AzTrials
AzTrials

DiabetesPhase 3DEVOTENCT01959529

A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events

A Phase 3 study testing insulin degludec and insulin glargine in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 446 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This trial is conducted globally. The aim of this trial is to compare cardiovascular safety of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of cardiovascular events. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Diabetes, Diabetes Mellitus, Type 2
What is being tested?
insulin degludec and insulin glargine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7,637 participants
Where
446 sitesin 20 countries
Study dates
29 Oct 2013to 16 Oct 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Inclusion Criteria: - Type 2 diabetes - Age above or equal to 50 years with predefined previous cardiovascular disease(s) or renal disease or age above or equal to 60 years with predefined cardiovascular risk factors - HbA1c (glycosylated haemoglobin) above or equal to 7.0% or HbA1c below 7.0% and current insulin treatment corresponding to above or equal to 20 U of basal insulin per day - One or more oral or injectable antidiabetic agent(s) Exclusion Criteria: - An acute coronary or cerebrovascular event in the previous 60 days - Planned coronary, carotid or peripheral artery revascularisation - Chronic heart failure NYHA (New York Heart Association) class IV - Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma)

Trial locations and contacts

446 sites in 20 countries.

446 sites in 20 countries

United States267 sites

  • Novo Nordisk Investigational Site

    Addison, Illinois, 60101

  • Novo Nordisk Investigational Site

    Albany, New York, 12206

  • Novo Nordisk Investigational Site

    Altoona, Pennsylvania, 16602

  • Novo Nordisk Investigational Site

    Anderson, South Carolina, 29621

  • Novo Nordisk Investigational Site

    Ann Arbor, Michigan, 48105

  • Novo Nordisk Investigational Site

    Ann Arbor, Michigan, 48106

  • Novo Nordisk Investigational Site

    Arlington, Texas, 76012

  • Novo Nordisk Investigational Site

    Asheville, North Carolina, 28801

  • Novo Nordisk Investigational Site

    Asheville, North Carolina, 28803

  • Novo Nordisk Investigational Site

    Atlanta, Georgia, 30339

  • Novo Nordisk Investigational Site

    Austin, Texas, 78705

  • Novo Nordisk Investigational Site

    Austin, Texas, 78731

  • Novo Nordisk Investigational Site

    Austin, Texas, 78749

  • Novo Nordisk Investigational Site

    Bangor, Maine, 04401

  • Novo Nordisk Investigational Site

    Beaver, Pennsylvania, 15009

  • Novo Nordisk Investigational Site

    Bennington, Vermont, 05201

  • Novo Nordisk Investigational Site

    Billings, Montana, 59101

  • Novo Nordisk Investigational Site

    Birmingham, Alabama, 35216

  • Novo Nordisk Investigational Site

    Birmingham, Alabama, 35294

  • Novo Nordisk Investigational Site

    Boca Raton, Florida, 33433

  • Novo Nordisk Investigational Site

    Boynton Beach, Florida, 33472

  • Novo Nordisk Investigational Site

    Bradenton, Florida, 34201

  • Novo Nordisk Investigational Site

    Brandon, Florida, 33511

  • Novo Nordisk Investigational Site

    Brownsburg, Indiana, 46112

  • Novo Nordisk Investigational Site

    Buckley, Michigan, 49620

  • Novo Nordisk Investigational Site

    Burlington, North Carolina, 27215

  • Novo Nordisk Investigational Site

    Carrollton, Texas, 75007

  • Novo Nordisk Investigational Site

    Carrollton, Texas, 75010

  • Novo Nordisk Investigational Site

    Cary, North Carolina, 27518

  • Novo Nordisk Investigational Site

    Champaign, Illinois, 61821

  • Novo Nordisk Investigational Site

    Chapel Hill, North Carolina, 27517

  • Novo Nordisk Investigational Site

    Charlotte, North Carolina, 28209

  • Novo Nordisk Investigational Site

    Chattanooga, Tennessee, 37404-1192

  • Novo Nordisk Investigational Site

    Chattanooga, Tennessee, 37404

  • Novo Nordisk Investigational Site

    Chattanooga, Tennessee, 37411

  • Novo Nordisk Investigational Site

    Chicago, Illinois, 60607

  • Novo Nordisk Investigational Site

    Chicago, Illinois, 60616

  • Novo Nordisk Investigational Site

    Chula Vista, California, 91910

  • Novo Nordisk Investigational Site

    Cincinnati, Ohio, 45236

  • Novo Nordisk Investigational Site

    Clearwater, Florida, 33756

  • Novo Nordisk Investigational Site

    Cleveland, Ohio, 44106-1702

  • Novo Nordisk Investigational Site

    Cleveland, Ohio, 44121

  • Novo Nordisk Investigational Site

    Cleveland, Ohio, 44195

  • Novo Nordisk Investigational Site

    Colorado Springs, Colorado, 80909

  • Novo Nordisk Investigational Site

    Columbus, Ohio, 43235

  • Novo Nordisk Investigational Site

    Concord, California, 94520

  • Novo Nordisk Investigational Site

    Cooper City, Florida, 33024

  • Novo Nordisk Investigational Site

    Corpus Christi, Texas, 78404

  • Novo Nordisk Investigational Site

    Council Bluffs, Iowa, 51501

  • Novo Nordisk Investigational Site

    Crystal Lake, Illinois, 60012

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75230

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75231

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75246

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75390-9302

  • Novo Nordisk Investigational Site

    Danbury, Connecticut, 06810

