AzTrials
AzTrials

Type 2 Diabetes MellitusPhase 3SURPASS-4NCT03730662

A Study of Tirzepatide (LY3298176) Once a Week Versus Insulin Glargine Once a Day in Participants With Type 2 Diabetes and Increased Cardiovascular Risk

A Phase 3 study testing Tirzepatide and Insulin Glargine in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 216 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of the trial is to assess the efficacy and safety of tirzepatide taken once a week to insulin glargine taken once daily in participants with type 2 diabetes and increased cardiovascular risk. The study will last about 108 weeks and may include up to 30 visits. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Tirzepatide and Insulin Glargine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,002 participants
Where
216 sitesin 15 countries
Study dates
20 Nov 2018to 22 Apr 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must:
  • Have been diagnosed with type 2 diabetes mellitus (T2DM)
  • Have HbA1c between ≥7.5% and ≤10.5%
  • Be on stable treatment with unchanged dose of at least 1 and no more than 3 types of oral antihyperglycemic drugs, which may only include metformin, SGLT-2 inhibitors, and/or sulfonylureas for at least 3 months before screening
  • Have increased risk for cardiovascular (CV) events
  • Be of stable weight (± 5%)
  • Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening

Who cannot join

  • 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 immediate or urgent 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 there ALT level is ≤3.0 the ULN for the reference range
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  • 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, SGLT-2 inhibitors, and/or sulfonylureas during the last 3 months
  • Have been taking weight loss drugs, including over-the-counter medications during the last 3 months

Trial locations and contacts

216 sites in 15 countries.

216 sites in 15 countries

United States74 sites

  • Advanced Research Center

    Anaheim, California, 92805

  • Primary Care Specialists, LLC

    Atlanta, Georgia, 30312

  • Heritage Valley Medical Group, Inc.

    Beaver, Pennsylvania, 15009

  • Burke Internal Medicine & Research

    Burke, Virginia, 22015

  • Capital Area Research

    Camp Hill, Pennsylvania, 17011

  • Clinical Research Professionals

    Chesterfield, Missouri, 63005

  • Northwestern Feinberg School of Medicine

    Chicago, Illinois, 60611

  • Rapid Medical Research Inc

    Cleveland, Ohio, 44122

  • Ohio State Univ College Of Medicine

    Columbus, Ohio, 43210

  • Aventiv Research

    Columbus, Ohio, 43213

  • ALL Medical Research, LLC

    Cooper City, Florida, 33024

  • The Corvallis Clinic P.C.

    Corvallis, Oregon, 97330

  • Valley Clinical Trials, Inc.

    Covina, California, 91723

  • Advanced Pharma Research

    Cutler Bay, Florida, 33189

  • Dallas Diabetes Endocrine Center

    Dallas, Texas, 75230

  • NECCR PrimaCare Research, LLC

    Fall River, Massachusetts, 02721

  • Lillestol Research LLC

    Fargo, North Dakota, 58104

  • Alpine Research Organization

    Farmington, Utah, 84025

  • Private: Dr. Larry Stonesifer

    Federal Way, Washington, 98003

  • AA Medical Research Center

    Flint, Michigan, 48504

  • Marin Endocrine Associates

    Greenbrae, California, 94904

  • PharmQuest

    Greensboro, North Carolina, 27408

  • Mountain View Clinical Research, Inc.

