search
Back to results

A Long-term Safety Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Tirzepatide
Oral antihyperglycemic medication (OAM)
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 Mellitus

Eligibility Criteria

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

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

  • Akaicho Clinic
  • Kashiwa hospital
  • Yuri Ono Clinic
  • Manda Hospital
  • Miyanomori Hospital
  • Ikeda Hospital
  • Nakamoto Naika Clinic
  • Naka Memorial Clinic
  • Ohishi Naika Clinic
  • Takai Naika Clinic
  • Tsuruma Kaneshiro Diabetes Clinic
  • Yokohama Minoru Clinic
  • H.E.C. Science Clinic
  • Takatsuki Red Cross Hospital
  • Otsu City Hospital
  • Wakakusa Clinic
  • Seiwa Clinic
  • HDC Atlas Clinic
  • Asahi Life Foundation Adult Disease Research Center
  • Nihonbashi Sakura Clinic
  • Tokyo-Eki Center-building Clinic
  • Tokyo Center Clinic
  • Tokyo Clinical Trial Centre Fukuwa Clinic
  • Kanno Naika
  • Shinjuku Research Park Clinic
  • Futata Tetsuhiro Clinic
  • Morinaga Ueno Clinic
  • Jinnouchi Hospital
  • Abe Diabetes Clinic
  • Saiseikai Noe Hospital
  • Kitada Clinic
  • Kansai Denryoku Hospital
  • Shizuoka City Shizuoka Hospital
  • Suruga Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

5 mg Tirzepatide

10 mg Tirzepatide

15 mg Tirzepatide

Arm Description

5 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 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 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 + oral antihyperglycemic medication (OAM) Group 1 + Treatment + Time + Treatment*Time (Type III sum of squares).
Percentage of Participants Who Achieve HbA1c <7%
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
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 for post-baseline measures: Variable = Baseline + OAM Group 1 + Treatment + Time + Treatment*Time (Type III sum of squares).
Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values
The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Postmeal, Midday Premeal, Midday 2-hour Postmeal, Evening Premeal, Evening 2-hour Postmeal and Bedtime. LS mean was determined by analysis of covariance (ANCOVA) model for endpoint measures: Variable = Baseline + OAM Group 1 + Treatment (Type III sum of squares).
Change From Baseline in Body Weight
LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + OAM Group 1 + Treatment + Time + Treatment*Time (Type III sum of squares).
Percentage of Participants Who Achieve Weight Loss of ≥5% From Baseline
Percentage of Participants who Achieve Weight Loss of ≥5% from Baseline
Change From Baseline in Fasting Insulin
LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + Treatment + Time + Treatment*Time (Type III sum of squares).
Change From Baseline in Fasting C-Peptide
LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + Treatment + Time + Treatment*Time (Type III sum of squares).
Change From Baseline in Homeostasis Model Assessment B (HOMA-2B) (Insulin)
The HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) and to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. The change from baseline for fasting insulin concentrations are presented as insulin secretion (HOMA2-%B) and insulin sensitivity (HOMA2-%S). LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + Treatment + Time + Treatment*Time (Type III sum of squares).
Change From Baseline in HOMA-2S (Insulin)
The HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) and to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. The change from baseline for fasting insulin concentrations are presented as insulin secretion (HOMA2-%B) and insulin sensitivity (HOMA2-%S). LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + Treatment + Time + Treatment*Time (Type III sum of squares).
Number of Participants With Hypoglycemia Incidence and Rate With Blood Glucose <54 mg/dL or Severe Hypoglycemia, Exclude Hypoglycemic Events Occurring After Initiation of a New Antihyperglycemic Therapy
The hypoglycemia events were defined by participant reported events with blood glucose <54mg/dL (<3.0 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.
Number of Participants With Anti-Tirzepatide Antibodies
Number of Participants with Anti-Tirzepatide Antibodies

Full Information

First Posted
March 1, 2019
Last Updated
January 21, 2022
Sponsor
Eli Lilly and Company
search

