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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04537923
Other study ID # 17204
Secondary ID I8F-MC-GPHD2020-
Status Completed
Phase Phase 3
First received
Last updated
Start date October 19, 2020
Est. completion date November 1, 2022

Study information

Verified date October 2023
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 1428
Est. completion date November 1, 2022
Est. primary completion date October 11, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria - 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)]

Study Design


Intervention

Drug:
Tirzepatide
Administered SC
Insulin Lispro (U100)
Administered SC

Locations

Country Name City State
Argentina Asociación de Beneficencia Hospital Sirio Libanés Buenos Aires
Argentina Instituto Médico Especializado (IME) Buenos Aires
Argentina Centro Médico Viamonte Caba Buenos Aires
Argentina Instituto Centenario Caba Buenos Aires
Argentina Investigaciones Medicas Imoba Srl Caba Buenos Aires
Argentina CENUDIAB Ciudad Autónoma de Buenos Aire
Argentina Centro Diabetologico Dr Waitman Cordoba
Argentina Centro Medico Privado San Vicente Diabetes Cordoba
Argentina CIPADI Godoy Cruz Mendoza
Argentina Instituto de Investigaciones Clínicas Rosario (IIC-Rosario)- Sanatorio Delta Rosario Buenos Aires
Argentina Instituto Médico Catamarca Rosario Santa Fe
Argentina Sanatorio Parque Salta
Belgium AZ Damiaan Oostende Oostende
Brazil Hospital PUC-CAMPINAS Campinas São Paulo
Brazil Cline Research Center Curitiba Paraná
Brazil QUANTA - Medicina Nuclear Alto da XV Curitiba Paraná
Brazil Centro de Pesq. em Diabetes e Doencas Endocrino Metabol. Fortaleza Ceará
Brazil CECIP - Centro de Estudos do Interior Paulista Jaú São Paulo
Brazil Centro de Pesquisas em Diabetes Porto Alegre Rio Grande Do Sul
Brazil Instituto Brasil de Pesquisa Clínica - IBPCLIN Rio de Janeiro
Brazil CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda São Bernardo do Campo São Paulo
Brazil ISPEM - Instituto São José dos Campos em Pesquisas Médicas São José dos Campos São Paulo
Brazil BR Trials - Ensaios Clínicos e Consultoria Ltda São Paulo
Brazil CEPIC - Centro Paulista de Investigação Clínica São Paulo
Brazil CPCLIN São Paulo SP
Brazil CPQuali Pesquisa Clínica São Paulo
Brazil IPEC - Instituto de Pesquisa Clínica São Paulo
Brazil CEDOES Vitoria ES
Czechia Diabetologicka a obezitologicka ambulance Ceske Budejovice
Czechia Diabetologicka ordinace pro dospele Krnov Moravskoslezský Kraj
Czechia Diahelp s.r.o., Interni a diabetologicka ambulance Pardubice
Czechia ResTrial s.r.o. Praha 8
Germany InnoDiab Forschung Gmbh Essen Nordrhein-Westfalen
Germany Medizentrum Essen-Borbeck Essen Nordrhein-Westfalen
Germany MVZ im Altstadt-Carree Fulda GmbH Fulda
Germany Diabeteszentrum Hamburg West Hamburg
Germany Diabetologische Schwerpunktpraxis Harburg Hamburg
Germany Schwerpunktpraxis für Diabetes Hof Bavaria
Germany RED-Institut GmbH Oldenburg Schleswig-Holstein
Germany Zentrum für klinische Studien Saint Ingbert Saarland
Germany Gemeinschaftspraxis Dr. med. Josef und Wilma Großkopf Wallerfing
Greece Athens Euroclinic Athens Attiki
Greece General Hospital of Thessaloniki Papageorgiou N. Efkarpia Thessaloniki
Greece Iatriko Palaiou Falirou, Medical Center Palaio Faliro Athens
Greece Thermi Clinic Thermi Thessaloniki
Hungary Szent Margit Rendelointézet Nonprofit Kft Budapest
Hungary TRANTOR'99 Bt. Anyagcsere Centrum Budapest
Hungary Belinus Bt Debrecen Hajdu-Bihar
Hungary Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Intezet Debrecen Hajdu-Bihar
Italy Policlinico Mater Domini Germaneto Catanzaro
Italy Ospedale Luigi Sacco Milano
Italy Policlinico Univ. Agostino Gemelli Roma
Italy Casa di Cura Multimedica-Policlinico Multispecialistico Sesto San Giovanni MI
Mexico Instituto Jalisciense de Investigacion en Diabetes y Obesida Guadalajara Jalisco
Mexico Unidad de patologia Clinica Guadalajara Jalisco
Mexico Centro de Estudios de Investigacion Metabolicos y Cardiovasculares Madero Tamaulipas
Mexico Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Monterrey N.l.
Mexico Centro de Inv. Medica de Occidente, SC Zapopan Jalisco
Puerto Rico Centro de Endocrinologia y Nutricion del Turabo Caguas
Puerto Rico Paola Mansilla-Letelier, MD Guaynabo
Romania CMI DNBM Dr. Pop Lavinia Baia Mare Maramures
Romania C.M.D.T.A. Neomed Brasov Bra?ov
Romania Cabinetul Medical Nicodiab SRL Bucharest
Romania SC Nutrilife SRL Bucuresti
Romania Milena Sante SRL Galati
Romania SC Gama Diamed SRL Mangalia Constanta
Romania S. C. Grandmed S.R.L. Oradea Bihor
Romania SC Endodigest SRL Oradea Bihor
Romania SC Diabmed Dr Popescu Alexandrina SRL Ploiesti Prahova
Romania SC Dianutrilife Medica SRL Ploiesti Prahova
Romania SC Cosamext SRL Targu Mures Mures
Romania Centrul Medical Dr. Negrisanu Timisoara Timis
Russian Federation Arkhangelsk Regional Clinical Hospital Arkhangelsk
Russian Federation Scientific and Clinical Center for Precision and Regenerative Medicine Kazan
