Clinical trial NCT05433584: A Study of Tirzepatide Compared With Intensified Conventional Care in Adult Participants With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: T2D
Diabetes
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-06-27
Enrollment: 780
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 104
Secondary outcomes:
measure: Change from Baseline in HbA1c
timeFrame: Baseline, Week 208
measure: Change from Baseline in Weight
timeFrame: Baseline, Week 104
measure: Change from Baseline in Weight
timeFrame: Baseline, Week 208
measure: Change from Baseline in Waist Circumference
timeFrame: Baseline, Week 104
measure: Change from Baseline in Waist Circumference
timeFrame: Baseline, Week 208
measure: Change from Baseline in Fasting Serum Glucose (FSG)
timeFrame: Baseline, Week 104
measure: Change from Baseline in FSG
timeFrame: Baseline, Week 208
measure: Change from Baseline in Lipids
timeFrame: Baseline, Week 104
measure: Change from Baseline in Lipids
timeFrame: Baseline, Week 208
measure: Percentage of Participants Achieving HbA1c <7.0%
timeFrame: Week 104
measure: Percentage of Participants Achieving HbA1c ≤6.5%
timeFrame: Week 104
measure: Percentage of Participants Achieving HbA1c <5.7%
timeFrame: Week 104
measure: Percentage of Participants Achieving HbA1c <7.0%
timeFrame: Week 208
measure: Percentage of Participants Achieving HbA1c ≤6.5%
timeFrame: Week 208
measure: Percentage of Participants Achieving HbA1c <5.7%
timeFrame: Week 208
measure: Change from Baseline in Weight loss of ≥5%,
timeFrame: Baseline, Week 104
measure: Change from Baseline in Weight loss of ≥10%
timeFrame: Baseline, Week 104
measure: Change from Baseline in Weight loss of ≥15%
timeFrame: Baseline, Week 104
measure: Change from Baseline in Weight loss of ≥5%
timeFrame: Baseline, Week 208
measure: Change from Baseline in Weight loss of ≥10%
timeFrame: Baseline, Week 208
measure: Change from Baseline in Weight loss of ≥15%
timeFrame: Baseline, Week 208
measure: A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia
timeFrame: Week 104
measure: A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia
timeFrame: Week 208
measure: Change from Baseline in β-cell Glucose Sensitivity
timeFrame: Baseline, Week 104
measure: Change from Baseline in β-cell glucose sensitivity
timeFrame: Baseline, Week 208
measure: Change from Baseline in Insulin Secretion Rate at a Fixed Glucose Concentration
timeFrame: Baseline, Week 104
measure: Change from Baseline in Insulin Secretion Rate at a Fixed Glucose Concentration
timeFrame: Baseline, Week 208
measure: Change from Baseline in Postprandial Insulin Sensitivity Indices
timeFrame: Baseline, Week 104
measure: Change from Baseline in Postprandial Insulin Sensitivity Indices
timeFrame: Baseline, Week 208
measure: Change from Baseline in Fasting and Post-challenge Glucose [total and incremental AUC(₀-₂₄₀min)]
timeFrame: Baseline through Week 104
measure: Change from Baseline in Fasting and Post-challenge Glucose [total and incremental (AUC₀-₂₄₀min)]
timeFrame: Baseline through Week 208
measure: Change from Baseline in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) - Physical Functioning Domain
timeFrame: Baseline, Week 104
measure: Change from Baseline in the IWQOL-Lite-CT - Physical Functioning Domain
timeFrame: Baseline, Week 208
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cahaba Research - Trussville
state: Alabama
city: Canoga Park
country: United States
facility: San Fernando Valley Health Institute
state: California
city: Huntington Park
country: United States
facility: Velocity Clinical Research, Huntington Park
state: California
city: La Mesa
country: United States
facility: Velocity Clinical Research, San Diego
state: California
city: Lincoln
country: United States
facility: Clinical Trials Research
state: California
city: Los Angeles
country: United States
facility: Velocity Clinical Research, Westlake
state: California
city: Montclair
country: United States
facility: Catalina Research Institute, LLC
state: California
city: North Hollywood
country: United States
facility: Velocity Clinical Research, North Hollywood
state: California
city: Panorama City
country: United States
facility: Velocity Clinical Research, Panorama City
state: California
city: Pomona
country: United States
facility: Western University of Health Sciences
state: California
city: Santa Ana
country: United States
facility: Velocity Clinical Research, Santa Ana
state: California
city: Bridgeport
country: United States
facility: New England Research Associates, LLC
state: Connecticut
city: Boca Raton
country: United States
facility: Excel Medical Clinical Trials
state: Florida
city: Coral Gables
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Florida
city: Margate
country: United States
facility: South Florida Clinical Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine- Grady Campus
state: Georgia
city: Gainesville
country: United States
facility: Center for Advanced Research & Education
state: Georgia
city: Evansville
country: United States
facility: Qualmedica Research, LLC
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center
state: Iowa
city: Bowling Green
country: United States
facility: Qualmedica Research
state: Kentucky
city: Fall River
country: United States
facility: NECCR PrimaCare Research
state: Massachusetts
city: Ridgeland
country: United States
facility: SKY Integrative Medical Center/SKYCRNG
state: Mississippi
city: Saint Peters
country: United States
facility: StudyMetrix Research
state: Missouri
city: Springfield
country: United States
facility: Clinvest Research LLC
state: Missouri
city: Buffalo
country: United States
facility: Research Foundation of SUNY - University of Buffalo
state: New York
city: Morehead City
country: United States
facility: Lucas Research, Inc
state: North Carolina
city: Corvallis
country: United States
facility: The Corvallis Clinic, P.C.
