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A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes on Metformin With or Without Sulfonylurea (SURPASS-AP-Combo)

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tirzepatide
Insulin Glargine
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring T2DM

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 infaction (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

Sites / Locations

  • Paratus Clinical Research Western Sydney
  • Paratus Clinical Research Central Coast
  • Holdsworth House Medical Practice
  • Illawarra Shoalhaven Local Health District
  • Core Research Group
  • Barwon Health - The Geelong Hospital
  • Adelaide Medical Solutions
  • Peking University People's Hospital
  • Huizhou Municipal Central Hospital
  • Cangzhou People's Hospital
  • Hebei Medical University
  • The Fourth Affiliated Hospital of Harbin Medical University
  • The First Affiliated Hospital of Henan University of Science &Technology
  • The Second Affiliated Hospital of Zhengzhou University
  • The First People's Hospital of Yueyang
  • Bao Tou Central Hospital
  • Changzhou No.2 People's Hospital
  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
  • The First Hospital of Nanjing
  • Zhongda Hospital Southeast University
  • The Second Affiliated Hospital of Nanjing Medical University
  • Nanjing Medical University - Nanjing Jiangning Hospital
  • Suzhou Municipal Hospital
  • The First Affiliated Hospital of Soochow University
  • Wuxi People's Hospital
  • Affiliated Hospital of Jiangsu University
  • The Third Hospital of Nanchang
  • The First Hospital of Jilin University
  • Dalian University - The Affiliated Zhongshan Hospital
  • Shengjing Hospital of China Medical University
  • First Affiliated Hospital of Xi'an Jiaotong University
  • 1st affiliated Hospital of Shanxi Medical University
  • Jinan Central Hospital
  • Qingdao Central Hospital
  • Shanghai 6th people's hospital
  • The First Affiliated Hospital of Xi'an Medical University
  • West China Hospital Sichuan University
  • Chengdu Fifth People's Hospital
  • Tianjin Medical University General Hospital
  • Chongqing Three Gorges Central Hospital
  • Chongqing General Hospital
  • Huzhou Central Hospital
  • Shaoxing People's Hospital
  • Beijing Peking Union Medical College Hospital
  • Beijing Pinggu District Hospital
  • Beijing Tsinghua Changgung Hospital
  • Pingxiang People's Hospital
  • Shanghai Putuo District Center Hospital
  • Tianjin People's Hospital
  • The Fourth People's Hospital of Zigong City
  • King Edward Memorial Hospital and Research Center
  • BSES Municipal General Hsptl
  • Apollo Gleneagles Hospitals Kolkata
  • Fortis Hospital
  • Kyung Hee University Hospital
  • Seoul National University Bundang Hospital
  • Bucheon St. Mary's Hospital
  • Hanyang University Guri Hospital
  • Yonsei University Wonju Severance Christian Hospital
  • Ulsan University Hospital
  • Inje University Sanggye Paik Hospital
  • Korea University Anam Hospital
  • Keimyung University Dongsan Hospital
  • Korea University Ansan Hospital
  • Severance Hospital
  • Asan Medical Center
  • Hallym University Kangnam Sacred Heart Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

5 mg Tirzepatide

10 mg Tirzepatide

15 mg Tirzepatide

Insulin Glargine

Arm Description

Participants received 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once weekly (QW).

Participants received 10 mg tirzepatide administered SC QW.

