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

Phase 3

Completed

• Conditions: Cardiovascular Disease; Diabetes Mellitus, Type 2
• Interventions: Drug: Placebo; Drug: Dulaglutide

• Registration Number: NCT01394952
• Lead Sponsor: Eli Lilly and Company

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 available

Study Timeline

• Study First Submitted: 2011-07-13
• Study First Submitted QC: 2011-07-13
• Study First Posted: 2011-07-15
• Study Start: 2011-07-22
• Primary Completion: 2018-08-21
• Study Completion: 2018-08-21
• Results First Submitted: 2019-08-09
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-18
• Last Update Submitted: 2019-09-18
• Results First Posted: 2019-10-08
• Last Update Posted: 2019-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9901

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• Completed or withdrawn from any study investigating dulaglutide

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Administered once weekly, subcutaneously
1.5 mg Dulaglutide	Dulaglutide	Administered once weekly, subcutaneously

Primary Outcome Measures

Name	Time	Method
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)	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced an Event for Time to All-cause Mortality	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 Heart Failure Requiring Hospitalization or an Urgent Heart Failure Clinic Visit	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	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.
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	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 First Occurrence After Randomization of the Composite Microvascular Endpoint	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.

Trial Locations

Locations (1)

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.; 🇬🇧 Londonderry, United Kingdom