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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03987919




Registration number
NCT03987919
Ethics application status
Date submitted
14/06/2019
Date registered
17/06/2019

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
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
Secondary ID [1] 0 0
I8F-MC-GPGL
Secondary ID [2] 0 0
17001
Universal Trial Number (UTN)
Trial acronym
SURPASS-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg)
Timepoint [1] 0 0
Baseline, Week 40
Secondary outcome [1] 0 0
Change From Baseline in HbA1c (5 mg)
Timepoint [1] 0 0
Baseline, Week 40
Secondary outcome [2] 0 0
Change From Baseline in Body Weight
Timepoint [2] 0 0
Baseline, Week 40
Secondary outcome [3] 0 0
Percentage of Participants Achieving an HbA1c Target Value of <7%
Timepoint [3] 0 0
Week 40
Secondary outcome [4] 0 0
Change From Baseline in Fasting Serum Glucose (FSG)
Timepoint [4] 0 0
Baseline, Week 40
Secondary outcome [5] 0 0
Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values
Timepoint [5] 0 0
Baseline, Week 40
Secondary outcome [6] 0 0
Percentage of Participants Who Achieved Weight Loss =5%
Timepoint [6] 0 0
Week 40
Secondary outcome [7] 0 0
Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) Hyperglycemia, Hypoglycemia and Total Score
Timepoint [7] 0 0
Baseline, Week 40
Secondary outcome [8] 0 0
Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 Millimole/Liter (mmol/L)] or Severe Hypoglycemia
Timepoint [8] 0 0
Baseline through Safety Follow-Up (Up to Week 44)
Secondary outcome [9] 0 0
Percentage of Participants Achieving an HbA1c Target Value of <5.7%
Timepoint [9] 0 0
Week 40

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/02/2021
Sample size
Target
Accrual to date
Final
1879
Recruitment in Australia
Recruitment state(s)
Au-nswNSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Paratus Clinical Research Western Sydney - Blacktown
Recruitment hospital [2] 0 0
Campbelltown Medical & Dental Centre - Campbelltown
Recruitment hospital [3] 0 0
Paratus Clinical Research Central Coast - Kanwal
Recruitment hospital [4] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment hospital [5] 0 0
GenesisCare - Bundaberg - Bundaberg
Recruitment hospital [6] 0 0
Royal Brisbane and Womens Hospital - Herston
Recruitment hospital [7] 0 0
Core Research Group - Milton
Recruitment hospital [8] 0 0
AusTrials - Taringa
Recruitment hospital [9] 0 0
Eastern Clinical Research Unit - Box Hill
Recruitment hospital [10] 0 0
Barwon Health - The Geelong Hospital - Geelong
Recruitment hospital [11] 0 0
GenesisCare - Wexford Medical Centre WA - Joondalup
Recruitment hospital [12] 0 0
GenesisCare - Wexford Medical Centre WA - Murdoch
Recruitment hospital [13] 0 0
Adelaide Medical Solutions - Woodville South
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2560 - Campbelltown
Recruitment postcode(s) [3] 0 0
2259 - Kanwal
Recruitment postcode(s) [4] 0 0
2010 - Sydney
Recruitment postcode(s) [5] 0 0
4670 - Bundaberg
Recruitment postcode(s) [6] 0 0
4029 - Herston
Recruitment postcode(s) [7] 0 0
4064 - Milton
Recruitment postcode(s) [8] 0 0
4068 - Taringa
Recruitment postcode(s) [9] 0 0
3128 - Box Hill
Recruitment postcode(s) [10] 0 0
3220 - Geelong
Recruitment postcode(s) [11] 0 0
6027 - Joondalup
Recruitment postcode(s) [12] 0 0
6150 - Murdoch
Recruitment postcode(s) [13] 0 0
5011 - Woodville South
Recruitment outside Australia
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Alabama
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Gb-lan
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Gb-wil
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Leicestershire
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Warwickshire
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Rotherham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03987919