  • Novo Nordisk Investigational Site

    Danville, Pennsylvania, 17822

  • Novo Nordisk Investigational Site

    Decatur, Georgia, 30033

  • Novo Nordisk Investigational Site

    Delaware, Ohio, 43015

  • Novo Nordisk Investigational Site

    Denver, Colorado, 80220

  • Novo Nordisk Investigational Site

    Denver, Colorado, 80246

  • Novo Nordisk Investigational Site

    Detroit, Michigan, 48201

  • Novo Nordisk Investigational Site

    Detroit, Michigan, 48202

  • Novo Nordisk Investigational Site

    Downey, California, 90242

  • Novo Nordisk Investigational Site

    Duarte, California, 91010

  • Novo Nordisk Investigational Site

    Dunwoody, Georgia, 30338

  • Novo Nordisk Investigational Site

    East Brunswick, New Jersey, 08816

  • Novo Nordisk Investigational Site

    Elkhorn, Nebraska, 68022

  • Novo Nordisk Investigational Site

    Encino, California, 91436

  • Novo Nordisk Investigational Site

    Evansville, Indiana, 47714

  • Novo Nordisk Investigational Site

    Fargo, North Dakota, 58104

  • Novo Nordisk Investigational Site

    Fleming Island, Florida, 32003

  • Novo Nordisk Investigational Site

    Fort Lauderdale, Florida, 33316

  • Novo Nordisk Investigational Site

    Fort Worth, Texas, 76117

  • Novo Nordisk Investigational Site

    Fort Worth, Texas, 76132

  • Novo Nordisk Investigational Site

    Franklin, Indiana, 46131

  • Novo Nordisk Investigational Site

    Franklin, Ohio, 45005

  • Novo Nordisk Investigational Site

    Fremont, Nebraska, 68025

  • Novo Nordisk Investigational Site

    Fresno, California, 93720

  • Novo Nordisk Investigational Site

    Gainesville, Florida, 32610

  • Novo Nordisk Investigational Site

    Gilbert, Arizona, 85295

  • Novo Nordisk Investigational Site

    Glendale, Arizona, 85308

  • Novo Nordisk Investigational Site

    Golden, Colorado, 80401

  • Novo Nordisk Investigational Site

    Green Cove Springs, Florida, 32043

  • Novo Nordisk Investigational Site

    Greenbrae, California, 94904

  • Novo Nordisk Investigational Site

    Greenfield, Indiana, 46140

  • Novo Nordisk Investigational Site

    Greenville, North Carolina, 27834

  • Novo Nordisk Investigational Site

    Greer, South Carolina, 29651

  • Novo Nordisk Investigational Site

    Gurnee, Illinois, 60031

  • Novo Nordisk Investigational Site

    Hazelwood, Missouri, 63042

  • Novo Nordisk Investigational Site

    Hermitage, Pennsylvania, 16148

  • Novo Nordisk Investigational Site

    Hialeah, Florida, 33012

  • Novo Nordisk Investigational Site

    Hines, Illinois, 60141

  • Novo Nordisk Investigational Site

    Hoboken, New Jersey, 07030

  • Novo Nordisk Investigational Site

    Honolulu, Hawaii, 96814

  • Novo Nordisk Investigational Site

    Houston, Texas, 77008

  • Novo Nordisk Investigational Site

    Houston, Texas, 77024

  • Novo Nordisk Investigational Site

    Houston, Texas, 77029

  • Novo Nordisk Investigational Site

    Houston, Texas, 77060

  • Novo Nordisk Investigational Site

    Houston, Texas, 77061

  • Novo Nordisk Investigational Site

    Houston, Texas, 77070

  • Novo Nordisk Investigational Site

    Houston, Texas, 77093

  • Novo Nordisk Investigational Site

    Houston, Texas, 77099

  • Novo Nordisk Investigational Site

    Humble, Texas, 77338

  • Novo Nordisk Investigational Site

    Huntington Beach, California, 92648

  • Novo Nordisk Investigational Site

    Hurst, Texas, 76054

  • Novo Nordisk Investigational Site

    Hyattsville, Maryland, 20782

  • Novo Nordisk Investigational Site

    Idaho Falls, Idaho, 83404-7596

  • Novo Nordisk Investigational Site

    Indianapolis, Indiana, 46254

  • Novo Nordisk Investigational Site

    Inglewood, California, 90301

  • Novo Nordisk Investigational Site

    Irving, Texas, 75039

  • Novo Nordisk Investigational Site

    Jacksonville, Florida, 32207

  • Novo Nordisk Investigational Site

    Jacksonville, Florida, 32216

  • Novo Nordisk Investigational Site

    Jefferson City, Missouri, 65109

  • Novo Nordisk Investigational Site

    Kalamazoo, Michigan, 49009

  • Novo Nordisk Investigational Site

    Kalispell, Montana, 59901

  • Novo Nordisk Investigational Site

    Kansas City, Missouri, 64111

  • Novo Nordisk Investigational Site

    Kenosha, Wisconsin, 53144

  • Novo Nordisk Investigational Site

    Kingsport, Tennessee, 37660

  • Novo Nordisk Investigational Site

    Knoxville, Tennessee, 37938

  • Novo Nordisk Investigational Site

    La Jolla, California, 92037

  • Novo Nordisk Investigational Site

    La Mesa, California, 91942

  • Novo Nordisk Investigational Site

    Lake Success, New York, 11042

  • Novo Nordisk Investigational Site

    Lancaster, California, 93534

  • Novo Nordisk Investigational Site

    Las Vegas, Nevada, 89120

  • Novo Nordisk Investigational Site

    Las Vegas, Nevada, 89128

  • Novo Nordisk Investigational Site

    Las Vegas, Nevada, 89148

  • Novo Nordisk Investigational Site

    Lawrenceville, Georgia, 30046

  • Novo Nordisk Investigational Site

    Lewisville, Texas, 75067

  • Novo Nordisk Investigational Site

    Lexington, Kentucky, 40502

  • Novo Nordisk Investigational Site

    Lexington, Kentucky, 40503

  • Novo Nordisk Investigational Site

    Lexington, North Carolina, 27292

  • Novo Nordisk Investigational Site

    Litchfield Park, Arizona, 85340

  • Novo Nordisk Investigational Site

    Little Rock, Arkansas, 72205-5446

