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Type 2 DiabetesPhase 3SURPASS-6NCT04537923

A Study of Tirzepatide (LY3298176) Versus Insulin Lispro (U100) in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin

A Phase 3 study testing Tirzepatide and Insulin Lispro (U100) in people with Type 2 Diabetes, run by Eli Lilly and Company at 135 sites in 16 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 safety and efficacy of the study drug tirzepatide to insulin lispro (U100) three times a day in participants with type 2 diabetes that are already on insulin glargine (U100), with or without metformin. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
Tirzepatide and Insulin Lispro (U100)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,428 participants
Where
135 sitesin 16 countries
Study dates
19 Oct 2020to 1 Nov 2022
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

  • Have been diagnosed with type 2 diabetes mellitus (T2DM)
  • Have HbA1c between ≥7.5% and ≤11%
  • Have been treated for at least 90 days prior to day of screening with once or twice daily basal insulin with or without stable dose of metformin ≥1500 mg/day and up to maximum approved dose per country specific approved label, sulfonylureas or dipeptidyl peptidase 4 inhibitors
  • Be of stable weight (± 5%) for at least 90 days
  • Have a BMI ≥23 kilograms per meter squared (kg/m²) and ≤45 kg/m² at screening

Who cannot join

  • Have type 1 diabetes mellitus
  • Have had chronic or acute pancreatitis any time prior to study entry
  • Have proliferative diabetic retinopathy or diabetic macular edema or nonproliferative diabetic retinopathy requiring immediate or urgent treatment
  • Have disorders associated with slowed emptying of the stomach, have had any stomach surgeries for the purpose of weight loss, or are chronically taking drugs that directly affect gastrointestinal motility
  • 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 weight loss drugs, including over-the-counter medications during the last 3 months
  • Have an estimated glomerular filtration rate <30 mL/minute/1.73 m² [for participants on metformin, estimated glomerular filtration rate <45 mL/min/1.73 m2 (or lower than the country-specific threshold for using the protocol-required dose of metformin per local label)]

Trial locations and contacts

135 sites in 16 countries.

135 sites in 16 countries

United States40 sites

  • Albany Medical College

    Albany, New York, 12203

  • University of Colorado

    Aurora, Colorado, 80045

  • Heritage Valley Medical Group, Inc.

    Beaver, Pennsylvania, 15009

  • Excel Medical Clinical Trials

    Boca Raton, Florida, 33434

  • Capital Diabetes and Endocrine Associates

    Camp Springs, Maryland, 20746

  • J H. Stroger Hosp of Cook Co

    Chicago, Illinois, 60612

  • Dallas Diabetes Research Center

    Dallas, Texas, 75230

  • Diabetes and Thyroid Center of Fort Worth

    Fort Worth, Texas, 76132

  • Valley Research

    Fresno, California, 93720

  • Tribe Clinical Research, LLC

    Greenville, South Carolina, 29607

  • I R & Health Center, Inc.

    Hialeah, Florida, 33012

  • Juno Research

    Houston, Texas, 77040

  • Biopharma Informatic, LLC

    Houston, Texas, 77084

  • National Research Institute - Huntington Park

    Huntington Park, California, 90255

  • MedStar Health Research Institute

    Hyattsville, Maryland, 20782

  • Rocky Mountain Clinical Research

    Idaho Falls, Idaho, 83404

  • Glacier View Research Institute - Endocrinology

    Kalispell, Montana, 59901

  • National Research Institute - Huntington Park

    Los Angeles, California, 90057

  • Southern Nh Diabetes and Endocrinology

    Nashua, New Hampshire, 03060

  • Sun Coast Clinical Research, Inc

    New Port Richey, Florida, 34652

  • Intend Research, LLC

    Norman, Oklahoma, 73069

  • North Hills Medical Research

    North Richland Hills, Texas, 76180

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325

  • National Research Institute - Huntington Park

    Panorama City, California, 91402

  • South Broward Research

    Pembroke Pines, Florida, 33027

  • Rainier Clinical Research Center

    Renton, Washington, 98057

  • Endocrine and Metabolic Consultants

    Rockville, Maryland, 20852

  • Texas Diabetes & Endocrinology, P.A.

    Round Rock, Texas, 78681

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78229

  • National Research Institute (NRI) - Santa Ana

    Santa Ana, California, 92704

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231

  • Syed Research Consultants Llc

    Sheffield, Alabama, 35660

  • Encompass Clinical Research

    Spring Valley, California, 91978

  • Prairie Education and Research Cooperative

    Springfield, Illinois, 62711

  • Martin Diagnostic Clinic

    Tomball, Texas, 77375

  • University Clinical Investigators, Inc.