Russian Federation First Moscow State Medical University Moscow
Russian Federation Pirogov Russian National Research Medical University Moscow
Russian Federation SPb GUZ "Diagnostic Center #85" Saint Petersburg
Russian Federation City Consultative and Diagnostic Center #1 Saint-Petersburg
Russian Federation Saint-Petersburg State Budgetary Institution of Healthcare Institution Saint-Petersburg
Russian Federation St.Petersburg Polyclinic #117 Saint-Petersburg
Slovakia Diacrin s.r.o. Bratislava Bratislavský Kraj
Slovakia Diabetes care s.r.o. Hnusta
Slovakia Human care s.r.o. Kosice Slovak Republic
Slovakia MediVet s.r.o. Malacky Bratislavský Kraj
Slovakia Areteus s.r.o. Trebisov
Spain Complejo Hospitalario Universitario De Ferrol - Hospital Naval Ferrol La Coruna
Spain Clínica Juaneda Palma de Mallorca
Spain Hospital Universitario Marqués de Valdecilla Santander Cantabria
Spain Hospital Quiron Infanta Luisa Sevilla Andalucía
Spain Hospital Universitario Virgen Macarena Sevilla
Turkey Baskent Universitesi Adana Uygulama ve Arastirma Merkezi Yuregir Hastanesi Adana
Turkey Akdeniz University Medical Faculty Antalya
Turkey Aydin Adnan Menderes Universitesi Aydin
Turkey Gaziantep University Medical Faculty Gaziantep
Turkey Inonu Universitesi Malatya
United States Albany Medical College Albany New York
United States University of Colorado Aurora Colorado
United States Heritage Valley Medical Group, Inc. Beaver Pennsylvania
United States Excel Medical Clinical Trials Boca Raton Florida
United States Capital Diabetes and Endocrine Associates Camp Springs Maryland
United States J H. Stroger Hosp of Cook Co Chicago Illinois
United States Dallas Diabetes Research Center Dallas Texas
United States Diabetes and Thyroid Center of Fort Worth Fort Worth Texas
United States Valley Research Fresno California
United States Tribe Clinical Research, LLC Greenville South Carolina
United States I R & Health Center, Inc. Hialeah Florida
United States Biopharma Informatic, LLC Houston Texas
United States Juno Research Houston Texas
United States National Research Institute - Huntington Park Huntington Park California
United States MedStar Health Research Institute Hyattsville Maryland
United States Rocky Mountain Clinical Research Idaho Falls Idaho
United States Glacier View Research Institute - Endocrinology Kalispell Montana
United States National Research Institute - Huntington Park Los Angeles California
United States Southern Nh Diabetes and Endocrinology Nashua New Hampshire
United States Sun Coast Clinical Research, Inc New Port Richey Florida
United States Intend Research, LLC Norman Oklahoma
United States North Hills Medical Research North Richland Hills Texas
United States Valley Clinical Trials, Inc. Northridge California
United States National Research Institute - Huntington Park Panorama City California
United States South Broward Research Pembroke Pines Florida
United States Rainier Clinical Research Center Renton Washington
United States Endocrine and Metabolic Consultants Rockville Maryland
United States Texas Diabetes & Endocrinology, P.A. Round Rock Texas
United States Clinical Trials of Texas, Inc. San Antonio Texas
United States National Research Institute (NRI) - Santa Ana Santa Ana California
United States Consano Clinical Research, LLC Shavano Park Texas
United States Syed Research Consultants Llc Sheffield Alabama
United States Encompass Clinical Research Spring Valley California
United States Prairie Education and Research Cooperative Springfield Illinois
United States Martin Diagnostic Clinic Tomball Texas
United States University Clinical Investigators, Inc. Tustin California
United States Preferred Primary Care Physicians Uniontown Pennsylvania
United States Iowa Diabetes and Endocrinology Research Center West Des Moines Iowa
United States Metabolic Research Institute, Inc. West Palm Beach Florida
United States PMG Research of Wilmington Wilmington North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Czechia,  Germany,  Greece,  Hungary,  Italy,  Mexico,  Puerto Rico,  Romania,  Russian Federation,  Slovakia,  Spain,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). Baseline, Week 52
Secondary 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). Baseline, Week 52
Secondary 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. Week 52
Secondary 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). Baseline, Week 52
Secondary 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). Baseline, Week 52
Secondary 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). Baseline, Week 52
Secondary 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. Week 52
Secondary Percentage of Participants Who Achieved Weight Loss =5% Percentage of Participants who Achieved Weight Loss =5% is reported here. Week 52
Secondary 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). Baseline, Week 52
Secondary 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). Baseline, Week 52
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