  • Novo Nordisk Investigational Site

    Little Rock, Arkansas, 72205

  • Novo Nordisk Investigational Site

    Livonia, Michigan, 48152

  • Novo Nordisk Investigational Site

    Long Beach, California, 90822

  • Novo Nordisk Investigational Site

    Longview, Texas, 75605

  • Novo Nordisk Investigational Site

    Los Alamitos, California, 90720

  • Novo Nordisk Investigational Site

    Louisville, Kentucky, 40206

  • Novo Nordisk Investigational Site

    Louisville, Kentucky, 40213

  • Novo Nordisk Investigational Site

    Lubbock, Texas, 79423

  • Novo Nordisk Investigational Site

    Madisonville, Kentucky, 42431

  • Novo Nordisk Investigational Site

    Maumee, Ohio, 43537

  • Novo Nordisk Investigational Site

    Memphis, Tennessee, 38119

  • Novo Nordisk Investigational Site

    Memphis, Tennessee, 38163

  • Novo Nordisk Investigational Site

    Mentor, Ohio, 44060

  • Novo Nordisk Investigational Site

    Miami, Florida, 33135

  • Novo Nordisk Investigational Site

    Miami, Florida, 33136

  • Novo Nordisk Investigational Site

    Miami, Florida, 33155

  • Novo Nordisk Investigational Site

    Miami, Florida, 33165

  • Novo Nordisk Investigational Site

    Miami, Florida, 33183

  • Novo Nordisk Investigational Site

    Michigan City, Indiana, 46360

  • Novo Nordisk Investigational Site

    Midland, Texas, 79707

  • Novo Nordisk Investigational Site

    Midlothian, Virginia, 23114

  • Novo Nordisk Investigational Site

    Milwaukee, Wisconsin, 53209

  • Novo Nordisk Investigational Site

    Milwaukee, Wisconsin, 53295

  • Novo Nordisk Investigational Site

    Mineola, New York, 11501

  • Novo Nordisk Investigational Site

    Mission Hills, California, 91345

  • Novo Nordisk Investigational Site

    Moncks Corner, South Carolina, 29461

  • Novo Nordisk Investigational Site

    Monroe, Louisiana, 71203

  • Novo Nordisk Investigational Site

    Montclair, California, 91763

  • Novo Nordisk Investigational Site

    Monterey, California, 93940

  • Novo Nordisk Investigational Site

    Montgomery, Alabama, 36106

  • Novo Nordisk Investigational Site

    Montgomery, Alabama, 36109

  • Novo Nordisk Investigational Site

    Morehead City, North Carolina, 28557

  • Novo Nordisk Investigational Site

    Muncie, Indiana, 47304

  • Novo Nordisk Investigational Site

    Murrells Inlet, South Carolina, 29576

  • Novo Nordisk Investigational Site

    Myrtle Beach, South Carolina, 29572

  • Novo Nordisk Investigational Site

    Naples, Florida, 34119

  • Novo Nordisk Investigational Site

    Nashua, New Hampshire, 03063

  • Novo Nordisk Investigational Site

    Nashville, Tennessee, 37203

  • Novo Nordisk Investigational Site

    Nashville, Tennessee, 37208

  • Novo Nordisk Investigational Site

    Nashville, Tennessee, 37212

  • Novo Nordisk Investigational Site

    New Bern, North Carolina, 28562

  • Novo Nordisk Investigational Site

    New Orleans, Louisiana, 70119

  • Novo Nordisk Investigational Site

    New Port Richey, Florida, 34652

  • Novo Nordisk Investigational Site

    New Windsor, New York, 12553

  • Novo Nordisk Investigational Site

    New York, New York, 10029

  • Novo Nordisk Investigational Site

    Norfolk, Virginia, 23510

  • Novo Nordisk Investigational Site

    Norman, Oklahoma, 73069

  • Novo Nordisk Investigational Site

    North Hollywood, California, 91606

  • Novo Nordisk Investigational Site

    North Massapequa, New York, 11758-1802

  • Novo Nordisk Investigational Site

    Northport, New York, 11768

  • Novo Nordisk Investigational Site

    Norwalk, Connecticut, 06851

  • Novo Nordisk Investigational Site

    Odessa, Texas, 79761

  • Novo Nordisk Investigational Site

    Oklahoma City, Oklahoma, 73104

  • Novo Nordisk Investigational Site

    Olive Branch, Mississippi, 38654

  • Novo Nordisk Investigational Site

    Omaha, Nebraska, 68105

  • Novo Nordisk Investigational Site

    Omaha, Nebraska, 68114

  • Novo Nordisk Investigational Site

    Omaha, Nebraska, 68124

  • Novo Nordisk Investigational Site

    Omaha, Nebraska, 68144

  • Novo Nordisk Investigational Site

    Omaha, Nebraska, 68198-4120

  • Novo Nordisk Investigational Site

    Orangeburg, South Carolina, 29118

  • Novo Nordisk Investigational Site

    Orlando, Florida, 32806

  • Novo Nordisk Investigational Site

    Palm Springs, California, 92262

  • Novo Nordisk Investigational Site

    Panama City, Florida, 32401

  • Novo Nordisk Investigational Site

    Pearland, Texas, 77584

  • Novo Nordisk Investigational Site

    Perrysburg, Ohio, 43551

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania, 19107

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania, 19114

  • Novo Nordisk Investigational Site

    Phoenix, Arizona, 85050

  • Novo Nordisk Investigational Site

    Pittsburgh, Pennsylvania, 15212

  • Novo Nordisk Investigational Site

    Pittsburgh, Pennsylvania, 15243

  • Novo Nordisk Investigational Site

    Ponte Vedra, Florida, 32081

  • Novo Nordisk Investigational Site

    Port Charlotte, Florida, 33952

  • Novo Nordisk Investigational Site

    Port Orange, Florida, 32127

  • Novo Nordisk Investigational Site

    Portland, Oregon, 97239-3098

  • Novo Nordisk Investigational Site

    Poway, California, 92064

  • Novo Nordisk Investigational Site

    Richardson, Texas, 75080

  • Novo Nordisk Investigational Site

    Richland, Washington, 99352

