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
- Registration Number
- NCT04537923
- Lead Sponsor
- Eli Lilly and Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1428
- 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)]
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Insulin Lispro Insulin Lispro (U100) Insulin lispro 100 units per milliliter (U100) administered SC three times a day. 5 mg Tirzepatide Tirzepatide 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. 15 mg Tirzepatide Tirzepatide 15 mg tirzepatide administered SC once a week. 10 mg Tirzepatide Tirzepatide 10 mg tirzepatide administered SC once a week.
- Primary Outcome Measures
Name Time Method Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) Baseline, Week 52 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).
- Secondary Outcome Measures
Name Time Method Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score Baseline, Week 52 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).
Change From Baseline in HbA1c Baseline, Week 52 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).
Percentage of Participants With HbA1c Target Values <7.0% Week 52 HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Change From Baseline in Body Weight Baseline, Week 52 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).
Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values Baseline, Week 52 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).
Change From Baseline in 36-Item SF-36 Mental Component Summary (MCS) Score Baseline, Week 52 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).
Change From Baseline in Fasting Serum Glucose Baseline, Week 52 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).
Percentage of Participants Who Achieved HbA1c Target Value of <7.0% Without Hypoglycemia Week 52 Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Percentage of Participants Who Achieved Weight Loss ≥5% Week 52 Percentage of Participants who Achieved Weight Loss ≥5% is reported here.
Trial Locations
- Locations (133)
University Clinical Investigators, Inc.
🇺🇸Tustin, California, United States
Metabolic Research Institute, Inc.
🇺🇸West Palm Beach, Florida, United States
J H. Stroger Hosp of Cook Co
🇺🇸Chicago, Illinois, United States
Dallas Diabetes Research Center
🇺🇸Dallas, Texas, United States
South Broward Research
🇺🇸Pembroke Pines, Florida, United States
Glacier View Research Institute - Endocrinology
🇺🇸Kalispell, Montana, United States
Sun Coast Clinical Research, Inc
🇺🇸New Port Richey, Florida, United States
Excel Medical Clinical Trials
🇺🇸Boca Raton, Florida, United States
Rocky Mountain Clinical Research
🇺🇸Idaho Falls, Idaho, United States
I R & Health Center, Inc.
🇺🇸Hialeah, Florida, United States
Endocrine and Metabolic Consultants
🇺🇸Rockville, Maryland, United States
ResTrial s.r.o.
🇨🇿Praha 8, Czechia
Asociación de Beneficencia Hospital Sirio Libanés
🇦🇷Buenos Aires, Argentina
Diabetes care s.r.o.
🇸🇰Hnusta, Slovakia
Diabetologicka a obezitologicka ambulance
🇨🇿Ceske Budejovice, Czechia
Hospital Quiron Infanta Luisa
🇪🇸Sevilla, Andalucía, Spain
Athens Euroclinic
🇬🇷Athens, Attiki, Greece
Thermi Clinic
🇬🇷Thermi, Thessaloniki, Greece
Milena Sante SRL
🇷🇴Galati, Romania
Szent Margit Rendelőintézet Nonprofit Kft
🇭🇺Budapest, Hungary
Policlinico Univ. Agostino Gemelli
🇮🇹Roma, Italy
Diahelp s.r.o., Interni a diabetologicka ambulance
🇨🇿Pardubice, Czechia
BR Trials - Ensaios Clínicos e Consultoria Ltda
🇧🇷São Paulo, Brazil
Diabetologicka ordinace pro dospele
🇨🇿Krnov, Moravskoslezský Kraj, Czechia
Belinus Bt
🇭🇺Debrecen, Hajdu-Bihar, Hungary
Clínica Juaneda
🇪🇸Palma de Mallorca, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Saint-Petersburg State Budgetary Institution of Healthcare Institution
🇷🇺Saint-Petersburg, Russian Federation
Pirogov Russian National Research Medical University
🇷🇺Moscow, Russian Federation
City Consultative and Diagnostic Center #1
🇷🇺Saint-Petersburg, Russian Federation
St.Petersburg Polyclinic #117
🇷🇺Saint-Petersburg, Russian Federation
Human care s.r.o.
🇸🇰Kosice, Slovak Republic, Slovakia
Areteus s.r.o.
