A Study of Tirzepatide Compared With Intensified Conventional Care in Adult Participants With Type 2 Diabetes
- Conditions
- Type 2 Diabetes
- Interventions
- Drug: Antihyperglycemic medication
- Registration Number
- NCT05433584
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 780
-
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.
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intensified Conventional Care Dose Antihyperglycemic medication Participants will receive an antihyperglycemic medication Tirzepatide Tirzepatide Participants will receive tirzepatide at the maximum tolerated dose subcutaneously (SC)
- Primary Outcome Measures
Name Time Method Change from Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 104
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving HbA1c <7.0% Week 208 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
Change from Baseline in HbA1c Baseline, Week 208 Change from Baseline in Fasting Serum Glucose (FSG) Baseline, Week 104 Change from Baseline in Weight Baseline, Week 208 Change from Baseline in Waist Circumference Baseline, Week 208 Change from Baseline in FSG Baseline, Week 208 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
Change from Baseline in β-cell Glucose Sensitivity Baseline, Week 104 β-cell Glucose Sensitivity assessed by Oral Glucose Tolerance Test (OGTT)
Percentage of Participants Achieving HbA1c <5.7% Week 208 Change from Baseline in Weight loss of ≥5%, Baseline, Week 104 Change from Baseline in Postprandial Insulin Sensitivity Indices Baseline, Week 208 Postprandial Insulin Sensitivity Indices assessed by OGTT
Change from Baseline in Lipids Baseline, Week 208 Change from Baseline in Weight loss of ≥15% Baseline, Week 208 Change from Baseline in Weight loss of ≥5% Baseline, Week 208 Change from Baseline in β-cell glucose sensitivity Baseline, Week 208 Change from baseline in β-cell glucose sensitivity assessed by OGTT
Percentage of Participants Achieving HbA1c ≤6.5% Week 208 Change from Baseline in Weight loss of ≥10% Baseline, Week 208 Change from Baseline in the IWQOL-Lite-CT - Physical Functioning Domain Baseline, Week 208 Change from Baseline in Insulin Secretion Rate at a Fixed Glucose Concentration Baseline, Week 208 Insulin Secretion Rate assessed by OGTT
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
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
Trial Locations
- Locations (90)
New England Research Associates, LLC
🇺🇸Bridgeport, Connecticut, United States
Velocity Clinical Research, San Diego
🇺🇸La Mesa, California, United States
Research Foundation of SUNY - University of Buffalo
🇺🇸Buffalo, New York, United States
Velocity Clinical Research, Huntington Park
🇺🇸Huntington Park, California, United States
Velocity Clinical Research, North Hollywood
🇺🇸North Hollywood, California, United States
Instituto de Investigaciones Clínicas Mar del Plata
🇦🇷Mar del Plata, Buenos Aires, Argentina
Clinical Trials Research
🇺🇸Lincoln, California, United States
Kaplan Medical Center
🇮🇱Rehovot, HaMerkaz, Israel
San Fernando Valley Health Institute
🇺🇸Canoga Park, California, United States
Clalit Health Services - Sakhnin Community Clinic
🇮🇱Sakhnin, HaTsafon, Israel
Bluewater Clinical Research Group Inc.
🇨🇦Sarnia, Ontario, Canada
Edith Wolfson Medical Center
🇮🇱Holon, HaMerkaz, Israel
Qualmedica Research, LLC
🇺🇸Evansville, Indiana, United States
InnoDiab Forschung Gmbh
🇩🇪Essen, Nordrhein-Westfalen, Germany
Diabetespraxis Mergentheim
🇩🇪Bad Mergentheim, Germany
Linn Medical Center
🇮🇱Haifa, Ḥeifā, Israel
Dorado Medical Complex
🇵🇷Dorado, Puerto Rico
A.O.U.C. Policlinico di Bari
🇮🇹Bari, Puglia, Italy
Ospedale san Giovanni di Dio-Diabetologia
🇮🇹Olbia, Sardegna, Italy
CIAD Moron
🇦🇷Moron, Buenos Air, Argentina
Preferred Primary Care Physicians
🇺🇸Uniontown, Pennsylvania, United States
Hadassah Medical Center
🇮🇱Jerusalem, Yerushalayim, Israel
ClinPhenomics CVC GmbH
🇩🇪Frankfurt, Hessen, Germany
Aberdeen Royal Infirmary
🇬🇧Aberdeen, Aberdeen City, United Kingdom
MEDIKALS
🇸🇰Piešťany, Slovakia
Ninewells Hospital and Medical School
🇬🇧Dundee, Angus, United Kingdom
Centro Cardiologico Monzino
🇮🇹Milan, Milano, Italy
Azienda Ospedaliera Universitaria Pisana
🇮🇹Pisa, Toscana, Italy
University of Naples Federico II
🇮🇹Napoli, Campania, Italy
AOU Renato Dulbecco
🇮🇹Catanzaro, Italy
Diabetes Zentrum Dr. Tews
🇩🇪Gelnhausen, Germany
Wickersley Health Centre - Clifton Medical Centre
🇬🇧Rotherham, United Kingdom
San Juan Bautista School of Medicine - Clinical Research Unit
🇵🇷Caguas, Puerto Rico
GCM Medical Group, PSC - Hato Rey Site
🇵🇷San Juan, Puerto Rico
Ospedale Civile Santa Croce Pronto Soccorso
🇮🇹Moncalieri, Piemonte, Italy
A.O.U. Policlinico Paolo Giaccone
🇮🇹Palermo, Sicilia, Italy
Hull Royal Infirmary
🇬🇧Hull, Kingston Upon Hull, United Kingdom
Bnai Zion Medical Center
🇮🇱Haifa, HaTsafon, Israel
Zentrum für klinische Studien
🇩🇪Saint Ingbert, Saarland, Germany
RED-Institut GmbH
🇩🇪Oldenburg, Schleswig-Holstein, Germany
Milena Sante
🇷🇴Galați, Romania
ProDia s.r.o.
