A Study of Tirzepatide (LY3298176) Compared to Dulaglutide in Participants With Type 2 Diabetes
SURPASS J-mono
A Phase 3 Study of Tirzepatide Monotherapy Compared to Dulaglutide 0.75 mg in Patients With Type 2 Diabetes Mellitus
2 other identifiers
interventional
636
1 country
46
Brief Summary
The reason for this study is to see if the study drug tirzepatide (LY3298176) is effective and safe compared to dulaglutide in participants with type 2 diabetes in Japan.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes
Started May 2019
Typical duration for phase_3 type-2-diabetes
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2019
CompletedFirst Posted
Study publicly available on registry
March 4, 2019
CompletedStudy Start
First participant enrolled
May 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2021
CompletedResults Posted
Study results publicly available
April 14, 2022
CompletedApril 14, 2022
April 1, 2022
1.8 years
March 1, 2019
March 4, 2022
April 13, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Hemoglobin A1c (HbA1c)
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model for post-baseline measures: Variable = Baseline + Baseline BMI Group (\<25 or \>=25 kg/m\^2) + Washout of Antidiabetic Medication + Treatment + Time + Treatment\*Time (Type III sum of squares).
Baseline, Week 52
Secondary Outcomes (11)
Percentage of Participants With HbA1c of <7.0%
Week 52
Change From Baseline in Fasting Serum Glucose
Baseline, Week 52
Change From Baseline in Average 7-Point Self-Monitored Blood Glucose (SMBG) Values
Baseline, Week 52
Change From Baseline in Body Weight
Baseline, Week 52
Percentage of Participants Who Achieve Weight Loss ≥5% From Baseline
Week 52
- +6 more secondary outcomes
Study Arms (4)
5 mg Tirzepatide
EXPERIMENTALParticipants received 5 milligram (mg) tirzepatide administered subcutaneously (SC) once weekly for 52 weeks.
10 mg Tirzepatide
EXPERIMENTALParticipants received 10 mg tirzepatide administered SC once weekly for 52 weeks.
15 mg Tirzepatide
EXPERIMENTALParticipants received 15 mg tirzepatide administered SC once weekly for 52 weeks.
0.75 mg Dulaglutide
ACTIVE COMPARATORParticipants received 0.75 mg dulaglutide administered SC once weekly for 52 weeks.
Interventions
Administered SC
Eligibility Criteria
You may qualify if:
- Participant must:
- Have been diagnosed with type 2 diabetes mellitus based on the World Health Organization classification before the screening visit.
- Have HbA1c meeting the following criteria, as determined by the central laboratory at screening and baseline:
- for participants who are oral antihyperglycemic medication (OAM)-naïve at screening, ≥7.0% to ≤10.0% at both screening and baseline.
- for participants who have been taking OAM monotherapy at screening, ≥6.5% to ≤9.0% at screening, and ≥7.0% to ≤10.0% at baseline.
- Have body mass index (BMI) of ≥23 kilograms per meter squared at screening.
- Be of stable weight (±5%) during 3 months preceding screening; and agree to not initiate an intensive diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment.
You may not qualify if:
- Participant must not:
- 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 immediate or urgent 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 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 weight loss drugs, including over-the-counter medications during the last 3 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (46)
Akaicho Clinic
Chiba, Chiba, 260 0804, Japan
Medical corporation THY Tokuyama Clinic
Chiba Mihama-ku, Chiba, 261-0004, Japan
National Hospital Organization Kure Medical Center
Kure, Hiroshima, 737-0023, Japan
Hasegawa Medical Clinic
Chitose, Hokkaido, 066-0032, Japan
Yuri Ono Clinic
Sapporo, Hokkaido, 060-0001, Japan
Watanabe Naika Clinic
Nishinomiya, Hyōgo, 662-0971, Japan
Hayashi Clinic
Nishinomiya, Hyōgo, 663-8113, Japan
Naka Memorial Clinic
Naka, Ibaraki, 311-0113, Japan
Hayashi Diabetes Internal Medicine Clinic
Chigasaki-sh, Kanagawa, 253-0044, Japan
