AzTrials
AzTrials

DiabetesPhase 3DUAL™ INCT01336023

Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes: A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Subjects With Type 2 Diabetes

A Phase 3 study testing insulin degludec/liraglutide, insulin degludec and liraglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 302 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 the efficacy and safety of insulin degludec/liraglutide (IDegLira) versus insulin degludec (IDeg) and liraglutide (Lira) in subjects with type 2 diabetes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes, Diabetes Mellitus, Type 2
What is being tested?
insulin degludec/liraglutide, insulin degludec and liraglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,663 participants
Where
302 sitesin 20 countries
Study dates
23 May 2011to 22 Nov 2012
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects with type 2 diabetes
  • HbA1c 7.0-10.0 % (both inclusive) with the aim of a median HbA1c of 8.3%. Accordingly, when approximately 50% of the randomised subjects have a HbA1c above 8.3%, the remaining subjects randomised must have a HbA1c of below or equal to 8.3%, or when approximately 50% of the randomised subjects have a HbA1c of below or equal to 8.3%, the remaining subjects randomised must have a HbA1c above 8.3%
  • Male or female, age 18 years or above (Taiwan: 20 years or above for a site 653 in Taiwan: Taichung Veterans General Hospital)
  • Subjects on stable dose of 1-2 OADs (metformin [at least 1500 mg or max tolerated dose] or metformin [at least 1500 mg or max tolerated dose] + pioglitazone [at least 30 mg]) for at least 90 days prior to screening
  • Body Mass Index (BMI) maximum 40 kg/m^2

Who cannot join

  • Treatment with insulin (except for short-term treatment due to intercurrent illness at the discretion of the Investigator)
  • Treatment with GLP-1 (glucagon-like peptide-1) receptor agonists (eg exenatide, liraglutide), sulphonylurea or dipeptidyl peptidase 4 (DPP-4) inhibitors within 90 days prior to trial
  • Impaired liver function, defined as alanine aminotransferese (ALAT) at least 2.5 times Upper Normal Range (UNR) (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive)
  • Impaired renal function defined as serum-creatinine at least 133 mcmol/l (at least 1.5 mg/dl) for males and at least 125 mcmol/l (at least 1.4) for females, or as allowed according to local contraindications for metformin (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive)
  • Screening calcitonin at least 50 ng/L
  • Subjects with personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2)
Show all 10Show fewer
  • Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 12 months and planned coronary, carotid or peripheral artery revascularisation procedures
  • Severe uncontrolled treated or untreated hypertension (systolic blood pressure at least 180 mm Hg or diastolic blood pressure at least 100 mm Hg)
  • Acute treatment required proliferative retinopathy or maculopathy (macular oedema)
  • History of chronic pancreatitis or idiopathic acute pancreatitis

Trial locations and contacts

302 sites in 20 countries.

