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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 (DUAL™ I)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01336023
First received: April 13, 2011
Last updated: April 26, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: insulin degludec/liraglutide Drug: insulin degludec Drug: liraglutide Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Mean Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 26. [ Time Frame: Week 0, week 26 ]
    Values of mean change in HbA1c.


Secondary Outcome Measures:
  • Mean Change From Baseline in Body Weight at Week 26 [ Time Frame: Week 0, Week 26 ]
    Values of mean change in body weight.

  • Number of Hypoglycaemic Episodes [ Time Frame: Weeks 0-26 ]
    Reported hypoglycemaic episodes are number of hypoglycemic events per 100 patient years of exposure.

  • Change From Baseline in Incremental Area Under the Curve 0-4h (iAUC0-4h) Derived From the Glucose Concentration Profile During Meal Test [ Time Frame: Week 0, Week 26 ]
    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.

  • Mean Actual Daily Insulin Dose [ Time Frame: Week 26 ]
    Mean of the actual doses recorded at visit 28 (Week 26).


Enrollment: 1663
Actual Study Start Date: May 23, 2011
Study Completion Date: November 22, 2012
Primary Completion Date: May 24, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDeg Drug: insulin degludec
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.
Experimental: IDegLira Drug: insulin degludec/liraglutide
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.
Experimental: Lira Drug: liraglutide
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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
  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: NCT01336023

