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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01394952




Registration number
NCT01394952
Ethics application status
Date submitted
13/07/2011
Date registered
15/07/2011
Date last updated
8/10/2019

Titles & IDs
Public title
Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND)
Scientific title
The Effect of Dulaglutide on Major Cardiovascular Events in Patients With Type 2 Diabetes: Researching Cardiovascular Events With a Weekly INcretin in Diabetes (REWIND)
Secondary ID [1] 0 0
H9X-MC-GBDJ
Secondary ID [2] 0 0
13438
Universal Trial Number (UTN)
Trial acronym
REWIND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease 0 0
Diabetes Mellitus, Type 2 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 - Dulaglutide
Treatment: Drugs - Placebo

Experimental: 1.5 mg Dulaglutide - Administered once weekly, subcutaneously

Placebo Comparator: Placebo - Administered once weekly, subcutaneously


Treatment: Drugs: Dulaglutide
Administered subcutaneously

Treatment: Drugs: Placebo
Administered subcutaneously

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Who Experienced an Event For Time, From Randomization to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome) - The time from randomization to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite endpoint) was evaluated using time-to-event analysis. The primary analysis model was a Cox proportional hazards regression model for the time to the first occurrence of a primary endpoint event, with treatment as a fixed effect using the intent-to-treat population. The number of participants who experienced a primary cardiovascular (CV) endpoint event is presented.
Timepoint [1] 0 0
From randomization to first occurrence or death from any cause or study completion (Median Follow-Up of 5.4 Years)
Secondary outcome [1] 0 0
Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke, Individually - The time from randomization to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (individually) was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. Death from CV causes is defined as a death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, or death due to other CV causes. The number of participants who experienced an event is presented.
Timepoint [1] 0 0
From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)
Secondary outcome [2] 0 0
Number of Participants Who Experienced an Event for Time to All-cause Mortality - The time to all-cause mortality was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.
Timepoint [2] 0 0
From randomization to study completion (Median Follow-Up of 5.4 Years)
Secondary outcome [3] 0 0
Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of the Composite Microvascular Endpoint - The time from randomization to first occurrence of the composite microvascular endpoint was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The composite microvascular endpoint is defined as diabetic retinopathy requiring laser therapy, vitrectomy, or anti-vascular endothelial growth factor therapy (VEGF), clinical proteinuria, a greater than equal = 30% decline in estimated glomerular filtration rate, or need for chronic renal replacement therapy. The number of participants who experienced the composite microvascular endpoint event is presented.
Timepoint [3] 0 0
From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)
Secondary outcome [4] 0 0
Number of Participants Who Experienced An Event for Time to First Occurrence After Randomization of Heart Failure Requiring Hospitalization or an Urgent Heart Failure Clinic Visit - The time to first occurrence after randomization of heart failure requiring hospitalization or an urgent heart failure clinic visit was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.
Timepoint [4] 0 0
From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)
Secondary outcome [5] 0 0
Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of First Hospitalization for Unstable Angina - Time to first occurrence after randomization of first hospitalization for unstable angina was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.
Timepoint [5] 0 0
From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)

Eligibility
Key inclusion criteria
- Type 2 diabetes with Hemoglobin A1c equal to or less than 9.5% (equal to or less than
81 mmol/mol)

- Anti-hyperglycemic drug naive or treated with up to 2 oral hyperglycemic drugs with or
without a glucagon-like peptide-1analog or basal insulin, or basal insulin alone

- On stable antihyperglycemic regimen for at least 3 months

- Age equal to or greater than 50 years with established clinical vascular disease, or
age equal to or greater than 55 years and subclinical vascular disease or age equal to
or greater than 60 years and at least 2 or more cardiovascular risk factors
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Uncontrolled diabetes requiring immediate therapy

- History of severe hypoglycemia in past year

- Acute coronary or cerebrovascular event within past 2 months

- Planned or anticipated revascularization procedure

- History of pancreatitis, hepatic insufficiency , chronic renal failure or of C-cell
thyroid disorder

- Pregnancy or planned pregnancy during the trial period

- Completed or withdrawn from any study investigating dulaglutide

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - St Leonards
Recruitment hospital [2] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - St. Leonards
Recruitment hospital [3] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Milton
Recruitment hospital [4] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Elizabeth Vale
Recruitment hospital [5] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Clayton
Recruitment hospital [6] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Heidelberg Heights
Recruitment hospital [7] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Melbourne
Recruitment hospital [8] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Parkville
Recruitment hospital [9] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Nedlands
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
2065 - St. Leonards
Recruitment postcode(s) [3] 0 0
4064 - Milton
Recruitment postcode(s) [4] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 0 0
3081 - Heidelberg Heights
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment postcode(s) [8] 0 0
3050 - Parkville
Recruitment postcode(s) [9] 0 0
6009 - Nedlands
Recruitment outside Australia
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Londonderry

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this trial is to assess whether dulaglutide can reduce major cardiovascular
events and other serious outcomes in persons with type 2 diabetes, when added to their
anti-hyperglycemic regimen.
Trial website
https://clinicaltrials.gov/show/NCT01394952
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 - 5PM 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

Summary results
Other publications