302 sites in 20 countries

United States146 sites

  • Novo Nordisk Investigational Site

    Albany, New York, 12206

  • Novo Nordisk Investigational Site

    Anaheim, California, 92801

  • Novo Nordisk Investigational Site

    Asheboro, North Carolina, 27203

  • Novo Nordisk Investigational Site

    Asheville, North Carolina, 28801

  • Novo Nordisk Investigational Site

    Atlanta, Georgia, 30318

  • Novo Nordisk Investigational Site

    Avon, Illinois, 46123

  • Novo Nordisk Investigational Site

    Beaver, Pennsylvania, 15009

  • Novo Nordisk Investigational Site

    Bermuda Dunes, California, 92203

  • Novo Nordisk Investigational Site

    Birmingham, Alabama, 35216

  • Novo Nordisk Investigational Site

    Bridgeville, Pennsylvania, 15017

  • Novo Nordisk Investigational Site

    Buckley, Michigan, 49620

  • Novo Nordisk Investigational Site

    Burke, Virginia, 22015

  • Novo Nordisk Investigational Site

    Burlington, North Carolina, 27215

  • Novo Nordisk Investigational Site

    Canton, Ohio, 44718

  • Novo Nordisk Investigational Site

    Chapel Hill, North Carolina, 27517

  • Novo Nordisk Investigational Site

    Charlotte, North Carolina, 28277

  • Novo Nordisk Investigational Site

    Chattanooga, Tennessee, 37404

  • Novo Nordisk Investigational Site

    Chattanooga, Tennessee, 37411

  • Novo Nordisk Investigational Site

    Chesterfield, Missouri, 63017

  • Novo Nordisk Investigational Site

    Chicago, Illinois, 60607

  • Novo Nordisk Investigational Site

    Cincinnati, Ohio, 45224

  • Novo Nordisk Investigational Site

    Cincinnati, Ohio, 45242-4494

  • Novo Nordisk Investigational Site

    Cincinnati, Ohio, 45242

  • Novo Nordisk Investigational Site

    Clearwater, Florida, 33765

  • Novo Nordisk Investigational Site

    Cleveland, Ohio, 44113

  • Novo Nordisk Investigational Site

    Colorado Springs, Colorado, 80910

  • Novo Nordisk Investigational Site

    Columbia, South Carolina, 29201-2970

  • Novo Nordisk Investigational Site

    Columbus, Georgia, 31909

  • Novo Nordisk Investigational Site

    Columbus, Ohio, 43213

  • Novo Nordisk Investigational Site

    Concord, California, 94520

  • Novo Nordisk Investigational Site

    Conyers, Georgia, 30094-5965

  • Novo Nordisk Investigational Site

    Crestview Hills, Kentucky, 41017-3464

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75230

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75246

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75251

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75390-9302

  • Novo Nordisk Investigational Site

    Decatur, Georgia, 30035

  • Novo Nordisk Investigational Site

    Delray Beach, Florida, 33484

  • Novo Nordisk Investigational Site

    Denver, Colorado, 80209

  • Novo Nordisk Investigational Site

    DeSoto, Texas, 75115

  • Novo Nordisk Investigational Site

    East Providence, Rhode Island, 02914

  • Novo Nordisk Investigational Site

    Encino, California, 91436

  • Novo Nordisk Investigational Site

    Fair Oaks, California, 95628

  • Novo Nordisk Investigational Site

    Fishers, Indiana, 46038-1862

  • Novo Nordisk Investigational Site

    Flemington, New Jersey, 08822-5763

  • Novo Nordisk Investigational Site

    Fort Lauderdale, Florida, 33316

  • Novo Nordisk Investigational Site

    Fort Worth, Texas, 76113

  • Novo Nordisk Investigational Site

    Franklin, Indiana, 46131

  • Novo Nordisk Investigational Site

    Franklin, Ohio, 45005

  • Novo Nordisk Investigational Site

    Fresno, California, 93702

  • Novo Nordisk Investigational Site

    Golden, Colorado, 80401

  • Novo Nordisk Investigational Site

    Greenbrae, California, 94904

  • Novo Nordisk Investigational Site

    Greensboro, North Carolina, 27408

  • 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

    Henderson, Nevada, 89052-2649

  • Novo Nordisk Investigational Site

    Hialeah, Florida, 33012

  • Novo Nordisk Investigational Site

    Houston, Texas, 77004-7000

