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Type 2 Diabetes MellitusPhase 3SURPASS-3NCT03882970

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

A Phase 3 study testing Tirzepatide and Insulin Degludec in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 122 sites in 13 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 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. 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 Degludec
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,444 participants
Where
122 sitesin 13 countries
Study dates
1 Apr 2019to 4 Jan 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 ≥7.0% 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

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 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
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  • 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

Trial locations and contacts

122 sites in 13 countries.

122 sites in 13 countries

United States33 sites

  • Heritage Valley Medical Group, Inc.

    Beaver, Pennsylvania, 15009

  • Elite Clinical Trials LLLP

    Blackfoot, Idaho, 83221

  • Humphreys Diabetes Center

    Boise, Idaho, 83702

  • Clinical Research Professionals

    Chesterfield, Missouri, 63005

  • Aventiv Research

    Columbus, Ohio, 43213

  • Office of Dr. Osvaldo Brusco

    Corpus Christi, Texas, 78414

  • The Corvallis Clinic P.C.

    Corvallis, Oregon, 97330

  • Valley Research

    Fresno, California, 93720

  • Indago Research & Health Center, Inc.

    Hialeah, Florida, 33012

  • National Research Institute

    Huntington Park, California, 90255

  • Rocky Mountain Diabetes and Osteoporosis Center

    Idaho Falls, Idaho, 83404

  • East Coast Clinical Research

    Jacksonville, Florida, 32204

  • East Coast Institute For Research

    Jacksonville, Florida, 32216

  • Detweiler Family Medicine

    Lansdale, Pennsylvania, 19446

  • Palm Research Center

    Las Vegas, Nevada, 89128

  • Palm Research Center

    Las Vegas, Nevada, 89148

  • Arkansas Clinical Research

    Little Rock, Arkansas, 72205

  • National Research Institute

    Los Angeles, California, 90057

  • East Coast Institute For Research

    Macon, Georgia, 31210

  • Crescent City Clinical Research

    Metairie, Louisiana, 70006

  • International Diabetes Center

    Minneapolis, Minnesota, 55416

  • Catalina Research Institute, LLC

    Montclair, California, 91763

  • Bayside Clinical Research, LLC

    New Port Richey, Florida, 34655

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325

  • National Research Institute

    Panorama City, California, 91402

  • Endocrine and Metabolic Consultants

    Rockville, Maryland, 20852

  • Consano Clinical Research

    Shavano Park, Texas, 78231

  • Encompass Clinical Research

    Spring Valley, California, 91978

  • Springfield Diabetes & Endocrine Center

    Springfield, Illinois, 62711

  • Troy Internal Medicine, PC

    Troy, Michigan, 48098

  • University Clinical Investigators, Inc.

    Tustin, California, 92780

  • Sky Clinical Research Network

    Union City, Georgia, 30291

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

Other trials in United States

Greece10 sites

  • Laiko General Hospital of Athens

    Ampelokipoi, Attica, 11527

  • Gen Hospital of Athens G Gennimatas

    Athens, Attica, 11527

  • Athens Euroclinic

    Athens, 11521

  • University General Hospital of Larissa

    Larissa, 41110

  • General Hospital of Thessaloniki Papageorgiou

    N. Efkarpia, Thessaloniki, 56403

  • Iatriko Palaiou Falirou, Medical Center

    Palaió Fáliro, Athens, 17562

  • Thermi Clinic

    Thermi, Thessaloniki, 57001

  • AHEPA Hospital

    Thessaloniki, 54636

  • Ippokrateio General Hospital of Thessaloniki

    Thessaloniki, 54639

  • Euromedica - General Clinic of Thessaloniki

    Thessaloniki, 54645

Other trials in Greece

Romania10 sites

  • CMI DNBM Dr. Pop Lavinia

    Baia Mare, Maramureş, 430222

  • Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL

    Brasov, 500283

  • Societatea Civila Medicala "Dr. Paveliu"

    Bucharest, Sect.5, 050538

  • Cabinetul Medical Nicodiab SRL

    Bucharest, 010507

  • SC Nutrilife SRL

    Bucharest, 013671

  • SC Diamed Obesity SRL

    Galati, Galați County, 800291

  • Consultmed SRL

    Iași, 700547

  • S. C. Grandmed S.R.L., Str.