  • Novo Nordisk Investigational Site

    Richmond, Virginia, 23249

  • Novo Nordisk Investigational Site

    Rochester, New York, 14607

  • Novo Nordisk Investigational Site

    Rockville, Maryland, 20852

  • Novo Nordisk Investigational Site

    Roswell, Georgia, 30076

  • Novo Nordisk Investigational Site

    Round Rock, Texas, 78681

  • Novo Nordisk Investigational Site

    Salt Lake City, Utah, 84102

  • Novo Nordisk Investigational Site

    Salt Lake City, Utah, 84132

  • Novo Nordisk Investigational Site

    San Antonio, Texas, 78215

  • Novo Nordisk Investigational Site

    San Antonio, Texas, 78228-6205

  • Novo Nordisk Investigational Site

    San Antonio, Texas, 78229

  • Novo Nordisk Investigational Site

    San Antonio, Texas, 78258

  • Novo Nordisk Investigational Site

    San Diego, California, 92111

  • Novo Nordisk Investigational Site

    San Diego, California, 92120

  • Novo Nordisk Investigational Site

    San Ramon, California, 94583

  • Novo Nordisk Investigational Site

    Santa Ana, California, 92704

  • Novo Nordisk Investigational Site

    Savannah, Georgia, 31406

  • Novo Nordisk Investigational Site

    Searcy, Arkansas, 72143

  • Novo Nordisk Investigational Site

    Sherman Oaks, California, 91403

  • Novo Nordisk Investigational Site

    Shreveport, Louisiana, 71103

  • Novo Nordisk Investigational Site

    Slidell, Louisiana, 70461-4231

  • Novo Nordisk Investigational Site

    Smithfield, Pennsylvania, 15478

  • Novo Nordisk Investigational Site

    South Burlington, Vermont, 05403

  • Novo Nordisk Investigational Site

    South Miami, Florida, 33143

  • Novo Nordisk Investigational Site

    Spartanburg, South Carolina, 29303

  • Novo Nordisk Investigational Site

    Splendora, Texas, 77372

  • Novo Nordisk Investigational Site

    Spokane, Washington, 99201

  • Novo Nordisk Investigational Site

    Springfield, Illinois, 62702

  • Novo Nordisk Investigational Site

    Springfield, Illinois, 62711

  • Novo Nordisk Investigational Site

    Statesville, North Carolina, 28625

  • Novo Nordisk Investigational Site

    Sugar Land, Texas, 77478

  • Novo Nordisk Investigational Site

    Sugar Land, Texas, 77479

  • Novo Nordisk Investigational Site

    Tampa, Florida, 33619

  • Novo Nordisk Investigational Site

    Tampa, Florida, 33624

  • Novo Nordisk Investigational Site

    Thousand Oaks, California, 91360

  • Novo Nordisk Investigational Site

    Troy, Michigan, 48098

  • Novo Nordisk Investigational Site

    Tucson, Arizona, 85704

  • Novo Nordisk Investigational Site

    Tucson, Arizona, 85714

  • Novo Nordisk Investigational Site

    Tucson, Arizona, 85723

  • Novo Nordisk Investigational Site

    Tullahoma, Tennessee, 37388

  • Novo Nordisk Investigational Site

    Tustin, California, 92780

  • Novo Nordisk Investigational Site

    Uniontown, Pennsylvania, 15401

  • Novo Nordisk Investigational Site

    Upper Darby, Pennsylvania, 19082

  • Novo Nordisk Investigational Site

    Ventura, California, 93003

  • Novo Nordisk Investigational Site

    Vista, California, 92083

  • Novo Nordisk Investigational Site

    Waco, Texas, 76710

  • Novo Nordisk Investigational Site

    Waterbury, Connecticut, 06708

  • Novo Nordisk Investigational Site

    Watertown, Massachusetts, 02472

  • Novo Nordisk Investigational Site

    West Seneca, New York, 14224

  • Novo Nordisk Investigational Site

    Westfield, New York, 14787

  • Novo Nordisk Investigational Site

    Westminster, California, 92683

  • Novo Nordisk Investigational Site

    Whiteville, North Carolina, 28472

  • Novo Nordisk Investigational Site

    Wichita, Kansas, 67205

  • Novo Nordisk Investigational Site

    Wilkes-Barre, Pennsylvania, 18702

  • Novo Nordisk Investigational Site

    Wilmington, North Carolina, 28401

  • Novo Nordisk Investigational Site

    Winchester, Virginia, 22601-3834

  • Novo Nordisk Investigational Site

    Winston-Salem, North Carolina, 27103

  • Novo Nordisk Investigational Site

    Worcester, Massachusetts, 01655

Other trials in United States

India30 sites

  • Novo Nordisk Investigational Site

    Ahmedabad, Gujarat, 380006

  • Novo Nordisk Investigational Site

    Ahmedabad, Gujarat, 380007

  • Novo Nordisk Investigational Site

    Ahmedabad, Gujarat, 380016

  • Novo Nordisk Investigational Site

    Ahmedabad, Gujarat, 380052

  • Novo Nordisk Investigational Site

    Bangalore, Karnataka, 560 017

  • Novo Nordisk Investigational Site

    Bangalore, Karnataka, 560034

  • Novo Nordisk Investigational Site

    Bhubaneswar, Odisha, 751005

  • Novo Nordisk Investigational Site

    Chennai, Tamil Nadu, 600031

  • Novo Nordisk Investigational Site

    Chennai, Tamil Nadu, 600086

  • Novo Nordisk Investigational Site

    Coimbatore, Tamil Nadu, 641018

  • Novo Nordisk Investigational Site

    Goa, Maharashtra, 403 202

  • Novo Nordisk Investigational Site

    Gurgaon, Haryana, 122001

  • Novo Nordisk Investigational Site

    Hyderabad, Andhra Pradesh, 500034

  • Novo Nordisk Investigational Site

    Hyderbad, Andhra Pradesh, 500 012

  • Novo Nordisk Investigational Site

    Indore, Madhya Pradesh, 452010

  • Novo Nordisk Investigational Site

    Kolkata, West Bengal, 700020

  • Novo Nordisk Investigational Site

    Kolkata, West Bengal, 700054

  • Novo Nordisk Investigational Site

    Kozhikode, Kerala, 673017

  • Novo Nordisk Investigational Site