  • Novo Nordisk Investigational Site

    Houston, Texas, 77074

  • Novo Nordisk Investigational Site

    Houston, Texas, 77095

  • Novo Nordisk Investigational Site

    Hyattsville, Maryland, 20782

  • Novo Nordisk Investigational Site

    Indianapolis, Indiana, 46254

  • Novo Nordisk Investigational Site

    Irving, Texas, 75061-2210

  • Novo Nordisk Investigational Site

    Jacksonville, Florida, 32258

  • Novo Nordisk Investigational Site

    Kansas City, Missouri, 64111

  • Novo Nordisk Investigational Site

    Kettering, Ohio, 45429

  • Novo Nordisk Investigational Site

    Killeen, Texas, 76543-5600

  • Novo Nordisk Investigational Site

    Kingsport, Tennessee, 37660

  • Novo Nordisk Investigational Site

    Kissimmee, Florida, 34741

  • Novo Nordisk Investigational Site

    La Jolla, California, 92037

  • Novo Nordisk Investigational Site

    Las Vegas, Nevada, 89102

  • Novo Nordisk Investigational Site

    Lawrenceville, Georgia, 30046

  • Novo Nordisk Investigational Site

    Lexington, Kentucky, 40503

  • Novo Nordisk Investigational Site

    Long Beach, California, 90807

  • Novo Nordisk Investigational Site

    Los Angeles, California, 90057

  • Novo Nordisk Investigational Site

    Lubbock, Texas, 79423

  • Novo Nordisk Investigational Site

    Manassas, Virginia, 20110

  • Novo Nordisk Investigational Site

    Mason, Ohio, 45040-6815

  • Novo Nordisk Investigational Site

    Maumee, Ohio, 43537

  • Novo Nordisk Investigational Site

    Melbourne, Florida, 32934

  • Novo Nordisk Investigational Site

    Meridian, Idaho, 83646

  • Novo Nordisk Investigational Site

    Metairie, Louisiana, 70006-2930

  • Novo Nordisk Investigational Site

    Metairie, Louisiana, 70006

  • Novo Nordisk Investigational Site

    Miami, Florida, 33135

  • Novo Nordisk Investigational Site

    Miami, Florida, 33156

  • Novo Nordisk Investigational Site

    Michigan City, Indiana, 46360

  • Novo Nordisk Investigational Site

    Milwaukee, Wisconsin, 53209

  • Novo Nordisk Investigational Site

    Montclair, California, 91763

  • Novo Nordisk Investigational Site

    Monterey, California, 93940

  • Novo Nordisk Investigational Site

    Morehead City, North Carolina, 28557

  • Novo Nordisk Investigational Site

    Muncie, Indiana, 47304

  • Novo Nordisk Investigational Site

    Nampa, Idaho, 83686-6011

  • Novo Nordisk Investigational Site

    Nashua, New Hampshire, 03063

  • Novo Nordisk Investigational Site

    Newark, Delaware, 19713

  • Novo Nordisk Investigational Site

    Newport News, Virginia, 23606

  • Novo Nordisk Investigational Site

    Norristown, Pennsylvania, 19401

  • Novo Nordisk Investigational Site

    North East, Maryland, 21901

  • Novo Nordisk Investigational Site

    Northport, New York, 11768

  • Novo Nordisk Investigational Site

    O'Fallon, Illinois, 62246

  • Novo Nordisk Investigational Site

    Ogden, Utah, 84403

  • Novo Nordisk Investigational Site

    Oklahoma City, Oklahoma, 73104

  • Novo Nordisk Investigational Site

    Orange, California, 92868

  • Novo Nordisk Investigational Site

    Orlando, Florida, 32804

  • Novo Nordisk Investigational Site

    Pelzer, South Carolina, 29669

  • Novo Nordisk Investigational Site

    Pembroke Pines, Florida, 33027

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania, 19107

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania, 19152

  • Novo Nordisk Investigational Site

    Pittsburgh, Pennsylvania, 15224-2215

  • Novo Nordisk Investigational Site

    Pittsburgh, Pennsylvania, 15235

  • Novo Nordisk Investigational Site

    Poway, California, 92064

  • Novo Nordisk Investigational Site

    Rockville, Maryland, 20852

  • Novo Nordisk Investigational Site

    Roswell, Georgia, 30076

  • Novo Nordisk Investigational Site

    Saint Charles, Missouri, 63303

  • Novo Nordisk Investigational Site

    Salt Lake City, Utah, 84107

  • Novo Nordisk Investigational Site

    San Antonio, Texas, 78215

  • Novo Nordisk Investigational Site

