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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03730662




Registration number
NCT03730662
Ethics application status
Date submitted
2/11/2018
Date registered
5/11/2018

Titles & IDs
Public title
A Study of Tirzepatide (LY3298176) Once a Week Versus Insulin Glargine Once a Day in Participants With Type 2 Diabetes and Increased Cardiovascular Risk
Scientific title
Efficacy and Safety of LY3298176 Once Weekly Versus Insulin Glargine in Patients With Type 2 Diabetes and Increased Cardiovascular Risk (SURPASS-4)
Secondary ID [1] 0 0
I8F-MC-GPGM
Secondary ID [2] 0 0
17072
Universal Trial Number (UTN)
Trial acronym
SURPASS-4
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 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 - Insulin Glargine

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: Insulin Glargine - Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.

The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG \<100 mg/dL, following a treat-to-target (TTT) algorithm.


Treatment: Drugs: Tirzepatide
Administered SC.

Treatment: Drugs: Insulin Glargine
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 52
Secondary outcome [1] 0 0
Change From Baseline in HbA1c (5 mg)
Timepoint [1] 0 0
Baseline, Week 52
Secondary outcome [2] 0 0
Change From Baseline in Body Weight
Timepoint [2] 0 0
Baseline, Week 52
Secondary outcome [3] 0 0
Percentage of Participants With HbA1c of <7.0%
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
Change From Baseline in Fasting Serum Glucose
Timepoint [4] 0 0
Baseline, Week 52
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 52
Secondary outcome [6] 0 0
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve From Zero to Tau (AUC 0-Tau) of Tirzepatide
Timepoint [6] 0 0
1 to 24 hours, 24 to 96 hours, or 120 to 168 hours post dose of Week 7, 15, 23, 35
Secondary outcome [7] 0 0
Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 (Millimole/Liter (mmol/L))] or Severe Hypoglycemia
Timepoint [7] 0 0
Baseline through Week 52

Eligibility
Key inclusion criteria
Participants must:

* Have been diagnosed with type 2 diabetes mellitus (T2DM)
* Have HbA1c between =7.5% and =10.5%
* Be on stable treatment with unchanged dose of at least 1 and no more than 3 types of oral antihyperglycemic drugs, which may only include metformin, SGLT-2 inhibitors, and/or sulfonylureas for at least 3 months before screening
* Have increased risk for cardiovascular (CV) events
* Be of stable weight (± 5%)
* Have a 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
Exclusion Criteria

Participants must not:

* 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 immediate or urgent 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 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, SGLT-2 inhibitors, and/or sulfonylureas 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
20/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/04/2021
Sample size
Target
Accrual to date
Final
2002
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Paratus Clinical Blacktown Clinic - Blacktown
Recruitment hospital [2] 0 0
Campbelltown Medical & Dental Centre - Campbelltown
Recruitment hospital [3] 0 0
Paratus Clinical Kanwal Clinic - Kanwal
Recruitment hospital [4] 0 0
The AIM Centre - Merewether
Recruitment hospital [5] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [6] 0 0
CORE Research Group Pty Ltd - Brisbane
Recruitment hospital [7] 0 0
Morayfield Medical and Dental Centre - Morayfield
Recruitment hospital [8] 0 0
AusTrials Pty Ltd - Sherwood
Recruitment hospital [9] 0 0
Victoria Point Medical and Dental Centre - Victoria Point
Recruitment hospital [10] 0 0
GP Plus Marion - Oaklands Park
Recruitment hospital [11] 0 0
Eastern Clinical Research Unit - Box Hill
Recruitment hospital [12] 0 0
Forest Hill Medical and Dental Centre - Forest Hill
Recruitment hospital [13] 0 0
Barwon Health - The Geelong Hospital - Geelong
Recruitment hospital [14] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [15] 0 0
Fremantle Hospital - Fremantle
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
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2560 - Campbelltown
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2259 - Kanwal
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2291 - Merewether
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2065 - St. Leonards
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4064 - Brisbane
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4506 - Morayfield
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4075 - Sherwood
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4165 - Victoria Point
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5046 - Oaklands Park
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3128 - Box Hill
Recruitment postcode(s) [12] 0 0
3131 - Forest Hill
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3220 - Geelong
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3050 - Parkville
Recruitment postcode(s) [15] 0 0
6160 - Fremantle
Recruitment outside Australia
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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 not provided in https://clinicaltrials.gov/study/NCT03730662