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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01394952
First received: July 13, 2011
Last updated: September 8, 2014
Last verified: September 2014

July 13, 2011
September 8, 2014
July 2011
April 2019   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01394952 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as safety issue: No ]
    Diabetic retinopathy requiring laser therapy, vitrectomy, or anti-vascular endothelial growth factor therapy (VEGF), 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Time to all cause mortality [ Time Frame: From randomization to study completion (average duration of follow up of 6.5 years) ] [ Designated as safety issue: No ]
  • Time to first occurrence after randomization of heart failure requiring hospitalization or an urgent heart failure clinic visit [ Time Frame: From randomization to study completion (average duration of follow up of 6.5 years) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Time to all cause mortality [ Time Frame: From randomization to study completion (average duration of follow up of 6.5 years) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND)
The Effect of Dulaglutide on Major Cardiovascular Events in Patients With Type 2 Diabetes: Researching Cardiovascular Events With a Weekly INcretin in Diabetes (REWIND)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Cardiovascular Disease
  • Diabetes Mellitus, Type 2
  • Drug: Dulaglutide
    Administered subcutaneously
    Other Name: LY2189265
  • Drug: Placebo
    Administered subcutaneously
    Other Name: Placebo
  • Experimental: 1.5 mg Dulaglutide
    Administered subcutaneously, weekly for up to 8 years
    Intervention: Drug: Dulaglutide
  • Placebo Comparator: Placebo
    Administered subcutaneously, weekly for up to 8 years
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
9622
April 2019
April 2019   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Brazil,   Bulgaria,   Canada,   Chile,   Colombia,   Czech Republic,   Germany,   Hungary,   India,   Korea, Republic of,   Latvia,   Lithuania,   Mexico,   New Zealand,   Poland,   Puerto Rico,   Romania,   Russian Federation,   South Africa,   Spain,   Sweden,   Taiwan,   United Kingdom
 
NCT01394952
13438, H9X-MC-GBDJ
Yes
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
September 2014

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