    San Antonio, Texas, 78224

  • Novo Nordisk Investigational Site

    San Diego, California, 92111

  • Novo Nordisk Investigational Site

    San Diego, California, 92117

  • Novo Nordisk Investigational Site

    San Diego, California, 92161-0002

  • Novo Nordisk Investigational Site

    San Mateo, California, 94401

  • Novo Nordisk Investigational Site

    Santa Barbara, California, 93105

  • Novo Nordisk Investigational Site

    Shelby, North Carolina, 28152

  • Novo Nordisk Investigational Site

    Simpsonville, South Carolina, 29681

  • Novo Nordisk Investigational Site

    Southfield, Michigan, 48034-7661

  • Novo Nordisk Investigational Site

    Southfield, Michigan, 48075

  • Novo Nordisk Investigational Site

    Spartanburg, South Carolina, 29303

  • Novo Nordisk Investigational Site

    Spokane, Washington, 99208

  • Novo Nordisk Investigational Site

    St. George, Utah, 84790

  • Novo Nordisk Investigational Site

    Statesville, North Carolina, 28625

  • Novo Nordisk Investigational Site

    Sugar Land, Texas, 77478

  • Novo Nordisk Investigational Site

    Syracuse, New York, 13210

  • Novo Nordisk Investigational Site

    Tampa, Florida, 33603

  • Novo Nordisk Investigational Site

    Taylors, South Carolina, 29687

  • Novo Nordisk Investigational Site

    The Bronx, New York, 10461

  • Novo Nordisk Investigational Site

    Toms River, New Jersey, 08753-2975

  • Novo Nordisk Investigational Site

    Toms River, New Jersey, 08755-8050

  • Novo Nordisk Investigational Site

    Troy, Michigan, 48098

  • Novo Nordisk Investigational Site

    Tustin, California, 92780

  • Novo Nordisk Investigational Site

    Valencia, California, 91355

  • Novo Nordisk Investigational Site

    Virginia Beach, Virginia, 23462

  • Novo Nordisk Investigational Site

    Walnut Creek, California, 94598

  • Novo Nordisk Investigational Site

    Waterbury, Connecticut, 06708

  • Novo Nordisk Investigational Site

    West Seneca, New York, 14224

  • Novo Nordisk Investigational Site

    Winston-Salem, North Carolina, 27103

  • Novo Nordisk Investigational Site

    Woodstock, Georgia, 30189-4255

Other trials in United States

India23 sites

  • Novo Nordisk Investigational Site

    Ahmedabad, Gujarat, 380006

  • Novo Nordisk Investigational Site

    Bangalore, Karnataka, 560034

  • Novo Nordisk Investigational Site

    Bangalore, Karnataka, 560092

  • Novo Nordisk Investigational Site

    Bhubaneswar, Odisha, 751019

  • Novo Nordisk Investigational Site

    Chennai, Tamil Nadu, 600 013

  • Novo Nordisk Investigational Site

    Chennai, Tamil Nadu, 600028

  • Novo Nordisk Investigational Site

    Gurgaon, Haryana, 122001

  • Novo Nordisk Investigational Site

    Hyderabad, 600034

  • Novo Nordisk Investigational Site

    Indore, Madhya Pradesh, 452010

  • Novo Nordisk Investigational Site

    Jaipur, Rajasthan, 302006

  • Novo Nordisk Investigational Site

    Jaipur, Rajasthan, 302017

  • Novo Nordisk Investigational Site

    Kochi, Kerala, 682041

  • Novo Nordisk Investigational Site

    Kochi, Kerala, 695010

  • Novo Nordisk Investigational Site

    Kolkata, West Bengal, 700031

  • Novo Nordisk Investigational Site

    Kolkata, 700017

  • Novo Nordisk Investigational Site

    Mumbai, Maharashtra, 400008

  • Novo Nordisk Investigational Site

    Mumbai, Maharashtra, 400012

  • Novo Nordisk Investigational Site

    Patna, 800020

  • Novo Nordisk Investigational Site

    Pune, Maharashtra, 411 037

  • Novo Nordisk Investigational Site

    Pune, 411011

  • Novo Nordisk Investigational Site

    Thiruvanathapuram, Kerala, 695010

  • Novo Nordisk Investigational Site

    Trichy, Tamil Nadu, 620018

  • Novo Nordisk Investigational Site

    Trivandrum, Kerala, 695011

Other trials in India

United Kingdom17 sites

  • Novo Nordisk Investigational Site

    Belfast, BT16 1RH

  • Novo Nordisk Investigational Site

    Bury St Edmunds, IP33 2QZ

  • Novo Nordisk Investigational Site

    Carmarthen, SA31 2AF

