A Study of Tirzepatide Compared With Intensified Conventional Care in Adult Participants With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

— SURPASS-EARLY  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05433584
• Other study ID #: 17205
• Secondary ID: I8F-MC-GPHE2022-
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: August 1, 2022
• Est. completion date: November 29, 2027

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 780
• Est. completion date: November 29, 2027
• Est. primary completion date: October 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Tirzepatide
Administered SC
• Antihyperglycemic medication
As prescribed

Locations

Country	Name	City	State
Argentina	Centro Médico Viamonte	Buenos Aires	Ciudad Aut
Argentina	Centro de Investigaciones Metabólicas (CINME)	Ciudad Autónoma de Buenos Aire	Buenos Aires
Argentina	Instituto de Investigaciones Clínicas Mar del Plata	Mar del Plata	Buenos Aires
Argentina	CIAD Moron	Moron	Buenos Air
Argentina	Go Centro Medico San Nicolás	San Nicolas	Buenos Aires
Canada	9109-0126 Quebec Inc.	Montreal	Quebec
Canada	Bluewater Clinical Research Group Inc.	Sarnia	Ontario
Canada	Stouffville Medical Centre	Stouffville	Ontario
Canada	Dr. M.B. Jones Inc.	Victoria	British Columbia
Germany	Diabetespraxis Mergentheim	Bad Mergentheim
Germany	Diabetes- und Stoffwechselpraxis Bochum	Bochum	Nordrhein-Westfalen
Germany	InnoDiab Forschung Gmbh	Essen	Nordrhein-Westfalen
Germany	ClinPhenomics GmbH & Co KG	Frankfurt	Hessen
Germany	Diabetes Zentrum Dr. Tews	Gelnhausen
Germany	RED-Institut GmbH	Oldenburg	Schleswig-Holstein
Germany	Private Practice - Dr. Christine Kosch	Pirna	Sachsen
Germany	Zentrum für klinische Studien	Saint Ingbert	Saarland
Israel	Clalit Health Services - Atlit	Atlit	HaTsafon
Israel	Bnai Zion Medical Center	Haifa	HaTsafon
Israel	Linn Medical Center	Haifa	?eifa
Israel	Edith Wolfson Medical Center	Holon	HaMerkaz
Israel	Hadassah Medical Center	Jerusalem	Yerushalayim
Israel	Rabin Medical Center	Petah-Tikva	HaMerkaz
Israel	Sheba Medical Center	Ramat Gan	HaMerkaz
Israel	Kaplan Medical Center	Rehovot	HaMerkaz
Israel	Clalit Health Services - Sakhnin Community Clinic	Sakhnin	HaTsafon
Italy	A.O.U.C. Policlinico di Bari	Bari	Puglia
Italy	Azienda Ospedaliera Mater Domini	Catanzaro
Italy	Centro Cardiologico Monzino	Milan	Milano
Italy	Ospedale Civile Santa Croce Pronto Soccorso	Moncalieri	Piemonte
Italy	University of Naples Federico II	Napoli	Campania
Italy	Ospedale san Giovanni di Dio-Diabetologia	Olbia	Sardegna
Italy	A.O.U. Policlinico Paolo Giaccone	Palermo	Sicilia
Italy	Azienda Ospedaliera Universitaria Pisana	Pisa	Toscana
Mexico	Investigacion En Salud Y Metabolismo Sc	Chihuahua
Mexico	Private Practice - Dr. Arechavaleta Granell Maria del Rosario	Guadalajara	Jalisco
Mexico	Hospital Universitario "Dr. Jose Eleuterio Gonzalez"	Monterrey	Nuevo León
Puerto Rico	San Juan Bautista School of Medicine - Clinical Research Unit	Caguas
Puerto Rico	Dorado Medical Complex	Dorado
Puerto Rico	GCM Medical Group, PSC - Hato Rey Site	San Juan
Romania	C.M.D.T.A. Neomed	Brasov	Bra?ov
Romania	Centrul Medical NutriLife	Bucharest	Bucure?ti
Romania	Milena Sante	Gala?i
Romania	Gama Diamed	Mangalia	Constan?a
Romania	Diabdana	Oradea	Bihor
Romania	Diabmed Dr. Popescu Alexandrina	Ploie?ti	Prahova
Romania	Clinica Korall	Satu Mare
Slovakia	MEDIKALS	Pieštany
Slovakia	ProDia s.r.o.	Povazska Bystrica
Slovakia	JAL	Trnava
Slovakia	IRIDIA	Vrutky	Žilinský Kraj
United Kingdom	Aberdeen Royal Infirmary	Aberdeen	Aberdeen City
United Kingdom	Ninewells Hospital and Medical School	Dundee	Angus
United Kingdom	Staploe Medical Centre	Ely	Cambridgeshire
United Kingdom	Hull and East Yorkshire Hospitals NHS Trust	Hull	Kingston Upon Hull
United Kingdom	Leicester General Hospital	Leicester	Leicestershire
United Kingdom	Knowle House Surgery	Plymouth	Devon
United Kingdom	Wickersley Health Centre - Clifton Medical Centre	Rotherham
United States	Emory University School of Medicine- Grady Campus	Atlanta	Georgia
United States	Cahaba Research - Trussville	Birmingham	Alabama
United States	Excel Medical Clinical Trials	Boca Raton	Florida
United States	Qualmedica Research	Bowling Green	Kentucky
United States	New England Research Associates, LLC	Bridgeport	Connecticut
United States	Research Foundation of SUNY - University of Buffalo	Buffalo	New York
United States	San Fernando Valley Health Institute	Canoga Park	California
United States	Alliance for Multispecialty Research, LLC	Coral Gables	Florida
United States	The Corvallis Clinic, P.C.	Corvallis	Oregon
United States	Dallas Diabetes Research Center	Dallas	Texas
United States	Qualmedica Research, LLC	Evansville	Indiana
United States	NECCR PrimaCare Research	Fall River	Massachusetts
United States	Center for Advanced Research & Education	Gainesville	Georgia
United States	Tribe Clinical Research, LLC	Greenville	South Carolina
United States	National Research Institute - Huntington Park	Huntington Park	California
