar del Plata
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
7600
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
0223155189482
First Name & Middle Initial & Last Name & Degree
Natalia Cluigt
Facility Name
Go Centro Medico San Nicolás
City
San Nicolas
State/Province
Buenos Aires
ZIP/Postal Code
2900
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
5493415597777
First Name & Middle Initial & Last Name & Degree
Marisa Liliana Vico
Facility Name
CIAD Moron
City
Moron
State/Province
Buenos Air
ZIP/Postal Code
B1708EPE
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
5491144796383
First Name & Middle Initial & Last Name & Degree
Sonia Griselda Hermida
Facility Name
Centro Médico Viamonte
City
Buenos Aires
State/Province
Ciudad Aut
ZIP/Postal Code
C1120AAC
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
541149635650
First Name & Middle Initial & Last Name & Degree
Diego Aizenberg
Facility Name
Bluewater Clinical Research Group Inc.
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Stouffville Medical Centre
City
Stouffville
State/Province
Ontario
ZIP/Postal Code
L4A 1H2
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
9109-0126 Quebec Inc.
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4N 2W2
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
ClinPhenomics GmbH & Co KG
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60596
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
49069577028
First Name & Middle Initial & Last Name & Degree
Bernhard Rudolf Winkelmann
Facility Name
Diabetes- und Stoffwechselpraxis Bochum
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44869
Country
Germany
Individual Site Status
Completed
Facility Name
InnoDiab Forschung Gmbh
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45136
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
4920189942100
First Name & Middle Initial & Last Name & Degree
Helga Zeller-Stefan
Facility Name
Zentrum für klinische Studien
City
Saint Ingbert
State/Province
Saarland
ZIP/Postal Code
66386
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
0049689499881
First Name & Middle Initial & Last Name & Degree
Alexander Segner
Facility Name
Private Practice - Dr. Christine Kosch
City
Pirna
State/Province
Sachsen
ZIP/Postal Code
01796
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
00493501781523
First Name & Middle Initial & Last Name & Degree
Christine Kosch
Facility Name
RED-Institut GmbH
City
Oldenburg
State/Province
Schleswig-Holstein
ZIP/Postal Code
23758
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
004943615063012
First Name & Middle Initial & Last Name & Degree
Thomas Schaum
Facility Name
Diabetespraxis Mergentheim
City
Bad Mergentheim
ZIP/Postal Code
97980
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
497931594143
First Name & Middle Initial & Last Name & Degree
Simon Vidal
Facility Name
Diabetes Zentrum Dr. Tews
City
Gelnhausen
ZIP/Postal Code
63571
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dietrich Tews
Facility Name
Edith Wolfson Medical Center
City
Holon
State/Province
HaMerkaz
ZIP/Postal Code
5810001
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
Phone
97235028392
First Name & Middle Initial & Last Name & Degree
orit twito
Facility Name
Rabin Medical Center
City
Petah-Tikva
State/Province
HaMerkaz
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
Phone
97239239082
First Name & Middle Initial & Last Name & Degree
Alon Grossman
Facility Name
Kaplan Medical Center
City
Rehovot
State/Province
HaMerkaz
ZIP/Postal Code
7610001
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taiba Zornitzki
Facility Name
Clalit Health Services - Atlit
City
Atlit
State/Province
HaTsafon
ZIP/Postal Code
3032343
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
Phone
049842020
First Name & Middle Initial & Last Name & Degree
Elie Haddad
Facility Name
Bnai Zion Medical Center
City
Haifa
State/Province
HaTsafon
ZIP/Postal Code
3339419
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
Phone
97248359510
First Name & Middle Initial & Last Name & Degree
Leonard Saiegh
Facility Name
Clalit Health Services - Sakhnin Community Clinic
City
Sakhnin
State/Province
HaTsafon
ZIP/Postal Code
3081000
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
Phone
97246745729
First Name & Middle Initial & Last Name & Degree
Mahmud Darawsha
Facility Name
Linn Medical Center
City
Haifa
State/Province
Ḥeifā
ZIP/Postal Code
3515209
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
Phone
97248568685
First Name & Middle Initial & Last Name & Degree
Muhammad Sabbah
Facility Name
University of Naples Federico II
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raffaele Napoli
Facility Name
Centro Cardiologico Monzino
City
Milan
State/Province
Milano
ZIP/Postal Code
20138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Genovese
Facility Name
Ospedale Civile Santa Croce Pronto Soccorso
City
Moncalieri
State/Province
Piemonte
ZIP/Postal Code
10024
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
3901194293139
First Name & Middle Initial & Last Name & Degree
CARLO BRUNO GIORDA
Facility Name
A.O.U.C. Policlinico di Bari
City
Bari
State/Province
Puglia
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
0805478784
First Name & Middle Initial & Last Name & Degree
Francesco Giorgino
Facility Name
Ospedale san Giovanni di Dio-Diabetologia
City
Olbia
State/Province
Sardegna
ZIP/Postal Code
07026
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giancarlo Tonolo
Facility Name
A.O.U. Policlinico Paolo Giaccone