    Lucknow, Uttar Pradesh, 226014

  • Novo Nordisk Investigational Site

    Ludhiana, 141001

  • Novo Nordisk Investigational Site

    Mohali, Punjab, 160062

  • Novo Nordisk Investigational Site

    Mumbai, Maharashtra, 400007

  • Novo Nordisk Investigational Site

    Mumbai, Maharashtra, 400008

  • Novo Nordisk Investigational Site

    Mumbai, Maharashtra, 400010

  • Novo Nordisk Investigational Site

    Mumbai, Maharashtra, 400012

  • Novo Nordisk Investigational Site

    Mumbai, Maharashtra, 400022

  • Novo Nordisk Investigational Site

    New Dehli, New Delhi, 110029

  • Novo Nordisk Investigational Site

    New Delhi, 110001

  • Novo Nordisk Investigational Site

    Pune, Maharashtra, 411001

  • Novo Nordisk Investigational Site

    Pune, Maharashtra, 411040

Other trials in India

Russia22 sites

  • Novo Nordisk Investigational Site

    Kemerovo, 650002

  • Novo Nordisk Investigational Site

    Kirov, 610014

  • Novo Nordisk Investigational Site

    Krasnodar, 350012

  • Novo Nordisk Investigational Site

    Krasnodar, 350086

  • Novo Nordisk Investigational Site

    Moscow, 111539

  • Novo Nordisk Investigational Site

    Moscow, 123423

  • Novo Nordisk Investigational Site

    Nizhny Novgorod, 603018

  • Novo Nordisk Investigational Site

    Rostov-on-Don, 344068

  • Novo Nordisk Investigational Site

    Saint Petersburg, 191119

  • Novo Nordisk Investigational Site

    Saint Petersburg, 194354

  • Novo Nordisk Investigational Site

    Saint Petersburg, 194356

  • Novo Nordisk Investigational Site

    Saint Petersburg, 195213

  • Novo Nordisk Investigational Site

    Saint Petersburg, 196084

  • Novo Nordisk Investigational Site

    Saratov, 410031

  • Novo Nordisk Investigational Site

    Saratov, 410053

  • Novo Nordisk Investigational Site

    Syktyvkar, 167981

  • Novo Nordisk Investigational Site

    Tver', 170036

  • Novo Nordisk Investigational Site

    Tyumen, 625023

  • Novo Nordisk Investigational Site

    Ulyanovsk, 432063

  • Novo Nordisk Investigational Site

    Volgograd, 400131

  • Novo Nordisk Investigational Site

    Yaroslavl, 150010

  • Novo Nordisk Investigational Site

    Yekaterinburg, 620102

Other trials in Russia

South Africa15 sites

  • Novo Nordisk Investigational Site

    Brits, North West, 0250

  • Novo Nordisk Investigational Site

    Cape Town, Western Cape, 7130

  • Novo Nordisk Investigational Site

    Cape Town, Western Cape, 7460

  • Novo Nordisk Investigational Site

    Cape Town, Western Cape, 7500

  • Novo Nordisk Investigational Site

    Cape Town, Western Cape, 7700

  • Novo Nordisk Investigational Site

    Durban, KwaZulu-Natal, 4001

  • Novo Nordisk Investigational Site

    Durban, KwaZulu-Natal, 4092

  • Novo Nordisk Investigational Site

    eMkhomazi, KwaZulu-Natal, 4170

  • Novo Nordisk Investigational Site

    Johannesburg, Gauteng, 1818

  • Novo Nordisk Investigational Site

    Johannesburg, Gauteng, 2193

  • Novo Nordisk Investigational Site

    Johannesburg, Gauteng, 2198

  • Novo Nordisk Investigational Site

    Middleburg, Mpumalanga, 1055

  • Novo Nordisk Investigational Site

    Port Elizabeth, Eastern Cape, 6014

  • Novo Nordisk Investigational Site

    Port Elizabeth, Eastern Cape, 6045

  • Novo Nordisk Investigational Site

    Pretoria, Gauteng, 0001

Other trials in South Africa

Italy14 sites

  • Novo Nordisk Investigational Site

    Bari, 70124

  • Novo Nordisk Investigational Site

    Bergamo, 24127

  • Novo Nordisk Investigational Site

    Catanzaro, 88100

  • Novo Nordisk Investigational Site

    Chieti, 66100

  • Novo Nordisk Investigational Site

    Milan, 20122

  • Novo Nordisk Investigational Site

    Milan, 20162

  • Novo Nordisk Investigational Site

    Milano (MI), 20132

  • Novo Nordisk Investigational Site

    Olbia, 07026

  • Novo Nordisk Investigational Site

    Padova, 35143

  • Novo Nordisk Investigational Site

    Palermo, 90127

  • Novo Nordisk Investigational Site

    Ravenna, 48121

  • Novo Nordisk Investigational Site

    Roma, 00133

  • Novo Nordisk Investigational Site

    Roma, 00161

  • Novo Nordisk Investigational Site

    Sesto San Giovanni (MI), 20099

Other trials in Italy

Brazil11 sites

  • Novo Nordisk Investigational Site

    Aparecida de Goiânia, Goiás, 74935-530

  • Novo Nordisk Investigational Site

    Belém, Pará, 66073-000

  • Novo Nordisk Investigational Site

    Brasília, Federal District, 71625-009

  • Novo Nordisk Investigational Site

    Fortaleza, Ceará, 60115-282

  • Novo Nordisk Investigational Site

    Fortaleza, 60430-350

  • Novo Nordisk Investigational Site

    Mogi das Cruzes, São Paulo, 08780-090

  • Novo Nordisk Investigational Site

    Porto Alegre, 90035-170

  • Novo Nordisk Investigational Site

    São Paulo, São Paulo, 01223-001

  • Novo Nordisk Investigational Site

    São Paulo, São Paulo, 01228-000

  • Novo Nordisk Investigational Site

    São Paulo, São Paulo, 01228-200

  • Novo Nordisk Investigational Site

    São Paulo, São Paulo, 05403-000

Other trials in Brazil

Mexico10 sites

  • Novo Nordisk Investigational Site

    Aguascalientes, 20230

  • Novo Nordisk Investigational Site

    Chihuahua City, 31200

  • Novo Nordisk Investigational Site

    Cuernavaca, Morelos, 62250

  • Novo Nordisk Investigational Site

    Distrito Federal, México, D.F., 14080

  • Novo Nordisk Investigational Site

    Guadalajara, Jalisco, 44130