  • Novo Nordisk Investigational Site

    Dundee, DD1 9SY

  • Novo Nordisk Investigational Site

    Edgbaston, Birmingham, B15 2TH

  • Novo Nordisk Investigational Site

    Fife, KY2 5AH

  • Novo Nordisk Investigational Site

    Glasgow, G45 9AW

  • Novo Nordisk Investigational Site

    Gloucester, GL1 3NN

  • Novo Nordisk Investigational Site

    Headington, OX3 7LE

  • Novo Nordisk Investigational Site

    Lancaster, LA1 4RP

  • Novo Nordisk Investigational Site

    Letchworth Garden City, SG6 4UB

  • Novo Nordisk Investigational Site

    Llantrisant, CF72 8XR

  • Novo Nordisk Investigational Site

    London, W6 7HY

  • Novo Nordisk Investigational Site

    St Helens, WA9 3DA

  • Novo Nordisk Investigational Site

    Stevenage, SG1 4AB

  • Novo Nordisk Investigational Site

    Weston-super-Mare, BS23 4TQ

  • Novo Nordisk Investigational Site

    Wrexham, LL13 7TD

Other trials in United Kingdom

Canada15 sites

  • Novo Nordisk Investigational Site

    Brampton, Ontario, L6T 0G1

  • Novo Nordisk Investigational Site

    Burlington, Ontario, L7R 1E2

  • Novo Nordisk Investigational Site

    Chilliwack, British Columbia, V2P 4M9

  • Novo Nordisk Investigational Site

    Cornwall, Ontario, K6H 4M4

  • Novo Nordisk Investigational Site

    Drummondville, Quebec, J2B 7T1

  • Novo Nordisk Investigational Site

    Edmonton, Alberta, T5J 3N4

  • Novo Nordisk Investigational Site

    Hamilton, Ontario, L8L 5G8

  • Novo Nordisk Investigational Site

    Hamilton, Ontario, L8M 1K7

  • Novo Nordisk Investigational Site

    Laval, Quebec, H7T 2P5

  • Novo Nordisk Investigational Site

    Mississauga, Ontario, L5M 2V8

  • Novo Nordisk Investigational Site

    Québec, G1G 3Y8

  • Novo Nordisk Investigational Site

    Québec, G1N 4V3

  • Novo Nordisk Investigational Site

    Toronto, Ontario, M3J 1N2

  • Novo Nordisk Investigational Site

    Vancouver, British Columbia, V5Z 1M9

  • Novo Nordisk Investigational Site

    Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

Germany14 sites

  • Novo Nordisk Investigational Site

    Bad Neuenahr-Ahrweiler, 53474

  • Novo Nordisk Investigational Site

    Eisenach, 99817

  • Novo Nordisk Investigational Site

    Esslingen am Neckar, 73728

  • Novo Nordisk Investigational Site

    Frankfurt, 60388

  • Novo Nordisk Investigational Site

    Grevenbroich, 41515

  • Novo Nordisk Investigational Site

    Hamburg, 21073

  • Novo Nordisk Investigational Site

    Herrenberg, 71083

  • Novo Nordisk Investigational Site

    Hohenmölsen, 06679

  • Novo Nordisk Investigational Site

    Münster, 48145

  • Novo Nordisk Investigational Site

    Oldenburg, 23758

  • Novo Nordisk Investigational Site

    Pohlheim, 35415

  • Novo Nordisk Investigational Site

    Rehburg-Loccum, 31547

  • Novo Nordisk Investigational Site

    Rehlingen-Siersburg, 66780

  • Novo Nordisk Investigational Site

    Stuttgart, 70378

Other trials in Germany

South Africa14 sites

  • Novo Nordisk Investigational Site

    Bloemfontein, Free State, 9301

  • Novo Nordisk Investigational Site

    Brits, North West, 0250

  • Novo Nordisk Investigational Site

    Cape Town, Western Cape, 7572

  • Novo Nordisk Investigational Site

    Durban, KwaZulu-Natal, 4001

  • Novo Nordisk Investigational Site

    Durban, KwaZulu-Natal, 4091

  • Novo Nordisk Investigational Site

    Durban, KwaZulu-Natal, 4126

  • Novo Nordisk Investigational Site

    Durban, KwaZulu-Natal, 4450

  • Novo Nordisk Investigational Site

    eMkhomazi, KwaZulu-Natal, 4170

  • Novo Nordisk Investigational Site

    Johannesburg, Gauteng, 1812

  • Novo Nordisk Investigational Site

    Johannesburg, Gauteng, 1827

  • Novo Nordisk Investigational Site

    Johannesburg, Gauteng, 2001

  • Novo Nordisk Investigational Site

    Johannesburg, Gauteng, 2198

  • Novo Nordisk Investigational Site

    Port Elizabeth, Eastern Cape, 6014

  • Novo Nordisk Investigational Site

    Vaderbijlpark, Gauteng, 1900

Other trials in South Africa

Russia11 sites

