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

December 12, 2021 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
475

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Brandys Nad Labem-Stara Bolesl, Czechia, 25001
        • Diacentrum Brandys n.L. s.r.o.
      • Krnov, Czechia, 79401
        • Diabetologicka ordinace pro dospele
      • Pardubice, Czechia, 53002
        • Diahelp s.r.o., Interni a diabetologicka ambulance
      • Praha 1, Czechia, 11000
        • Lekarna Dr. Max
      • Praha 4, Czechia, 149 00
        • MILAN KVAPIL s.r.o.
      • Praha 8, Czechia, 181 00
        • ResTrial s.r.o.
    • Středočeský Kraj
      • Pribram, Středočeský Kraj, Czechia, 26201
        • MILAN KVAPIL s.r.o.
  • Germany
      • Hamburg, Germany, 21073
        • Diabetologische Schwerpunktpraxis B. Scholz/Dr. B. Paschen
      • Hamburg, Germany, 22607
        • Gemeinschaftspraxis für innere Medizin und Diabetologie
    • Brandenburg
      • Falkensee, Brandenburg, Germany, 14612
        • Praxis Dr. Jörg Lüdemann
    • Hessen
      • Pohlheim, Hessen, Germany, 35415
        • Arztpraxis Dr. Cornelia Marck
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45136
        • InnoDiab Forschung Gmbh
      • Münster, Nordrhein-Westfalen, Germany, 48145
        • Institut für Diabetesforschung Münster GmbH
    • Rheinland-Pfalz
      • Ludwigshafen am Rhein, Rheinland-Pfalz, Germany, 67059
        • Praxis Dr. Kempe - Dr. Stemler
    • Saarland
      • Saint Ingbert-Oberwürzbach, Saarland, Germany, 66386
        • Schwerpunktpraxis Diabetes
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Germany, 39112
        • SMO.MD GmbH
    • Schleswig Holstein
      • Oldenburg in Holstein, Schleswig Holstein, Germany, 23758
        • Red-Institut GmbH
  • Japan
      • Kumamoto, Japan, 862-0976
        • Jinnouchi Hospital
    • Chiba
      • Kashiwa, Chiba, Japan, 277-0825
        • Kashiwa hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-0062
        • Manda Hospital
    • Kanagawa
      • Kamakura, Kanagawa, Japan, 247-0056
        • Takai Naika Clinic
    • Osaka
      • Takatsuki, Osaka, Japan, 569-1096
        • Takatsuki Red Cross Hospital
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 103-0027
        • Tokyo-Eki Center-building Clinic
      • Chuo-ku, Tokyo, Japan, 103-0028
        • Tokyo Center Clinic
      • Chuo-ku, Tokyo, Japan, 104-0031
        • Tokyo Clinical Trial Centre Fukuwa Clinic
      • Chuou-ku, Tokyo, Japan, 1030002
        • The Institute for Adult Diseases, Asahi Life Foundation
      • Ota-ku, Tokyo, Japan, 143-0015
        • Sato Naika Clinic
  • Poland
      • Lublin, Poland, 20-538
        • NZOZ Przychodnia Specjalistyczna Medica
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 01-518
        • Centrum Medyczne AMED
    • Podlaskie
      • Bialystok, Podlaskie, Poland, 15-351
        • Nzoz Zdrowie Osteo-Medic
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-546
        • Centrum Badan Klinicznych, PI House
  • Puerto Rico
      • Caguas, Puerto Rico, 00725
        • Centro de Endocrinologia y Nutricion del Turabo
      • Manati, Puerto Rico, 00674
        • Manati Center for Clinical Research Inc
  • Slovakia
      • Hnusta, Slovakia, 98101
        • Ambulancia vnútorného lekárstva Hnúša (Diabetes care)
      • Malacky, Slovakia, 901 01
        • Sin Azucar
      • Prievidza, Slovakia, 971 01
        • Dia-Clarus.s.r.o.
      • Trnava, Slovakia, 917 01
        • JAL
      • Zilina, Slovakia, 01001
        • MEDIVASA, s.r.o.
  • Spain
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Sevilla, Spain, 41010
        • Hospital Infanta Luisa
      • València, Spain, 46026
        • Hospital Universitari i Politecnic La Fe-ENDO
    • Andalucia
      • Malaga, Andalucia, Spain, 29010
        • Hospital Clinico Universitario Virgen de la Victoria
    • Valencia
      • Alcira, Valencia, Spain, 46600
        • Hospital de la Ribera
  • United States
    • California
      • Fresno, California, United States, 93720
        • Valley Endocrine, Fresno
    • Florida
      • New Port Richey, Florida, United States, 34652
        • Sun Coast Clinical Research, Inc
    • New Hampshire
      • Nashua, New Hampshire, United States, 03063
        • Southern New Hampshire Diabetes and Endocrinology
    • New York
      • New York, New York, United States, 10016
        • Manhattan Medical Research
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Intend Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 5 mg Tirzepatide
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
Drug: Tirzepatide
Administered SC as add-on to the pre-trial background medication.
Other Names:
  • LY3298176
Experimental: 10 mg Tirzepatide
10 mg tirzepatide administered SC once a week.
Drug: Tirzepatide
Administered SC as add-on to the pre-trial background medication.
Other Names:
  • LY3298176
Experimental: 15 mg Tirzepatide
15 mg tirzepatide administered SC once a week.
Drug: Tirzepatide
Administered SC as add-on to the pre-trial background medication.
Other Names:
  • LY3298176
Placebo Comparator: Placebo
Placebo administered SC once a week.
Drug: Placebo
Administered SC as add-on to the pre-trial background medication.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg)
Time Frame: Baseline, Week 40
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).
Baseline, Week 40

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in HbA1c (5 mg)
Time Frame: Baseline, Week 40
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).
Baseline, Week 40
Change From Baseline in Body Weight
Time Frame: Baseline, Week 40
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).
Baseline, Week 40
Percentage of Participants Achieving an HbA1c Target Value of <7%
Time Frame: Week 40
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A.HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Week 40
Change From Baseline in Fasting Serum Glucose
Time Frame: Baseline, Week 40
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.
Baseline, Week 40
Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values
Time Frame: Baseline, Week 40
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).
Baseline, Week 40
Percentage of Participants Who Achieved Weight Loss ≥5%
Time Frame: Week 40
Percentage of Participants who Achieved Weight Loss ≥5%.
Week 40
Percentage Change From Baseline in Daily Mean Insulin Glargine Dose
Time Frame: Baseline, Week 40
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.
Baseline, Week 40
Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 Millimole/Liter (mmol/L)] or Severe Hypoglycemia
Time Frame: Baseline through Safety Follow-Up (Up to Week 44)
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.
Baseline through Safety Follow-Up (Up to Week 44)
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide
Time Frame: Week 7, 15, 23 and 39 post dose
AUC is a combined measure obtained from Week 7, 15, 23 and 39 and a single averaged measure of AUC was reported.
Week 7, 15, 23 and 39 post dose
Percentage of Participants Achieving an HbA1c Target Value of <5.7%
Time Frame: Week 40
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Week 40

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 22, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 13, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16998
  • I8F-MC-GPGI (Other Identifier: Eli Lilly and Company)
  • 2019-000860-99 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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 Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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