A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes on Metformin With or Without Sulfonylurea (SURPASS-AP-Combo)
NCT ID: NCT04093752
Last Updated: 2023-01-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
917 participants
INTERVENTIONAL
2019-12-09
2021-11-24
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
NONE
Study Groups
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5 mg Tirzepatide
Participants received 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once weekly (QW).
Tirzepatide
Administered SC
10 mg Tirzepatide
Participants received 10 mg tirzepatide administered SC QW.
Tirzepatide
Administered SC
15 mg Tirzepatide
Participants received 15 mg tirzepatide administered SC QW.
Tirzepatide
Administered SC
Insulin Glargine
Participants 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.
Insulin Glargine
Administered SC
Interventions
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Tirzepatide
Administered SC
Insulin Glargine
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 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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Paratus Clinical Research Western Sydney
Blacktown, New South Wales, Australia
Paratus Clinical Research Central Coast
Kanwal, New South Wales, Australia
Holdsworth House Medical Practice
Sydney, New South Wales, Australia
Illawarra Shoalhaven Local Health District
Wollongong, New South Wales, Australia
Core Research Group
Milton, Queensland, Australia
Barwon Health - The Geelong Hospital
Geelong, Victoria, Australia
Adelaide Medical Solutions
Woodville South, , Australia
Peking University People's Hospital
Beijing, Beijing Municipality, China
Huizhou Municipal Central Hospital
Huizhou, Guangdong, China
Cangzhou People's Hospital
Cangzhou, Hebei, China
Hebei Medical University
Hengshui Shi, Hebei, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, Henan, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The First People's Hospital of Yueyang
Yueyang, Hunan, China
Bao Tou Central Hospital
Baotou, Inner Mongolia, China
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
The First Hospital of Nanjing
Nanjing, Jiangsu, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Nanjing Medical University - Nanjing Jiangning Hospital
Nanjing, Jiangsu, China
Suzhou Municipal Hospital
Suzhou, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Wuxi People's Hospital
Wuxi, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
The Third Hospital of Nanchang
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
Dalian University - The Affiliated Zhongshan Hospital
Dalian, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Jinan Central Hospital
Jinan, Shandong, China
Qingdao Central Hospital
Qingdao, Shandong, China
Shanghai 6th people's hospital
Shanghai, Shanghai Municipality, China
1st affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
The First Affiliated Hospital of Xi'an Medical University
Xi’an, Shanxi, China
West China Hospital Sichuan University
Chengdu, Sichuan, China
Chengdu Fifth People's Hospital
Chengdu, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Chongqing Three Gorges Central Hospital
Wanzhou, Wanzhou, China
Chongqing General Hospital
Chongqing, Yuzhong District, China
Huzhou Central Hospital
Huzhou, Zhejiang, China
Shaoxing People's Hospital
Shaoxing, Zhejiang, China
Beijing Peking Union Medical College Hospital
Beijing, , China
Beijing Pinggu District Hospital
Beijing, , China
Beijing Tsinghua Changgung Hospital
Beijing, , China
Pingxiang People's Hospital
Pingxiang, , China
Shanghai Putuo District Center Hospital
Shanghai, , China
Tianjin People's Hospital
Tianjin, , China
The Fourth People's Hospital of Zigong City
Zigong, , China
King Edward Memorial Hospital and Research Center
Mumbai, Maharashtra, India
BSES Municipal General Hsptl
Mumbai, Maharashtra, India
Apollo Gleneagles Hospitals Kolkata
Kolkata, West Bengal, India
Fortis Hospital
Delhi, , India
Kyung Hee University Hospital
Seoul, Gangdong-gu, South Korea
Seoul National University Bundang Hospital
Seongnam, Geonggi-do, South Korea
Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggi-do, South Korea
Hanyang University Guri Hospital
Guri-si, Gyeonggido, South Korea
Yonsei University Wonju Severance Christian Hospital
Gangwon-do, Korea, South Korea
Ulsan University Hospital
Ulsan, Korea, South Korea
Inje University Sanggye Paik Hospital
Seoul, Seoul-teukbyeolsi, South Korea
Korea University Anam Hospital
Seoul, Seoul-teukbyeolsi, South Korea
Keimyung University Dongsan Hospital
Daegu, Taegu-Kwangyǒkshi, South Korea
Korea University Ansan Hospital
Ansan-si, , South Korea
Severance Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, , South Korea
Countries
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References
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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.
Gao 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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I8F-MC-GPHO
Identifier Type: OTHER
Identifier Source: secondary_id
17210
Identifier Type: -
Identifier Source: org_study_id
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