- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03954834
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone (SURPASS-1)
October 18, 2021 updated by: Eli Lilly and Company
A Randomized, Double-blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Three Tirzepatide Doses Versus Placebo in Patients With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone
The goal for this study is to evaluate the efficacy and safety of tirzepatide versus placebo in participants with type 2 diabetes not under control with diet and exercise alone.
The study will last approximately 47 weeks and may include about 15 visits.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
478
Phase
- 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
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Telangana, India, 500003
- Gandhi Hospital
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Gujarat
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Ahmedabad, Gujarat, India, 380007
- Dr. Jivraj Mehta Smarak Health Foundation
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Karnataka
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Bangalore, Karnataka, India, 560 002
- Bangalore Medical College and Research Institute
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Bangalore, Karnataka, India, 560054
- M S Ramaiah Medical College Hospital
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Maharashtra
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Mumbai, Maharashtra, India, 400058
- BSES Municipal General Hsptl
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Pune, Maharashtra, India, 411001
- Ruby Hall Clinic and Grant Medical Foundation
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Virar, Maharashtra, India, 401303
- Vijay Vallabh Hospital
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Pune
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Wakad, Pune, India, 411057
- Lifepoint Multispecialty Hsptl
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Telangana
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Hyderabad, Telangana, India, 500072
- Ramdevrao Hospital
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Ibaraki
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Mito, Ibaraki, Japan, 311-4153
- Minamiakatsuka Clinic
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Kanagawa
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Kamakura, Kanagawa, Japan, 247-0056
- Takai Naika Clinic
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Yamato, Kanagawa, Japan, 242-0004
- Tsuruma Kaneshiro Diabetes Clinic
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Yokohama, Kanagawa, Japan, 232-0064
- Yokohama Minoru Clinic
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Osaka
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Takatsuki, Osaka, Japan, 569-1096
- Takatsuki Red Cross Hospital
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Tokyo
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Chiyodaku, Tokyo, Japan, 101 0041
- Meiwa Hospital
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Chuo-ku, Tokyo, Japan, 103-0027
- Tokyo-Eki Center-building Clinic
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Chuo-ku, Tokyo, Japan, 103-0028
- Tokyo Center Clinic
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Minato-ku, Tokyo, Japan, 108 0075
- IHL Shinagawa East One Medical Clinic
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Ota-ku, Tokyo, Japan, 143-0015
- Sato Naika Clinic
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Chihuahua, Mexico, 31217
- Investigacion en Salud y Metabolismo S.C
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Nuevo León
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Monterrey, Nuevo León, Mexico, 66465
- Unidad Medica para la Salud Integral (UMSI)
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Monterrey, Nuevo León, Mexico, 64460
- Hospital Universitario UANL
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Tamaulipas
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Madero, Tamaulipas, Mexico, 89440
- Centro de Estudios de Investigacion Metabolicos y Cardiovasc
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San Juan, Puerto Rico, 00909
- Clinical Research Puerto Rico, Inc.
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San Juan, Puerto Rico, 00917
- GCM Medical Group PSC
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California
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Huntington Park, California, United States, 90255
- National Research Institute
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Los Angeles, California, United States, 90057
- National Research Institute
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Montclair, California, United States, 91763
- Catalina Research Institute, LLC
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Northridge, California, United States, 91325
- Valley Clinical Trials, Inc.
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Panorama City, California, United States, 91402
- National Research Institute
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Santa Ana, California, United States, 92701
- Southern California Dermatology
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Florida
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Coral Gables, Florida, United States, 33134
- Clinical Research of South Florida
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Hollywood, Florida, United States, 33021
- Encore Medical Research, LLC
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Loxahatchee Groves, Florida, United States, 33470
- Axcess Medical Research
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Margate, Florida, United States, 33063
- South Florida Wellness & Clinical Research Institute
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Miami, Florida, United States, 33135
- Suncoast Research Group, LLC
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Georgia
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Atlanta, Georgia, United States, 30328
- Agile Clinical Research Trials
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Atlanta, Georgia, United States, 30331
- Sky Clinical Research Network
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Kansas
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Topeka, Kansas, United States, 66606
- Cotton O'Neil Clinic
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Missouri
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Chesterfield, Missouri, United States, 63005
- Clinical Research Professionals
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Saint Peters, Missouri, United States, 63303
- StudyMetrix Research, LLC
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Ohio
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Columbus, Ohio, United States, 43213
- Aventiv Research
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Oklahoma
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Norman, Oklahoma, United States, 73069
- Intend Research
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Oregon
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Corvallis, Oregon, United States, 97330
- The Corvallis Clinic P.C.
