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Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND) (REWIND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01394952
Recruitment Status : Completed
First Posted : July 15, 2011
Results First Posted : October 8, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE July 13, 2011
First Posted Date  ICMJE July 15, 2011
Results First Submitted Date  ICMJE August 9, 2019
Results First Posted Date  ICMJE October 8, 2019
Last Update Posted Date October 8, 2019
Actual Study Start Date  ICMJE July 22, 2011
Actual Primary Completion Date August 21, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2019)
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) [ Time Frame: From randomization to first occurrence or death from any cause or study completion (Median Follow-Up of 5.4 Years) ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 13, 2011)
Time from randomization to first occurrence of cardiovascular death, non fatal myocardial infarction, or non fatal stroke (a composite cardiovascular outcome) [ Time Frame: From randomization to study completion (average duration of follow up of 6.5 years) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2019)
  • 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 [ Time Frame: From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years) ]
    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.
  • Number of Participants Who Experienced an Event for Time to All-cause Mortality [ Time Frame: From randomization to study completion (Median Follow-Up of 5.4 Years) ]
    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.
  • Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of the Composite Microvascular Endpoint [ Time Frame: From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years) ]
    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.
  • 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 [ Time Frame: From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years) ]
    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.
  • Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of First Hospitalization for Unstable Angina [ Time Frame: From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years) ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2011)
  • Time to first occurrence after randomization of the composite microvascular endpoint [ Time Frame: From randomization to study completion (average duration of follow up of 6.5 years) ]
    Diabetic retinopathy requiring laser therapy, vitrectomy, clinical proteinuria, a 30% decline in estimated glomerular filtration rate, or need for chronic renal replacement therapy
  • Time to first occurrence after randomization of first hospitalization for unstable angina [ Time Frame: From randomization to study completion (average duration of follow up of 6.5 years) ]
  • Time to first occurrence after randomization of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke, individually [ Time Frame: From randomization to study completion (average duration of follow up of 6.5 years) ]
  • Time to all cause mortality [ Time Frame: From randomization to study completion (average duration of follow up of 6.5 years) ]
  • Time to first occurrence after randomization of heart failure requiring hospitalization [ Time Frame: From randomization to study completion (average duration of follow up of 6.5 years) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND)
Official Title  ICMJE The Effect of Dulaglutide on Major Cardiovascular Events in Patients With Type 2 Diabetes: Researching Cardiovascular Events With a Weekly INcretin in Diabetes (REWIND)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Cardiovascular Disease
  • Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: Dulaglutide
    Administered subcutaneously
    Other Name: LY2189265
  • Drug: Placebo
    Administered subcutaneously
Study Arms  ICMJE
  • Experimental: 1.5 mg Dulaglutide
    Administered once weekly, subcutaneously
    Intervention: Drug: Dulaglutide
  • Placebo Comparator: Placebo
    Administered once weekly, subcutaneously
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2018)
9901
Original Estimated Enrollment  ICMJE
 (submitted: July 13, 2011)
9622
Actual Study Completion Date  ICMJE August 21, 2018
Actual Primary Completion Date August 21, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Brazil,   Bulgaria,   Canada,   Chile,   Colombia,   Czechia,   Germany,   Hungary,   Korea, Republic of,   Latvia,   Lithuania,   Mexico,   New Zealand,   Poland,   Puerto Rico,   Romania,   Russian Federation,   South Africa,   Spain,   Sweden,   Taiwan,   United Kingdom,   United States
Removed Location Countries Czech Republic,   India,   Peru
 
Administrative Information
NCT Number  ICMJE NCT01394952
Other Study ID Numbers  ICMJE 13438
H9X-MC-GBDJ ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: 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) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP