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

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ClinicalTrials.gov Identifier: NCT01394952
Recruitment Status : Active, not recruiting
First Posted : July 15, 2011
Last Update Posted : October 21, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Diabetes Mellitus, Type 2 Drug: Dulaglutide Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9622 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Dulaglutide on Major Cardiovascular Events in Patients With Type 2 Diabetes: Researching Cardiovascular Events With a Weekly INcretin in Diabetes (REWIND)
Study Start Date : July 2011
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Dulaglutide
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1.5 mg Dulaglutide
Administered subcutaneously, weekly for up to 8 years
Drug: Dulaglutide
Administered subcutaneously
Other Name: LY2189265
Placebo Comparator: Placebo
Administered subcutaneously, weekly for up to 8 years
Drug: Placebo
Administered subcutaneously


Outcome Measures

Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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, 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

  2. 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) ]
  3. 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) ]
  4. Time to all cause mortality [ Time Frame: From randomization to study completion (average duration of follow up of 6.5 years) ]
  5. 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) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01394952


  Show 320 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
More Information

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01394952     History of Changes
Other Study ID Numbers: 13438
H9X-MC-GBDJ ( Other Identifier: Eli Lilly and Company )
First Posted: July 15, 2011    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016

Keywords provided by Eli Lilly and Company:
Cardiovascular disease
Diabetes Mellitus
Dulaglutide

Additional relevant MeSH terms:
Diabetes Mellitus
Cardiovascular Diseases
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Incretins
Dulaglutide
Immunoglobulin Fc Fragments
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Hypoglycemic Agents
Immunologic Factors