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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05433584
Collaborator
(none)
780
Enrollment
97
Locations
2
Arms
58.2
Anticipated Duration (Months)
8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
780 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open-Label, Parallel-Group, Two-Arm, Phase 4 Study to Evaluate the Long-Term Efficacy and Safety of Tirzepatide Compared With Intensified Conventional Care in Adults When Initiating Treatment Early in the Course of Type 2 Diabetes
Actual Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
May 9, 2025
Anticipated Study Completion Date :
Jun 7, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tirzepatide

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

Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176

    		•
    Active Comparator: Intensified Conventional Care Dose

    Participants will receive an antihyperglycemic medication

    Drug: Antihyperglycemic medication
    As prescribed

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline in Hemoglobin A1c (HbA1c) [Baseline, Week 104]

    Secondary Outcome Measures

    1. Change from Baseline in HbA1c [Baseline, Week 208]

    2. Change from Baseline in Weight [Baseline, Week 104]

    3. Change from Baseline in Weight [Baseline, Week 208]

    4. Change from Baseline in Waist Circumference [Baseline, Week 104]

    5. Change from Baseline in Waist Circumference [Baseline, Week 208]

    6. Change from Baseline in Fasting Serum Glucose (FSG) [Baseline, Week 104]

    7. Change from Baseline in FSG [Baseline, Week 208]

    8. Change from Baseline in Lipids [Baseline, Week 104]

    9. Change from Baseline in Lipids [Baseline, Week 208]

    10. Percentage of Participants Achieving HbA1c <7.0% [Week 104]

    11. Percentage of Participants Achieving HbA1c ≤6.5% [Week 104]

    12. Percentage of Participants Achieving HbA1c <5.7% [Week 104]

    13. Percentage of Participants Achieving HbA1c <7.0% [Week 208]

    14. Percentage of Participants Achieving HbA1c ≤6.5% [Week 208]

    15. Percentage of Participants Achieving HbA1c <5.7% [Week 208]

    16. Change from Baseline in Weight loss of ≥5%, [Baseline, Week 104]

    17. Change from Baseline in Weight loss of ≥10% [Baseline, Week 104]

    18. Change from Baseline in Weight loss of ≥15% [Baseline, Week 104]

    19. Change from Baseline in Weight loss of ≥5% [Baseline, Week 208]

    20. Change from Baseline in Weight loss of ≥10% [Baseline, Week 208]

    21. Change from Baseline in Weight loss of ≥15% [Baseline, Week 208]

    22. A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia [Week 104]

      A composite endpoint defined as HbA1c ≤ 6.5%, weight loss ≥10%, no hypoglycemia, defined as blood glucose (BG) <54 milligram/deciliter (mg/dL) <3.0 millimole/liter (mmol/L) and/or severe hypoglycemia

    23. A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia [Week 208]

      A composite endpoint defined as HbA1c ≤ 6.5%, weight loss ≥10%, no hypoglycemia, defined as BG <54 mg/dL (<3.0 mmol/L) and/or severe hypoglycemia

    24. Change from Baseline in β-cell Glucose Sensitivity [Baseline, Week 104]

      β-cell Glucose Sensitivity assessed by Oral Glucose Tolerance Test (OGTT)

    25. Change from Baseline in β-cell glucose sensitivity [Baseline, Week 208]

      Change from baseline in β-cell glucose sensitivity assessed by OGTT

    26. Change from Baseline in Insulin Secretion Rate at a Fixed Glucose Concentration [Baseline, Week 104]

      Insulin Secretion Rate assessed by OGTT

    27. Change from Baseline in Insulin Secretion Rate at a Fixed Glucose Concentration [Baseline, Week 208]

      Insulin Secretion Rate assessed by OGTT

    28. Change from Baseline in Postprandial Insulin Sensitivity Indices [Baseline, Week 104]

      Postprandial Insulin Sensitivity Indices assessed by OGTT

    29. Change from Baseline in Postprandial Insulin Sensitivity Indices [Baseline, Week 208]

      Postprandial Insulin Sensitivity Indices assessed by OGTT

    30. Change from Baseline in Fasting and Post-challenge Glucose [total and incremental AUC(₀-₂₄₀min)] [Baseline through Week 104]

      Fasting and Post-challenge Glucose [total and incremental AUC(₀-₂₄₀min)] assessed by OGTT

    31. Change from Baseline in Fasting and Post-challenge Glucose [total and incremental (AUC₀-₂₄₀min)] [Baseline through Week 208]

      Fasting and Post-challenge Glucose [total and incremental AUC(₀-₂₄₀min)] assessed by OGTT

    32. Change from Baseline in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) - Physical Functioning Domain [Baseline, Week 104]

    33. Change from Baseline in the IWQOL-Lite-CT - Physical Functioning Domain [Baseline, Week 208]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Have, within the last 4 years, been diagnosed with T2D based on the World Health Organization classification or other locally applicable diagnostic standards.

