A Study of Tirzepatide (LY3298176) Versus Insulin Degludec in Participants With Type 2 Diabetes (SURPASS-3)

A Randomized, Phase 3, Open-Label Trial Comparing the Effect of LY3298176 Versus Titrated Insulin Degludec on Glycemic Control in Patients With Type 2 Diabetes

The purpose of this study is to compare the effect of the study drug tirzepatide to insulin degludec on blood sugar levels in participants with type 2 diabetes. The study will last about 67 weeks and may include up to 22 visits.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Tirzepatide; Drug: Insulin Degludec

• Study Type: Interventional
• Enrollment (Actual): 1444
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1430CKE
    • AXISMED SRL - Bioclinica Research Network
  • Ciudad Autonoma de Buenos Aire, Argentina, C1120AAC
    • Centro Médico Viamonte
  • Ciudad Autonoma de Buenos Aire, Argentina, C1204AAD
    • Instituto Centenario
  • Ciudad Autonoma de Buenos Aire, Argentina, C1440AAD
    • CENUDIAB
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1128AAF
      • Mautalen Salud e Investigación - Servicio de Endocrinología
    • Caba, Buenos Aires, Argentina, C1179AAB
      • Investigaciones Medicas IMOBA S.R.L.
    • Caba, Buenos Aires, Argentina, C1425DES
      • CEDIC-Centro de Investigaciones Clinicas
    • Ciudad Autonoma de, Buenos Aires, Argentina, C1119ACN
      • Centro de Investigacion y Prevencion Cardiovascular (CIPREC)
  • Mendoza
    • Godoy Cruz, Mendoza, Argentina, M5501ARP
      • CIPADI
• Austria
  • Salzburg, Austria, 5020
    • Universitätsklinikum Salzburg
  • Wien, Austria, 1030
    • KA Rudolfstiftung
  • Niederösterreich
    • Stockerau, Niederösterreich, Austria, 2000
      • Landesklinikum Korneuburg-Stockerau, Standort Stockerau
  • Steiermark
    • Graz, Steiermark, Austria, 8036
      • Universitätsklinikum Graz
• Greece
  • Athens, Greece, 11521
    • Athens Euroclinic
  • Larissa, Greece, 41110
    • University General Hospital of Larissa
  • Thessaloniki, Greece, 54645
    • Euromedica - General Clinic of Thessaloniki
  • Thessaloniki, Greece, 54636
    • AHEPA Hospital
  • Thessaloniki, Greece, 54639
    • Ippokrateio General Hospital of Thessaloniki
  • Athens
    • Palaio Faliro, Athens, Greece, 17562
      • Iatriko Palaiou Falirou, Medical Center
  • Attica
    • Ampelokipoi, Attica, Greece, 11527
      • Laiko General Hospital of Athens
  • Attiki
    • Athens, Attiki, Greece, 11527
      • Gen Hospital of Athens G Gennimatas
  • Thessaloniki
    • N. Efkarpia, Thessaloniki, Greece, 56403
      • General Hospital Of Thessaloniki Papageorgiou
    • Thermi, Thessaloniki, Greece, 57001
      • Thermi Clinic
• Hungary
  • Budapest, Hungary, 1089
    • ClinDiab Kft.
  • Budapest, Hungary, 1032
    • Szent Margit Rendelointézet
  • Budapest, Hungary, 1139
    • XIII.ker Onkormanyzat Egeszsegugyi Szolgalat
  • Budapest, Hungary, 1171
    • Strazsahegy Medicina Bt.
  • Budapest, Hungary, 1213
    • TRANTOR 99 Bt.
  • Nagykanizsa, Hungary, 8800
    • Kanizsai Dorottya Korhaz
  • Zalaegerszeg, Hungary, 8900
    • Zala Megyei Szent Rafael Kórház
  • Hajdu-Bihar
    • Debrecen, Hajdu-Bihar, Hungary, 4031
      • Kenézy Gyula Kórház És Rendelőintézet
• Italy
  • Bari, Italy, 70124
    • Azienda Ospedaliera Policlinico Consorziale
  • Bergamo, Italy, 24128
    • Azienda Ospedaliera Papa Giovanni XXIII
  • Latina, Italy, 04100
    • Ospedale Santa Maria Goretti
  • Catanzaro
    • Germaneto, Catanzaro, Italy, 88100
      • Azienda ospedaliero-universitaria Mater Domini
  • Lazio
    • Roma, Lazio, Italy, 00168
