A Study of Tirzepatide (LY3298176) Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Participants With Type 2 Diabetes
Launched by ELI LILLY AND COMPANY · Jun 14, 2019
Trial Information
Current as of May 02, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Have been diagnosed with type 2 diabetes mellitus (T2DM)
- • Have HbA1c between ≥7.0% and ≤10.5%
- • Be on stable treatment with unchanged dose of metformin \>1500 mg/day for at least 3 months prior to screening
- • Be of stable weight (±5%) for at least 3 months before screening
- • Have a body mass index (BMI) ≥25 kilograms per meter squared (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 maculopathy or nonproliferative diabetic retinopathy requiring acute treatment
- • Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss
- • Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) enzyme level \>3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory. Participants with nonalcoholic fatty liver disease (NAFLD) are eligible for participation in this trial only if there ALT level is ≤3.0 the ULN for the reference range
- • Have an estimated glomerular filtration rate \<45 milliliters/minute/1.73 m² (or lower than the country specific threshold for using the protocol required dose of metformin per local label)
- • 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 any other diabetes medicines other than metformin during the last 3 months
- • Have been taking weight loss drugs, including over-the-counter medications during the last 3 months
About Eli Lilly And Company
Eli Lilly and Company is a global healthcare leader dedicated to creating innovative medicines that improve patient outcomes across a range of therapeutic areas, including diabetes, oncology, immunology, and neurodegenerative diseases. With a rich history of scientific research and a commitment to advancing healthcare, Lilly invests significantly in clinical trials to develop new treatments and enhance existing therapies. The company prioritizes patient safety and ethical standards in its clinical research, fostering collaboration with healthcare professionals and stakeholders to ensure the delivery of high-quality, evidence-based solutions that address unmet medical needs worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ramat Gan, , Israel
Coral Gables, Florida, United States
Philadelphia, Pennsylvania, United States
Gainesville, Georgia, United States
Olive Branch, Mississippi, United States
Herston, Queensland, Australia
Bristol, Tennessee, United States
Morehead City, North Carolina, United States
Sydney, New South Wales, Australia
Wilmington, North Carolina, United States
Milton, Queensland, Australia
San Juan, , Puerto Rico
Greensboro, North Carolina, United States
Leicester, Leicestershire, United Kingdom
Geelong, Victoria, Australia
Box Hill, Victoria, Australia
Topeka, Kansas, United States
Olympia, Washington, United States
Tustin, California, United States
Tomball, Texas, United States
Vancouver, Washington, United States
Trenton, New Jersey, United States
Portsmouth, Hampshire, United Kingdom
Burke, Virginia, United States
Miami, Florida, United States
Camp Hill, Pennsylvania, United States
Northridge, California, United States
San Diego, California, United States
Birmingham, Alabama, United States
Lansdale, Pennsylvania, United States
Cordoba, , Argentina
São Paulo, Sp, Brazil
Blackfoot, Idaho, United States
Albany, New York, United States
Margate, Florida, United States
Pembroke Pines, Florida, United States
Oviedo, Florida, United States
Lansdale, Pennsylvania, United States
Beaver, Pennsylvania, United States
Topeka, Kansas, United States
Jerusalem, Yerushalayim, Israel
Montclair, California, United States
San Marcos, California, United States
San Juan, , Puerto Rico
Porto Alegre, Rio Grande Do Sul, Brazil
Fall River, Massachusetts, United States
Fargo, North Dakota, United States
Dallas, Texas, United States
Miami, Florida, United States
Ciudad Autonoma De Buenos Aire, , Argentina
Coventry, Warwickshire, United Kingdom
Columbus, Ohio, United States
Houston, Texas, United States
Huntington Park, California, United States
Sugar Land, Texas, United States
Godoy Cruz, Mendoza, Argentina
Tel Aviv Jaffa, , Israel
Ponce, , Puerto Rico
Panorama City, California, United States
Ciudad Autonoma De Buenos Air, Buenos Aires, Argentina
Riverside, California, United States
Monterrey, N.L., Mexico
Iowa City, Iowa, United States
Caba, Buenos Aires, Argentina
Springfield, Missouri, United States
Methuen, Massachusetts, United States
Union City, Georgia, United States
Miami, Florida, United States
Hamden, Connecticut, United States
Ramat Gan, Hamerkaz, Israel
Kfar Saba, Hamerkaz, Israel
Haifa, ḥeifā, Israel
Norman, Oklahoma, United States
Caba, Buenos Aires, Argentina
Shavano Park, Texas, United States
Sheffield, Alabama, United States
Lake City, Florida, United States
Pittsburgh, Pennsylvania, United States
Caba, Ar B, Argentina
Ciudad Autonoma De Buenos Aire, Ar B, Argentina
Buenos Aires, Ar C, Argentina
C.A.B.A., Ar C, Argentina
Santiago Del Estero, Ar G, Argentina
Caba, Buenos Aires, Argentina
Mar Del Plata, Provincia De Buenos Aires, Argentina
Blacktown, Au Nsw, Australia
Campbelltown, Au Nsw, Australia
Kanwal, Au Nsw, Australia
Bundaberg, Queensland, Australia
Taringa, Queensland, Australia
Joondalup, Western Australia, Australia
Murdoch, Western Australia, Australia
Woodville South, , Australia
Vitória, Br Es, Brazil
São José Dos Campos, Br Sp, Brazil
São Paulo, Br Sp, Brazil
São Paulo, Br Sp, Brazil
São Paulo, , Brazil
London, Ca On, Canada
Sarnia, Ca On, Canada
Toronto, Ca On, Canada
Lévis, Ca Qc, Canada
Burlington, Ontario, Canada
Nepean, Ontario, Canada
Stoney Creek, Ontario, Canada
Toronto, Ontario, Canada
Raanana, Hamerkaz, Israel
Tel Aviv, Il Ta, Israel
Sakhnin, , Israel
Haifa, ḥeifā, Israel
Mexico, D.F., Mexico
Guadalajara, Jalisco, Mexico
Guadalajara, Jalisco, Mexico
Guadalajara, Mx Jal, Mexico
San Nicolás De Los Garza, Nuevo León, Mexico
Ciudad Madero, Tamaulipas, Mexico
Chihuahua, , Mexico
Guaynabo, , Puerto Rico
Bath, Avon, United Kingdom
Ely, Gb Cam, United Kingdom
Fowey, Gb Con, United Kingdom
Liskeard, Gb Con, United Kingdom
Torpoint, Gb Con, United Kingdom
Chesterfield, Gb Dby, United Kingdom
Plymouth, Gb Dev, United Kingdom
Portsmouth, Gb Ham, United Kingdom
Stevenage, Gb Hrt, United Kingdom
Blackburn, Gb Lan, United Kingdom
Chippenham, Gb Wil, United Kingdom
Rotherham, , United Kingdom
Patients applied
Trial Officials
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)
Study Director
Eli Lilly and Company
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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