    • Have HbA1c ≥7% to ≤9.5% as determined by the central laboratory.

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

    • with the minimum effective dose of ≥1500 mg/day, but not higher than the maximum approved dose per country-specific label, or

    • <1500 mg/day in case of intolerance of full therapeutic dose.

    Exclusion Criteria:

    • Have type 1 diabetes mellitus

    • Have a history of chronic or acute pancreatitis any time prior to study entry

    • Have a history of

    • proliferative diabetic retinopathy

    • diabetic macular edema, or

    • no proliferative diabetic retinopathy requiring immediate or urgent treatment

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

    • myocardial infarction

    • percutaneous coronary revascularization procedure

    • carotid stenting or surgical revascularization

    • nontraumatic amputation

    • peripheral vascular procedure (e.g., stenting or surgical revascularization)

    • cerebrovascular accident (stroke), or congestive heart failure

    • Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)

    • Have within 90 days prior to screening received treatment with medications intended to promote weight loss. This includes prescribed, over the counter, or alternative remedies

    • Have an estimated glomerular filtration rate (eGFR) <30 mL/minute/1.73 m2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label), calculated by chronic kidney disease-epidemiology equation as determined by central laboratory at screening.

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

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cahaba Research - Trussville Birmingham Alabama United States 35235
    2 Phoenician Centers for Research & Innovation Phoenix Arizona United States 85021
    3 San Fernando Valley Health Institute Canoga Park California United States 91304
    4 Velocity Clinical Research, Huntington Park Huntington Park California United States 90255
    5 Velocity Clinical Research, San Diego La Mesa California United States 91942
    6 Clinical Trials Research Lincoln California United States 95648
    7 Velocity Clinical Research, Westlake Los Angeles California United States 90057
    8 Catalina Research Institute, LLC Montclair California United States 91763
    9 Velocity Clinical Research - North Hollywood North Hollywood California United States 91606
    10 National Research Institute Panorama City California United States 91402
    11 Western University of Health Sciences Pomona California United States 91766
    12 Velocity Clinical Research, Santa Ana Santa Ana California United States 92704
    13 New England Research Associates, LLC Bridgeport Connecticut United States 06606
    14 Excel Medical Clinical Trials Boca Raton Florida United States 33434
    15 Alliance for Multispecialty Research, LLC Coral Gables Florida United States 33134
    16 South Florida Clinical Research Institute Margate Florida United States 33063
    17 Emory University School of Medicine- Grady Campus Atlanta Georgia United States 30303
    18 Center for Advanced Research & Education Gainesville Georgia United States 30501
    19 Iowa Diabetes and Endocrinology Research Center West Des Moines Iowa United States 50265
    20 Qualmedica Research Bowling Green Kentucky United States 42101
    21 Qualmedica Research, LLC Owensboro Kentucky United States 42301
    22 Qualmedica Research, LLC Owensboro Kentucky United States 42301
    23 NECCR PrimaCare Research Fall River Massachusetts United States 02721
    24 Quinn Healthcare/SKYCRNG Ridgeland Mississippi United States 39157
    25 StudyMetrix Research Saint Peters Missouri United States 63303
    26 Clinvest Research LLC Springfield Missouri United States 65807
    27 Research Foundation of SUNY - University of Buffalo Buffalo New York United States 14221
    28 Lucas Research, Inc Morehead City North Carolina United States 28557
    29 The Corvallis Clinic, P.C. Corvallis Oregon United States 97330
    30 Clinical Research of Philadelphia Philadelphia Pennsylvania United States 19114
    31 Preferred Primary Care Physicians Uniontown Pennsylvania United States 15401
    32 Tribe Clinical Research, LLC Greenville South Carolina United States 29607
    33 Velocity Clinical Research, Spartanburg Spartanburg South Carolina United States 29303
    34 Dallas Diabetes Research Center Dallas Texas United States 75230
    35 Centro de Investigaciones Metabólicas (CINME) Ciudad Autónoma de Buenos Aire Buenos Aires Argentina 1056
    36 Instituto de Investigaciones Clínicas Mar del Plata Mar del Plata Buenos Aires Argentina 7600
