A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Mellitus
NCT ID: NCT03131687
Last Updated: 2019-08-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
318 participants
INTERVENTIONAL
2017-05-24
2018-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
Placebo
Administered SC
1 mg Tirzepatide
1 milligrams (mg) tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
tirzepatide
Administered SC
Placebo
Administered SC
5 mg Tirzepatide
5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
tirzepatide
Administered SC
Placebo
Administered SC
10 mg Tirzepatide
10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
tirzepatide
Administered SC
Placebo
Administered SC
15 mg Tirzepatide
15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
tirzepatide
Administered SC
Placebo
Administered SC
1.5 mg Dulaglutide
1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.
Dulaglutide
Administered SC
Placebo
Administered SC
Interventions
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tirzepatide
Administered SC
Dulaglutide
Administered SC
Placebo
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have HbA1c of 7.0% to 10.5%, inclusive, as assessed by the central laboratory.
* If on metformin, have been treated with stable doses of metformin for at least 3 months.
* Have a body mass index (BMI) ≥23 and \<50 kilograms per square meter.
Exclusion Criteria
* Have used any glucose-lowering medication other than metformin within 3 months prior to study entry or during screening/lead-in period or have used any glucagon-like peptide-1 receptor agonists (GLP-1 RAs) at any time in the past.
* Have had any of the following cardiovascular conditions: acute myocardial infarction (MI), New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident (stroke).
* Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level \>2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial.
* Have had chronic or acute pancreatitis any time prior to study entry.
* Have an estimated glomerular filtration rate (eGFR) \<45 milliliters/minute/1.73 square meter, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation.
* Have serum calcitonin ≥20 picograms per milliliter, as determined by the central laboratory at study entry.
* Have any condition that is a contraindication for use of the GLP-1 RA class (per country-specific labels) at study entry or develop such condition between study entry and randomization.
18 Years
75 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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
Eli Lilly and Company
Locations
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Internal Medicine Center LLC
Mobile, Alabama, United States
Anaheim Clinical Trails
Anaheim, California, United States
Valley Research
Fresno, California, United States
National Research Institute
Huntington Park, California, United States
National Research Institute
Los Angeles, California, United States
Catalina Research Institute
Montclair, California, United States
Valley Clinical Trails, Inc
Northridge, California, United States
Artemis Institute For Clinical Research
San Diego, California, United States
Artemis Institute For Clinical Research
San Marcos, California, United States
Encompass Clinical Research
Spring Valley, California, United States
University Clinical Investigators INC
Tustin, California, United States
Chase Medical Research
Waterbury, Connecticut, United States
Clinical Research of South Florida
Coral Gables, Florida, United States
East Coast Institute For Research
Jacksonville, Florida, United States
Suncoast Research Group, LCC
Miami, Florida, United States
New Horizon Research Center
Miami, Florida, United States
Sensible Healthcare
Ocoee, Florida, United States
Palm Harbor Medical Associate
Palm Harbor, Florida, United States
Solaris Clinical Research
Meridian, Idaho, United States
Iderc P.L.C.
West Des Moines, Iowa, United States
Cotton O'Neil Diabetes and Endocrine
Topeka, Kansas, United States
ActivMed Practices & Research
Methuen, Massachusetts, United States
Clinical Research Professionals
St Louis, Missouri, United States
Palm Research Center
Las Vegas, Nevada, United States
Premier Research
Trenton, New Jersey, United States
Manhattan Medical Research
New York, New York, United States
Lillestol Research LLC
Fargo, North Dakota, United States
Aventiv Research
Columbus, Ohio, United States
The Corvallis Clinic P.C.
Corvallis, Oregon, United States
PMG Research Of Charleston LLC
Moncks Corner, South Carolina, United States
New Phase Research & Development
Knoxville, Tennessee, United States
PMG Research Of Knoxville
Knoxville, Tennessee, United States
Dallas Diabetes Endocrine Center
Dallas, Texas, United States
Consano Clinical Research
Shavano Park, Texas, United States
Chrysalis Clinical Research
St. George, Utah, United States
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Gdansk, , Poland
"For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician."
Gdynia, , Poland
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Gdynia, , Poland
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Katowice, , Poland
Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária LTDA
Lodz, , Poland
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Szczecin, , Poland
Manati Center for Clinical Research
Manatí, PR, Puerto Rico
Clinical Research Puerto Rico. Inc
San Juan, , Puerto Rico
GCM Medical Group PSC
San Juan, , Puerto Rico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Košice, , Slovakia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Malacky, , Slovakia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Púchov, , Slovakia
"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician."
Trenčín, , Slovakia
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Trenčín, , Slovakia
Countries
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References
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Sattar N, McGuire DK, Pavo I, Weerakkody GJ, Nishiyama H, Wiese RJ, Zoungas S. Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis. Nat Med. 2022 Mar;28(3):591-598. doi: 10.1038/s41591-022-01707-4. Epub 2022 Feb 24.
Pirro V, Roth KD, Lin Y, Willency JA, Milligan PL, Wilson JM, Ruotolo G, Haupt A, Newgard CB, Duffin KL. Effects of Tirzepatide, a Dual GIP and GLP-1 RA, on Lipid and Metabolite Profiles in Subjects With Type 2 Diabetes. J Clin Endocrinol Metab. 2022 Jan 18;107(2):363-378. doi: 10.1210/clinem/dgab722.
Hartman ML, Sanyal AJ, Loomba R, Wilson JM, Nikooienejad A, Bray R, Karanikas CA, Duffin KL, Robins DA, Haupt A. Effects of Novel Dual GIP and GLP-1 Receptor Agonist Tirzepatide on Biomarkers of Nonalcoholic Steatohepatitis in Patients With Type 2 Diabetes. Diabetes Care. 2020 Jun;43(6):1352-1355. doi: 10.2337/dc19-1892. Epub 2020 Apr 14.
Frias JP, Nauck MA, Van J, Kutner ME, Cui X, Benson C, Urva S, Gimeno RE, Milicevic Z, Robins D, Haupt A. Efficacy and safety of LY3298176, a novel dual GIP and GLP-1 receptor agonist, in patients with type 2 diabetes: a randomised, placebo-controlled and active comparator-controlled phase 2 trial. Lancet. 2018 Nov 17;392(10160):2180-2193. doi: 10.1016/S0140-6736(18)32260-8. Epub 2018 Oct 4.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of tirzepatide in Participants With Type 2 Diabetes Mellitus
Other Identifiers
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I8F-MC-GPGB
Identifier Type: OTHER
Identifier Source: secondary_id
2016-004179-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16335
Identifier Type: -
Identifier Source: org_study_id
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