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| ID | Type | Description | Link |
|---|---|---|---|
| I8F-MC-GPJD | Other Identifier | Eli Lilly and Company | |
| 2024-519685-51-00 | EU Trial (CTIS) Number |
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The main purpose of this study is to find out how well and how safely tirzepatide works long-term in adults who have type 1 diabetes and obesity or overweight. Participation in the study will last about 20 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tirzepatide | Experimental | Participants will receive tirzepatide subcutaneously (SC) |
|
| Placebo | Placebo Comparator | Participants will receive placebo SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirzepatide | Drug | Administered SC |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Hemoglobin A1c (HbA1c) | Baseline, Week 40 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in HbA1c | Baseline, Week 72 | |
| Percentage of Time Continuous Glucose Monitor (CGM) Glucose Values are Between 70 and 180 milligrams per deciliter (mg/dL) (3.9 and 10.0 millimoles per liter (mmol/L)) Inclusive, Per Day | Within 30 days prior to Week 40, Within 30 days prior to Week 72 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Bonita Medical Offices | Bonita | California | 91902 | United States | ||
| AMCR Institute |
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| Label | URL |
|---|---|
| A Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight (SURPASS-T1D-2) | View source |
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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.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| Placebo | Drug | Administered SC |
|
| Change from Baseline in Body Weight | Baseline, Week 40, Week 72 |
| Percent Change from Baseline in Body Weight | Baseline, Week 40, Week 72 |
| Percentage of Participants with ≥5% Body Weight Reduction | Baseline, Week 40, Week 72 |
| Percentage of Participants with ≥10% Body Weight Reduction | Baseline, Week 40, Week 72 |
| Percentage of Participants with ≥15% Body Weight Reduction | Baseline, Week 40, Week 72 |
| Change from Baseline in Waist Circumference | Baseline, Week 40, Week 72 |
| Change from Baseline in Systolic Blood Pressure (SBP) | Baseline, Week 40, Week 72 |
| Percent Change from Baseline in Fasting Triglycerides | Baseline, Week 40, Week 72 |
| Percent Change from Baseline in Fasting Non-High-Density Lipoprotein (non-HDL) Cholesterol | Baseline, Week 40, Week 72 |
| Percent Change from Baseline in Total Daily Insulin Dose | Baseline, Week 40, Week 72 |
| Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP) | Baseline, Week 40, Week 72 |
| Change from Baseline in EQ-5D-5L | Baseline, Week 40, Week 72 |
| Escondido |
| California |
| 92025 |
| United States |
| Mary & Dick Allen Diabetes Center | Newport Beach | California | 92663 | United States |
| University Clinical Investigators, Inc. | Tustin | California | 92780 | United States |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| Metabolic Research Institute, Inc. | West Palm Beach | Florida | 33401 | United States |
| Iowa Diabetes and Endocrinology Research Center | West Des Moines | Iowa | 50266 | United States |
| HealthPartners Institute dba International Diabetes Center | Minneapolis | Minnesota | 55416 | United States |
| Clinical Research Professionals | Chesterfield | Missouri | 63005 | United States |
| Clinvest Headlands Llc | Springfield | Missouri | 65807 | United States |
| Las Vegas Endocrinology | Henderson | Nevada | 89074 | United States |
| University of North Carolina Medical Center | Chapel Hill | North Carolina | 27514 | United States |
| Velocity Clinical Research, Dallas | Dallas | Texas | 75230 | United States |
| Juno Research | Houston | Texas | 77040 | United States |
| Southern Endocrinology Associates | Mesquite | Texas | 75149 | United States |
| Texas Diabetes & Endocrinology, P.A. | Round Rock | Texas | 78681 | United States |
| San Antonio Clinical Trials | San Antonio | Texas | 78240 | United States |
| Texas Valley Clinical Research | Weslaco | Texas | 78596 | United States |
| Buenos Aires Macula S.A | Buenos Aires | 1061 | Argentina |