    Greer, South Carolina, 29651

  • PCP for Life

    Houston, Texas, 77070

  • National Research Institute

    Huntington Park, California, 90255

  • Rocky Mountain Diabetes and Osteoporosis Center

    Idaho Falls, Idaho, 83404

  • University of Iowa Hospital & Clinic

    Iowa City, Iowa, 52242

  • Glacier View Research Institute

    Kalispell, Montana, 59901

  • Holston Medical Group Clinical Research

    Kingsport, Tennessee, 37660

  • New Phase Research & Development

    Knoxville, Tennessee, 37909

  • Scripps Whittier Diabetes Institute

    La Jolla, California, 92037

  • First Valley Medical Group

    Lancaster, California, 93534

  • Detweiler Family Medicine

    Lansdale, Pennsylvania, 19446

  • Palm Research Center

    Las Vegas, Nevada, 89128

  • Palm Research Center

    Las Vegas, Nevada, 89148

  • National Research Institute

    Los Angeles, California, 90057

  • Robley Rex VAMC

    Louisville, Kentucky, 40206

  • South Florida Wellness & Clinical Research Institute

    Margate, Florida, 33063

  • The Research Center of the Upstate

    Mauldin, South Carolina, 29662

  • Solaris Clinical Research

    Meridian, Idaho, 83646

  • Suncoast Research Group, LLC

    Miami, Florida, 33135

  • New Horizon Research Center

    Miami, Florida, 33165

  • Montana Medical Research, Inc

    Missoula, Montana, 59808

  • Catalina Research Institute, LLC

    Montclair, California, 91763

  • Monterey Endocrine & Diabetes Institute, Inc.

    Monterey, California, 93940

  • Saltzer Medical Group. P.A.

    Nampa, Idaho, 83686

  • Southern New Hampshire Diabetes and Endocrinology

    Nashua, New Hampshire, 03063

  • Capital Area Research

    Newport, Pennsylvania, 17074

  • Intend Research

    Norman, Oklahoma, 73069

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325

  • Capital Clinical Research Center

    Olympia, Washington, 98502

  • Clinical Neuroscience Solutions Inc

    Orlando, Florida, 32801

  • Desert Medical Group Inc

    Palm Springs, California, 92262

  • Havana Research Institute

    Pasadena, California, 91105

  • Parkside Family Medical

    Philadelphia, Pennsylvania, 19144

  • Preferred Primary Care Physicians- Bower Hill

    Pittsburgh, Pennsylvania, 15243

  • Western University of Health Sciences

    Pomona, California, 91766

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • BFHC Research

    San Antonio, Texas, 78249

  • LCGK Research

    San Carlos, California, 94070

  • Consano Clinical Research

    Shavano Park, Texas, 78231

  • NorthShore University HealthSystem

    Skokie, Illinois, 60077

  • Olive View Medical Center

    Sylmar, California, 91342

  • Martin Diagnostic Clinic

    Tomball, Texas, 77375

  • Cotton O'Neil Diabetes and Endocrinology Center

    Topeka, Kansas, 66606

  • Troy Internal Medicine, PC

    Troy, Michigan, 48098

  • University Clinical Investigators, Inc.

    Tustin, California, 92780

  • Touro University

    Vallejo, California, 94592

  • Coastal Metabolic Research Centre

    Ventura, California, 93003

  • Walla Walla Clinic

    Walla Walla, Washington, 99362

  • Diablo Clinical Research

    Walnut Creek, California, 94598

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

  • Iowa Diabetes Research

    West Des Moines, Iowa, 50265

Other trials in United States

Canada19 sites

  • LMC Endocrinology Centres Ltd.

    Barrie, Ontario, L4N 7L3

  • LMC Endocrinology Centers Brampton

    Brampton, Ontario, L6S 0C6

  • Aggarwal and Associates Ltd

    Brampton, Ontario, L6T 0G1

  • LMC Manna Research

    Calgary, Alberta, T2H 2G4

  • C-Health Diabetes and Endocrinology Clinic Calgary

    Calgary, Alberta, T2V 4J2

  • LMC Endocrinology Centres Ltd.

    Concord, Ontario, L4K 4M2

  • Q & T Research Outaouais

    Gatineau, Quebec, J8Y 6S8

  • Medicor Research Inc

    Greater Sudbury, Ontario, P3A 1W8

  • Centre De Recherche Clinique De Laval

    Laval, Quebec, H7T 2P5

  • Manna Research (Quebec)

    Lévis, Quebec, G6W 0M5

  • Milestone Research Inc.

    London, Ontario, N5W6A2

  • LMC Endocrinology Centres Ltd.

    Nepean, Ontario, K2J 0V2

  • LMC Endocrinology Centres Ltd.

    Saint-Laurent, Quebec, H4T 1Z9

  • Bluewater Clinical Research Group Inc

    Sarnia, Ontario, N7T 4X3

  • Synergy Medical Research

    Sherwood Park, Alberta, T8H 0N2

  • Canadian Centre for Research on Diabetes

    Smiths Falls, Ontario, K7A 4W8

  • Manna Research, Inc.

