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

Eli Lilly and Company9,901 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

9,901

Conditions

Cardiovascular Disease Diabetes Mellitus, Type 2

Interventions

DulaglutideDRUG

Administered subcutaneously

PlaceboDRUG

Administered subcutaneously

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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renal failure or of C-cell thyroid disorder * Pregnancy or planned pregnancy during the trial period * Completed or withdrawn from any study investigating dulaglutide

Locations (300)

Outcomes

Primary Outcomes

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.

Time frame: From randomization to first occurrence or death from any cause or study completion (Median Follow-Up of 5.4 Years)

Secondary Outcomes

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.

Time frame: From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)

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.

Time frame: From randomization to study completion (Median Follow-Up of 5.4 Years)

Data from ClinicalTrials.gov

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Mobile, Alabama, United States

Pell City, Alabama, United States

Phoenix, Arizona, United States

Tucson, Arizona, United States

Little Rock, Arkansas, United States

Burlingame, California, United States

Lakewood, California, United States

Long Beach, California, United States

Los Angeles, California, United States

Northridge, California, United States

...and 290 more locations