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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: September 8, 2014
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:
Diabetes Mellitus
Cardiovascular Diseases
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 October 01, 2014