    Stoney Creek, Ontario, L8J 3W2

  • LMC Endocrinology Centres Ltd.

    Toronto, Ontario, M4G 3E8

  • Sameh Fikry Medicine Professional Corporation

    Waterloo, Ontario, N2J 1C4

Other trials in Canada

Argentina15 sites

  • AXISMED SRL - Bioclinica Research Network

    Buenos Aires, C1430CKE

  • Investigaciones Medicas IMOBA S.R.L.

    Caba, Buenos Aires, C1179AAB

  • CEDIC-Centro de Investigaciones Clinicas

    Caba, Buenos Aires, C1425DES

  • Centro de Investigaciones Metabólicas (CINME)

    CABA, Buenos Aires, C1056ABJ

  • Mautalen Salud e Investigación - Servicio de Endocrinología

    CABA, Buenos Aires, C1128AAF

  • CEMEDIC

    CABA, Buenos Aires, C1440CFD

  • Centro de Investigacion y Prevencion Cardiovascular (CIPREC)

    Ciudad Autonoma de, Buenos Aires, C1119ACN

  • Centro Medico Dr Laura Maffei Investigacion Clinica Aplicada

    Ciudad Autonoma de Buenos Aire, Buenos Aires, C1425AGC

  • Centro Médico Viamonte

    Ciudad Autonoma de Buenos Aire, C1120AAC

  • Instituto Centenario

    Ciudad Autonoma de Buenos Aire, C1204AAD

  • Cemediab - Centro Médico Diabetológico Dr. Alejandro Chertkoff

    Ciudad Autonoma de Buenos Aire, C1205AAO

  • Centro Diabetologico Dr Waitman

    Córdoba, 5000

  • Centro Medico Privado San Vicente Diabetes

    Córdoba, X5006CBI

  • Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC

    Córdoba, X5008HHW

  • CIPADI

    Godoy Cruz, Mendoza Province, M5501ARP

Other trials in Argentina

Australia15 sites

  • Paratus Clinical Blacktown Clinic

    Blacktown, New South Wales, 2148

  • Eastern Clinical Research Unit

    Box Hill, Victoria, 3128

  • CORE Research Group Pty Ltd

    Brisbane, Queensland, 4064

  • Campbelltown Medical & Dental Centre

    Campbelltown, New South Wales, 2560

  • Forest Hill Medical and Dental Centre

    Forest Hill, Victoria, 3131

  • Fremantle Hospital

    Fremantle, Western Australia, 6160

  • Barwon Health - The Geelong Hospital

    Geelong, Victoria, 3220

  • Paratus Clinical Kanwal Clinic

    Kanwal, New South Wales, 2259

  • The AIM Centre

    Merewether, New South Wales, 2291

  • Morayfield Medical and Dental Centre

    Morayfield, Queensland, 4506

  • GP Plus Marion

    Oaklands Park, South Australia, 5046

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • AusTrials Pty Ltd

    Sherwood, Queensland, 4075

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • Victoria Point Medical and Dental Centre

    Victoria Point, Queensland, 4165

Other trials in Australia

Spain12 sites

  • Complexo Hospitalario Universitario A Coruña, CHUAC

    A Coruña, 15006

  • Instituto de Ciencias medicas

    Alicante, 03004

  • Centro Periférico de Especialidades Bola Azul

    Almería, 04009

  • Hospital de la Ribera

    Alzira, Valencia, 46600

  • Hospital Quironsalud Barcelona- END

    Barcelona, 08023

  • Hospital Clinico Universitario San Cecilio

    Granada, 18016

  • Centro Especialidades San Jose Obrero (Barbarela)

    Málaga, 29006

  • Clinica Juaneda

    Palma de Mallorca, 07014

  • Hospital Universitario Quiron Madrid

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital Universitario Marques De Valdecilla

    Santander, Cantabria, 39011

  • Clinica Nuevas Tecnologias en Diabetes y Endocrinologia

    Seville, 41003

  • Hospital Universitario Virgen Macarena

    Seville, 41009

Other trials in Spain

Poland11 sites

  • Poradnia Diabetologiczna SN ZOZ Lege Artis

    Bialystok, 15-404

  • NZOZ Diab-Endo-Met

    Krakow, 31-261

  • Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.