Participants received 15 mg tirzepatide administered SC QW.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Mean Change From Baseline in HbA1c (5 mg)
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by MMRM model with covariates Baseline + Country + Baseline OAM Use (Met, Met plus SU) + Treatment + Time + Treatment*Time (Type III sum of squares).
Mean Change From Baseline in Body Weight
LS mean was determined by MMRM model with Baseline + Country + Baseline OAM Use (Met, Met plus SU) + Baseline HbA1c Group (<= 8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares) as covariates.
Percentage of Participants Achieving an HbA1c Target Value of <7.0%
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Imputed data includes observed value and imputed value if endpoint measure is missing.
Percentage of Participants Achieving an HbA1c Target Value of <5.7%
HbA1c is the glycosylated fraction of hemoglobin A. Imputed data includes observed value and imputed value if endpoint measure is missing.
Mean Change From Baseline in Fasting Serum Glucose
Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast. LS mean was determined by MMRM model with Baseline + Country + Baseline OAM Use (Met, Met plus SU) + Baseline HbA1c Group (<= 8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares) as covariates.
Mean Change in Daily Glucose Average From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values
The SMBG data was collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Post-meal, Midday Premeal, Midday 2-hour Post-meal, Evening Premeal, Evening 2-hour Post-meal and Bedtime. LS mean was determined by MMRM model with Baseline + Country + Baseline OAM Use (Met, Met plus SU) + Baseline HbA1c Group (<= 8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares) as covariates.
Percentage of Participants Who Achieved Weight Loss ≥5%
Imputed data includes observed value and imputed value if endpoint measure is missing.
Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) Hyperglycemia, Hypoglycemia and Treatment Satisfaction Score
DTSQc, an 8-item questionnaire, assesses relative change in treatment satisfaction perceived frequency of hyperglycemia, and perceived frequency of hypoglycemia from baseline to week 40 or early termination. The treatment satisfaction score ranges from -18 to 18 where the higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment. The hyperglycemia and hypoglycemia scores range from -3 to 3 where negative scores indicate fewer problems with blood glucose levels and positive scores indicate more problems than before. LS mean was determined by ANCOVA model for endpoint measures with Baseline + Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Baseline OAM Use (Met, Met plus SU) + Treatment (Type III sum of squares) as covariates.
Rate of Hypoglycemia With Blood Glucose < 54 mg/dL or Severe Hypoglycemia
The hypoglycemia events were defined by participant reported events with blood glucose < 54 mg/dL [<3.0 Millimole per Liter (mmol/L)] or severe hypoglycemia. Severe hypoglycemia is defined as an episode with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. The rate of post-baseline hypoglycemia was estimated by negative binomial model: Number of episodes = Country + Baseline OAM Use (Met, Met plus SU) + Baseline HbA1c Group (<= 8.5%, >8.5%) + Treatment, with log (exposure in days/365.25) as an offset variable.

Full Information

First Posted
September 17, 2019
Last Updated
December 12, 2022
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04093752
Brief Title
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes on Metformin With or Without Sulfonylurea (SURPASS-AP-Combo)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
December 9, 2019 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
November 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
T2DM