state: Oregon
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia
state: Pennsylvania
city: Uniontown
country: United States
facility: Preferred Primary Care Physicians
state: Pennsylvania
city: Greenville
country: United States
facility: Tribe Clinical Research, LLC
state: South Carolina
city: Spartanburg
country: United States
facility: Velocity Clinical Research, Spartanburg
state: South Carolina
city: Dallas
country: United States
facility: Dallas Diabetes Research Center
state: Texas
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clínicas Mar del Plata
state: Buenos Aires
city: San Nicolas
country: Argentina
facility: Go Centro Medico San Nicolás
state: Buenos Aires
city: Moron
country: Argentina
facility: CIAD Moron
state: Buenos Air
city: Buenos Aires
country: Argentina
facility: Centro Médico Viamonte
state: Ciudad Aut
city: Victoria
country: Canada
facility: Dr. M.B. Jones Inc.
state: British Columbia
city: Sarnia
country: Canada
facility: Bluewater Clinical Research Group Inc.
state: Ontario
city: Stouffville
country: Canada
facility: Stouffville Medical Centre
state: Ontario
city: Montreal
country: Canada
facility: 9109-0126 Quebec Inc.
state: Quebec
city: Frankfurt
country: Germany
facility: ClinPhenomics CVC GmbH
state: Hessen
city: Bochum
country: Germany
facility: Diabetes- und Stoffwechselpraxis Bochum
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: InnoDiab Forschung Gmbh
state: Nordrhein-Westfalen
city: Saint Ingbert
country: Germany
facility: Zentrum für klinische Studien
state: Saarland
city: Pirna
country: Germany
facility: Arztpraxis Christine Kosch Pirna
state: Sachsen
city: Oldenburg
country: Germany
facility: RED-Institut GmbH
state: Schleswig-Holstein
city: Bad Mergentheim
country: Germany
facility: Diabetespraxis Mergentheim
city: Gelnhausen
country: Germany
facility: Diabetes Zentrum Dr. Tews
city: Atlit
country: Israel
facility: Clalit Health Services - Atlit
state: HaDarom
city: Holon
country: Israel
facility: Edith Wolfson Medical Center
state: HaMerkaz
city: Petah-Tikva
country: Israel
facility: Rabin Medical Center
state: HaMerkaz
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
state: HaMerkaz
city: Rehovot
country: Israel
facility: Kaplan Medical Center
state: HaMerkaz
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
state: HaTsafon
city: Sakhnin
country: Israel
facility: Clalit Health Services - Sakhnin Community Clinic
state: HaTsafon
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
state: Yerushalayim
city: Haifa
country: Israel
facility: Linn Medical Center
state: Ḥeifā
city: Napoli
country: Italy
facility: University of Naples Federico II
state: Campania
city: Milan
country: Italy
facility: Centro Cardiologico Monzino
state: Milano
city: Moncalieri
country: Italy
facility: Ospedale Civile Santa Croce Pronto Soccorso
state: Piemonte
city: Bari
country: Italy
facility: A.O.U.C. Policlinico di Bari
state: Puglia
city: Olbia
country: Italy
facility: Ospedale san Giovanni di Dio-Diabetologia
state: Sardegna
city: Palermo
country: Italy
facility: A.O.U. Policlinico Paolo Giaccone
state: Sicilia
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana
state: Toscana
city: Catanzaro
country: Italy
facility: AOU Renato Dulbecco
city: Guadalajara
country: Mexico
facility: Private Practice - Dr. Arechavaleta Granell Maria del Rosario
state: Jalisco
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
state: Nuevo León
city: Chihuahua
country: Mexico
facility: Investigacion En Salud Y Metabolismo Sc
city: Caguas
country: Puerto Rico
facility: San Juan Bautista School of Medicine - Clinical Research Unit
city: Dorado
country: Puerto Rico
facility: Dorado Medical Complex
city: San Juan
country: Puerto Rico
facility: GCM Medical Group, PSC - Hato Rey Site
city: Oradea
country: Romania
facility: Diabdana
state: Bihor
city: Brasov
country: Romania
facility: C.M.D.T.A. Neomed
state: Brașov
city: Bucharest
country: Romania
facility: Centrul Medical NutriLife
state: București
city: Mangalia
country: Romania
facility: Gama Diamed
state: Constanța
city: Ploiești
country: Romania
facility: Diabmed Dr. Popescu Alexandrina
state: Prahova
city: Galați
country: Romania
facility: Milena Sante
city: Satu Mare
country: Romania
facility: Clinica Korall
city: Piešťany
country: Slovakia
facility: MEDIKALS
city: Povazska Bystrica
country: Slovakia
facility: ProDia s.r.o.
city: Trnava
country: Slovakia
facility: JAL
city: Vrutky
country: Slovakia
facility: IRIDIA
state: Žilinský Kraj
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
state: Aberdeen City
city: Dundee
country: United Kingdom
facility: Ninewells Hospital and Medical School
state: Angus
city: Ely
country: United Kingdom
facility: Staploe Medical Centre
state: Cambridgeshire
city: Plymouth
country: United Kingdom
facility: Knowle House Surgery
state: Devon
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
state: Kingston Upon Hull
city: Leicester
country: United Kingdom
facility: Leicester General Hospital
state: Leicestershire
city: Rotherham
country: United Kingdom
facility: Wickersley Health Centre - Clifton Medical Centre
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: