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A Study of Tirzepatide (LY3298176) Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin (SURPASS-5)

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tirzepatide
Placebo
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 glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-1 (GLP-1), GIP/GLP-1 dual receptor agonist, T2DM

Eligibility Criteria

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

Inclusion Criteria:

  • Have been diagnosed with type 2 diabetes mellitus (T2DM) and have been treated with insulin glargine (U100), once daily with or without metformin ≥3 months prior to screening visit.
  • Have HbA1c between ≥7.0% and ≤10.5%.
  • Have a stable weight (± 5%) for at least 3 months before screening.
  • Have a body mass index (BMI) ≥23 kilograms per meter squared (kg/m²) at screening.

Exclusion Criteria:

  • 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 acute treatment.
  • Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss.
  • Have an estimated glomerular filtration rate <30 mL/minute/1.73 m² [for participants on metformin, estimated glomerular filtration rate <45 mL/min/1.73 m2 (or lower than the country-specific threshold for using the protocol-required dose of metformin per local label)]
  • 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

  • Valley Endocrine, Fresno
  • Sun Coast Clinical Research, Inc
  • Southern New Hampshire Diabetes and Endocrinology
  • Manhattan Medical Research
  • Intend Research
  • Milan Kvapil s.r.o.
  • Diacentrum Brandys n.L. s.r.o.
  • Diabetologicka ordinace pro dospele
  • Diahelp s.r.o., Interni a diabetologicka ambulance
  • Lekarna Dr. Max
  • Milan Kvapil s.r.o.
  • RESTRIAL s.r.o.
  • Praxis Dr. Jörg Lüdemann
  • Arztpraxis Dr. Cornelia Marck
  • InnoDiab Forschung GmbH
  • Institut für Diabetesforschung Münster GmbH
  • Praxis Dr. Kempe - Dr. Stemler
  • Schwerpunktpraxis Diabetes
  • SMO.MD GmbH
  • RED-Institut GmbH
  • Diabetologische Schwerpunktpraxis B. Scholz/Dr. B. Paschen
  • Gemeinschaftspraxis für innere Medizin und Diabetologie
  • Kashiwa hospital
  • Manda Hospital
  • Takai Naika Clinic
  • Takatsuki Red Cross Hospital
  • Tokyo-Eki Center-building Clinic
  • Tokyo Center Clinic
  • Tokyo Clinical Trial Centre Fukuwa Clinic
  • The Institute for Adult Diseases, Asahi Life Foundation
  • Sato Naika Clinic
  • Jinnouchi Hospital
  • Centrum Medyczne AMED
  • NZOZ ZDROWIE Osteo-Medic
  • Centrum Badan Klinicznych, PI House
  • NZOZ Przychodnia Specjalistyczna MEDICA
  • Centro de Endocrinologia y Nutricion del Turabo
  • Manati Center for Clinical Research Inc
  • Ambulancia vnútorného lekárstva Hnúša (Diabetes care)
  • Sin Azucar
  • Dia-Clarus.s.r.o.
  • JAL
  • Medivasa, s.r.o.
  • Hospital Clinico Universitario Virgen de la Victoria
  • Hospital de la Ribera
  • Hospital Universitario Virgen Macarena
  • Hospital Infanta Luisa
  • Hospital Universitari i Politecnic La Fe-ENDO

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

5 mg Tirzepatide

10 mg Tirzepatide

15 mg Tirzepatide

Placebo

Arm Description

5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.

10 mg tirzepatide administered SC once a week.

15 mg tirzepatide administered SC once a week.

Placebo administered SC once a week.

Outcomes

Primary Outcome Measures

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 Baseline + Baseline Metformin Use (Yes, No) + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares).

Secondary Outcome Measures

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. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Baseline Metformin Use (Yes, No) + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares).
Change From Baseline in Body Weight
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Baseline HbA1c Group (<= 8.0%, >8.0%) + Baseline Metformin Use (Yes, No) + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares).
Percentage of Participants Achieving an HbA1c Target Value of <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 with Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (<= 8.0%, >8.0%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.
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. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Baseline HbA1c Group (<= 8.0%, >8.0%) + Baseline Metformin Use (Yes, No) + Pooled Country + Treatment (Type III sum of squares).
Percentage of Participants Who Achieved Weight Loss ≥5%
Percentage of Participants who Achieved Weight Loss ≥5%.
Percentage Change From Baseline in Daily Mean Insulin Glargine Dose
LS mean was calculated using MMRM model with log (Baseline) + Baseline Metformin Use (Yes, No) + Pooled Country + Baseline HbA1c Group (<= 8.0%, >8.0%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.
Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 Millimole/Liter (mmol/L)] or Severe Hypoglycemia
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. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. The rate of postbaseline hypoglycemia was estimated by negative binomial model: number of episodes = Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (<= 8.0%, >8.0%) + Treatment, with log (exposure in days/365.25) as an offset variable.
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide
AUC is a combined measure obtained from Week 7, 15, 23 and 39 and a single averaged measure of AUC was reported.
Percentage of Participants Achieving an HbA1c Target Value of <5.7%
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