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
917 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5 mg Tirzepatide
Arm Type
Experimental
Arm Description
Participants received 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once weekly (QW).
Arm Title
10 mg Tirzepatide
Arm Type
Experimental
Arm Description
Participants received 10 mg tirzepatide administered SC QW.
Arm Title
15 mg Tirzepatide
Arm Type
Experimental
Arm Description
Participants received 15 mg tirzepatide administered SC QW.
Arm Title
Insulin Glargine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tirzepatide
Other Intervention Name(s)
LY3298176
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Insulin Glargine
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg)
Description
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).
Time Frame
Baseline, Week 40
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in HbA1c (5 mg)
Description
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by MMRM model with covariates Baseline + Country + Baseline OAM Use (Met, Met plus SU) + Treatment + Time + Treatment*Time (Type III sum of squares).
Time Frame
Baseline, Week 40
Title
Mean Change From Baseline in Body Weight
Description
LS mean was determined by MMRM model with Baseline + Country + Baseline OAM Use (Met, Met plus SU) + Baseline HbA1c Group (<= 8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares) as covariates.
Time Frame
Baseline, Week 40
Title
Percentage of Participants Achieving an HbA1c Target Value of <7.0%
Description
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Imputed data includes observed value and imputed value if endpoint measure is missing.
Time Frame
Week 40
Title
Percentage of Participants Achieving an HbA1c Target Value of <5.7%
Description
HbA1c is the glycosylated fraction of hemoglobin A. Imputed data includes observed value and imputed value if endpoint measure is missing.
Time Frame
Week 40
Title
Mean Change From Baseline in Fasting Serum Glucose
Description
Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast. LS mean was determined by MMRM model with Baseline + Country + Baseline OAM Use (Met, Met plus SU) + Baseline HbA1c Group (<= 8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares) as covariates.
Time Frame
Baseline, Week 40
Title
Mean Change in Daily Glucose Average From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values
Description
The SMBG data was collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Post-meal, Midday Premeal, Midday 2-hour Post-meal, Evening Premeal, Evening 2-hour Post-meal and Bedtime. LS mean was determined by MMRM model with Baseline + Country + Baseline OAM Use (Met, Met plus SU) + Baseline HbA1c Group (<= 8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares) as covariates.
Time Frame
Baseline, Week 40
Title
Percentage of Participants Who Achieved Weight Loss ≥5%
Description
Imputed data includes observed value and imputed value if endpoint measure is missing.
Time Frame
Week 40
Title
Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) Hyperglycemia, Hypoglycemia and Treatment Satisfaction Score
Description
DTSQc, an 8-item questionnaire, assesses relative change in treatment satisfaction perceived frequency of hyperglycemia, and perceived frequency of hypoglycemia from baseline to week 40 or early termination. The treatment satisfaction score ranges from -18 to 18 where the higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment. The hyperglycemia and hypoglycemia scores range from -3 to 3 where negative scores indicate fewer problems with blood glucose levels and positive scores indicate more problems than before. LS mean was determined by ANCOVA model for endpoint measures with Baseline + Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Baseline OAM Use (Met, Met plus SU) + Treatment (Type III sum of squares) as covariates.
Time Frame
Baseline, Week 40
Title
Rate of Hypoglycemia With Blood Glucose < 54 mg/dL or Severe Hypoglycemia
Description
The hypoglycemia events were defined by participant reported events with blood glucose < 54 mg/dL [<3.0 Millimole per Liter (mmol/L)] or severe hypoglycemia. Severe hypoglycemia is defined as an episode with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. The rate of post-baseline hypoglycemia was estimated by negative binomial model: Number of episodes = Country + Baseline OAM Use (Met, Met plus SU) + Baseline HbA1c Group (<= 8.5%, >8.5%) + Treatment, with log (exposure in days/365.25) as an offset variable.
Time Frame
Baseline through end of safety follow-up (Up To Week 44)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Paratus Clinical Research Western Sydney
City
Blacktown
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
Facility Name
Paratus Clinical Research Central Coast
City
Kanwal
State/Province
New South Wales
ZIP/Postal Code
2259
Country
Australia
Facility Name
Holdsworth House Medical Practice
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Illawarra Shoalhaven Local Health District
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Core Research Group
City
Milton
State/Province
Queensland
ZIP/Postal Code
4064
Country
Australia
Facility Name
Barwon Health - The Geelong Hospital
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Adelaide Medical Solutions
City
Woodville South
ZIP/Postal Code
5011
Country
Australia
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Huizhou Municipal Central Hospital
City
Huizhou
State/Province
Guangdong
ZIP/Postal Code
516001
Country
China
Facility Name
Cangzhou People's Hospital
City
Cangzhou
State/Province
Hebei
ZIP/Postal Code
061600
Country
China
Facility Name
Hebei Medical University
City
Hengshui Shi
State/Province
Hebei
ZIP/Postal Code
053000
Country
China
Facility Name