Matoba Diabetes Clinic
Ebina, Kanagawa, 243-0432, Japan
Takai Naika Clinic
Kamakura, Kanagawa, 247-0056, Japan
Kanto Rosai Hospital
Kawasaki, Kanagawa, 211-8510, Japan
H.E.C. Science Clinic
Yokohama, Kanagawa, 235-0045, Japan
Medical Corporation Heishinkai OCROM Clinic
Suita-shi, Osaka, 565-0853, Japan
Takatsuki Red Cross Hospital
Takatsuki, Osaka, 569-1096, Japan
Senrichuo Ekimae Clinic
Toyonaka, Osaka, 560-0082, Japan
Asano Clinic
Kawagoe, Saitama, 350 0581, Japan
Kawaguchi General Hospital
Kawaguchi, Saitama, 332-8558, Japan
Wakakusa Clinic
Shimotsuke, Tochigi, 329-0433, Japan
Seiwa Clinic
Adachi-ku, Tokyo, 123 0845, Japan
HDC Atlas Clinic
Chiyoda City, Tokyo, 102-0082, Japan
Meiwa Hospital
Chiyodaku, Tokyo, 101 0041, Japan
Asahi Life Foundation Adult Disease Research Center
Chuo-ku, Tokyo, 103 0002, Japan
Nihonbashi Sakura Clinic
Chuo-ku, Tokyo, 103-0025, Japan
Tokyo-Eki Center-building Clinic
Chuo-ku, Tokyo, 103-0027, Japan
Medical Corporation Chiseikai Tokyo Center Clinic
Chuo-ku, Tokyo, 103-0028, Japan
Tokyo aSBo Clinic
Chuo-ku, Tokyo, 104 0031, Japan
Fukuwa Clinic
Chuo-ku, Tokyo, 104-0031, Japan
IHL Shinagawa East One Medical Clinic
Minato-ku, Tokyo, 108-0075, Japan
Sato Medical Clinic
Ootaku, Tokyo, 143-0015, Japan
Shinjuku Research Park Clinic
Shinjuku, Tokyo, 169-0073, Japan
Medical Corporation Heishinkai ToCROM Clinic
Shinjuku-ku, Tokyo, 160 0008, Japan
Tomonaga Clinic
Shinjuku-ku, Tokyo, 160 0022, Japan
Shinei Clinic
Suginami, Tokyo, 166-0003, Japan
Ikebukuro Metropolitan Clinic
Toshima-ku, Tokyo, 171-0021, Japan
Futata Tetsuhiro Clinic
Fukuoka, 810-0006, Japan
JR Hiroshima Hospital
Hiroshima, 732-0057, Japan
Yoshimura Clinic
Kumamoto, 861-8039, Japan
Keiseikai Kajiyama Clinic
Kyoto, 6008898, Japan
OKAYAMA Medical Center
Okayama, 701-1192, Japan
AMC Nishiumeda Clinic
Osaka, 530-0001, Japan
Kitada Clinic
Osaka, 538-0044, Japan
Nanko Clinic
Osaka, 559-0011, Japan
Abe Clinic
Ōita, 870-0039, Japan
Suruga Clinic
Shizuoka, 424-0855, Japan
Yokohama Minoru Clinic
Yokohama, 232-0064, Japan
Related Publications (6)
Mimura H, Oura T, Chin R, Hirase T, Shimono D. Association Between Early Weight Loss and Metabolic Outcomes with Tirzepatide in Japanese Patients with Type 2 Diabetes: A SURPASS J Post Hoc Analysis. Diabetes Ther. 2025 Sep;16(9):1871-1885. doi: 10.1007/s13300-025-01775-y. Epub 2025 Jul 25.
PMID: 40711720DERIVEDHamamoto Y, Oura T, Hirase T. Insulin Sensitivity and Beta-Cell Function Following Tirzepatide in Japanese Patients with Type 2 Diabetes: A SURPASS J-mono Analysis. Diabetes Ther. 2025 Apr;16(4):717-729. doi: 10.1007/s13300-025-01704-z. Epub 2025 Feb 14.
PMID: 39951042DERIVEDOnishi Y, Oura T, Takeuchi M. Metabolic Abnormalities Following Tirzepatide Monotherapy in Japanese Patients with Type 2 Diabetes: A Phase 3 SURPASS J-mono Post Hoc Analysis. Diabetes Ther. 2024 Mar;15(3):649-661. doi: 10.1007/s13300-024-01534-5. Epub 2024 Feb 4.
PMID: 38310163DERIVEDIshii H, Oura T, Takeuchi M. Treatment Satisfaction and Quality of Life with Tirzepatide Versus Dulaglutide Among Japanese Patients with Type 2 Diabetes: Exploratory Evaluation of the SURPASS J-mono Trial. Diabetes Ther. 2023 Dec;14(12):2173-2183. doi: 10.1007/s13300-023-01485-3. Epub 2023 Oct 16.
PMID: 37843771DERIVEDInagaki N, Takeuchi M, Oura T, Imaoka T, Seino Y. Efficacy and safety of tirzepatide monotherapy compared with dulaglutide in Japanese patients with type 2 diabetes (SURPASS J-mono): a double-blind, multicentre, randomised, phase 3 trial. Lancet Diabetes Endocrinol. 2022 Sep;10(9):623-633. doi: 10.1016/S2213-8587(22)00188-7. Epub 2022 Jul 30.
PMID: 35914543DERIVEDSattar 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.
PMID: 35210595DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2019
First Posted
March 4, 2019
Study Start
May 7, 2019
Primary Completion
March 10, 2021
Study Completion
March 31, 2021
Last Updated
April 14, 2022
Results First Posted
April 14, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.