Full Information

First Posted
July 30, 2019
Last Updated
December 12, 2021
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04039503
Brief Title
A Study of Tirzepatide (LY3298176) Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin
Acronym
SURPASS-5
Official Title
Randomized, Phase 3, Double-blind Trial Comparing the Effect of the Addition of Tirzepatide Versus Placebo in Patients With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin
Study Type
Interventional

2. Study Status

Record Verification Date
December 1, 2021
Overall Recruitment Status
Completed
Study Start Date
August 30, 2019 (Actual)
Primary Completion Date
December 22, 2020 (Actual)
Study Completion Date
January 13, 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
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to placebo in participants with type 2 diabetes that are already on insulin glargine, with or without metformin. Participants will administer tirzepatide or placebo along with their previous glucose lowering medications. The study will last approximately 47 weeks and may include about 23 visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-1 (GLP-1), GIP/GLP-1 dual receptor agonist, T2DM

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
475 (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.
Arm Title
10 mg Tirzepatide
Arm Type
Experimental
Arm Description
10 mg tirzepatide administered SC once a week.
Arm Title
15 mg Tirzepatide
Arm Type
Experimental
Arm Description
15 mg tirzepatide administered SC once a week.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered SC once a week.
Intervention Type
Drug
Intervention Name(s)
Tirzepatide
Other Intervention Name(s)
LY3298176
Intervention Description
Administered SC as add-on to the pre-trial background medication.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC as add-on to the pre-trial background medication.
Primary Outcome Measure Information:
Title
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 Baseline + Baseline Metformin Use (Yes, No) + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares).
Time Frame
Baseline, Week 40
Secondary Outcome Measure Information:
Title
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. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Baseline Metformin Use (Yes, No) + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares).
Time Frame
Baseline, Week 40
Title
Change From Baseline in Body Weight
Description
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Baseline HbA1c Group (<= 8.0%, >8.0%) + Baseline Metformin Use (Yes, No) + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares).
Time Frame
Baseline, Week 40
Title
Percentage of Participants Achieving an HbA1c Target Value of <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 40
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 with Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (<= 8.0%, >8.0%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.
Time Frame
Baseline, Week 40
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. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Baseline HbA1c Group (<= 8.0%, >8.0%) + Baseline Metformin Use (Yes, No) + Pooled Country + Treatment (Type III sum of squares).
Time Frame
Baseline, Week 40
Title
Percentage of Participants Who Achieved Weight Loss ≥5%
Description
Percentage of Participants who Achieved Weight Loss ≥5%.
Time Frame
Week 40
Title
Percentage Change From Baseline in Daily Mean Insulin Glargine Dose
Description
LS mean was calculated using MMRM model with log (Baseline) + Baseline Metformin Use (Yes, No) + Pooled Country + Baseline HbA1c Group (<= 8.0%, >8.0%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.
Time Frame
Baseline, Week 40
Title
Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 Millimole/Liter (mmol/L)] or Severe Hypoglycemia
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. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. The rate of postbaseline hypoglycemia was estimated by negative binomial model: number of episodes = Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (<= 8.0%, >8.0%) + Treatment, with log (exposure in days/365.25) as an offset variable.
Time Frame
Baseline through Safety Follow-Up (Up to Week 44)
Title
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide
Description
AUC is a combined measure obtained from Week 7, 15, 23 and 39 and a single averaged measure of AUC was reported.
Time Frame
Week 7, 15, 23 and 39 post dose
Title
Percentage of Participants Achieving an HbA1c Target Value of <5.7%
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 40