The Fourth Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Facility Name
The First Affiliated Hospital of Henan University of Science &Technology
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471003
Country
China
Facility Name
The Second Affiliated Hospital of Zhengzhou University
City
Zhengzhou Shi
State/Province
Henan
ZIP/Postal Code
450014
Country
China
Facility Name
The First People's Hospital of Yueyang
City
Yueyang
State/Province
Hunan
ZIP/Postal Code
414000
Country
China
Facility Name
Bao Tou Central Hospital
City
Bao Tou
State/Province
Inner Mongolia
ZIP/Postal Code
014040
Country
China
Facility Name
Changzhou No.2 People's Hospital
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213003
Country
China
Facility Name
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Name
The First Hospital of Nanjing
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
Facility Name
Zhongda Hospital Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Facility Name
The Second Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210011
Country
China
Facility Name
Nanjing Medical University - Nanjing Jiangning Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
211100
Country
China
Facility Name
Suzhou Municipal Hospital
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215002
Country
China
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215066
Country
China
Facility Name
Wuxi People's Hospital
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214023
Country
China
Facility Name
Affiliated Hospital of Jiangsu University
City
Zhenjiang
State/Province
Jiangsu
ZIP/Postal Code
212000
Country
China
Facility Name
The Third Hospital of Nanchang
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330009
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Dalian University - The Affiliated Zhongshan Hospital
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116001
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Facility Name
First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Facility Name
1st affiliated Hospital of Shanxi Medical University
City
Tai Yuan
State/Province
Shan XI
ZIP/Postal Code
030001
Country
China
Facility Name
Jinan Central Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Facility Name
Qingdao Central Hospital
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266042
Country
China
Facility Name
Shanghai 6th people's hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Medical University
City
XI 'an
State/Province
Shanxi
Country
China
Facility Name
West China Hospital Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Chengdu Fifth People's Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
611130
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Chongqing Three Gorges Central Hospital
City
Wanzhou
State/Province
Wanzhou
ZIP/Postal Code
404199
Country
China
Facility Name
Chongqing General Hospital
City
Chongqing
State/Province
Yuzhong District
ZIP/Postal Code
400014
Country
China
Facility Name
Huzhou Central Hospital
City
Huzhou
State/Province
Zhejiang
ZIP/Postal Code
313000
Country
China
Facility Name
Shaoxing People's Hospital
City
Shaoxing
State/Province
Zhejiang
ZIP/Postal Code
312000
Country
China
Facility Name
Beijing Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Beijing Pinggu District Hospital
City
Beijing
ZIP/Postal Code
101200
Country
China
Facility Name
Beijing Tsinghua Changgung Hospital
City
Beijing
ZIP/Postal Code
102202
Country
China
Facility Name
Pingxiang People's Hospital
City
Pingxiang
ZIP/Postal Code
337000
Country
China
Facility Name
Shanghai Putuo District Center Hospital
City
Shanghai
ZIP/Postal Code
200062
Country
China
Facility Name
Tianjin People's Hospital
City
Tianjin
ZIP/Postal Code
300121
Country
China
Facility Name
The Fourth People's Hospital of Zigong City
City
Zigong
Country
China
Facility Name
King Edward Memorial Hospital and Research Center
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Facility Name
BSES Municipal General Hsptl
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400058
Country
India
Facility Name
Apollo Gleneagles Hospitals Kolkata
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700054
Country
India
Facility Name
Fortis Hospital
City
Delhi
ZIP/Postal Code
110088
Country
India
Facility Name
Kyung Hee University Hospital
City
Seoul
State/Province
Gangdong-gu
ZIP/Postal Code
02447
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Geonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Bucheon St. Mary's Hospital
City
Bucheon,
State/Province
Gyeonggi-do
ZIP/Postal Code
14647
Country
Korea, Republic of
Facility Name
Hanyang University Guri Hospital
City
Guri-si
State/Province
Gyeonggido
ZIP/Postal Code
11923
Country
Korea, Republic of
Facility Name
Yonsei University Wonju Severance Christian Hospital
City
Gangwon-do
State/Province
Korea
ZIP/Postal Code
220-701
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
State/Province
Korea
ZIP/Postal Code
44033
Country
Korea, Republic of
Facility Name
Inje University Sanggye Paik Hospital
City
Seoul
State/Province
Seoul-teukbyeolsi
ZIP/Postal Code
01757
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
State/Province
Seoul-teukbyeolsi
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Hospital
City
Daegu
State/Province
Taegu-Kwangyǒkshi
ZIP/Postal Code
41931
Country
Korea, Republic of
Facility Name
Korea University Ansan Hospital
City
Ansan-si
ZIP/Postal Code
15355
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Hallym University Kangnam Sacred Heart Hospital
City
Seoul
ZIP/Postal Code
07441
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
http://vivli.org/

Learn more about this trial

A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes on Metformin With or Without Sulfonylurea (SURPASS-AP-Combo)

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