| Stat Research S.A. | Buenos Aires | C1023AAB | Argentina |
| Mautalen Salud e Investigación | Buenos Aires | C1128AAF | Argentina |
| Centro Diabetológico Dr. Waitman | Córdoba | 5000 | Argentina |
| CIPADI - Centro Integral de Prevencion y Atencion en Diabetes | Godoy Cruz | M5501ARP | Argentina |
| Centro de Investigaciones Clínicas Baigorria | Granadero Baigorria | 2152 | Argentina |
| Instituto Médico Catamarca IMEC | Rosario | 2000 | Argentina |
| Investigaciones Clínicas Tucumán | San Miguel de Tucumán | T4000ICL | Argentina |
| Centro de Pesquisa Clinica do Brasil | Brasília | 71625-175 | Brazil |
| Centro de Pesquisa Sao Lucas | Campinas | 13060-803 | Brazil |
| Quanta Diagnóstico e Terapia | Curitiba | 80045170 | Brazil |
| Cendi - Endocrinologia e Diabetes | Goiânia | 74230-035 | Brazil |
| Instituto da Crianca com Diabetes | Porto Alegre | 91350-250 | Brazil |
| IBPClin - Instituto Brasil de Pesquisa Clínica | Rio de Janeiro | 20241-180 | Brazil |
| CPCLIN | São Paulo | 01228-200 | Brazil |
| CEPIC - Centro Paulista de Investigação Clínica | São Paulo | 04266-010 | Brazil |
| Endocrinologie Oasis | Montreal | H4J 1E3 | Canada |
| Centricity Research Ottawa LMC Endocrinology | Ottawa | K2J 0V2 | Canada |
| Centre de Recherche Saint-Louis | Sherbrooke | J1G 1X9 | Canada |
| TLC Diabetes and Endocrinology | Surrey | V3T 2V6 | Canada |
| Care Access - Cape Breton | Sydney | B1M 0A1 | Canada |
| INTENDIA klinika s.r.o. | Chrudim III | 537 01 | Czechia |
| AIDIN VK s.r.o. | Hranice | 753 01 | Czechia |
| MUDr. Tomas Edelsberger | Krnov | 79401 | Czechia |
| Diabetologicke centrum s.r.o. | Olomouc | 779 00 | Czechia |
| Milan Kvapil s.r.o., Diabetologicka ambulance | Prague | 14900 | Czechia |
| ResTrial s.r.o. | Prague | 18100 | Czechia |
| Centre Hospitalier Universitaire - Hôpitaux de Rouen - Hôpital de Bois-Guillaume | Bois-Guillaume | 76230 | France |
| Centre Hospitalier Sud Francilien | Corbeil-Essonnes | 91106 | France |
| Centre Hospitalier Universitaire de Grenoble | Grenoble | 38700 | France |
| Hôtel-Dieu du Creusot - site Harfleur | Le Creusot | 71200 | France |
| Hôpital de la Conception | Marseille | 13005 | France |
| Assistance Publique Hôpitaux de Paris - Groupe Hospitalier 10e - Hôpital Lariboisière | Paris | 75010 | France |
| CHU Rangueil | Toulouse | 31059 | France |
| Groupe Hospitalier Mutualiste Les Portes du Sud | Vénissieux | 69200 | France |
| Athens Medical Center | Athens | 151 25 | Greece |
| Iatriko Paleou Falirou Medical Center | Palaió Fáliro | 17562 | Greece |
| Euromedica General Clinic of Thessaloniki | Thessaloniki | 546 45 | Greece |
| Ippokrateio General Hospital of Thessaloniki | Thessaloniki | 54642 | Greece |
| Enclifar Ensayos Clínicos Farmacológicos Sc | Chihuahua City | 31110 | Mexico |
| Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente | Guadalajara | 44150 | Mexico |
| Private Practice - Dr. Arechavaleta Granell Maria del Rosario | Guadalajara | 44670 | Mexico |
| Unidad de Investigación Clínica y Atención Médica HEPA S.C. | Guadalajara | 44670 | Mexico |
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Mexico City | 14080 | Mexico |
| CEINV Salud | Monterrey | 64020 | Mexico |
| Clínica García Flores SC | Monterrey | 64610 | Mexico |
| Consultorio Médico de Endocrinología y Pediatría | Puebla City | 72190 | Mexico |
| Medsal Centro Médico | Tampico | 89210 | Mexico |
| CMI DNBM Dr. Pop Lavinia | Baia Mare | 430222 | Romania |
| Mariodiab Clinic | Brasov | 500097 | Romania |
| Centrul medical DiabNutriMed | Bucharest | 020359 | Romania |
| Diabet Med | Bucharest | 050913 | Romania |
| Sanamed Hospital | Bucharest | 060013 | Romania |
| Diamed Obesity | Galați | 800291 | Romania |
| Centrul Medical Consultmed | Iași | 700547 | Romania |
| Rinart Diab SRL | Targoviste | 130168 | Romania |
| Hospital Infanta Cristina | Badajoz | 06080 | Spain |
| Hospital Germans Trias i Pujol | Badalona | 08916 | Spain |
| Hospital Clínic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario Virgen Del Rocio | Seville | 41013 | Spain |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000098860 | Tirzepatide |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |
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