    Oradea, Bihor County, 410159

  • Spitalul Judetean de Urgenta Satu Mare

    Satu Mare, Jud Satu-Mare, 440055

  • Cosamext SRL

    Târgu Mureş, Mureș County, 540098

Other trials in Romania

South Korea10 sites

  • Korea University Ansan Hospital

    Ansan-si, 15355

  • Bucheon St. Mary's Hospital

    Bucheon-si, Gyeonggi-do, 14647

  • Hanyang University Guri Hospital

    Guri-si, Gyeonggido, 11923

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Seoul St. Mary's Hospital

    Seoul, Korea, 06591

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Kyunghee University Hospital at Gangdong

    Seoul, 05278

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Argentina9 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

  • Mautalen Salud e Investigación - Servicio de Endocrinología

    CABA, Buenos Aires, C1128AAF

  • Centro de Investigacion y Prevencion Cardiovascular (CIPREC)

    Ciudad Autonoma de, Buenos Aires, C1119ACN

  • Centro Médico Viamonte

    Ciudad Autonoma de Buenos Aire, C1120AAC

  • Instituto Centenario

    Ciudad Autonoma de Buenos Aire, C1204AAD

  • CENUDIAB

    Ciudad Autonoma de Buenos Aire, C1440AAD

  • CIPADI

    Godoy Cruz, Mendoza Province, M5501ARP

Other trials in Argentina

Taiwan9 sites

  • Changhua Christian Hospital

    Changhua, 500

  • Chang Gung Memorial Hospital - Kaohsiung

    Kaohsiung City, 833

  • Taipei Medical University- Shuang Ho Hospital

    New Taipei City, 23561

  • Chung Shan Medical University Hospital

    Taichung, 40201

  • Taichung Veterans General Hospital

    Taichung, 40705, ROC

  • Kuang Tien General Hospital

    Taichung County, 433

  • National Cheng Kung University Hospital

    Tainan, 70403

  • Chi-Mei Medical Center

    Tainan, 71004

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Hungary8 sites

  • Szent Margit Rendelointezet

    Budapest, 1032

  • ClinDiab Kft.

    Budapest, 1089

  • XIII.ker Onkormanyzat Egeszsegugyi Szolgalat

    Budapest, 1139

  • Strazsahegy Medicina Bt.

    Budapest, 1171

  • TRANTOR 99 Bt.

    Budapest, 1213

  • Kenezy Gyula Korhaz es Rendelointezet

    Debrecen, Hajdú-Bihar, 4031

  • Kanizsai Dorottya Korhaz

    Nagykanizsa, 8800

  • Zala Megyei Szent Rafael Korhaz

    Zalaegerszeg, 8900

Other trials in Hungary

Poland8 sites

  • NZOZ ZDROWIE Osteo-Medic

    Bialystok, 15-351

  • Poradnia Diabetologiczna SN ZOZ Lege Artis

    Bialystok, 15-404

  • Ambulatorium Barbara Bazela

    Elblag, Warminsko-Mazurki, 82300

  • NZOZ Diab-Endo-Met

    Krakow, 31-261

  • Gabinet Lekarski Malgorzata Saryusz-Wolska

    Lodz, 90-132

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

    Lodz, 90-242

  • NZOZ Przychodnia Specjalistyczna MEDICA

    Lublin, 20-538

  • NZOZ Przychodnia Specjalistyczna Henryk RudzkiAndrzej Wittek

    Ruda Śląska, 41-709

Other trials in Poland

Spain8 sites

  • Instituto de Ciencias médicas

    Alicante, 03004

  • Hospital Clinico Universitario San Cecilio

    Granada, 18016

  • Clinica Juaneda

    Palma de Mallorca, 07014

  • Hospital Universitario Quiron Madrid

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital Universitario Marques De Valdecilla

    Santander, Cantabria, 39011

  • Hospital Infanta Luisa

    Seville, Andalusia, 41010

  • Clinica Nuevas Tecnologias en Diabetes y Endocrinologia

    Seville, 41003

  • Policlinica Galileo

    Teruel, 44002

Other trials in Spain

Italy6 sites

  • Azienda Ospedaliera Policlinico Consorziale

    Bari, 70124

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, 24128

  • Azienda ospedaliero-universitaria Mater Domini

    Germaneto, Catanzaro, 88100

  • Ospedale Santa Maria Goretti

    Latina, 04100

  • Centro Cardiologico Monzino, IRCCS

    Milan, MI, 20138

  • Policlinico Univ. Agostino Gemelli

    Rome, Lazio, 00168

Other trials in Italy

Austria4 sites

  • Universitätsklinikum Graz

    Graz, Styria, 8036

  • Universitätsklinikum Salzburg

    Salzburg, 5020

  • Landesklinikum Korneuburg-Stockerau, Standort Stockerau

    Stockerau, Lower Austria, 2000

  • KA Rudolfstiftung

    Vienna, 1030

Other trials in Austria

Ukraine4 sites

  • Dnipro City Clinical Hospital #9

    Dnipro, 49023

  • V.P. Komisarenko Institute of Endocrinology and Metabolism of NAMS of Ukraine

    Kyiv, 04114

  • Communal Institution "Poltava Reg.Cl.H. n.a.M.V.Sklifosovskogo"