  • Novo Nordisk Investigational Site

    Guadalajara, Jalisco, 44150

  • Novo Nordisk Investigational Site

    Guadalajara, Jalisco, 44600

  • Novo Nordisk Investigational Site

    Guadalajara, Jalisco, 44650

  • Novo Nordisk Investigational Site

    Guadalajara, Jalisco, 44670

  • Novo Nordisk Investigational Site

    San Luis Potosí City, 78200

Other trials in Mexico

Japan8 sites

  • Novo Nordisk Investigational Site

    Chuo-ku, Tokyo, 103-0002

  • Novo Nordisk Investigational Site

    Kanagawa, 235-0045

  • Novo Nordisk Investigational Site

    Kumamoto, 862-0976

  • Novo Nordisk Investigational Site

    Miyazaki, 880-0034

  • Novo Nordisk Investigational Site

    Nagano, 390-8621

  • Novo Nordisk Investigational Site

    Ōta-ku, 144 0035

  • Novo Nordisk Investigational Site

    Ota-ku, Tokyo, 1430015

  • Novo Nordisk Investigational Site

    Shinjuku-ku, Tokyo, 162-8655

Other trials in Japan

Poland8 sites

  • Novo Nordisk Investigational Site

    Bytom, 41-902

  • Novo Nordisk Investigational Site

    Gdansk, 80-546

  • Novo Nordisk Investigational Site

    Krakow, 31-455

  • Novo Nordisk Investigational Site

    Oświęcim, 32-600

  • Novo Nordisk Investigational Site

    Poznan, 60-589

  • Novo Nordisk Investigational Site

    Szczecin, 70-506

  • Novo Nordisk Investigational Site

    Warsaw, 02-507

  • Novo Nordisk Investigational Site

    Zamość, 22-400

Other trials in Poland

United Kingdom8 sites

  • Novo Nordisk Investigational Site

    Bristol, BS10 5NB

  • Novo Nordisk Investigational Site

    Dundee, DD1 9SY

  • Novo Nordisk Investigational Site

    Edinburgh, EH4 2XU

  • Novo Nordisk Investigational Site

    Guildford, GU2 7XX

  • Novo Nordisk Investigational Site

    Norwich, NR4 7TJ

  • Novo Nordisk Investigational Site

    Nuneaton, CV10 7DJ

  • Novo Nordisk Investigational Site

    Stevenage, SG1 4AB

  • Novo Nordisk Investigational Site

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Malaysia7 sites

  • Novo Nordisk Investigational Site

    Alor Star, 05460

  • Novo Nordisk Investigational Site

    Kota Samarahan, 94300

  • Novo Nordisk Investigational Site

    Kuala Lumpur, 59100

  • Novo Nordisk Investigational Site

    Kuantan, 25100

  • Novo Nordisk Investigational Site

    Malacca, 75400

  • Novo Nordisk Investigational Site

    Serdang, 43000

  • Novo Nordisk Investigational Site

    Seremban, 70300

Other trials in Malaysia

Spain7 sites

  • Novo Nordisk Investigational Site

    Granada, 18003

  • Novo Nordisk Investigational Site

    Granada, 18012

  • Novo Nordisk Investigational Site

    Madrid, 28046

  • Novo Nordisk Investigational Site

    Málaga, 29006

  • Novo Nordisk Investigational Site

    Seville, 41009

  • Novo Nordisk Investigational Site

    Valencia, 46014

  • Novo Nordisk Investigational Site

    Valencia, 46015

Other trials in Spain

Canada6 sites

  • Novo Nordisk Investigational Site

    Chatham, Ontario, N7L 1C1

  • Novo Nordisk Investigational Site

    Edmonton, Alberta, T5J 3N4

  • Novo Nordisk Investigational Site

    Laval, Quebec, H7T 2P5

  • Novo Nordisk Investigational Site

    Ottawa, Ontario, K1K 4L2

  • Novo Nordisk Investigational Site

    Sarnia, Ontario, N7T 4X3

  • Novo Nordisk Investigational Site

    Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

Greece6 sites

  • Novo Nordisk Investigational Site

    Athens, GR-10552

  • Novo Nordisk Investigational Site

    Athens, GR-115 27

  • Novo Nordisk Investigational Site

    Athens, GR-11527

  • Novo Nordisk Investigational Site

    Athens, GR-17562

  • Novo Nordisk Investigational Site

    Thessaloniki, GR-54642

  • Novo Nordisk Investigational Site

    Thessaloniki, GR-57001

Other trials in Greece

Argentina5 sites

  • Novo Nordisk Investigational Site

    CABA, C1440AAD

  • Novo Nordisk Investigational Site

    Córdoba, 5000

  • Novo Nordisk Investigational Site

    Mar del Plata, B7600FZN

  • Novo Nordisk Investigational Site

    Rosario, S2000CUD

  • Novo Nordisk Investigational Site

    Zárate, B2800DGH

Other trials in Argentina

Croatia5 sites

  • Novo Nordisk Investigational Site

    Bjelovar, 43000

  • Novo Nordisk Investigational Site

    Osijek, 31 000

  • Novo Nordisk Investigational Site

    Slavonski Brod, 35 000

  • Novo Nordisk Investigational Site

    Zagreb, 10 000

  • Novo Nordisk Investigational Site

    Zagreb, 10000

Other trials in Croatia

Thailand5 sites

  • Novo Nordisk Investigational Site

    Bangkok, 10330

  • Novo Nordisk Investigational Site

    Bangkok, 10400

  • Novo Nordisk Investigational Site

    Bangkoknoi, Bangkok, 10700

  • Novo Nordisk Investigational Site

    Chiang Mai, 50200

  • Novo Nordisk Investigational Site

    Nakhon Ratchasima, 30000

Other trials in Thailand

Algeria4 sites

  • Novo Nordisk Investigational Site

    Algiers, 16000

  • Novo Nordisk Investigational Site

    Constantine, 25000

  • Novo Nordisk Investigational Site

    Oran, 31000

  • Novo Nordisk Investigational Site

    Sidi Bel Abbes, 22000

Other trials in Algeria

Romania4 sites

  • Novo Nordisk Investigational Site

    Alba Iulia, Alba, 510053

  • Novo Nordisk Investigational Site

    Baia Mare, Maramureş, 430222

  • Novo Nordisk Investigational Site

    Ploieşti, Prahova, 100163

  • Novo Nordisk Investigational Site

    Târgu Mureş, Mureș County, 540142

Other trials in Romania

South Korea4 sites