    Tustin, California, 92780

  • Preferred Primary Care Physicians

    Uniontown, Pennsylvania, 15401

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa, 50265

  • Metabolic Research Institute, Inc.

    West Palm Beach, Florida, 33401

  • PMG Research of Wilmington

    Wilmington, North Carolina, 28401

Other trials in United States

Brazil15 sites

  • Hospital PUC-CAMPINAS

    Campinas, São Paulo, 13060-904

  • Cline Research Center

    Curitiba, Paraná, 80030

  • QUANTA - Medicina Nuclear Alto da XV

    Curitiba, Paraná, 80045-170

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

    Fortaleza, Ceará, 60430-350

  • CECIP - Centro de Estudos do Interior Paulista

    Jaú, São Paulo, 17201-130

  • Centro de Pesquisas em Diabetes

    Porto Alegre, Rio Grande do Sul, 90430-001

  • Instituto Brasil de Pesquisa Clínica - IBPCLIN

    Rio de Janeiro, 20241180

  • CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda

    São Bernardo do Campo, São Paulo, 09715-090

  • ISPEM - Instituto São José dos Campos em Pesquisas Médicas

    São José dos Campos, São Paulo, 12243-280

  • CPCLIN

    São Paulo, São Paulo, 01228-200

  • IPEC - Instituto de Pesquisa Clínica

    São Paulo, 01223-001

  • CPQuali Pesquisa Clínica

    São Paulo, 01228-000

  • BR Trials - Ensaios Clínicos e Consultoria Ltda

    São Paulo, 03325-050

  • CEPIC - Centro Paulista de Investigação Clínica

    São Paulo, 04266-010

  • CEDOES

    Vitória, Espírito Santo, 29055-450

Other trials in Brazil

Argentina12 sites

  • Instituto Médico Especializado (IME)

    Buenos Aires, 1405

  • Asociación de Beneficencia Hospital Sirio Libanés

    Buenos Aires, C1419AHN

  • Centro Médico Viamonte

    CABA, Buenos Aires, C1120AAC

  • Investigaciones Medicas Imoba Srl

    CABA, Buenos Aires, C1179AAB

  • Instituto Centenario

    CABA, Buenos Aires, C1204AAD

  • CENUDIAB

    Ciudad Autónoma de Buenos Aire, C1440AAD

  • Centro Diabetologico Dr Waitman

    Córdoba, 5000

  • Centro Medico Privado San Vicente Diabetes

    Córdoba, X5006CBI

  • CIPADI

    Godoy Cruz, Mendoza Province, M5501ARP

  • Instituto de Investigaciones Clínicas Rosario (IIC-Rosario)- Sanatorio Delta

    Rosario, Buenos Aires, S2000BIF

  • Instituto Médico Catamarca

    Rosario, Santa Fe Province, 2000

  • Sanatorio Parque

    Salta, 4400

Other trials in Argentina

Romania12 sites

  • CMI DNBM Dr. Pop Lavinia

    Baia Mare, Maramureş, 430222

  • C.M.D.T.A. Neomed

    Brasov, Brașov County, 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

  • SC Endodigest SRL

    Oradea, Bihor County, 410151

  • S. C. Grandmed S.R.L.

