Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND) - Full Text View

Purpose

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	Intervention	Phase
Cardiovascular Disease Diabetes Mellitus, Type 2	Drug: Dulaglutide Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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)

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2 Heart Attack

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	9622
Study Start Date:	July 2011
Estimated Study Completion Date:	April 2019
Estimated Primary Completion Date:	April 2019 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Other Name: Placebo

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394952

Contacts

Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

Show 325 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

No publications provided

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01394952 History of Changes
Other Study ID Numbers:	13438, H9X-MC-GBDJ
Study First Received:	July 13, 2011
Last Updated:	May 14, 2013
Health Authority:	United States: Food and Drug Administration Argentina: Ministry of Health Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Australia: National Health and Medical Research Council Brazil: Ministry of Health Bulgaria: Ministry of Health Bulgaria: Bulgarian Drug Agency Chile: Ministry of Health Colombia: National Institutes of Health Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Czech Republic: State Institute for Drug Control Germany: Federal Institute for Drugs and Medical Devices Germany: Ministry of Health Hungary: Scientific and Medical Research Council Ethics Committee India: Ministry of Health Latvia: State Agency of Medicines Lithuania: State Medicine Control Agency - Ministry of Health Mexico: Ministry of Health New Zealand: Ministry of Health Peru: Ministry of Health Peru: General Directorate of Pharmaceuticals, Devices, and Drugs Poland: Ministry of Health Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Romania: Ministry of Public Health Russia: Ministry of Health of the Russian Federation South Africa: National Health Research Ethics Council South Korea: Korea Food and Drug Administration (KFDA) Spain: Ministry of Health Sweden: The National Board of Health and Welfare Taiwan : Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency Canada: Health Canada Canada: Canadian Institutes of Health Research European Union: European Medicines Agency Finland: Finnish Medicines Agency Finland: Ministry of Social Affairs and Health Ireland: Medical Ethics Research Committee Ireland: Ministry of Health Israel: Ministry of Health Israel: Ethics Commission Italy: Ethics Committee Italy: Ministry of Health Slovakia: State Institute for Drug Control Ukraine: Ethics Committee Ukraine: Ministry of Health

Keywords provided by Eli Lilly and Company:

Cardiovascular disease
Diabetes Mellitus
Dulaglutide

Additional relevant MeSH terms:

Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013