  • Novo Nordisk Investigational Site

    Goyang, 10380

  • Novo Nordisk Investigational Site

    Seoul, 02841

  • Novo Nordisk Investigational Site

    Seoul, 03080

  • Novo Nordisk Investigational Site

    Suwon-si, Gyeonggi-do, 16247

Other trials in South Korea

About this study

This trial is conducted globally. The aim of this trial is to compare cardiovascular safety of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of cardiovascular events.

Being tested
insulin degludec, insulin glargine
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • insulin degludecDrug

    Injected once daily subcutaneously (s.c., under the skin)

  • insulin glargineDrug

    Injected once daily subcutaneously (s.c., under the skin)

Study groups in NCT01959529
Study groupRoleWhat they receive
Insulin degludec (IDeg)ExperimentalAll subjects will continue their current antidiabetic therapy except for the basal insulin component (if any) that will be replaced by the investigational product.
Receives: Drug: insulin degludec
Insulin glargine (IGlar)Active comparatorAll subjects will continue their current antidiabetic therapy except for the basal insulin component (if any) that will be replaced by the investigational product.
Receives: Drug: insulin glargine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke

    Time from randomisation to first occurrence of an event adjudication committee (EAC)-confirmed 3-component major adverse cardiovascular event (MACE): cardiovascular death, non-fatal myocardial infarction, or nonfatal stroke. Events with EAC-confirmed onset date between randomisation and individual end of trial were included in the analyses. The number of subjects experiencing first EAC-confirmed MACEs, date between randomisation to the end of trial, both days included were presented. The trial was event driven and planned to last up to a maximum of 60.5 months. The actual trial duration (time from first subject first visit to last subject last visit) was 35.6 months. The maximum trial duration for a single subject was 33.1 months.

    Measured: From randomisation to individual end of trial date (maximum patient year observation: 2.75 years)

Secondary outcomes (3)

  1. Number of EAC-confirmed Severe Hypoglycaemic Episodes

    Number of severe hypoglycaemic episodes from week 0 to the last assessment (up to 35.6 months). The episode of severe hypoglycaemia is an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The trial was event driven and planned to last up to a maximum of 60.5 months. The actual trial duration (time from first subject first visit to last subject last visit) was 35.6 months. The maximum trial duration for a single subject was 33.1 months.

    Measured: From randomisation to individual end of trial (maximum patient year observation: 2.75 years)

  2. Occurrence of at Least One EAC Confirmed Severe Hypoglycaemic Episode Within a Subject (Yes/no)

    Occurrence of at least one EAC-confirmed severe hypoglycaemic episode within a subject from week 0 to the last assessment (up to 35.6 months). The episode of severe hypoglycaemia is an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions.

    Measured: From randomisation to individual end of trial date (maximum patient year observation: 2.75 years)

  3. Change in Glycosylated Haemoglobin (HbA1c)

    Mean change in HbA1c from week 0 to month 24.

    Measured: Randomisation to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2013 (estimated)
  2. Study start29 Oct 2013
  3. Primary completion16 Oct 2016
  4. Study completion16 Oct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
7,637 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01959529
Sponsor's protocol ID
EX1250-4080
Other IDs
2013-002371-17, U1111-1141-7614, JapicCTI-142464
Acronym
DEVOTE
Status last verified
Jul 2019
First submitted
8 Oct 2013
Last updated
24 Jul 2019
Data monitoring committee
Yes

Publications

  • Pollock RF, Heller S, Pieber TR, Woo V, Gundgaard J, Hallen N, Luckevich M, Tutkunkardas D, Zinman B; DEVOTE Study Group. Short-term cost-utility of degludec versus glargine U100 for patients with type 2 diabetes at high risk of hypoglycaemia and cardiovascular events: A Canadian setting (DEVOTE 9). Diabetes Obes Metab. 2019 Jul;21(7):1706-1714. doi: 10.1111/dom.13730. Epub 2019 Apr 14.

    PubMed 30924579

  • Pollock RF, Valentine WJ, Marso SP, Andersen A, Gundgaard J, Hallen N, Tutkunkardas D, Magnuson EA, Buse JB; DEVOTE study group. Long-term Cost-effectiveness of Insulin Degludec Versus Insulin Glargine U100 in the UK: Evidence from the Basal-bolus Subgroup of the DEVOTE Trial (DEVOTE 16). Appl Health Econ Health Policy. 2019 Oct;17(5):615-627. doi: 10.1007/s40258-019-00494-3.

    PubMed 31264138

  • Marso SP, McGuire DK, Zinman B, Poulter NR, Emerson SS, Pieber TR, Pratley RE, Haahr PM, Lange M, Frandsen KB, Rabol R, Buse JB. Design of DEVOTE (Trial Comparing Cardiovascular Safety of Insulin Degludec vs Insulin Glargine in Patients With Type 2 Diabetes at High Risk of Cardiovascular Events) - DEVOTE 1. Am Heart J. 2016 Sep;179:175-83. doi: 10.1016/j.ahj.2016.06.004. Epub 2016 Jun 18.

    PubMed 27595693

  • Marso SP, McGuire DK, Zinman B, Poulter NR, Emerson SS, Pieber TR, Pratley RE, Haahr PM, Lange M, Brown-Frandsen K, Moses A, Skibsted S, Kvist K, Buse JB; DEVOTE Study Group. Efficacy and Safety of Degludec versus Glargine in Type 2 Diabetes. N Engl J Med. 2017 Aug 24;377(8):723-732. doi: 10.1056/NEJMoa1615692. Epub 2017 Jun 12.