🇸🇰Trebisov, Slovakia
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Cantabria, Spain
Baskent Universitesi Adana Uygulama ve Arastirma Merkezi Yuregir Hastanesi
🇹🇷Adana, Turkey
Aydin Adnan Menderes Universitesi
🇹🇷Aydin, Turkey
Complejo Hospitalario Universitario De Ferrol - Hospital Naval
🇪🇸Ferrol, La Coruna, Spain
Instituto Médico Catamarca
🇦🇷Rosario, Santa Fe, Argentina
Schwerpunktpraxis für Diabetes
🇩🇪Hof, Bavaria, Germany
Investigaciones Medicas Imoba Srl
🇦🇷Caba, Buenos Aires, Argentina
Sanatorio Parque
🇦🇷Salta, Argentina
CPQuali Pesquisa Clínica
🇧🇷São Paulo, Brazil
Southern Nh Diabetes and Endocrinology
🇺🇸Nashua, New Hampshire, United States
CENUDIAB
🇦🇷Ciudad Autónoma de Buenos Aire, Argentina
Centro Diabetologico Dr Waitman
🇦🇷Cordoba, Argentina
Cline Research Center
🇧🇷Curitiba, Paraná, Brazil
RED-Institut GmbH
🇩🇪Oldenburg, Schleswig-Holstein, Germany
IPEC - Instituto de Pesquisa Clínica
🇧🇷São Paulo, Brazil
Centro de Pesquisas em Diabetes
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
InnoDiab Forschung Gmbh
🇩🇪Essen, Nordrhein-Westfalen, Germany
Zentrum für klinische Studien
🇩🇪Saint Ingbert, Saarland, Germany
Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Intezet
🇭🇺Debrecen, Hajdu-Bihar, Hungary
Centro de Endocrinologia y Nutricion del Turabo
🇵🇷Caguas, Puerto Rico
SC Endodigest SRL
🇷🇴Oradea, Bihor, Romania
C.M.D.T.A. Neomed
🇷🇴Brasov, Brașov, Romania
SC Gama Diamed SRL
🇷🇴Mangalia, Constanta, Romania
CMI DNBM Dr. Pop Lavinia
🇷🇴Baia Mare, Maramures, Romania
Cabinetul Medical Nicodiab SRL
🇷🇴Bucharest, Romania
SC Diabmed Dr Popescu Alexandrina SRL
🇷🇴Ploiesti, Prahova, Romania
SC Dianutrilife Medica SRL
🇷🇴Ploiesti, Prahova, Romania
Centrul Medical Dr. Negrisanu
🇷🇴Timisoara, Timis, Romania
SC Nutrilife SRL
🇷🇴Bucuresti, Romania
Scientific and Clinical Center for Precision and Regenerative Medicine
🇷🇺Kazan, Russian Federation
First Moscow State Medical University
🇷🇺Moscow, Russian Federation
MediVet s.r.o.
🇸🇰Malacky, Bratislavský Kraj, Slovakia
Akdeniz University Medical Faculty
🇹🇷Antalya, Turkey
National Research Institute - Huntington Park
🇺🇸Panorama City, California, United States
Syed Research Consultants Llc
🇺🇸Sheffield, Alabama, United States
Valley Research
🇺🇸Fresno, California, United States
National Research Institute (NRI) - Santa Ana
🇺🇸Santa Ana, California, United States
Prairie Education and Research Cooperative
🇺🇸Springfield, Illinois, United States
Valley Clinical Trials, Inc.
🇺🇸Northridge, California, United States
Encompass Clinical Research
🇺🇸Spring Valley, California, United States
Iowa Diabetes and Endocrinology Research Center
🇺🇸West Des Moines, Iowa, United States
Albany Medical College
🇺🇸Albany, New York, United States
Intend Research, LLC
🇺🇸Norman, Oklahoma, United States
PMG Research of Wilmington
🇺🇸Wilmington, North Carolina, United States
Heritage Valley Medical Group, Inc.
🇺🇸Beaver, Pennsylvania, United States
Preferred Primary Care Physicians
🇺🇸Uniontown, Pennsylvania, United States
Texas Diabetes & Endocrinology, P.A.
🇺🇸Round Rock, Texas, United States
Diabetes and Thyroid Center of Fort Worth
🇺🇸Fort Worth, Texas, United States
Juno Research
🇺🇸Houston, Texas, United States
Biopharma Informatic, LLC
🇺🇸Houston, Texas, United States
North Hills Medical Research
🇺🇸North Richland Hills, Texas, United States
Clinical Trials of Texas, Inc.