    Lodz, 90-242

  • NZOZ CenterMed Lublin

    Lublin, 20-044

  • Gabinety Terpa

    Lublin, 20-333

  • NZOZ Przychodnia Specjalistyczna MEDICA

    Lublin, 20-538

  • Praktyka Lekarska

    Poznan, 61-655

  • Nzoz Neuro - Kard

    Poznan, 61-853

  • NZOZ Przychodnia Specjalistyczna Henryk RudzkiAndrzej Wittek

    Ruda Śląska, 41-709

  • Centralny Szpital Kliniczny MSWiA Klinika Dermatologiczna

    Warsaw, Masovian Voivodeship, 02-507

  • Woj. Zesp. Spec. Opieki Zdrowotnej

    Wroclaw, 50-403

Other trials in Poland

Russia10 sites

  • Arkhangelsk the first city clinical hospital

    Arkhangelsk, 163045

  • FSBI Endocrinological Research Center of the MOH of the ROF

    Moscow, 117036

  • Novosibirsk Regional Clinical Hospital

    Novosibirsk, 630087

  • Ryazan Regional Clinincal Cardiology Dispensary

    Ryazan, 390026

  • City Hospital of Saint Martyr Elizabeth

    Saint Petersburg, 193257

  • Medical Military Academy

    Saint Petersburg, 194044

  • City Consultative and Diagnostic Center

    Saint Petersburg, 194354

  • SPb GUZ "Diagnostic Center #85"

    Saint Petersburg, 198255

  • Regional Clinical Hospital

    Saratov, Russian Federation, 410053

  • Research & Practice Ltd

    Yaroslavl, 150003

Other trials in Russia

Brazil9 sites

  • Centro de Pesquisa Clinica do Brasil

    Brasília, Federal District, 71625-009

  • Centro de Diabetes Curitiba

    Curitiba, Paraná, 80810-040

  • Instituto de Ensino e Pesquisa Clinica do Ceara

    Fortaleza, Ceará, 60170-195

  • Centro de Pesq. em Diabetes e Doencas Endocrino Metabol.

    Fortaleza, 60430-350

  • CCBR Brasil Centro de Analises e Pesquisas Clínicas LTDA

    Rio de Janeiro, Rio de Janeiro, 22271-100

  • CPQuali Pesquisa Clínica Ltda.