    PubMed 28605603

  • Zinman B, Marso SP, Poulter NR, Emerson SS, Pieber TR, Pratley RE, Lange M, Brown-Frandsen K, Moses A, Ocampo Francisco AM, Barner Lekdorf J, Kvist K, Buse JB; DEVOTE Study Group. Day-to-day fasting glycaemic variability in DEVOTE: associations with severe hypoglycaemia and cardiovascular outcomes (DEVOTE 2). Diabetologia. 2018 Jan;61(1):48-57. doi: 10.1007/s00125-017-4423-z. Epub 2017 Sep 15.

    PubMed 28913575

  • Pieber TR, Marso SP, McGuire DK, Zinman B, Poulter NR, Emerson SS, Pratley RE, Woo V, Heller S, Lange M, Brown-Frandsen K, Moses A, Barner Lekdorf J, Lehmann L, Kvist K, Buse JB; DEVOTE Study Group. DEVOTE 3: temporal relationships between severe hypoglycaemia, cardiovascular outcomes and mortality. Diabetologia. 2018 Jan;61(1):58-65. doi: 10.1007/s00125-017-4422-0. Epub 2017 Sep 15.

    PubMed 28913543

  • Pollock RF, Valentine WJ, Marso SP, Gundgaard J, Hallen N, Hansen LL, Tutkunkardas D, Buse JB; DEVOTE Study Group. DEVOTE 5: Evaluating the Short-Term Cost-Utility of Insulin Degludec Versus Insulin Glargine U100 in Basal-Bolus Regimens for Type 2 Diabetes in the UK. Diabetes Ther. 2018 Jun;9(3):1217-1232. doi: 10.1007/s13300-018-0430-4. Epub 2018 Apr 30.

    PubMed 29713962

  • Theilgaard H, Mollerup I, Helmark IC, Endahl L, Hoskin S, Hvelplund A, Amby LK, Moses AC. Developing, Planning and Conducting an Interim Analysis: Lessons From the DEVOTE Cardiovascular Outcomes Trial (Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Patients With Type 2 Diabetes at High Risk of Cardiovascular Events). Ther Innov Regul Sci. 2019 Mar;53(2):279-286. doi: 10.1177/2168479018776943. Epub 2018 May 24.

    PubMed 29793353

  • Brown-Frandsen K, Emerson SS, McGuire DK, Pieber TR, Poulter NR, Pratley RE, Zinman B, Ranthe MF, Gron R, Lange M, Moses AC, Orsy P, Buse JB; DEVOTE Study Group. Lower rates of cardiovascular events and mortality associated with liraglutide use in patients treated with basal insulin: A DEVOTE subanalysis (DEVOTE 10). Diabetes Obes Metab. 2019 Jun;21(6):1437-1444. doi: 10.1111/dom.13677. Epub 2019 Apr 1.

    PubMed 30793465

  • Pratley RE, Emerson SS, Franek E, Gilbert MP, Marso SP, McGuire DK, Pieber TR, Zinman B, Hansen CT, Hansen MV, Mark T, Moses AC, Buse JB; DEVOTE Study Group. Cardiovascular safety and lower severe hypoglycaemia of insulin degludec versus insulin glargine U100 in patients with type 2 diabetes aged 65 years or older: Results from DEVOTE (DEVOTE 7). Diabetes Obes Metab. 2019 Jul;21(7):1625-1633. doi: 10.1111/dom.13699. Epub 2019 Apr 15.

    PubMed 30850995

  • Bergenstal RM, Hachmann-Nielsen E, Kvist K, Peters AL, Tarp JM, Buse JB. Increased Derived Time in Range Is Associated with Reduced Risk of Major Adverse Cardiovascular Events, Severe Hypoglycemia, and Microvascular Events in Type 2 Diabetes: A Post Hoc Analysis of DEVOTE. Diabetes Technol Ther. 2023 Jun;25(6):378-383. doi: 10.1089/dia.2022.0447. Epub 2023 May 8.

    PubMed 37017470

  • Klein KR, Franek E, Marso S, Pieber TR, Pratley RE, Gowda A, Kvist K, Buse JB. Hemoglobin glycation index, calculated from a single fasting glucose value, as a prediction tool for severe hypoglycemia and major adverse cardiovascular events in DEVOTE. BMJ Open Diabetes Res Care. 2021 Nov;9(2):e002339. doi: 10.1136/bmjdrc-2021-002339.

    PubMed 34819298

  • Amod A, Buse JB, McGuire DK, Pieber TR, Pop-Busui R, Pratley RE, Zinman B, Hansen MB, Jia T, Mark T, Poulter NR; DEVOTE Study Group. Risk factors for kidney disorders in patients with type 2 diabetes at high cardiovascular risk: An exploratory analysis (DEVOTE 12). Diab Vasc Dis Res. 2020 Nov-Dec;17(6):1479164120970933. doi: 10.1177/1479164120970933.

    PubMed 33280425

  • Heller S, Lingvay I, Marso SP, Philis-Tsimikas A, Pieber TR, Poulter NR, Pratley RE, Hachmann-Nielsen E, Kvist K, Lange M, Moses AC, Andresen MT, Buse JB; DEVOTE Study Group. Risk of severe hypoglycaemia and its impact in type 2 diabetes in DEVOTE. Diabetes Obes Metab. 2020 Dec;22(12):2241-2247. doi: 10.1111/dom.14049. Epub 2020 Jul 9.

    PubMed 32250536

  • Pratley RE, Husain M, Lingvay I, Pieber TR, Mark T, Saevereid HA, Moller DV, Zinman B; DEVOTE Study Group. Heart failure with insulin degludec versus glargine U100 in patients with type 2 diabetes at high risk of cardiovascular disease: DEVOTE 14. Cardiovasc Diabetol. 2019 Nov 15;18(1):156. doi: 10.1186/s12933-019-0960-8.

    PubMed 31729990

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing insulin degludec and insulin glargine in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 446 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 446 sites in United States, India, Russia, South Africa, Italy and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (time frame: From randomisation to individual end of trial date (maximum patient year observation: 2.75 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01959529, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.

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