🇺🇸San Antonio, Texas, United States
Consano Clinical Research, LLC
🇺🇸Shavano Park, Texas, United States
Martin Diagnostic Clinic
🇺🇸Tomball, Texas, United States
Rainier Clinical Research Center
🇺🇸Renton, Washington, United States
Centro Médico Viamonte
🇦🇷Caba, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Rosario (IIC-Rosario)- Sanatorio Delta
🇦🇷Rosario, Buenos Aires, Argentina
Medizentrum Essen-Borbeck
🇩🇪Essen, Nordrhein-Westfalen, Germany
MVZ im Altstadt-Carree Fulda GmbH
🇩🇪Fulda, Germany
Gemeinschaftspraxis Dr. med. Josef und Wilma Großkopf
🇩🇪Wallerfing, Germany
Paola Mansilla-Letelier, MD
🇵🇷Guaynabo, Puerto Rico
QUANTA - Medicina Nuclear Alto da XV
🇧🇷Curitiba, Paraná, Brazil
Diabeteszentrum Hamburg West
🇩🇪Hamburg, Germany
Capital Diabetes and Endocrine Associates
🇺🇸Camp Springs, Maryland, United States
CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda
🇧🇷São Bernardo do Campo, São Paulo, Brazil
CPCLIN
🇧🇷São Paulo, SP, Brazil
Instituto Centenario
🇦🇷Caba, Buenos Aires, Argentina
Instituto Brasil de Pesquisa Clínica - IBPCLIN
🇧🇷Rio de Janeiro, Brazil
S. C. Grandmed S.R.L.
🇷🇴Oradea, Bihor, Romania
Inonu Universitesi
🇹🇷Malatya, Turkey
Hospital PUC-CAMPINAS
🇧🇷Campinas, São Paulo, Brazil
ISPEM - Instituto São José dos Campos em Pesquisas Médicas
🇧🇷São José dos Campos, São Paulo, Brazil
Diabetologische Schwerpunktpraxis Harburg
🇩🇪Hamburg, Germany
Instituto Médico Especializado (IME)
🇦🇷Buenos Aires, Argentina
AZ Damiaan Oostende
🇧🇪Oostende, Belgium
CEDOES
🇧🇷Vitoria, ES, Brazil
General Hospital of Thessaloniki Papageorgiou
🇬🇷N. Efkarpia, Thessaloniki, Greece
Policlinico Mater Domini
🇮🇹Germaneto, Catanzaro, Italy
Tribe Clinical Research, LLC
🇺🇸Greenville, South Carolina, United States
MedStar Health Research Institute
🇺🇸Hyattsville, Maryland, United States
CIPADI
🇦🇷Godoy Cruz, Mendoza, Argentina
Centro de Pesq. em Diabetes e Doencas Endocrino Metabol.
🇧🇷Fortaleza, Ceará, Brazil
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
🇲🇽Madero, Tamaulipas, Mexico
Centro Medico Privado San Vicente Diabetes
🇦🇷Cordoba, Argentina
CEPIC - Centro Paulista de Investigação Clínica
🇧🇷São Paulo, Brazil
Iatriko Palaiou Falirou, Medical Center
🇬🇷Palaio Faliro, Athens, Greece
Casa di Cura Multimedica-Policlinico Multispecialistico
🇮🇹Sesto San Giovanni, MI, Italy
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
🇲🇽Monterrey, N.l., Mexico
SC Cosamext SRL
🇷🇴Targu Mures, Mures, Romania
Arkhangelsk Regional Clinical Hospital
🇷🇺Arkhangelsk, Russian Federation
SPb GUZ "Diagnostic Center #85"
🇷🇺Saint Petersburg, Russian Federation
Ospedale Luigi Sacco
🇮🇹Milano, Italy
Diacrin s.r.o.
🇸🇰Bratislava, Bratislavský Kraj, Slovakia
Gaziantep University Medical Faculty
🇹🇷Gaziantep, Turkey
TRANTOR'99 Bt. Anyagcsere Centrum
🇭🇺Budapest, Hungary
University of Colorado
🇺🇸Aurora, Colorado, United States
CECIP - Centro de Estudos do Interior Paulista
🇧🇷Jaú, São Paulo, Brazil
Instituto Jalisciense de Investigacion en Diabetes y Obesida
🇲🇽Guadalajara, Jalisco, Mexico
Unidad de patologia Clinica
🇲🇽Guadalajara, Jalisco, Mexico
Centro de Inv. Medica de Occidente, SC
🇲🇽Zapopan, Jalisco, Mexico