1. Study Identification

Unique Protocol Identification Number
NCT03861039
Brief Title
A Long-term Safety Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 30, 2019 (Actual)
Primary Completion Date
January 26, 2021 (Actual)
Study Completion Date
February 16, 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 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.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
5 mg Tirzepatide
Arm Type
Experimental
Arm Description
5 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.
Arm Title
10 mg Tirzepatide
Arm Type
Experimental
Arm Description
10 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.
Arm Title
15 mg Tirzepatide
Arm Type
Experimental
Arm Description
15 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.
Intervention Type
Drug
Intervention Name(s)
Tirzepatide
Other Intervention Name(s)
LY3298176
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Oral antihyperglycemic medication (OAM)
Intervention Description
Oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
Primary Outcome Measure Information:
Title
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Description
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.
Time Frame
Baseline through Week 52
Secondary Outcome Measure Information:
Title
Change From Baseline in Hemoglobin A1c (HbA1c)
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 for post-baseline measures: Variable = Baseline + oral antihyperglycemic medication (OAM) Group 1 + Treatment + Time + Treatment*Time (Type III sum of squares).
Time Frame
Baseline, Week 52
Title
Percentage of Participants Who Achieve HbA1c <7%
Description
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Time Frame
Week 52
Title
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 for post-baseline measures: Variable = Baseline + OAM Group 1 + Treatment + Time + Treatment*Time (Type III sum of squares).
Time Frame
Baseline, Week 52
Title
Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values
Description
The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Postmeal, Midday Premeal, Midday 2-hour Postmeal, Evening Premeal, Evening 2-hour Postmeal and Bedtime. LS mean was determined by analysis of covariance (ANCOVA) model for endpoint measures: Variable = Baseline + OAM Group 1 + Treatment (Type III sum of squares).
Time Frame
Baseline, Week 52
Title
Change From Baseline in Body Weight
Description
LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + OAM Group 1 + Treatment + Time + Treatment*Time (Type III sum of squares).
Time Frame
Baseline, Week 52
Title
Percentage of Participants Who Achieve Weight Loss of ≥5% From Baseline
Description
Percentage of Participants who Achieve Weight Loss of ≥5% from Baseline
Time Frame
Week 52
Title
Change From Baseline in Fasting Insulin
Description
LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + Treatment + Time + Treatment*Time (Type III sum of squares).
Time Frame
Baseline, Week 52
Title
Change From Baseline in Fasting C-Peptide
Description
LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + Treatment + Time + Treatment*Time (Type III sum of squares).
Time Frame
Baseline, Week 52
Title
Change From Baseline in Homeostasis Model Assessment B (HOMA-2B) (Insulin)
Description
The HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) and to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. The change from baseline for fasting insulin concentrations are presented as insulin secretion (HOMA2-%B) and insulin sensitivity (HOMA2-%S). LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + Treatment + Time + Treatment*Time (Type III sum of squares).
Time Frame
Baseline, Week 52
Title
Change From Baseline in HOMA-2S (Insulin)
Description
The HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) and to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. The change from baseline for fasting insulin concentrations are presented as insulin secretion (HOMA2-%B) and insulin sensitivity (HOMA2-%S). LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + Treatment + Time + Treatment*Time (Type III sum of squares).
Time Frame
Baseline, Week 52
Title
Number of Participants With Hypoglycemia Incidence and Rate With Blood Glucose <54 mg/dL or Severe Hypoglycemia, Exclude Hypoglycemic Events Occurring After Initiation of a New Antihyperglycemic Therapy
Description