    37 CIAD Moron Moron Buenos Aires Argentina B1708EPE
    38 Go Centro Medico San Nicolás San Nicolas Buenos Aires Argentina 2900
    39 Centro Médico Viamonte Buenos Aires Ciudad Aut Argentina C1120AAC
    40 Dr. M.B. Jones Inc. Victoria British Columbia Canada V8V 4A1
    41 Bluewater Clinical Research Group Inc. Sarnia Ontario Canada N7T 4X3
    42 Stouffville Medical Centre Stouffville Ontario Canada L4A 1H2
    43 9109-0126 Quebec Inc. Montreal Quebec Canada H4N 2W2
    44 MUDr. Tomas Edelsberger Krnov Moravskosl Czechia 79401
    45 Diabet2 s.r.o., diabetologicka a interni ambulance Praha Praha 1 Czechia 11000
    46 Milan Kvapil s.r.o., Diabetologicka ambulance Praha Praha 4 Czechia 14900
    47 ResTrial s.r.o. Praha Praha 8 Czechia 18100
    48 Milan Kvapil s.r.o., Diabetologicka ambulance Pribram Pribram Středočeský Kraj Czechia 26201
    49 ClinPhenomics CVC GmbH Frankfurt Hessen Germany 60596
    50 Diabetes- und Stoffwechselpraxis Bochum Bochum Nordrhein-Westfalen Germany 44869
    51 InnoDiab Forschung Gmbh Essen Nordrhein-Westfalen Germany 45136
    52 Zentrum für klinische Studien Saint Ingbert Saarland Germany 66386
    53 Arztpraxis Christine Kosch Pirna Pirna Sachsen Germany 01796
    54 RED-Institut GmbH Oldenburg Schleswig-Holstein Germany 23758
    55 Diabetespraxis Mergentheim Bad Mergentheim Germany 97980
    56 Diabetes Zentrum Dr. Tews Gelnhausen Germany 63571
    57 Edith Wolfson Medical Center Holon HaMerkaz Israel 5810001
    58 Rabin Medical Center Petah-Tikva HaMerkaz Israel
    59 Kaplan Medical Center Rehovot HaMerkaz Israel 7610001
    60 Clalit Health Services - Atlit Atlit HaTsafon Israel 3032343
    61 Bnai Zion Medical Center Haifa HaTsafon Israel 3339419
    62 Hadassah Medical Center Jerusalem Yerushalayim Israel 9112001
    63 Sheba Medical Center Ramat Gan Israel 5265601
    64 Linn Medical Center Haifa Ḥeifā Israel 3515209
    65 University of Naples Federico II Napoli Campania Italy 80131
    66 Centro Cardiologico Monzino Milan Milano Italy 20138
    67 Ospedale Civile Santa Croce Pronto Soccorso Moncalieri Piemonte Italy 10024
    68 A.O.U.C. Policlinico di Bari Bari Puglia Italy 70124
    69 Ospedale san Giovanni di Dio-Diabetologia Olbia Sardegna Italy 07026
    70 A.O.U. Policlinico Paolo Giaccone Palermo Sicilia Italy 90129
    71 Azienda Ospedaliera Universitaria Pisana Pisa Toscana Italy 56124
    72 Azienda Ospedaliera Mater Domini Catanzaro Italy 88100
    73 Private Practice - Dr. Arechavaleta Granell Maria del Rosario Guadalajara Jalisco Mexico 44670
    74 Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Monterrey Nuevo León Mexico 66460
    75 Investigacion En Salud Y Metabolismo Sc Chihuahua Mexico 31217
    76 San Juan Bautista School of Medicine - Clinical Research Unit Caguas Puerto Rico 00725
    77 Dorado Medical Complex Dorado Puerto Rico 00646
    78 GCM Medical Group, PSC - Hato Rey Site San Juan Puerto Rico 917
    79 Endodigest Clinica Medicala Oradea Bihor Romania 410151
    80 C.M.D.T.A. Neomed Brasov Brașov Romania 500283
    81 Centrul Medical NutriLife Bucharest București Romania 013761
    82 Gama Diamed Mangalia Constanța Romania 905500
    83 Diabmed Dr. Popescu Alexandrina Ploiești Prahova Romania 100163
    84 Milena Sante Galați Romania 800001
    85 Clinica Korall Satu Mare Romania 440055
    86 ENDIANT s.r.o. Sered Trnavský Kraj Slovakia 926 01
    87 MEDIKALS Piešťany Slovakia 921 01
    88 ProDia s.r.o. Povazska Bystrica Slovakia 017 01
    89 JAL Trnava Slovakia 917 01
    90 IRIDIA Vrutky Slovakia 038 61
    91 Aberdeen Royal Infirmary Aberdeen Aberdeen City United Kingdom AB25 2ZN
    92 Ninewells Hospital and Medical School Dundee Angus United Kingdom DD1 9SY
    93 Staploe Medical Centre Ely Cambridgeshire United Kingdom CB7 5JD
    94 Knowle House Surgery Plymouth Devon United Kingdom PL5 3JB
    95 Hull Royal Infirmary Hull Kingston Upon Hull United Kingdom HU3 2JZ
    96 Leicester General Hospital Leicester Leicestershire United Kingdom LE5 4PW
    97 Wickersley Health Centre - Clifton Medical Centre Rotherham United Kingdom S65 1DA

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT05433584
    Other Study ID Numbers:
    • 17205
    • I8F-MC-GPHE
    • 2022-000130-42
    • 2022-5010733-40-00
    First Posted:
    Jun 27, 2022
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eli Lilly and Company
    T2D
    Diabetes
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Tirzepatide
    Hypoglycemic Agents

    Study Results

    No Results Posted as of Aug 19, 2022