A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes on Metformin With or Without Sulfonylurea (SURPASS-AP-Combo)
A Randomized, Phase 3, Open-label Trial Comparing the Effect of Tirzepatide Once Weekly Versus Titrated Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes on Metformin With or Without a Sulfonylurea
2 other identifiers
interventional
917
4 countries
67
Brief Summary
The main reason for this study is to compare the study drug tirzepatide to insulin glargine in participants with type 2 diabetes on metformin with or without a sulfonylurea.
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 Dec 2019
Typical duration for phase_3 type-2-diabetes
67 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
September 17, 2019
CompletedFirst Posted
Study publicly available on registry
September 18, 2019
CompletedStudy Start
First participant enrolled
December 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 24, 2021
CompletedResults Posted
Study results publicly available
January 6, 2023
CompletedJanuary 6, 2023
December 1, 2022
1.9 years
September 17, 2019
October 27, 2022
December 12, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg)
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 with covariates Baseline + Country + Baseline Oral Antihyperglycemic Medication (OAM) Use (Metformin (Met), Met plus Sulfonylurea (SU)) + Treatment + Time + Treatment\*Time (Type III sum of squares).
Baseline, Week 40
Secondary Outcomes (9)
Mean Change From Baseline in HbA1c (5 mg)
Baseline, Week 40
Mean Change From Baseline in Body Weight
Baseline, Week 40
Percentage of Participants Achieving an HbA1c Target Value of <7.0%
Week 40
Percentage of Participants Achieving an HbA1c Target Value of <5.7%
Week 40
Mean Change From Baseline in Fasting Serum Glucose
Baseline, Week 40
- +4 more secondary outcomes
Study Arms (4)
5 mg Tirzepatide
EXPERIMENTALParticipants received 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once weekly (QW).
10 mg Tirzepatide
EXPERIMENTALParticipants received 10 mg tirzepatide administered SC QW.
15 mg Tirzepatide
EXPERIMENTALParticipants received 15 mg tirzepatide administered SC QW.
Insulin Glargine
ACTIVE COMPARATORParticipants received insulin glargine administered once daily (QD) SC. The starting dose of insulin glargine was 6 Insulin Units (IU)/day at bedtime, titrated to a fasting blood glucose (FBG) between 72-100 milligrams per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm.
Interventions
Administered SC
Eligibility Criteria
You may qualify if:
- Type 2 diabetes mellitus
- Treated with stable metformin with or without a sulfonylurea (metformin ≥1000 milligrams/day; sulfonylurea should be at least half the maximum dose) for at least 2 months
- Are insulin-naive (except for the use of insulin for treatment of gestational diabetes or short-term use \[≤14 consecutive days\] for acute conditions)
- HbA1c ≥7.5% to ≤11.0% at screening
- Stable weight (±5%) ≥3 months, and agree to not initiate a 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
- Body mass Index (BMI) ≥23 kilograms per meter squared
You may not qualify if:
- Type 1 diabetes mellitus
- Have history of chronic or acute pancreatitis
- Have history of proliferative diabetic retinopathy; or diabetic maculopathy; or non-proliferative diabetic retinopathy that requires acute treatment
- Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months
- Have a history of ketoacidosis or hyperosmolar state/coma
- Have a known clinically significant gastric emptying abnormality, have undergone or plan to have during the course of the study, or chronically take drugs that directly affect GI motility
- Have acute myocardial infarction (MI), stroke or hospitalization due to congestive heart failure (CHF) within 2 months
- Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- Have been treated with prescription drugs that promote weight loss or similar other body weight loss medications including over the counter (OTC) within 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (67)
Paratus Clinical Research Western Sydney
Blacktown, New South Wales, 2148, Australia
Paratus Clinical Research Central Coast
Kanwal, New South Wales, 2259, Australia
Holdsworth House Medical Practice
Sydney, New South Wales, 2010, Australia
Illawarra Shoalhaven Local Health District
Wollongong, New South Wales, 2500, Australia
Core Research Group
Milton, Queensland, 4064, Australia
Barwon Health - The Geelong Hospital
Geelong, Victoria, 3220, Australia
Adelaide Medical Solutions
Woodville South, 5011, Australia