      • Policlinico Univ. Agostino Gemelli
  • MI
    • Milano, MI, Italy, 20138
      • Centro Cardiologico Monzino, IRCCS
• Korea, Republic of
  • Ansan-si, Korea, Republic of, 15355
    • Korea University Ansan Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 02841
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital Yonsei University Health System
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 05278
    • Kyunghee University Hospital at Gangdong
  • Gyeonggi-do
    • Bucheon,, Gyeonggi-do, Korea, Republic of, 14647
      • Bucheon St. Mary's Hospital
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital
  • Gyeonggido
    • Guri-si, Gyeonggido, Korea, Republic of, 11923
      • Hanyang University GURI Hospital
  • Korea
    • Seoul, Korea, Korea, Republic of, 06591
      • Seoul st. mary's hospital
• Poland
  • Bialystok, Poland, 15-351
    • Nzoz Zdrowie Osteo-Medic
  • Bialystok, Poland, 15-404
    • Poradnia Diabetologiczna SN ZOZ Lege Artis
  • Krakow, Poland, 31-261
    • NZOZ Diab-Endo-Met
  • Lodz, Poland, 90-132
    • Gabinet Lekarski Malgorzata Saryusz-Wolska
  • Lodz, Poland, 90-242
    • Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
  • Lublin, Poland, 20-538
    • NZOZ Przychodnia Specjalistyczna Medica
  • Ruda Slaska, Poland, 41-709
    • NZOZ Przychodnia Specjalistyczna Henryk RudzkiAndrzej Wittek
  • Warminsko-Mazurki
    • Elblag, Warminsko-Mazurki, Poland, 82300
      • Ambulatorium Barbara Bazela
• Puerto Rico
  • San Juan, Puerto Rico, 00917
    • GCM Medical Group PSC
  • San Juan, Puerto Rico, 00909
    • Latin Clinical Trial Center
  • Trujillo Alto, Puerto Rico, 00976
    • San Miguel Medical
• Romania
  • Brasov, Romania, 500283
    • Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL
  • Bucharest, Romania, 010507
    • Cabinetul Medical Nicodiab SRL
  • Bucuresti, Romania, 013671
    • SC Nutrilife SRL
  • Iasi, Romania, 700547
    • Consultmed SRL
  • Bihor
    • Oradea, Bihor, Romania, 410159
      • S. C. Grandmed S.R.L., Str.
  • Jud Satu-Mare
    • Satu-Mare, Jud Satu-Mare, Romania, 440055
      • Spitalul Judetean de Urgenta Satu Mare
  • Judetul Galati
    • Galati, Judetul Galati, Romania, 800291
      • SC Diamed Obesity SRL
  • Maramures
    • Baia Mare, Maramures, Romania, 430222
      • CMI DNBM Dr. Pop Lavinia
  • Mures
    • Targu Mures, Mures, Romania, 540098
      • Cosamext SRL
  • Sect.5
    • Bucuresti, Sect.5, Romania, 050538
      • Societatea Civila Medicala "Dr. Paveliu"
• Spain
  • Alicante, Spain, 03004
    • Instituto de Ciencias Médicas
  • Granada, Spain, 18016
    • Hospital Clinico Universitario San Cecilio
  • Palma de Mallorca, Spain, 07014
    • Clínica Juaneda
  • Seville, Spain, 41003
    • Clínica Nuevas Tecnologías en Diabetes y Endocrinología
  • Teruel, Spain, 44002
    • Policlinica Galileo
  • Andalucía
    • Sevilla, Andalucía, Spain, 41010
      • Hospital Infanta Luisa
  • Cantabria
    • Santander, Cantabria, Spain, 39011
      • Hospital Universitario Marques de Valdecilla
  • Madrid
    • Pozuelo de Alarcon, Madrid, Spain, 28223
      • Hospital Universitario Quiron Madrid
• Taiwan
  • Changhua, Taiwan, 500
    • Changhua Christian Hospital
  • Kaohsiung City, Taiwan, 833
    • Chang Gung Memorial Hospital - Kaohsiung
  • New Taipei, Taiwan, 23561
    • Taipei Medical University- Shuang Ho Hospital
  • Taichung, Taiwan, 40705, ROC
    • Taichung Veterans General Hospital
  • Taichung City, Taiwan, 40201
    • Chung Shan Medical University Hospital
  • Taichung County, Taiwan, 433
    • Kuang Tien General Hospital
  • Tainan, Taiwan, 70403