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90129
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CARLA GIORDANO
Facility Name
Azienda Ospedaliera Universitaria Pisana
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
3905095103
First Name & Middle Initial & Last Name & Degree
Stefano Del Prato
Facility Name
Azienda Ospedaliera Mater Domini
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
00390961364
First Name & Middle Initial & Last Name & Degree
Franco Arturi
Facility Name
Private Practice - Dr. Arechavaleta Granell Maria del Rosario
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44670
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Phone
5233361654104
First Name & Middle Initial & Last Name & Degree
Maria Del Rosario Arechavaleta Granell
Facility Name
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
66460
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Gerardo Gonzalez-Gonzalez
Facility Name
Investigacion En Salud Y Metabolismo Sc
City
Chihuahua
ZIP/Postal Code
31217
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Phone
526144398618
First Name & Middle Initial & Last Name & Degree
Luis Alejandro Nevarez
Facility Name
San Juan Bautista School of Medicine - Clinical Research Unit
City
Caguas
ZIP/Postal Code
00726
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
Phone
7877433038
First Name & Middle Initial & Last Name & Degree
Loida Alejandra Gonzalez-Rodriguez
Facility Name
Dorado Medical Complex
City
Dorado
ZIP/Postal Code
00646
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
Phone
7872781576
First Name & Middle Initial & Last Name & Degree
Luis A Pagan-Cardona
Facility Name
GCM Medical Group, PSC - Hato Rey Site
City
San Juan
ZIP/Postal Code
917
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
Phone
7879362100
First Name & Middle Initial & Last Name & Degree
Gregorio Antonio Cortes-Maisonet
Facility Name
C.M.D.T.A. Neomed
City
Brasov
State/Province
Brașov
ZIP/Postal Code
500283
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valentina Neacsu
Facility Name
Centrul Medical NutriLife
City
Bucharest
State/Province
București
ZIP/Postal Code
013761
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marlena Pascu
Facility Name
Gama Diamed
City
Mangalia
State/Province
Constanța
ZIP/Postal Code
905500
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
Phone
0040241740581
First Name & Middle Initial & Last Name & Degree
Amalia Drobeta Thury-Burileanu
Facility Name
Diabmed Dr. Popescu Alexandrina
City
Ploiești
State/Province
Prahova
ZIP/Postal Code
100179
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
Phone
40244523484
First Name & Middle Initial & Last Name & Degree
Alexandrina Popescu
Facility Name
Milena Sante
City
Galați
ZIP/Postal Code
800001
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
Phone
0040724405355
First Name & Middle Initial & Last Name & Degree
Cristina-Victoria Mistodie
Facility Name
Clinica Korall
City
Satu Mare
ZIP/Postal Code
440055
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
Phone
40741135808
First Name & Middle Initial & Last Name & Degree
Adriana Filimon
Facility Name
MEDIKALS
City
Piešťany
ZIP/Postal Code
921 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
Phone
421903373484
First Name & Middle Initial & Last Name & Degree
Slavka Kalinova
Facility Name
ProDia s.r.o.
City
Povazska Bystrica
ZIP/Postal Code
017 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
Phone
421905154448
First Name & Middle Initial & Last Name & Degree
Vladimir Paulovic
Facility Name
JAL
City
Trnava
ZIP/Postal Code
917 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
Phone
421948411118
First Name & Middle Initial & Last Name & Degree
Jozef Lacka
Facility Name
IRIDIA
City
Vrutky
State/Province
Žilinský Kraj
ZIP/Postal Code
038 61
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
Phone
421907454191
First Name & Middle Initial & Last Name & Degree
Radovan Plasil
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Aberdeen City
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sam Philip
Facility Name
Ninewells Hospital and Medical School
City
Dundee
State/Province
Angus
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rory McCrimmon
Facility Name
Staploe Medical Centre
City
Ely
State/Province
Cambridgeshire
ZIP/Postal Code
CB7 5JD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Phone
+44 01353 727690
First Name & Middle Initial & Last Name & Degree
Anthony Gunstone
Facility Name
Knowle House Surgery
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL5 3JB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Phone
01752705090
First Name & Middle Initial & Last Name & Degree
Jonathan Edward Garstang
Facility Name
Leicester General Hospital
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Phone
01162586481
First Name & Middle Initial & Last Name & Degree
Melanie Davies
Facility Name
Wickersley Health Centre - Clifton Medical Centre
City
Rotherham
ZIP/Postal Code
S65 1DA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Phone
01709363950
First Name & Middle Initial & Last Name & Degree
Matthew Capehorn

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
http://vivli.org/
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/6uDOXjWupVuV6MjrZKbsNy
Description
A Study of Tirzepatide Compared With Intensified Conventional Care in Adult Participants With Type 2 Diabetes (SURPASS-EARLY)

Learn more about this trial

A Study of Tirzepatide Compared With Intensified Conventional Care in Adult Participants With Type 2 Diabetes

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