    Poltava, 36011

  • Vinnytsia Regional Clinical Highly Specialized Endocrinology Center

    Vinnytsia, 21000

Other trials in Ukraine

Puerto Rico3 sites

  • Latin Clinical Trial Center

    San Juan, PR, 00909

  • GCM Medical Group PSC

    San Juan, PR, 00917

  • San Miguel Medical

    Trujillo Alto, PR, 00976

Other trials in Puerto Rico

About this study

Official title: 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.

Being tested
Tirzepatide, Insulin Degludec
Keywords
T2DM
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • TirzepatideDrug

    Also called LY3298176

    Administered SC

  • Insulin DegludecDrug

    Administered SC

Study groups in NCT03882970
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 DegludecActive comparatorInsulin degludec administered SC once a day.
Receives: Drug: Insulin Degludec

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 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).

    Measured: Baseline, Week 52

Secondary outcomes (8)

  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. 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).

    Measured: Baseline, Week 52

  2. 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.

    Measured: Baseline, Week 52

  3. 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).

    Measured: Baseline, Week 52

  4. 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.

    Measured: 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 + 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).

    Measured: Baseline, Week 52

  6. Percentage of Participants Who Achieved Weight Loss ≥5%

    Percentage of Participants who Achieved Weight Loss ≥5%

    Measured: Week 52

  7. 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).

    Measured: Week 52

  8. 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.

    Measured: Baseline through Safety Follow-Up (Up to Week 56)

Timeline

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

  1. First posted20 Mar 2019
  2. Study start1 Apr 2019
  3. Primary completion11 Dec 2020
  4. Study completion4 Jan 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
1,444 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03882970
Sponsor's protocol ID
16997
Other IDs
I8F-MC-GPGH, 2018-003422-84, 2018
Acronym
SURPASS-3
Status last verified
Jan 2022
First submitted
19 Mar 2019
Last updated
19 Jan 2022
Data monitoring committee
Yes
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

  • Cusi K, Gastaldelli A, Lando LF, Sharma P, Torcello-Gomez A, Rodriguez A. Liver Fat Changes in Patients With Type 2 Diabetes by Presence of Genetic Hepatic Steatosis: A Post Hoc Analysis of SURPASS-3 MRI. Liver Int. 2026 Sep;46(9):e70837. doi: 10.1111/liv.70837.

    PubMed 42576670

  • Sattar N, Neeland IJ, Dahlqvist Leinhard O, Fernandez Lando L, Bray R, Linge J, Rodriguez A. Tirzepatide and muscle composition changes in people with type 2 diabetes (SURPASS-3 MRI): a post-hoc analysis of a randomised, open-label, parallel-group, phase 3 trial. Lancet Diabetes Endocrinol. 2025 Jun;13(6):482-493. doi: 10.1016/S2213-8587(25)00027-0. Epub 2025 Apr 30.

    PubMed 40318682

  • 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

  • Cariou B, Linge J, Neeland IJ, Dahlqvist Leinhard O, Petersson M, Fernandez Lando L, Bray R, Rodriguez A. Effect of tirzepatide on body fat distribution pattern in people with type 2 diabetes. Diabetes Obes Metab. 2024 Jun;26(6):2446-2455. doi: 10.1111/dom.15566. Epub 2024 Mar 26.

    PubMed 38528819

  • 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

  • Viljoen A, Pantalone KM, Galindo RJ, Cui X, Huh R, Hemmingway A, Fernandez Lando L, Patel H. Time to Reach Glycaemic and Body Weight Loss Thresholds with Tirzepatide in Patients with Type 2 Diabetes: A Pre-planned Exploratory Analysis of SURPASS-2 and SURPASS-3. Diabetes Ther. 2023 May;14(5):925-936. doi: 10.1007/s13300-023-01398-1. Epub 2023 Mar 31.

    PubMed 37000390

  • 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.

    PubMed 35468325

  • 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.

    PubMed 35468321

  • 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

  • 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.

    PubMed 34370970

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tirzepatide and Insulin Degludec in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 122 sites in 13 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 6 inclusion and 11 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 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 122 sites in United States, Greece, Romania, South Korea, Argentina and 8 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 19 Jan 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 NCT03882970, which also lists 11 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 19 Jan 2022.

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