    • National Cheng Kung University Hospital
  • Tainan City, Taiwan, 71004
    • Chi-Mei Medical Center
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
• Ukraine
  • Dnipro, Ukraine, 49023
    • Dnipro City Clinical Hospital #9
  • Kyiv, Ukraine, 04114
    • V.P. Komisarenko Institute of Endocrinology and Metabolism of NAMS of Ukraine
  • Poltava, Ukraine, 36011
    • Communal Institution "Poltava Reg.Cl.H. n.a.M.V.Sklifosovskogo"
  • Vinnytsia, Ukraine, 21000
    • Vinnytsia Regional Clinical Highly Specialized Endocrinology Center
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Arkansas Clinical Research
  • California
    • Fresno, California, United States, 93720
      • Valley Research
    • Huntington Park, California, United States, 90255
      • National Research Institute
    • Los Angeles, California, United States, 90057
      • National Research Institute
    • Montclair, California, United States, 91763
      • Catalina Research Institute, LLC
    • Northridge, California, United States, 91325
      • Valley Clinical Trials, Inc.
    • Panorama City, California, United States, 91402
      • National Research Institute
    • Spring Valley, California, United States, 91978
      • Encompass Clinical Research
    • Tustin, California, United States, 92780
      • University Clinical Investigators, Inc.
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Chase Medical Research, LLC
  • Florida
    • Hialeah, Florida, United States, 33012
      • Indago Research & Health Center, Inc.
    • Jacksonville, Florida, United States, 32216
      • East Coast Institute for Research
    • Jacksonville, Florida, United States, 32204
      • East Coast Clinical Research
    • New Port Richey, Florida, United States, 34655
      • Bayside Clinical Research, LLC
  • Georgia
    • Macon, Georgia, United States, 31210
      • East Coast Institute for Research
    • Union City, Georgia, United States, 30291
      • Sky Clinical Research Network
  • Idaho
    • Blackfoot, Idaho, United States, 83221
      • Elite Clinical Trials LLLP
    • Boise, Idaho, United States, 83702
      • Humphreys Diabetes Center
    • Idaho Falls, Idaho, United States, 83404
      • Rocky Mountain Diabetes and Osteoporosis Center
  • Illinois
    • Springfield, Illinois, United States, 62711
      • Springfield Diabetes & Endocrine Center
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Crescent City Clinical Research
  • Maryland
    • Rockville, Maryland, United States, 20852
      • Endocrine and Metabolic Consultants
  • Michigan
    • Troy, Michigan, United States, 48098
      • Troy Internal Medicine, PC
  • Minnesota
    • Minneapolis, Minnesota, United States, 55416
      • International Diabetes Center
  • Missouri
    • Chesterfield, Missouri, United States, 63005
      • Clinical Research Professionals
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Palm Research Center
    • Las Vegas, Nevada, United States, 89128
      • Palm Research Center
  • Ohio
    • Columbus, Ohio, United States, 43213
      • Aventiv Research
  • Oregon
    • Corvallis, Oregon, United States, 97330
      • The Corvallis Clinic P.C.
  • Pennsylvania
    • Beaver, Pennsylvania, United States, 15009
      • Heritage Valley Medical Group, Inc.
    • Lansdale, Pennsylvania, United States, 19446
      • Detweiler Family Medicine
  • Texas
    • Corpus Christi, Texas, United States, 78414
      • Office of Dr. Osvaldo Brusco
    • Shavano Park, Texas, United States, 78231
      • Consano Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants must:

  • Have been diagnosed with type 2 diabetes mellitus (T2DM)
  • Have HbA1c between ≥7.0% and ≤10.5%
  • Be on stable treatment with unchanged dose of metformin or metformin plus an SGLT-2 inhibitor for at least 3 months before screening
  • Be of stable weight (± 5%) for at least 3 months before screening
  • Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening

Exclusion Criteria:

• Participants must not:

  • Have type 1 diabetes mellitus
  • Have had chronic or acute pancreatitis any time prior to study entry
  • Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment
  • Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss
  • Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) enzyme level >3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory. Participants with nonalcoholic fatty liver disease (NAFLD) are eligible for participation in this trial only if their ALT level is ≤3.0 the ULN for the reference range
  • Have an estimated glomerular filtration rate <45 mL/minute/1.73 m2 (or lower than the country specific threshold for using the protocol required dose of metformin per local label)
  • Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months
  • Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2
  • Have been taking any other diabetes medicines other than metformin, or metformin plus an SGLT-2 inhibitor during the last 3 months
  • Have been taking weight loss drugs, including over-the-counter medications during the last 3 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 5 mg Tirzepatide; 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.	Drug: Tirzepatide; Administered SC; Other Names: LY3298176
Experimental: 10 mg Tirzepatide; 10 mg tirzepatide administered SC once a week.	Drug: Tirzepatide; Administered SC; Other Names: LY3298176
Experimental: 15 mg Tirzepatide; 15 mg tirzepatide administered SC once a week.	Drug: Tirzepatide; Administered SC; Other Names: LY3298176
Active Comparator: Insulin Degludec; Insulin degludec administered SC once a day.	Drug: Insulin Degludec; Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg)	HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates Baseline + Pooled Country + Baseline Oral Antihyperglycemic Medication (OAM) Use (Metformin (Met), Met plus SGLT-2i) + Treatment + Time + Treatment*Time (Type III sum of squares).	Baseline, Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in HbA1c (5 mg)	HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates Baseline + Pooled Country + Baseline OAM Use (Met, Met plus SGLT-2i) + Treatment + Time + Treatment*Time (Type III sum of squares).	Baseline, Week 52
Change From Baseline in Body Weight	LS mean was determined by MMRM model with Baseline + Pooled Country + Baseline OAM Use (Met, Met plus SGLT-2i) + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares) as covariates.	Baseline, Week 52
Change From Baseline in Fasting Serum Glucose	LS mean was determined by MMRM model with variables Baseline + Pooled Country + Baseline OAM Use (Met, Met plus SGLT-2i) + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares).	Baseline, Week 52
Percentage of Participants Achieving an HbA1c Target Value of <7%	Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Imputed data includes observed value and imputed value if endpoint measure is missing. Missing endpoint measures are imputed by predictions from an MMRM analysis model using observed data in the efficacy analysis set and adjusted for Baseline Value, Pooled Country, Baseline OAM Use (Met, Met plus SGLT-2i), Treatment, Visit and Visit*Treatment.	Week 52
Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values	The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Postmeal, Midday Premeal, Midday 2-hour Postmeal, Evening Premeal, Evening 2-hour Postmeal and Bedtime. LS mean was determined by mixed-model repeated measures (MMRM) model with variables Baseline + Baseline HbA1c Group (<=8.5%, >8.5%) + Pooled Country + Baseline OAM Use (Met, Met plus SGLT-2i) + Treatment + Time + Treatment*Time (Type III sum of squares).	Baseline, Week 52
Percentage of Participants Who Achieved Weight Loss ≥5%	Percentage of Participants who Achieved Weight Loss ≥5%	Week 52
Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) Hyperglycemia, Hypoglycemia and Treatment Satisfaction Score	DTSQc, an 8-item questionnaire, assesses relative change in treatment satisfaction perceived frequency of hyperglycemia, and perceived frequency of hypoglycemia from baseline to week 52 or early termination.The treatment satisfaction score ranges from -18 to 18 where the higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment. The hyperglycemia and hypoglycemia scores range from -3 to 3 where negative scores indicate fewer problems with blood glucose levels and positive scores indicate more problems than before. LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline DTSQs + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Baseline OAM Use (Met, Met plus SGLT-2i) + Treatment (Type III sum of squares).	Week 52
Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 (Millimole/Liter (mmol/L))] or Severe Hypoglycemia	The hypoglycemia events were defined by participant reported events with blood glucose <54mg/dL (<3.0 mmol/L) or severe hypoglycemia. Severe hypoglycemia is defined as an episode with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. The rate of postbaseline hypoglycemia was estimated by negative binomial model: Number of episodes = Pooled Country + Baseline OAM Use (Met, Met plus SGLT-2i) + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment, with log (exposure in days/365.25) as an offset variable.	Baseline through Safety Follow-Up (Up to Week 56)