  • Novo Nordisk Investigational Site

    Kursk, 305035

  • Novo Nordisk Investigational Site

    Moscow, 119435

  • Novo Nordisk Investigational Site

    Moscow, 127411

  • Novo Nordisk Investigational Site

    Penza, 440026

  • Novo Nordisk Investigational Site

    Saint Petersburg, 194156

  • Novo Nordisk Investigational Site

    Saint Petersburg, 195257

  • Novo Nordisk Investigational Site

    Saint Petersburg, 199034

  • Novo Nordisk Investigational Site

    Saratov, 410053

  • Novo Nordisk Investigational Site

    Stavropol, 355017

  • Novo Nordisk Investigational Site

    Voronezh, 394018

  • Novo Nordisk Investigational Site

    Vsevolozhsk, 188643

Other trials in Russia

Australia8 sites

  • Novo Nordisk Investigational Site

    Broadmeadow, New South Wales, 2292

  • Novo Nordisk Investigational Site

    Camperdown, New South Wales, 2050

  • Novo Nordisk Investigational Site

    Coffs Harbour, New South Wales, 2450

  • Novo Nordisk Investigational Site

    East Ringwood, Victoria, 3135

  • Novo Nordisk Investigational Site

    Keswick, South Australia, 5035

  • Novo Nordisk Investigational Site

    Meadowbrook, Queensland, 4131

  • Novo Nordisk Investigational Site

    Melbourne, Victoria, 3004

  • Novo Nordisk Investigational Site

    Penrith, New South Wales, 2751

Other trials in Australia

Italy8 sites

  • Novo Nordisk Investigational Site

    Cosenza, 87100

  • Novo Nordisk Investigational Site

    Forlì, 47100

  • Novo Nordisk Investigational Site

    Monserrato, Cagliari, 09042

  • Novo Nordisk Investigational Site

    Novara, 28100

  • Novo Nordisk Investigational Site

    Olbia, 07026

  • Novo Nordisk Investigational Site

    Palermo, 90127

  • Novo Nordisk Investigational Site

    Siena, 53100

  • Novo Nordisk Investigational Site

    Torino, 10126

Other trials in Italy

Spain8 sites

  • Novo Nordisk Investigational Site

    A Coruña, 15006

  • Novo Nordisk Investigational Site

    Almería, 04001

  • Novo Nordisk Investigational Site

    Granada, 18012

  • Novo Nordisk Investigational Site

    Partida de Bacarot, 03114

  • Novo Nordisk Investigational Site

    Seville, 41003

  • Novo Nordisk Investigational Site

    Seville, 41010

  • Novo Nordisk Investigational Site

    Valencia, 46026

  • Novo Nordisk Investigational Site

    Valladolid, 47005

Other trials in Spain

Hungary7 sites

  • Novo Nordisk Investigational Site

    Budapest, 1041

  • Novo Nordisk Investigational Site

    Budapest, H-1212

  • Novo Nordisk Investigational Site

    Debrecen, 4043

  • Novo Nordisk Investigational Site

    Eger, 3300

  • Novo Nordisk Investigational Site

    Gyula, 5700

  • Novo Nordisk Investigational Site

    Pécs, 7623

  • Novo Nordisk Investigational Site

    Szeged, H-6720

Other trials in Hungary

Malaysia6 sites

  • Novo Nordisk Investigational Site

    Cheras, 56000

  • Novo Nordisk Investigational Site

    George Town, 10459

  • Novo Nordisk Investigational Site

    Kota Bharu, Kelantan, 16150

  • Novo Nordisk Investigational Site

    Pulau Pinang, 10990

  • Novo Nordisk Investigational Site

    Putrajaya, 62250

  • Novo Nordisk Investigational Site

    Seremban, 70300

Other trials in Malaysia

Finland5 sites

  • Novo Nordisk Investigational Site

    Hanko, 10900

  • Novo Nordisk Investigational Site

    Helsinki, 00180

  • Novo Nordisk Investigational Site

    Imatra, FI-55120

  • Novo Nordisk Investigational Site

    Kokkola, FI-67100

  • Novo Nordisk Investigational Site

    Oulu, 90100

Other trials in Finland

Slovakia4 sites

  • Novo Nordisk Investigational Site

    Bratislava, 821 03

  • Novo Nordisk Investigational Site

    Lučenec, 984 01

  • Novo Nordisk Investigational Site

    Moldava nad Bodvou, 045 01

  • Novo Nordisk Investigational Site

    Nové Zámky, 940 59

Other trials in Slovakia

Taiwan4 sites

  • Novo Nordisk Investigational Site

    Taichung, 407

  • Novo Nordisk Investigational Site

    Tainan, 710

  • Novo Nordisk Investigational Site