United States	Velocity Clinical Research, San Diego	La Mesa	California
United States	Clinical Trials Research	Lincoln	California
United States	National Research Institute - Wilshire	Los Angeles	California
United States	South Florida Clinical Research Institute	Margate	Florida
United States	Catalina Research Institute, LLC	Montclair	California
United States	Lucas Research, Inc	Morehead City	North Carolina
United States	Velocity Clinical Research, North Hollywood	North Hollywood	California
United States	Velocity Clinical Research, Panorama City	Panorama City	California
United States	Clinical Research of Philadelphia	Philadelphia	Pennsylvania
United States	Western University of Health Sciences	Pomona	California
United States	SKY Clinical Research Network Group-Quinn	Ridgeland	Mississippi
United States	StudyMetrix Research	Saint Peters	Missouri
United States	Velocity Clinical Research, Santa Ana	Santa Ana	California
United States	VitaLink Research - Spartanburg	Spartanburg	South Carolina
United States	Clinvest Research LLC	Springfield	Missouri
United States	Preferred Primary Care Physicians	Uniontown	Pennsylvania
United States	Iowa Diabetes and Endocrinology Research Center	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Germany,  Israel,  Italy,  Mexico,  Puerto Rico,  Romania,  Slovakia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Hemoglobin A1c (HbA1c)		Baseline, Week 104
Secondary	Change from Baseline in HbA1c		Baseline, Week 208
Secondary	Change from Baseline in Weight		Baseline, Week 104
Secondary	Change from Baseline in Weight		Baseline, Week 208
Secondary	Change from Baseline in Waist Circumference		Baseline, Week 104
Secondary	Change from Baseline in Waist Circumference		Baseline, Week 208
Secondary	Change from Baseline in Fasting Serum Glucose (FSG)		Baseline, Week 104
Secondary	Change from Baseline in FSG		Baseline, Week 208
Secondary	Change from Baseline in Lipids		Baseline, Week 104
Secondary	Change from Baseline in Lipids		Baseline, Week 208
Secondary	Percentage of Participants Achieving HbA1c <7.0%		Week 104
Secondary	Percentage of Participants Achieving HbA1c =6.5%		Week 104
Secondary	Percentage of Participants Achieving HbA1c <5.7%		Week 104
Secondary	Percentage of Participants Achieving HbA1c <7.0%		Week 208
Secondary	Percentage of Participants Achieving HbA1c =6.5%		Week 208
Secondary	Percentage of Participants Achieving HbA1c <5.7%		Week 208
Secondary	Change from Baseline in Weight loss of =5%,		Baseline, Week 104
Secondary	Change from Baseline in Weight loss of =10%		Baseline, Week 104
Secondary	Change from Baseline in Weight loss of =15%		Baseline, Week 104
Secondary	Change from Baseline in Weight loss of =5%		Baseline, Week 208
Secondary	Change from Baseline in Weight loss of =10%		Baseline, Week 208
Secondary	Change from Baseline in Weight loss of =15%		Baseline, Week 208
Secondary	A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia	A composite endpoint defined as HbA1c = 6.5%, weight loss =10%, no hypoglycemia, defined as blood glucose (BG) <54 milligram/deciliter (mg/dL) <3.0 millimole/liter (mmol/L) and/or severe hypoglycemia	Week 104
Secondary	A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia	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	Week 208
Secondary	Change from Baseline in ß-cell Glucose Sensitivity	ß-cell Glucose Sensitivity assessed by Oral Glucose Tolerance Test (OGTT)	Baseline, Week 104
Secondary	Change from Baseline in ß-cell glucose sensitivity	Change from baseline in ß-cell glucose sensitivity assessed by OGTT	Baseline, Week 208
Secondary	Change from Baseline in Insulin Secretion Rate at a Fixed Glucose Concentration	Insulin Secretion Rate assessed by OGTT	Baseline, Week 104
Secondary	Change from Baseline in Insulin Secretion Rate at a Fixed Glucose Concentration	Insulin Secretion Rate assessed by OGTT	Baseline, Week 208
Secondary	Change from Baseline in Postprandial Insulin Sensitivity Indices	Postprandial Insulin Sensitivity Indices assessed by OGTT	Baseline, Week 104
Secondary	Change from Baseline in Postprandial Insulin Sensitivity Indices	Postprandial Insulin Sensitivity Indices assessed by OGTT	Baseline, Week 208
Secondary	Change from Baseline in Fasting and Post-challenge Glucose [total and incremental AUC(0-240min)]	Fasting and Post-challenge Glucose [total and incremental AUC(0-240min)] assessed by OGTT	Baseline through Week 104
Secondary	Change from Baseline in Fasting and Post-challenge Glucose [total and incremental (AUC0-240min)]	Fasting and Post-challenge Glucose [total and incremental AUC(0-240min)] assessed by OGTT	Baseline through Week 208
Secondary	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
Secondary	Change from Baseline in the IWQOL-Lite-CT - Physical Functioning Domain		Baseline, Week 208

External Links

•   A Study of Tirzepatide Compared With Intensified Conventional Care in Adult Participants With Type 2 Diabetes (SURPASS-EARLY)