    Oradea, Bihor County, 410159

  • SC Diabmed Dr Popescu Alexandrina SRL

    Ploieşti, Prahova, 100179

  • SC Dianutrilife Medica SRL

    Ploieşti, Prahova, 100561

  • SC Cosamext SRL

    Târgu Mureş, Mureș County, 540098

  • Centrul Medical Dr. Negrisanu

    Timișoara, Timiș County, 300456

Other trials in Romania

Germany9 sites

  • InnoDiab Forschung Gmbh

    Essen, North Rhine-Westphalia, 45136

  • Medizentrum Essen-Borbeck

    Essen, North Rhine-Westphalia, 45355

  • MVZ im Altstadt-Carree Fulda GmbH

    Fulda, 36037

  • Diabetologische Schwerpunktpraxis Harburg

    Hamburg, 21073

  • Diabeteszentrum Hamburg West

    Hamburg, 22607

  • Schwerpunktpraxis für Diabetes

    Hof, Bavaria, 95030

  • RED-Institut GmbH

    Oldenburg in Holstein, Schleswig-Holstein, 23758

  • Zentrum für klinische Studien

    Saint Ingbert, Saarland, 66386

  • Gemeinschaftspraxis Dr. med. Josef und Wilma Großkopf

    Wallerfing, 94574

Other trials in Germany

Russia8 sites

  • Arkhangelsk Regional Clinical Hospital

    Arkhangelsk, 163045

  • Scientific and Clinical Center for Precision and Regenerative Medicine

    Kazan', 420012

  • Pirogov Russian National Research Medical University

    Moscow, 109263

  • First Moscow State Medical University

    Moscow, 119435

  • City Consultative and Diagnostic Center #1

    Saint Petersburg, 194354

  • Saint-Petersburg State Budgetary Institution of Healthcare Institution

    Saint Petersburg, 194354

  • St.Petersburg Polyclinic #117

    Saint Petersburg, 194358

  • SPb GUZ "Diagnostic Center #85"

    Saint Petersburg, 198255

Other trials in Russia

Mexico5 sites

  • Instituto Jalisciense de Investigacion en Diabetes y Obesida

    Guadalajara, Jalisco, 44600

  • Unidad de patologia Clinica

    Guadalajara, Jalisco, 44650

  • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares

    Madero, Tamaulipas, 89440

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, N.L., 64460

  • Centro de Inv. Medica de Occidente, SC

    Zapopan, Jalisco, 45116

Other trials in Mexico

Slovakia5 sites

  • Diacrin s.r.o.

    Bratislava, Bratislava Region, 841 02

  • Diabetes care s.r.o.

    Hnúšťa, 98101

  • Human care s.r.o.

    Košice, Slovak Republic, 04012

  • MediVet s.r.o.

    Malacky, Bratislava Region, 901 01

  • Areteus s.r.o.

    Trebišov, 075 01

Other trials in Slovakia

Spain5 sites

  • Complejo Hospitalario Universitario De Ferrol - Hospital Naval

    Ferrol, La Coruna, 15405

  • Clínica Juaneda

    Palma de Mallorca, 07014

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39011

  • Hospital Quiron Infanta Luisa

    Seville, Andalusia, 41010

  • Hospital Universitario Virgen Macarena

    Seville, 41009

Other trials in Spain

Turkey (Türkiye)5 sites

  • Baskent Universitesi Adana Uygulama ve Arastirma Merkezi Yuregir Hastanesi

    Adana, 01240

  • Akdeniz University Medical Faculty

    Antalya, 07059

  • Aydin Adnan Menderes Universitesi

    Aydin, 09010

  • Gaziantep University Medical Faculty

    Gaziantep, 27310

  • Inonu Universitesi

    Malatya, 44282

Other trials in Turkey (Türkiye)

Czechia4 sites

  • Diabetologicka a obezitologicka ambulance

    České Budějovice, 370 11

  • Diabetologicka ordinace pro dospele

    Krnov, Moravian-Silesian Region, 79401

  • Diahelp s.r.o., Interni a diabetologicka ambulance

    Pardubice, 530 02

  • ResTrial s.r.o.

    Prague, 181 00

Other trials in Czechia

Greece4 sites

  • Athens Euroclinic

    Athens, Attica, 11521

  • General Hospital of Thessaloniki Papageorgiou

    N. Efkarpia, Thessaloniki, 56403

  • Iatriko Palaiou Falirou, Medical Center

    Palaió Fáliro, Athens, 17562

  • Thermi Clinic

    Thermi, Thessaloniki, 57001

Other trials in Greece

Hungary4 sites

  • Szent Margit Rendelőintézet Nonprofit Kft

    Budapest, 1032

  • TRANTOR'99 Bt. Anyagcsere Centrum

    Budapest, 1213

  • Belinus Bt

    Debrecen, Hajdú-Bihar, 4025

  • Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Intezet

    Debrecen, Hajdú-Bihar, 4032

Other trials in Hungary

Italy4 sites

  • Policlinico Mater Domini

    Germaneto, Catanzaro, 88100

  • Ospedale Luigi Sacco

    Milan, 20157

  • Policlinico Univ. Agostino Gemelli

    Roma, 00168

  • Casa di Cura Multimedica-Policlinico Multispecialistico

    Sesto San Giovanni, MI, 20099

Other trials in Italy

Puerto Rico2 sites

  • Centro de Endocrinologia y Nutricion del Turabo

    Caguas, PR, 00726

  • Paola Mansilla-Letelier, MD

    Guaynabo, PR, 00970

Other trials in Puerto Rico

Belgium1 site

  • AZ Damiaan Oostende

    Ostend, 8400

Other trials in Belgium

About this study

Official title: A Randomized, Phase 3, Open-label Trial Comparing the Effect of the Addition of Tirzepatide Once Weekly Versus Insulin Lispro (U100) Three Times Daily in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin (SURPASS-6)

The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to insulin lispro (U100) three times a day in participants with type 2 diabetes that are already on insulin glargine (U100), with or without metformin.