    Taipei, 100

  • Novo Nordisk Investigational Site

    Taoyuan, 333

Other trials in Taiwan

Thailand4 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

Other trials in Thailand

Singapore3 sites

  • Novo Nordisk Investigational Site

    Singapore, 119228

  • Novo Nordisk Investigational Site

    Singapore, 308433

  • Novo Nordisk Investigational Site

    Singapore, 768828

Other trials in Singapore

Ireland2 sites

  • Novo Nordisk Investigational Site

    Dublin, DUBLIN 7

  • Novo Nordisk Investigational Site

    Galway, H91 YR71

Other trials in Ireland

Mexico2 sites

  • Novo Nordisk Investigational Site

    Guadalajara, Jalisco, 44600

  • Novo Nordisk Investigational Site

    Monterrey, Nuevo León, 64460

Other trials in Mexico

Puerto Rico1 site

  • Novo Nordisk Investigational Site

    San Juan, 00921

Other trials in Puerto Rico

About this study

Official title: A 26 Week Randomised, Parallel Three-arm, Open-label, Multi-centre, Multinational Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide Versus Insulin Degludec or Liraglutide Alone, in Subjects With Type 2 Diabetes Treated With 1-2 Oral Anti-diabetic Drugs (OADs)With a 26 Week Extension

This trial is conducted globally. The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide (IDegLira) versus insulin degludec (IDeg) and liraglutide (Lira) in subjects with type 2 diabetes. Subjects are to continue their pre-trial treatment with metformin or metformin + pioglitazone throughout the entire trial.

Being tested
insulin degludec/liraglutide, insulin degludec, liraglutide
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 degludec/liraglutideDrug

    Insulin degludec/liraglutide treatment will be initiated and titrated (individually adjusted) twice weekly according to the mean self measured plasma glucose (SMPG) (fasting). Insulin degludec/liraglutide is injected subcutaneously (under the skin) once daily.

  • insulin degludecDrug

    Insulin degludec treatment will be initiated with 10 U and titrated (individually adjusted) twice weekly according to the mean SMPG (fasting). Insulin degludec is injected subcutaneously (under the skin) once daily.

  • liraglutideDrug

    Liraglutide will be started with 0.6 mg and subsequent 0.6 mg weekly dose escalation to 1.8 mg. Liraglutide dose of 1.8 mg/day will be continued for the remaining part of the trial. Liraglutide is injected subcutaneously (under the skin) once daily.

Study groups in NCT01336023
Study groupRoleWhat they receive
IDegExperimentalNot described
Receives: Drug: insulin degludec
IDegLiraExperimentalNot described
Receives: Drug: insulin degludec/liraglutide
LiraExperimentalNot described
Receives: Drug: liraglutide

What is being measured

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

  1. Mean Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 26.

    Values of mean change in HbA1c.

    Measured: Week 0, week 26

Secondary outcomes (4)

  1. Mean Change From Baseline in Body Weight at Week 26

    Values of mean change in body weight.

    Measured: Week 0, Week 26

  2. Number of Hypoglycaemic Episodes

    Reported hypoglycemaic episodes are number of hypoglycemic events per 100 patient years of exposure.

    Measured: Weeks 0-26

  3. Change From Baseline in Incremental Area Under the Curve 0-4h (iAUC0-4h) Derived From the Glucose Concentration Profile During Meal Test

    Values of mean change in normalised iAUC0-4h values based on LOCF data derived from the glucose concentration profiles during a meal test. The meal test was performed at selected sites at baseline and after 26 weeks of treatment in the main trial period. The incremental AUC was calculated using the trapezoidal method and the resulting area was divided length of the observation period to yield the (normalised) prandial increment in mmol/L using the available valid glucose observations and the associated actual elapsed time point.

    Measured: Week 0, Week 26

  4. Mean Actual Daily Insulin Dose

    Mean of the actual doses recorded at visit 28 (Week 26).