    São Paulo, São Paulo, 01228-000

  • Cpclin Centro de Pesquisas Clinicas

    São Paulo, São Paulo, 01228-200

  • Dr. Consulta Clínica Médica LTDA

    São Paulo, 01141-020

  • Cedoes Centro Diagnostico Pequisa Osteoporose E Santo Ltd

    Vitória, Espírito Santo, 29055-450

Other trials in Brazil

Israel9 sites

  • Ha'Emek Medical Center

    Afula, 1834111

  • Soroka Medical Center

    Beersheba, 8410101

  • Rambam Medical Center

    Haifa, 3109601

  • Wolfson Medical Center

    Holon, 5822012

  • Hadassah Medical Center

    Jerusalem, 911201

  • Rabin Medical Center

    Petah Tikva, 4941492

  • Sheba Medical Center

    Ramat Gan, 5266202

  • Sakhnin Community Clinic, Clalit Health Services

    Sakhnin, 3081000

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Romania9 sites

  • CMI DNBM Dr. Pop Lavinia

    Baia Mare, Maramureş, 430222

  • Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL

    Brasov, 500283

  • Cabinetul Medical Nicodiab SRL

    Bucharest, 010507

  • SC Nutrilife SRL

    Bucharest, 013671

  • Milena Sante SRL

    Galati, 800001

  • SC Gama Diamed SRL

    Mangalia, Constanța County, 905500

  • Spitalul Judetean de Urgenta Satu Mare

    Satu Mare, Jud Satu-Mare, 440055

  • Cosamext SRL

    Târgu Mureş, Mureș County, 540098

  • Centrul Medical Dr. Negrisanu

    Timișoara, Timiș County, 300456

Other trials in Romania

Taiwan9 sites

  • Chang Gung Memorial Hospital - Kaohsiung

    Kaohsiung City, 833

  • Cardinal Tien Hospital

    Sindian City, Taipei, 23148

  • Chung Shan Medical University Hospital

    Taichung, 40201

  • China Medical University Hospital

    Taichung, 40447

  • Kuang Tien General Hospital

    Taichung County, 433

  • National Cheng Kung University Hospital

    Tainan, 70403

  • Chi-Mei Medical Center

    Tainan, 71004

  • National Taiwan University Hospital

    Taipei, 10048

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Puerto Rico7 sites

  • Emanuelli Research & Development Center, LLC

    Arecibo, 00612

  • Manati Center for Clinical Research Inc

    Manati, PR, 00674

  • Ponce School of Medicine CAIMED Center

    Ponce, PR, 00716

  • Research and Cardiovascular Corp.

    Ponce, PR, 00717

  • University Of Puerto Rico

    Rio Pedras, PR, 00936

  • GCM Medical Group PSC

    San Juan, PR, 00909

  • Consultorio Medico

    San Juan, PR, 00921

Other trials in Puerto Rico

Mexico6 sites

  • Investigacion en Salud y Metabolismo S.C

    Chihuahua City, 31217

  • Instituto Jalisciense de Investigacion en Diabetes y Obesida

    Guadalajara, Jalisco, 04460

  • Diseno y Planeacion en Investigacion Medica S.C.

    Guadalajara, Jalisco, 44130

  • St. Lucas Clinical Research Center

    Merida, State of Mexico, 97217

  • Unidad Medica para la Salud Integral (UMSI)

    Monterrey, Nuevo León, 66465

  • Centro de Estudios de Investigacion Metabolicos y Cardiovasc

    Tampico, Tamaulipas, 89000

Other trials in Mexico

Slovakia6 sites

  • Human care s.r.o.

    Košice, Slovak Republic, 04012

  • MediVet s.r.o.

    Malacky, Slovak Republic, 90101

  • DIA-MED CENTRUM s.r.o.

    Púchov, 02001

  • Tatratrial s.r.o.

    Rožňava, 04801

  • MEDI-DIA s.r.o.

    Sabinov, 08301

  • Areteus s.r.o.

    Trebišov, Slovak Republic, 07501

Other trials in Slovakia

Greece5 sites

  • University General Hospital of Larissa

    Larissa, 41110

  • Iatriko Palaiou Falirou, Medical Center

    Palaió Fáliro, Athens, 17562

  • Thermi Clinic

    Thermi, Thessaloniki, 57001

  • AHEPA Hospital

    Thessaloniki, 54636

  • Euromedica - General Clinic of Thessaloniki

    Thessaloniki, 54645

Other trials in Greece

About this study

Official title: Efficacy and Safety of LY3298176 Once Weekly Versus Insulin Glargine in Patients With Type 2 Diabetes and Increased Cardiovascular Risk (SURPASS-4)

The purpose of the trial is to assess the efficacy and safety of tirzepatide taken once a week to insulin glargine taken once daily in participants with type 2 diabetes and increased cardiovascular risk. The study will last about 108 weeks and may include up to 30 visits.

Keywords
GIP, GLP-1, glucose metabolism disorders, metabolic diseases, endocrine system diseases, cardiovascular risk
Medical subject headings
Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03730662
Study groupRoleWhat they receive
5 mg TirzepatideExperimental5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
Receives: Drug: Tirzepatide
10 mg TirzepatideExperimental10 mg tirzepatide administered SC once a week.
Receives: Drug: Tirzepatide
15 mg TirzepatideExperimental15 mg tirzepatide administered SC once a week.
Receives: Drug: Tirzepatide
Insulin GlargineActive comparatorInsulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG <100 mg/dL, following a treat-to-target (TTT) algorithm.
Receives: Drug: Insulin Glargine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 for post-baseline measures: Variable = Baseline + Pooled Country + Baseline sodium-glucose co-transporter-2 inhibitor (SGLT-2i) use Flag (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares).

    Measured: Baseline, Week 52

Secondary outcomes (7)

  1. 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. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Pooled Country + Baseline SGLT-2i use Flag (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares).

    Measured: Baseline, Week 52

  2. Change From Baseline in Body Weight

    LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Baseline SGLT-2i use Flag (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares).