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Pennsylvania
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Beaver, Pennsylvania, United States, 15009
- Heritage Valley Medical Group, Inc.
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Levittown, Pennsylvania, United States, 19056
- Family Medical Associates
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Pittsburgh, Pennsylvania, United States, 15236
- Preferred Primary Care Physicians
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Uniontown, Pennsylvania, United States, 15401
- Preferred Primary Care Physicians
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Texas
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Dallas, Texas, United States, 75230
- Dallas Diabetes Endocrine Center
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San Antonio, Texas, United States, 78229
- Clinical Trials of Texas, Inc.
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Shavano Park, Texas, United States, 78231
- Consano Clinical Research
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Washington
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Olympia, Washington, United States, 98502
- Capital Clinical Research Center
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Spokane, Washington, United States, 99220
- Rockwood Clinic Research Center
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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
Ages Eligible for Study
16 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).
- Are naïve to diabetes injectable therapies and have not used any oral antihyperglycemic medications (OAMs) during the 3 months preceding screening.
- Have HbA1c between ≥7.0% and ≤9.5%.
- Be of stable weight (± 5%) for at least 3 months before screening.
- Have a 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.
- 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 |
Intervention / Treatment |
---|---|
Experimental: 5 mg Tirzepatide
Participants received 5 milligrams (mg) of tirzepatide as subcutaneous injection once a week.
|
Administered SC
Other Names:
|
Experimental: 10 mg Tirzepatide
Participants received 10mg of tirzepatide as subcutaneous injection once a week.
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Administered SC
Other Names:
|
Experimental: 15 mg Tirzepatide
Participants received 15mg of tirzepatide as subcutaneous injection once a week.
|
Administered SC
Other Names:
|
Placebo Comparator: Placebo
Participants received placebo as subcutaneous injection once a week.
|
Administered SC
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Hemoglobin A1c (HbA1c)
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 + Pooled Country + Prior Use of oral antihyperglycemic medication (OAM) (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares).
|
Baseline, Week 40
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Who Achieved Weight Loss ≥5%
Time Frame: Week 40
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Percentage of Participants who Achieved Weight Loss ≥5%.
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Week 40
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Change From Baseline in Body Weight
Time Frame: Baseline, Week 40
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Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Prior Use of OAM (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares).
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Baseline, Week 40
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Percentage of Participants With HbA1c Target Value of <7%
Time Frame: Week 40
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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
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Change From Baseline in Fasting Serum Glucose
Time Frame: Baseline, Week 40
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Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast.
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Prior Use of OAM (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares).
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Baseline, Week 40
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Percentage of Participants With HbA1c Target Value of <5.7%
Time Frame: Week 40
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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
|
Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values
Time Frame: Baseline, Week 40
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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 + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Prior Use of OAM (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares).
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Baseline, Week 40
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Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 Millimole/Liter (mmol/L)] or Severe Hypoglycemia
Time Frame: Baseline through end of 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 HbA1c Group (<=8.5%, >8.5%) + Prior Use of OAM (Yes, No) + Treatment, with log (exposure in days/365.25)
as an offset variable.
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Baseline through end of safety follow-up (up to week 44)
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Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide
Time Frame: Week 7, 15 and 23
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Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide.
AUC is a combined measure obtained from Week 7, 15 and 23, and a single averaged measure of AUC was reported.
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Week 7, 15 and 23
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- 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.
- Rosenstock J, Wysham C, Frias JP, Kaneko S, Lee CJ, Fernandez Lando L, Mao H, Cui X, Karanikas CA, Thieu VT. Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial. Lancet. 2021 Jul 10;398(10295):143-155. doi: 10.1016/S0140-6736(21)01324-6. Epub 2021 Jun 27. Erratum In: Lancet. 2021 Jul 17;398(10296):212.
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)
June 3, 2019
Primary Completion (Actual)
October 5, 2020
Study Completion (Actual)
October 28, 2020
Study Registration Dates
First Submitted
May 15, 2019
First Submitted That Met QC Criteria
May 16, 2019
First Posted (Actual)
May 17, 2019
Study Record Updates
Last Update Posted (Actual)
October 20, 2021
Last Update Submitted That Met QC Criteria
October 18, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17000
- I8F-MC-GPGK (Other Identifier: Eli Lilly and Company)
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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