A Long-term Safety Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes
A Phase 3, Long-Term Safety Study of Tirzepatide in Combination With Monotherapy of Oral Antihyperglycemic Medications in Patients With Type 2 Diabetes Mellitus (SURPASS J-combo)
2 other identifiers
interventional
443
1 country
34
Brief Summary
The purpose of this study is to determine the long-term safety of the study drug tirzepatide in combination with oral antihyperglycemic medications in participants with type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 type-2-diabetes-mellitus
Started Mar 2019
Typical duration for phase_3 type-2-diabetes-mellitus
34 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
March 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 16, 2021
CompletedResults Posted
Study results publicly available
February 14, 2022
CompletedFebruary 14, 2022
January 1, 2022
1.8 years
March 1, 2019
January 21, 2022
January 21, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
An SAE is any AE from this study that results in one of the following outcomes: * Death * Initial or prolonged inpatient hospitalization * A life-threatening experience (that is, immediate risk of dying) * Persistent or significant disability/incapacity * Congenital anomaly/birth defect. * Important medical events that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the patient or may require. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Baseline through Week 52
Secondary Outcomes (12)
Change From Baseline in Hemoglobin A1c (HbA1c)
Baseline, Week 52
Percentage of Participants Who Achieve HbA1c <7%
Week 52
Change From Baseline in Fasting Serum Glucose
Baseline, Week 52
Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values
Baseline, Week 52
Change From Baseline in Body Weight
Baseline, Week 52
- +7 more secondary outcomes
Study Arms (3)
5 mg Tirzepatide
EXPERIMENTAL5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
10 mg Tirzepatide
EXPERIMENTAL10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
15 mg Tirzepatide
EXPERIMENTAL15 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
Interventions
Administered SC
Oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
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 ≥7.0% to \<11.0%, as determined by the central laboratory at screening.
- Have been taking sulfonylureas, biguanides, thiazolidinedione, alpha-glucosidase inhibitor, glinides, or sodium-glucose cotransporter type 2 inhibitor monotherapy for at least 3 months before screening and have been on the following dose for at least 8 weeks before screening.
- 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 (34)
Akaicho Clinic
Chiba, Chiba, 260 0804, Japan
Kashiwa hospital
Kashiwa, Chiba, 277-0825, Japan
Yuri Ono Clinic
Sapporo, Hokkaido, 060-0001, Japan
Manda Hospital
Sapporo, Hokkaido, 060-0062, Japan
Miyanomori Hospital
Sapporo, Hokkaido, 064-8570, Japan
Ikeda Hospital
Amagasaki, Hyōgo, 661-0002, Japan
Nakamoto Naika Clinic
Mito, Ibaraki, 310 0826, Japan
Naka Memorial Clinic
Naka, Ibaraki, 311-0113, Japan
Ohishi Naika Clinic
Tsuchiura, Ibaraki, 300-0835, Japan
Takai Naika Clinic
Kamakura, Kanagawa, 247-0056, Japan
Tsuruma Kaneshiro Diabetes Clinic
Yamato, Kanagawa, 242-0004, Japan
Yokohama Minoru Clinic
Yokohama, Kanagawa, 232-0064, Japan
H.E.C. Science Clinic
Yokohama, Kanagawa, 235-0045, Japan
Takatsuki Red Cross Hospital
Takatsuki, Osaka, 569-1096, Japan
Otsu City Hospital
Ōtsu, Shiga, 520-0804, 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
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
Tokyo Center Clinic
Chuo-ku, Tokyo, 103-0028, Japan
Tokyo Clinical Trial Centre Fukuwa Clinic
Chuo-ku, Tokyo, 104-0031, Japan
Kanno Naika
Mitaka, Tokyo, 181 0013, Japan
Shinjuku Research Park Clinic
Shinjuku-Ku, Tokyo, 169-0073, Japan
Futata Tetsuhiro Clinic
Fukuoka, 819 0006, Japan
Morinaga Ueno Clinic
Kumamoto, 860 0863, Japan
Jinnouchi Hospital
Kumamoto, 862-0976, Japan
Saiseikai Noe Hospital
Osaka, 536 0001, Japan
Kitada Clinic
Osaka, 538 0044, Japan
Kansai Denryoku Hospital
Osaka, 553-0003, Japan
Abe Diabetes Clinic
Ōita, 870-0039, Japan
Shizuoka City Shizuoka Hospital
Shizuoka, 420-8630, Japan
Suruga Clinic
Shizuoka, 424-0855, Japan
Related Publications (2)
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: 40711720DERIVEDKadowaki T, Chin R, Ozeki A, Imaoka T, Ogawa Y. Safety and efficacy of tirzepatide as an add-on to single oral antihyperglycaemic medication in patients with type 2 diabetes in Japan (SURPASS J-combo): a multicentre, randomised, open-label, parallel-group, phase 3 trial. Lancet Diabetes Endocrinol. 2022 Sep;10(9):634-644. doi: 10.1016/S2213-8587(22)00187-5. Epub 2022 Jul 30.
PMID: 35914542DERIVED
Related Links
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
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- 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
March 30, 2019
Primary Completion
January 26, 2021
Study Completion
February 16, 2021
Last Updated
February 14, 2022
Results First Posted
February 14, 2022
Record last verified: 2022-01
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.