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Publications and helpful links

General Publications

• Sattar N, McGuire DK, Pavo I, Weerakkody GJ, Nishiyama H, Wiese RJ, Zoungas S. Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis. Nat Med. 2022 Mar;28(3):591-598. doi: 10.1038/s41591-022-01707-4. Epub 2022 Feb 24.
• Gastaldelli A, Cusi K, Fernandez Lando L, Bray R, Brouwers B, Rodriguez A. Effect of tirzepatide versus insulin degludec on liver fat content and abdominal adipose tissue in people with type 2 diabetes (SURPASS-3 MRI): a substudy of the randomised, open-label, parallel-group, phase 3 SURPASS-3 trial. Lancet Diabetes Endocrinol. 2022 Jun;10(6):393-406. doi: 10.1016/S2213-8587(22)00070-5. Epub 2022 Apr 22.
• Battelino T, Bergenstal RM, Rodriguez A, Fernandez Lando L, Bray R, Tong Z, Brown K. Efficacy of once-weekly tirzepatide versus once-daily insulin degludec on glycaemic control measured by continuous glucose monitoring in adults with type 2 diabetes (SURPASS-3 CGM): a substudy of the randomised, open-label, parallel-group, phase 3 SURPASS-3 trial. Lancet Diabetes Endocrinol. 2022 Jun;10(6):407-417. doi: 10.1016/S2213-8587(22)00077-8. Epub 2022 Apr 22. Erratum In: Lancet Diabetes Endocrinol. 2022 Aug;10(8):e8.
• Ludvik B, Giorgino F, Jodar E, Frias JP, Fernandez Lando L, Brown K, Bray R, Rodriguez A. Once-weekly tirzepatide versus once-daily insulin degludec as add-on to metformin with or without SGLT2 inhibitors in patients with type 2 diabetes (SURPASS-3): a randomised, open-label, parallel-group, phase 3 trial. Lancet. 2021 Aug 14;398(10300):583-598. doi: 10.1016/S0140-6736(21)01443-4. Epub 2021 Aug 6.

Helpful Links

• A Study of Tirzepatide (LY3298176) Versus Insulin Degludec in Participants With Type 2 Diabetes

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): December 11, 2020
• Study Completion (Actual): January 4, 2021

Study Registration Dates

• First Submitted: March 19, 2019
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (Actual): March 20, 2019

Study Record Updates

• Last Update Posted (Actual): January 19, 2022
• Last Update Submitted That Met QC Criteria: January 14, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: T2DM
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Tirzepatide
• Other Study ID Numbers: 16997; I8F-MC-GPGH (Other Identifier: Eli Lilly and Company); 2018-003422-84 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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 Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No