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have been diagnosed with type 2 diabetes mellitus (T2DM) and have been treated with insulin glargine (U100), once daily with or without metformin ≥3 months prior to screening visit. Have HbA1c between ≥7.0% and ≤10.5%. Have a stable weight (± 5%) for at least 3 months before screening. Have a body mass index (BMI) ≥23 kilograms per meter squared (kg/m²) at screening. Exclusion Criteria: 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 acute treatment. Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss. Have an estimated glomerular filtration rate <30 mL/minute/1.73 m² [for participants on metformin, estimated glomerular filtration rate <45 mL/min/1.73 m2 (or lower than the country-specific threshold for using the protocol-required dose of metformin per local label)] 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
Valley Endocrine, Fresno
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Sun Coast Clinical Research, Inc
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Southern New Hampshire Diabetes and Endocrinology
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03063
Country
United States
Facility Name
Manhattan Medical Research
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Intend Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Milan Kvapil s.r.o.
City
Pribram
State/Province
Středočeský Kraj
ZIP/Postal Code
26201
Country
Czechia
Facility Name
Diacentrum Brandys n.L. s.r.o.
City
Brandys Nad Labem-Stara Bolesl
ZIP/Postal Code
25001
Country
Czechia
Facility Name
Diabetologicka ordinace pro dospele
City
Krnov
ZIP/Postal Code
79401
Country
Czechia
Facility Name
Diahelp s.r.o., Interni a diabetologicka ambulance
City
Pardubice
ZIP/Postal Code
53002
Country
Czechia
Facility Name
Lekarna Dr. Max
City
Praha 1
ZIP/Postal Code
11000
Country
Czechia
Facility Name
Milan Kvapil s.r.o.
City
Praha 4
ZIP/Postal Code
149 00
Country
Czechia
Facility Name
RESTRIAL s.r.o.
City
Praha 8
ZIP/Postal Code
181 00
Country
Czechia
Facility Name
Praxis Dr. Jörg Lüdemann
City
Falkensee
State/Province
Brandenburg
ZIP/Postal Code
14612
Country
Germany
Facility Name
Arztpraxis Dr. Cornelia Marck
City
Pohlheim
State/Province
Hessen
ZIP/Postal Code
35415
Country
Germany
Facility Name
InnoDiab Forschung GmbH
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Institut für Diabetesforschung Münster GmbH
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48145
Country
Germany
Facility Name
Praxis Dr. Kempe - Dr. Stemler
City
Ludwigshafen am Rhein
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67059
Country
Germany
Facility Name
Schwerpunktpraxis Diabetes
City
Saint Ingbert-Oberwürzbach
State/Province
Saarland
ZIP/Postal Code
66386
Country
Germany
Facility Name
SMO.MD GmbH
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39112
Country
Germany
Facility Name
RED-Institut GmbH
City
Oldenburg in Holstein
State/Province
Schleswig Holstein
ZIP/Postal Code
23758
Country
Germany
Facility Name
Diabetologische Schwerpunktpraxis B. Scholz/Dr. B. Paschen
City
Hamburg
ZIP/Postal Code
21073
Country
Germany
Facility Name
Gemeinschaftspraxis für innere Medizin und Diabetologie
City
Hamburg
ZIP/Postal Code
22607
Country
Germany
Facility Name
Kashiwa hospital
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-0825
Country
Japan
Facility Name
Manda Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0062
Country
Japan
Facility Name
Takai Naika Clinic
City
Kamakura
State/Province
Kanagawa
ZIP/Postal Code
247-0056
Country
Japan
Facility Name
Takatsuki Red Cross Hospital
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-1096
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
The Institute for Adult Diseases, Asahi Life Foundation
City
Chuou-ku
State/Province
Tokyo
ZIP/Postal Code
1030002
Country
Japan
Facility Name
Sato Naika Clinic
City
Ota-ku
State/Province
Tokyo
ZIP/Postal Code
143-0015
Country
Japan
Facility Name
Jinnouchi Hospital
City
Kumamoto
ZIP/Postal Code
862-0976
Country
Japan
Facility Name
Centrum Medyczne AMED
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-518
Country
Poland
Facility Name
NZOZ ZDROWIE Osteo-Medic
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-351
Country
Poland
Facility Name
Centrum Badan Klinicznych, PI House
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-546
Country
Poland
Facility Name
NZOZ Przychodnia Specjalistyczna MEDICA
City
Lublin
ZIP/Postal Code
20-538
Country
Poland
Facility Name
Centro de Endocrinologia y Nutricion del Turabo
City
Caguas
ZIP/Postal Code
00725
Country
Puerto Rico
Facility Name
Manati Center for Clinical Research Inc
City
Manati
ZIP/Postal Code
00674
Country
Puerto Rico
Facility Name
Ambulancia vnútorného lekárstva Hnúša (Diabetes care)
City
Hnusta
ZIP/Postal Code
98101
Country
Slovakia
Facility Name
Sin Azucar
City
Malacky
ZIP/Postal Code
901 01
Country
Slovakia
Facility Name
Dia-Clarus.s.r.o.
City
Prievidza
ZIP/Postal Code
971 01
Country
Slovakia
Facility Name
JAL
City
Trnava
ZIP/Postal Code
917 01
Country
Slovakia
Facility Name
Medivasa, s.r.o.
City
Zilina
ZIP/Postal Code
01001
Country
Slovakia
Facility Name
Hospital Clinico Universitario Virgen de la Victoria
City
Malaga
State/Province
Andalucia
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital de la Ribera
City
Alcira
State/Province
Valencia
ZIP/Postal Code
46600
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Infanta Luisa
City
Sevilla
ZIP/Postal Code
41010
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe-ENDO
City
València
ZIP/Postal Code
46026
Country
Spain

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/
Citations:
PubMed Identifier
35210595
Citation
Sattar N, McGuire DK, Pavo I, Weerakkody GJ, Nishiyama H, Wiese RJ, Zoungas S. Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis. Nat Med. 2022 Mar;28(3):591-598. doi: 10.1038/s41591-022-01707-4. Epub 2022 Feb 24.
Results Reference
derived
PubMed Identifier
35133415
Citation
Dahl D, Onishi Y, Norwood P, Huh R, Bray R, Patel H, Rodriguez A. Effect of Subcutaneous Tirzepatide vs Placebo Added to Titrated Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes: The SURPASS-5 Randomized Clinical Trial. JAMA. 2022 Feb 8;327(6):534-545. doi: 10.1001/jama.2022.0078.
Results Reference
derived
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/33Mn9pqfndRwZEPVvpNxDR
Description
A Study of Tirzepatide (LY3298176) Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin

Learn more about this trial

A Study of Tirzepatide (LY3298176) Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin

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