🇸🇰Povazska Bystrica, Slovakia
Dr. M.B. Jones Inc.
🇨🇦Victoria, British Columbia, Canada
C.M.D.T.A. Neomed
🇷🇴Brasov, Brașov, Romania
Gama Diamed
🇷🇴Mangalia, Constanța, Romania
JAL
🇸🇰Trnava, Slovakia
Investigacion En Salud Y Metabolismo Sc
🇲🇽Chihuahua, Mexico
Diabdana
🇷🇴Oradea, Bihor, Romania
Clinica Korall
🇷🇴Satu Mare, Romania
Knowle House Surgery
🇬🇧Plymouth, Devon, United Kingdom
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
🇲🇽Monterrey, Nuevo León, Mexico
Staploe Medical Centre
🇬🇧Ely, Cambridgeshire, United Kingdom
Leicester General Hospital
🇬🇧Leicester, Leicestershire, United Kingdom
Private Practice - Dr. Arechavaleta Granell Maria del Rosario
🇲🇽Guadalajara, Jalisco, Mexico
IRIDIA
🇸🇰Vrutky, Žilinský Kraj, Slovakia
Centrul Medical NutriLife
🇷🇴Bucharest, București, Romania
Diabmed Dr. Popescu Alexandrina
🇷🇴Ploiești, Prahova, Romania
Cahaba Research - Trussville
🇺🇸Birmingham, Alabama, United States
Sheba Medical Center
🇮🇱Ramat Gan, HaMerkaz, Israel
Catalina Research Institute, LLC
🇺🇸Montclair, California, United States
Velocity Clinical Research, Westlake
🇺🇸Los Angeles, California, United States
Western University of Health Sciences
🇺🇸Pomona, California, United States
Velocity Clinical Research, Santa Ana
🇺🇸Santa Ana, California, United States
Velocity Clinical Research, Panorama City
🇺🇸Panorama City, California, United States
Excel Medical Clinical Trials
🇺🇸Boca Raton, Florida, United States
Alliance for Multispecialty Research, LLC
🇺🇸Coral Gables, Florida, United States
Emory University School of Medicine- Grady Campus
🇺🇸Atlanta, Georgia, United States
South Florida Clinical Research Institute
🇺🇸Margate, Florida, United States
Center for Advanced Research & Education
🇺🇸Gainesville, Georgia, United States
Iowa Diabetes and Endocrinology Research Center
🇺🇸West Des Moines, Iowa, United States
NECCR PrimaCare Research
🇺🇸Fall River, Massachusetts, United States
SKY Integrative Medical Center/SKYCRNG
🇺🇸Ridgeland, Mississippi, United States
Qualmedica Research
🇺🇸Bowling Green, Kentucky, United States
StudyMetrix Research
🇺🇸Saint Peters, Missouri, United States
Clinvest Research LLC
🇺🇸Springfield, Missouri, United States
Lucas Research, Inc
🇺🇸Morehead City, North Carolina, United States
Clinical Research of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Tribe Clinical Research, LLC
🇺🇸Greenville, South Carolina, United States
Velocity Clinical Research, Spartanburg
🇺🇸Spartanburg, South Carolina, United States
Dallas Diabetes Research Center
🇺🇸Dallas, Texas, United States
Centro de Investigaciones Metabólicas (CINME)
🇦🇷Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina
Go Centro Medico San Nicolás
🇦🇷San Nicolas, Buenos Aires, Argentina
Centro Médico Viamonte
🇦🇷Buenos Aires, Ciudad Aut, Argentina
Stouffville Medical Centre
🇨🇦Stouffville, Ontario, Canada
Diabetes- und Stoffwechselpraxis Bochum
🇩🇪Bochum, Nordrhein-Westfalen, Germany
Arztpraxis Christine Kosch Pirna
🇩🇪Pirna, Sachsen, Germany
9109-0126 Quebec Inc.
🇨🇦Montreal, Quebec, Canada
Clalit Health Services - Atlit
🇮🇱Atlit, HaDarom, Israel
Rabin Medical Center
🇮🇱Petah-Tikva, HaMerkaz, Israel
The Corvallis Clinic, P.C.
🇺🇸Corvallis, Oregon, United States