    Measured: Baseline, Week 52

  3. Percentage of Participants With HbA1c of <7.0%

    HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Imputed data includes observed value and imputed value if endpoint measure is missing.

    Measured: Week 52

  4. Change From Baseline in Fasting Serum Glucose

    LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Baseline SGLT-2i use Flag (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares).

    Measured: Baseline, Week 52

  5. 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 + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Baseline SGLT-2i use Flag (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares).

    Measured: Baseline, Week 52

  6. Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve From Zero to Tau (AUC 0-Tau) of Tirzepatide

    Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve From Zero to Tau (AUC 0-Tau) of Tirzepatide

    Measured: 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours post dose of Week 7, 15, 23, 35

  7. 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. Post-baseline comparisons between treatment and control group was evaluated using negative binomial model with variables : Number of episodes = Baseline HbA1c Group (<=8.5%, >8.5%) + Pooled Country + Baseline SGLT-2i use Flag (Yes, No) + Treatment, with log (exposure in days/365.25) as an offset variable

    Measured: Baseline through Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2018
  2. Study start20 Nov 2018
  3. Primary completion22 Jan 2021
  4. Study completion22 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,002 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03730662
Sponsor's protocol ID
17072
Other IDs
I8F-MC-GPGM, 2018-002618-11, 2018
Acronym
SURPASS-4
Status last verified
Jan 2022
First submitted
2 Nov 2018
Last updated
14 Feb 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • De Block C, Peleshok J, Wilding JPH, Kwan AYM, Rasouli N, Maldonado JM, Wysham C, Liu M, Aleppo G, Benneyworth BD. Post Hoc Analysis of SURPASS-1 to -5: Efficacy and Safety of Tirzepatide in Adults with Type 2 Diabetes are Independent of Baseline Characteristics. Diabetes Ther. 2025 Jan;16(1):43-71. doi: 10.1007/s13300-024-01660-0. Epub 2024 Nov 12.

    PubMed 39531161

  • Boye KS, Sapin H, Dong W, Williamson S, Lee CJ, Thieu VT. Improved Glycaemic and Weight Management Are Associated with Better Quality of Life in People with Type 2 Diabetes Treated with Tirzepatide. Diabetes Ther. 2023 Nov;14(11):1867-1887. doi: 10.1007/s13300-023-01457-7. Epub 2023 Sep 5.

    PubMed 37668888

  • Boye KS, Thieu VT, Sapin H, Lee CJ, Lando LF, Brown K, Bray R, Wiese RJ, Patel H, Rodriguez A, Yu M. Patient-Reported Outcomes in People with Type 2 Diabetes Receiving Tirzepatide in the SURPASS Clinical Trial Programme. Diabetes Ther. 2023 Nov;14(11):1833-1852. doi: 10.1007/s13300-023-01451-z. Epub 2023 Aug 1.

    PubMed 37526908

  • Heerspink HJL, Sattar N, Pavo I, Haupt A, Duffin KL, Yang Z, Wiese RJ, Tuttle KR, Cherney DZI. Effects of tirzepatide versus insulin glargine on kidney outcomes in type 2 diabetes in the SURPASS-4 trial: post-hoc analysis of an open-label, randomised, phase 3 trial. Lancet Diabetes Endocrinol. 2022 Nov;10(11):774-785. doi: 10.1016/S2213-8587(22)00243-1. Epub 2022 Sep 21.

    PubMed 36152639

  • 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.

    PubMed 35210595

  • Del Prato S, Kahn SE, Pavo I, Weerakkody GJ, Yang Z, Doupis J, Aizenberg D, Wynne AG, Riesmeyer JS, Heine RJ, Wiese RJ; SURPASS-4 Investigators. Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial. Lancet. 2021 Nov 13;398(10313):1811-1824. doi: 10.1016/S0140-6736(21)02188-7. Epub 2021 Oct 18.

    PubMed 34672967

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tirzepatide and Insulin Glargine in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 216 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 216 sites in United States, Canada, Argentina, Australia, Spain and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg) (time frame: Baseline, Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03730662, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022; AzTrials last refreshed its copy on 8 Nov 2026.

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