    Measured: Week 26

Timeline

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

  1. First posted15 Apr 2011 (estimated)
  2. Study start23 May 2011
  3. Primary completion24 May 2012
  4. Study completion22 Nov 2012

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
None (open label)
Enrolment
1,663 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01336023
Sponsor's protocol ID
NN9068-3697
Other IDs
U1111-1119-1174, 2010-021560-15
Acronym
DUAL™ I
Status last verified
Feb 2018
First submitted
13 Apr 2011
Last updated
19 Feb 2018
Data monitoring committee
No

Publications

  • Khunti K, Mohan V, Jain SM, Boesgaard TW, Begtrup K, Sethi B. Efficacy and Safety of IDegLira in Participants with Type 2 Diabetes in India Uncontrolled on Oral Antidiabetic Drugs and Basal Insulin: Data from the DUAL Clinical Trial Program. Diabetes Ther. 2017 Jun;8(3):673-682. doi: 10.1007/s13300-017-0252-9. Epub 2017 Mar 22.

    PubMed 28332144

  • Holst JJ, Buse JB, Rodbard HW, Linjawi S, Woo VC, Boesgaard TW, Kvist K, Gough SC. IDegLira Improves Both Fasting and Postprandial Glucose Control as Demonstrated Using Continuous Glucose Monitoring and a Standardized Meal Test. J Diabetes Sci Technol. 2015 Oct 6;10(2):389-97. doi: 10.1177/1932296815610124.

    PubMed 26443290

  • Vilsboll T, Vora J, Jarlov H, Kvist K, Blonde L. Type 2 Diabetes Patients Reach Target Glycemic Control Faster Using IDegLira than Either Insulin Degludec or Liraglutide Given Alone. Clin Drug Investig. 2016 Apr;36(4):293-303. doi: 10.1007/s40261-016-0376-0.

    PubMed 26894800

  • Gough SC, Bode B, Woo V, Rodbard HW, Linjawi S, Poulsen P, Damgaard LH, Buse JB; NN9068-3697 (DUAL-I) trial investigators. Efficacy and safety of a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with its components given alone: results of a phase 3, open-label, randomised, 26-week, treat-to-target trial in insulin-naive patients with type 2 diabetes. Lancet Diabetes Endocrinol. 2014 Nov;2(11):885-93. doi: 10.1016/S2213-8587(14)70174-3. Epub 2014 Sep 1.

    PubMed 25190523

  • Gough SC, Bode BW, Woo VC, Rodbard HW, Linjawi S, Zacho M, Reiter PD, Buse JB. One-year efficacy and safety of a fixed combination of insulin degludec and liraglutide in patients with type 2 diabetes: results of a 26-week extension to a 26-week main trial. Diabetes Obes Metab. 2015 Oct;17(10):965-73. doi: 10.1111/dom.12498. Epub 2015 Jul 1.

    PubMed 25980900

  • Kapitza C, Bode B, Ingwersen SH, Jacobsen LV, Poulsen P. Preserved pharmacokinetic exposure and distinct glycemic effects of insulin degludec and liraglutide in IDegLira, a fixed-ratio combination therapy. J Clin Pharmacol. 2015 Dec;55(12):1369-77. doi: 10.1002/jcph.549. Epub 2015 Jul 14.

    PubMed 25998481

  • King AB, Philis-Tsimikas A, Kilpatrick ES, Langbakke IH, Begtrup K, Vilsboll T. A Fixed Ratio Combination of Insulin Degludec and Liraglutide (IDegLira) Reduces Glycemic Fluctuation and Brings More Patients with Type 2 Diabetes Within Blood Glucose Target Ranges. Diabetes Technol Ther. 2017 Apr;19(4):255-264. doi: 10.1089/dia.2016.0405. Epub 2017 Mar 10.

    PubMed 28282219

  • Norwood P, Chen R, Jaeckel E, Lingvay I, Jarlov H, Lehmann L, Heller S. Rates of hypoglycaemia are lower in patients treated with insulin degludec/liraglutide (IDegLira) than with IDeg or insulin glargine, regardless of the hypoglycaemia definition used. Diabetes Obes Metab. 2017 Nov;19(11):1562-1569. doi: 10.1111/dom.12972. Epub 2017 Jul 10.

    PubMed 28417535

  • Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.

    PubMed 39963952

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing insulin degludec/liraglutide, insulin degludec and liraglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 302 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?

The sponsor lists 5 inclusion and 10 exclusion criteria. 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 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 302 sites in United States, India, United Kingdom, Canada, Germany 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 2 Jun 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?

Mean Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 26. (time frame: Week 0, week 26). 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 NCT01336023, which also lists 9 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 19 Feb 2018; AzTrials last refreshed its copy on 8 Nov 2026.

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