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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03987919
Registration number
NCT03987919
Ethics application status
Date submitted
14/06/2019
Date registered
17/06/2019
Date last updated
14/02/2022
Titles & IDs
Public title
A Study of Tirzepatide (LY3298176) Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Participants With Type 2 Diabetes
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Scientific title
A Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of Tirzepatide Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
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Secondary ID [1]
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I8F-MC-GPGL
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Secondary ID [2]
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17001
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Universal Trial Number (UTN)
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Trial acronym
SURPASS-2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tirzepatide
Treatment: Drugs - Semaglutide
Experimental: 5 mg Tirzepatide - 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
Experimental: 10 mg Tirzepatide - 10 mg tirzepatide administered SC once a week.
Experimental: 15 mg Tirzepatide - 15 mg tirzepatide administered SC once a week.
Active Comparator: 1 mg Semaglutide - 1 mg semaglutide administered SC once a week.
Treatment: Drugs: Tirzepatide
Administered SC
Treatment: Drugs: Semaglutide
Administered SC
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg)
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Assessment method [1]
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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 + Treatment + Time + Treatment*Time (Type III sum of squares).
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Timepoint [1]
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Baseline, Week 40
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Secondary outcome [1]
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Change From Baseline in HbA1c (5 mg)
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Assessment method [1]
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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 + Treatment + Time + Treatment*Time (Type III sum of squares).
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Timepoint [1]
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Baseline, Week 40
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Secondary outcome [2]
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Change From Baseline in Body Weight
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Assessment method [2]
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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%) + Treatment + Time + Treatment*Time (Type III sum of squares).
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Timepoint [2]
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Baseline, Week 40
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Secondary outcome [3]
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Percentage of Participants Achieving an HbA1c Target Value of <7%
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Assessment method [3]
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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.
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Timepoint [3]
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Week 40
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Secondary outcome [4]
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Change From Baseline in Fasting Serum Glucose (FSG)
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Assessment method [4]
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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%) + Treatment + Time + Treatment*Time (Type III sum of squares).
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Timepoint [4]
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Baseline, Week 40
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Secondary outcome [5]
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Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values
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Assessment method [5]
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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%) + Treatment + Time + Treatment*Time (Type III sum of squares).
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Timepoint [5]
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Baseline, Week 40
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Secondary outcome [6]
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Percentage of Participants Who Achieved Weight Loss =5%
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Assessment method [6]
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Percentage of Participants who Achieved Weight Loss =5%.
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Timepoint [6]
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Week 40
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Secondary outcome [7]
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Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) Hyperglycemia, Hypoglycemia and Total Score
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Assessment method [7]
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DTSQc, an 8-item questionnaire, assesses relative change in treatment satisfaction perceived frequency of hyperglycemia, and perceived frequency of hypoglycemia from baseline to week 40 or early termination. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 to 18 where the higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment. The hyperglycemia and hypoglycemia scores range from -3 to 3 where negative scores indicate fewer problems with blood glucose levels and positive scores indicate more problems than before. LS Mean was determined by ANCOVA with Baseline DTSQs + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment (Type III sum of squares).
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Timepoint [7]
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Baseline, Week 40
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Secondary outcome [8]
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Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 Millimole/Liter (mmol/L)] or Severe Hypoglycemia
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Assessment method [8]
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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%) + Treatment.
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Timepoint [8]
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Baseline through Safety Follow-Up (Up to Week 44)
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Secondary outcome [9]
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Percentage of Participants Achieving an HbA1c Target Value of <5.7%
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Assessment method [9]
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Percentage of Participants Achieving an HbA1c Target Value of <5.7%.
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Timepoint [9]
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Week 40
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Eligibility
Key inclusion criteria
- Have been diagnosed with type 2 diabetes mellitus (T2DM)
- Have HbA1c between =7.0% and =10.5%
- Be on stable treatment with unchanged dose of metformin >1500 mg/day for at least 3
months prior to screening
- Be of stable weight (±5%) for at least 3 months before screening
- Have a body mass index (BMI) =25 kilograms per meter squared (kg/m²) at screening
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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 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 an estimated glomerular filtration rate <45 milliliters/minute/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 any other diabetes medicines other than metformin during the last 3
months
- Have been taking weight loss drugs, including over-the-counter medications during the
last 3 months
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/07/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
15/02/2021
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Sample size
Target
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Accrual to date
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Final
1879
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Recruitment in Australia
Recruitment state(s)
Au-nswNSW,QLD,VIC,WA
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Recruitment hospital [1]
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Paratus Clinical Research Western Sydney - Blacktown
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Campbelltown Medical & Dental Centre - Campbelltown
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Paratus Clinical Research Central Coast - Kanwal
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Holdsworth House Medical Practice - Sydney
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GenesisCare - Bundaberg - Bundaberg
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Royal Brisbane and Womens Hospital - Herston
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Core Research Group - Milton
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AusTrials - Taringa
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Eastern Clinical Research Unit - Box Hill
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Barwon Health - The Geelong Hospital - Geelong
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GenesisCare - Wexford Medical Centre WA - Joondalup
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GenesisCare - Wexford Medical Centre WA - Murdoch
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Adelaide Medical Solutions - Woodville South
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2148 - Blacktown
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2560 - Campbelltown
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2259 - Kanwal
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2010 - Sydney
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4670 - Bundaberg
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4029 - Herston
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4064 - Milton
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4068 - Taringa
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3128 - Box Hill
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3220 - Geelong
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6027 - Joondalup
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Recruitment postcode(s) [12]
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6150 - Murdoch
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Recruitment postcode(s) [13]
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5011 - Woodville South
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Recruitment outside Australia
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Warwickshire
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Rotherham
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The reason for this study is to compare the effect of the study drug tirzepatide to
semaglutide on blood sugar levels in participants with type 2 diabetes. The study will last
approximately 47 weeks and may include about 12 visits.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03987919
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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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)
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Address
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Eli Lilly and Company
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03987919
Download to PDF