The hypoglycemia events were defined by participant reported events with blood glucose <54mg/dL (<3.0 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.
Time Frame
Baseline through Week 56
Title
Number of Participants With Anti-Tirzepatide Antibodies
Description
Number of Participants with Anti-Tirzepatide Antibodies
Time Frame
Baseline through Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
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
Akaicho Clinic
City
Chiba-shi
State/Province
Chiba
ZIP/Postal Code
260 0804
Country
Japan
Facility Name
Kashiwa hospital
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-0825
Country
Japan
Facility Name
Yuri Ono Clinic
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0001
Country
Japan
Facility Name
Manda Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0062
Country
Japan
Facility Name
Miyanomori Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
064-8570
Country
Japan
Facility Name
Ikeda Hospital
City
Amagasaki
State/Province
Hyogo
ZIP/Postal Code
661-0002
Country
Japan
Facility Name
Nakamoto Naika Clinic
City
Mito
State/Province
Ibaraki
ZIP/Postal Code
310 0826
Country
Japan
Facility Name
Naka Memorial Clinic
City
Naka
State/Province
Ibaraki
ZIP/Postal Code
311-0113
Country
Japan
Facility Name
Ohishi Naika Clinic
City
Tsuchiura
State/Province
Ibaraki
ZIP/Postal Code
300-0835
Country
Japan
Facility Name
Takai Naika Clinic
City
Kamakura
State/Province
Kanagawa
ZIP/Postal Code
247-0056
Country
Japan
Facility Name
Tsuruma Kaneshiro Diabetes Clinic
City
Yamato
State/Province
Kanagawa
ZIP/Postal Code
242-0004
Country
Japan
Facility Name
Yokohama Minoru Clinic
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0064
Country
Japan
Facility Name
H.E.C. Science Clinic
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
235-0045
Country
Japan
Facility Name
Takatsuki Red Cross Hospital
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-1096
Country
Japan
Facility Name
Otsu City Hospital
City
Otsu
State/Province
Shiga
ZIP/Postal Code
520-0804
Country
Japan
Facility Name
Wakakusa Clinic
City
Shimotsuke
State/Province
Tochigi
ZIP/Postal Code
329-0433
Country
Japan
Facility Name
Seiwa Clinic
City
Adachi-ku
State/Province
Tokyo
ZIP/Postal Code
123 0845
Country
Japan
Facility Name
HDC Atlas Clinic
City
Chiyoda
State/Province
Tokyo
ZIP/Postal Code
102-0082
Country
Japan
Facility Name
Asahi Life Foundation Adult Disease Research Center
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103 0002
Country
Japan
Facility Name
Nihonbashi Sakura Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0025
Country
Japan
Facility Name
Tokyo-Eki Center-building Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0027
Country
Japan
Facility Name
Tokyo Center Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0028
Country
Japan
Facility Name
Tokyo Clinical Trial Centre Fukuwa Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0031
Country
Japan
Facility Name
Kanno Naika
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181 0013
Country
Japan
Facility Name
Shinjuku Research Park Clinic
City
Shinjuku-Ku
State/Province
Tokyo
ZIP/Postal Code
169-0073
Country
Japan
Facility Name
Futata Tetsuhiro Clinic
City
Fukuoka
ZIP/Postal Code
819 0006
Country
Japan
Facility Name
Morinaga Ueno Clinic
City
Kumamoto
ZIP/Postal Code
860 0863
Country
Japan
Facility Name
Jinnouchi Hospital
City
Kumamoto
ZIP/Postal Code
862-0976
Country
Japan
Facility Name
Abe Diabetes Clinic
City
Oita
ZIP/Postal Code
870-0039
Country
Japan
Facility Name
Saiseikai Noe Hospital
City
Osaka
ZIP/Postal Code
536 0001
Country
Japan
Facility Name
Kitada Clinic
City
Osaka
ZIP/Postal Code
538 0044
Country
Japan
Facility Name
Kansai Denryoku Hospital
City
Osaka
ZIP/Postal Code
553-0003
Country
Japan
Facility Name
Shizuoka City Shizuoka Hospital
City
Shizuoka
ZIP/Postal Code
420-8630
Country
Japan
Facility Name
Suruga Clinic
City
Shizuoka
ZIP/Postal Code
424-0855
Country
Japan

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
https://vivli.org/
Citations:
PubMed Identifier
35914542
Citation
Kadowaki 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.
Results Reference
derived
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/2qJ9f49B7nrO6hGapNnDZD
Description
A Long-term Safety Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes

Learn more about this trial

A Long-term Safety Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes

We'll reach out to this number within 24 hrs