Conditions
Type 2 Diabetes
Being tested
Tirzepatide, Insulin Lispro (U100)
Keywords
glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-1 (GLP-1), GIP/GLP-1 dual receptor agonist, 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 Lispro (U100)Drug

    Also called LY275585

    Administered SC

Study groups in NCT04537923
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 LisproActive comparatorInsulin lispro 100 units per milliliter (U100) administered SC three times a day.
Receives: Drug: Insulin Lispro (U100)

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) (Pooled Doses of Tirzepatide 5 mg, 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 Metformin Use (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares).

    Measured: Baseline, Week 52

Secondary outcomes (9)

  1. Change From Baseline in HbA1c

    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 with covariates Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares).

    Measured: Baseline, Week 52

  2. Percentage of Participants With HbA1c Target Values <7.0%

    HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

    Measured: Week 52

  3. Change From Baseline in Body Weight

    LS mean was determined by MMRM model with Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares).

    Measured: Baseline, Week 52

  4. Change From Baseline in Fasting Serum Glucose

    LS mean was determined by MMRM model with variables Baseline + Pooled Country + Baseline metformin Use (Yes, No) + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares).

    Measured: Baseline, Week 52

  5. 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 Post meal, Midday Premeal, Midday 2-hour Post meal, Evening Premeal, Evening 2-hour Post meal and Bedtime. The daily average was calculated as the average of the 7 blood glucose values collected on a particular day. LS mean was determined by MMRM model with variables Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares).

    Measured: Baseline, Week 52

  6. Percentage of Participants Who Achieved HbA1c Target Value of <7.0% Without Hypoglycemia

    Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

    Measured: Week 52

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

    Percentage of Participants who Achieved Weight Loss ≥5% is reported here.

    Measured: Week 52

  8. Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score

    The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. PCS score is reported here. PCS domain is scored by summing individual items and transforming scores into a 0 to 100 scale with higher scores indicating better health status or functioning. LS mean was determined by analysis of covariance (ANCOVA) model with variables Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment (Type III sum of squares).

    Measured: Baseline, Week 52

  9. Change From Baseline in 36-Item SF-36 Mental Component Summary (MCS) Score

    The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. MCS consisted of social functioning, vitality, mental health, and role-emotional scales. MCS score is reported here. MCS domain is scored by summing individual items and transforming scores into a 0 to 100 scale with higher scores indicating better health status or functioning. LS mean was determined by ANCOVA model with variables Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment (Type III sum of squares).

    Measured: Baseline, 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 posted3 Sep 2020
  2. Study start19 Oct 2020
  3. Primary completion11 Oct 2022
  4. Study completion1 Nov 2022

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
1,428 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04537923
Sponsor's protocol ID
17204
Other IDs
I8F-MC-GPHD, 2020-000284-23
Acronym
SURPASS-6
Status last verified
Oct 2023
First submitted
2 Sep 2020
Last updated
2 Nov 2023
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

  • Bajaj HS, Billings LK, Sharma P, Levine JA, Rodriguez A, Patel H. Tirzepatide as an Add-on for Participants with Inadequate Glycemic Control Using Basal Insulin: Pooled Subgroup Analysis of SURPASS-5 and -6. Diabetes Ther. 2026 May;17(5):787-797. doi: 10.1007/s13300-026-01859-3. Epub 2026 Apr 10.

    PubMed 41961454

  • Rosenstock J, Frias JP, Rodbard HW, Tofe S, Sears E, Huh R, Fernandez Lando L, Patel H. Tirzepatide vs Insulin Lispro Added to Basal Insulin in Type 2 Diabetes: The SURPASS-6 Randomized Clinical Trial. JAMA. 2023 Nov 7;330(17):1631-1640. doi: 10.1001/jama.2023.20294.

    PubMed 37786396

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tirzepatide and Insulin Lispro (U100) in people with Type 2 Diabetes, run by Eli Lilly and Company at 135 sites in 16 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 5 inclusion and 8 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 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 135 sites in United States, Brazil, Argentina, Romania, Germany and 11 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 2 Nov 2023). 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) (Pooled Doses of Tirzepatide 5 mg, 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 NCT04537923, which also lists 2 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 2 Nov 2023.

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