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Huizhou Municipal Central Hospital
Huizhou, Guangdong, 516001, China
Cangzhou People's Hospital
Cangzhou, Hebei, 061600, China
Hebei Medical University
Hengshui Shi, Hebei, 053000, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, Henan, 471003, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450014, China
The First People's Hospital of Yueyang
Yueyang, Hunan, 414000, China
Bao Tou Central Hospital
Baotou, Inner Mongolia, 014040, China
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, 213003, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210000, China
The First Hospital of Nanjing
Nanjing, Jiangsu, 210006, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011, China
Nanjing Medical University - Nanjing Jiangning Hospital
Nanjing, Jiangsu, 211100, China
Suzhou Municipal Hospital
Suzhou, Jiangsu, 215002, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215066, China
Wuxi People's Hospital
Wuxi, Jiangsu, 214023, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212000, China
The Third Hospital of Nanchang
Nanchang, Jiangxi, 330009, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
Dalian University - The Affiliated Zhongshan Hospital
Dalian, Liaoning, 116001, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004, China
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Jinan Central Hospital
Jinan, Shandong, 250013, China
Qingdao Central Hospital
Qingdao, Shandong, 266042, China
Shanghai 6th people's hospital
Shanghai, Shanghai Municipality, China
1st affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
The First Affiliated Hospital of Xi'an Medical University
Xi’an, Shanxi, China
West China Hospital Sichuan University
Chengdu, Sichuan, 610041, China
Chengdu Fifth People's Hospital
Chengdu, Sichuan, 611130, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
Chongqing Three Gorges Central Hospital
Wanzhou, Wanzhou, 404199, China
Chongqing General Hospital
Chongqing, Yuzhong District, 400014, China
Huzhou Central Hospital
Huzhou, Zhejiang, 313000, China
Shaoxing People's Hospital
Shaoxing, Zhejiang, 312000, China
Beijing Peking Union Medical College Hospital
Beijing, 100730, China
Beijing Pinggu District Hospital
Beijing, 101200, China
Beijing Tsinghua Changgung Hospital
Beijing, 102202, China
Pingxiang People's Hospital
Pingxiang, 337000, China
Shanghai Putuo District Center Hospital
Shanghai, 200062, China
Tianjin People's Hospital
Tianjin, 300121, China
The Fourth People's Hospital of Zigong City
Zigong, China
King Edward Memorial Hospital and Research Center
Mumbai, Maharashtra, 400012, India
BSES Municipal General Hsptl
Mumbai, Maharashtra, 400058, India
Apollo Gleneagles Hospitals Kolkata
Kolkata, West Bengal, 700054, India
Fortis Hospital
Delhi, 110088, India
Kyung Hee University Hospital
Seoul, Gangdong-gu, 02447, South Korea
Seoul National University Bundang Hospital
Seongnam, Geonggi-do, 13620, South Korea
Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggi-do, 14647, South Korea
Hanyang University Guri Hospital
Guri-si, Gyeonggido, 11923, South Korea
Yonsei University Wonju Severance Christian Hospital
Gangwon-do, Korea, 220-701, South Korea
Ulsan University Hospital
Ulsan, Korea, 44033, South Korea
Inje University Sanggye Paik Hospital
Seoul, Seoul-teukbyeolsi, 01757, South Korea
Korea University Anam Hospital
Seoul, Seoul-teukbyeolsi, 02841, South Korea
Keimyung University Dongsan Hospital
Daegu, Taegu-Kwangyǒkshi, 41931, South Korea
Korea University Ansan Hospital
Ansan-si, 15355, South Korea
Severance Hospital
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07441, South Korea
Related Publications (2)
Bi Y, Lu S, Tang J, Du L, Ji L. Efficacy and Safety of Tirzepatide in Patients with Type 2 Diabetes: Analysis of SURPASS-AP-Combo by Different Subgroups. Diabetes Ther. 2024 May;15(5):1125-1137. doi: 10.1007/s13300-024-01561-2. Epub 2024 Mar 18.
PMID: 38494574DERIVEDGao L, Lee BW, Chawla M, Kim J, Huo L, Du L, Huang Y, Ji L. Tirzepatide versus insulin glargine as second-line or third-line therapy in type 2 diabetes in the Asia-Pacific region: the SURPASS-AP-Combo trial. Nat Med. 2023 Jun;29(6):1500-1510. doi: 10.1038/s41591-023-02344-1. Epub 2023 May 25.
PMID: 37231074DERIVED
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
September 17, 2019
First Posted
September 18, 2019
Study Start
December 9, 2019
Primary Completion
November 1, 2021
Study Completion
November 24, 2021
Last Updated
January 6, 2023
Results First Posted
January 6, 2023
Record last verified: 2022-12
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.