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

Conditions

• Cardiovascular Disease
• Diabetes Mellitus, Type 2

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dulaglutide — DRUG
  Administered subcutaneously
• Placebo — DRUG
  Administered subcutaneously

Study Details

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.

Key Dates

Start date

Jul 22, 2011

Status verified

Sep 2019

Primary completion

Aug 21, 2018

Completion

Aug 21, 2018

Study Design

Enrollment

9,901 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 1.5 mg Dulaglutide
  Administered once weekly, subcutaneously
• Placebo Comparator: Placebo
  Administered once weekly, subcutaneously

Primary Outcome Measure

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) ]

Locations (51)

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