  Hide Study Locations
Locations
United States, Alabama
Novo Nordisk Investigational Site
Birmingham, Alabama, United States, 35216
United States, California
Novo Nordisk Investigational Site
Anaheim, California, United States, 92801
Novo Nordisk Investigational Site
Bermuda Dunes, California, United States, 92203
Novo Nordisk Investigational Site
Concord, California, United States, 94520
Novo Nordisk Investigational Site
Encino, California, United States, 91436
Novo Nordisk Investigational Site
Fair Oaks, California, United States, 95628
Novo Nordisk Investigational Site
Fresno, California, United States, 93702
Novo Nordisk Investigational Site
Greenbrae, California, United States, 94904
Novo Nordisk Investigational Site
La Jolla, California, United States, 92037
Novo Nordisk Investigational Site
Long Beach, California, United States, 90807
Novo Nordisk Investigational Site
Los Angeles, California, United States, 90057
Novo Nordisk Investigational Site
Montclair, California, United States, 91763
Novo Nordisk Investigational Site
Monterey, California, United States, 93940
Novo Nordisk Investigational Site
Orange, California, United States, 92868
Novo Nordisk Investigational Site
Poway, California, United States, 92064
Novo Nordisk Investigational Site
San Diego, California, United States, 92111
Novo Nordisk Investigational Site
San Diego, California, United States, 92117
Novo Nordisk Investigational Site
San Diego, California, United States, 92161-0002
Novo Nordisk Investigational Site
San Mateo, California, United States, 94401
Novo Nordisk Investigational Site
Santa Barbara, California, United States, 93105
Novo Nordisk Investigational Site
Tustin, California, United States, 92780
Novo Nordisk Investigational Site
Valencia, California, United States, 91355
Novo Nordisk Investigational Site
Walnut Creek, California, United States, 94598
United States, Colorado
Novo Nordisk Investigational Site
Colorado Springs, Colorado, United States, 80910
Novo Nordisk Investigational Site
Denver, Colorado, United States, 80209
Novo Nordisk Investigational Site
Golden, Colorado, United States, 80401
United States, Connecticut
Novo Nordisk Investigational Site
Waterbury, Connecticut, United States, 06708
United States, Delaware
Novo Nordisk Investigational Site
Newark, Delaware, United States, 19713
United States, Florida
Novo Nordisk Investigational Site
Clearwater, Florida, United States, 33765
Novo Nordisk Investigational Site
Delray Beach, Florida, United States, 33484
Novo Nordisk Investigational Site
Fort Lauderdale, Florida, United States, 33316
Novo Nordisk Investigational Site
Hialeah, Florida, United States, 33012
Novo Nordisk Investigational Site
Jacksonville, Florida, United States, 32258
Novo Nordisk Investigational Site
Kissimmee, Florida, United States, 34741
Novo Nordisk Investigational Site
Melbourne, Florida, United States, 32934
Novo Nordisk Investigational Site
Miami, Florida, United States, 33135
Novo Nordisk Investigational Site
Miami, Florida, United States, 33156
Novo Nordisk Investigational Site
Orlando, Florida, United States, 32804
Novo Nordisk Investigational Site
Pembroke Pines, Florida, United States, 33027
Novo Nordisk Investigational Site
Tampa, Florida, United States, 33603
United States, Georgia
Novo Nordisk Investigational Site
Atlanta, Georgia, United States, 30318
Novo Nordisk Investigational Site
Columbus, Georgia, United States, 31909
Novo Nordisk Investigational Site
Conyers, Georgia, United States, 30094-5965
Novo Nordisk Investigational Site
Decatur, Georgia, United States, 30035
Novo Nordisk Investigational Site
Lawrenceville, Georgia, United States, 30046
Novo Nordisk Investigational Site
Roswell, Georgia, United States, 30076
Novo Nordisk Investigational Site
Woodstock, Georgia, United States, 30189-4255
United States, Idaho
Novo Nordisk Investigational Site
Meridian, Idaho, United States, 83646
Novo Nordisk Investigational Site
Nampa, Idaho, United States, 83686-6011
United States, Illinois
Novo Nordisk Investigational Site
Avon, Illinois, United States, 46123
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60607
Novo Nordisk Investigational Site
Gurnee, Illinois, United States, 60031
Novo Nordisk Investigational Site
O'Fallon, Illinois, United States, 62246
United States, Indiana
Novo Nordisk Investigational Site
Fishers, Indiana, United States, 46038-1862
Novo Nordisk Investigational Site
Franklin, Indiana, United States, 46131
Novo Nordisk Investigational Site
Indianapolis, Indiana, United States, 46254
Novo Nordisk Investigational Site
Michigan City, Indiana, United States, 46360
Novo Nordisk Investigational Site
Muncie, Indiana, United States, 47304
United States, Kentucky
Novo Nordisk Investigational Site
Crestview Hills, Kentucky, United States, 41017-3464
Novo Nordisk Investigational Site
Lexington, Kentucky, United States, 40503
United States, Louisiana
Novo Nordisk Investigational Site
Metairie, Louisiana, United States, 70006-2930
Novo Nordisk Investigational Site
Metairie, Louisiana, United States, 70006
United States, Maryland
Novo Nordisk Investigational Site
Hyattsville, Maryland, United States, 20782
Novo Nordisk Investigational Site
North East, Maryland, United States, 21901
Novo Nordisk Investigational Site
Rockville, Maryland, United States, 20852
United States, Michigan
Novo Nordisk Investigational Site
Buckley, Michigan, United States, 49620
Novo Nordisk Investigational Site
Southfield, Michigan, United States, 48034-7661
Novo Nordisk Investigational Site
Southfield, Michigan, United States, 48075
Novo Nordisk Investigational Site
Troy, Michigan, United States, 48098
United States, Missouri
Novo Nordisk Investigational Site
Chesterfield, Missouri, United States, 63017
Novo Nordisk Investigational Site
Kansas City, Missouri, United States, 64111
Novo Nordisk Investigational Site
Saint Charles, Missouri, United States, 63303
United States, Nevada
Novo Nordisk Investigational Site
Henderson, Nevada, United States, 89052-2649
Novo Nordisk Investigational Site
Las Vegas, Nevada, United States, 89102
United States, New Hampshire
Novo Nordisk Investigational Site
Nashua, New Hampshire, United States, 03063
United States, New Jersey
Novo Nordisk Investigational Site
Flemington, New Jersey, United States, 08822-5763
Novo Nordisk Investigational Site
Toms River, New Jersey, United States, 08753-2975
Novo Nordisk Investigational Site
Toms River, New Jersey, United States, 08755-8050
United States, New York
Novo Nordisk Investigational Site
Albany, New York, United States, 12206
Novo Nordisk Investigational Site
Northport, New York, United States, 11768
Novo Nordisk Investigational Site
Syracuse, New York, United States, 13210
Novo Nordisk Investigational Site
The Bronx, New York, United States, 10461
Novo Nordisk Investigational Site
West Seneca, New York, United States, 14224
United States, North Carolina
Novo Nordisk Investigational Site
Asheboro, North Carolina, United States, 27203
Novo Nordisk Investigational Site
Asheville, North Carolina, United States, 28801
Novo Nordisk Investigational Site
Burlington, North Carolina, United States, 27215
Novo Nordisk Investigational Site
Chapel Hill, North Carolina, United States, 27517
Novo Nordisk Investigational Site
Charlotte, North Carolina, United States, 28277
Novo Nordisk Investigational Site
Greensboro, North Carolina, United States, 27408
Novo Nordisk Investigational Site
Greenville, North Carolina, United States, 27834
Novo Nordisk Investigational Site
Morehead City, North Carolina, United States, 28557
Novo Nordisk Investigational Site
Shelby, North Carolina, United States, 28152
Novo Nordisk Investigational Site
Statesville, North Carolina, United States, 28625
Novo Nordisk Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Novo Nordisk Investigational Site
Canton, Ohio, United States, 44718
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States, 45224
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States, 45242-4494
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States, 45242
Novo Nordisk Investigational Site
Cleveland, Ohio, United States, 44113
Novo Nordisk Investigational Site
Columbus, Ohio, United States, 43213
Novo Nordisk Investigational Site
Franklin, Ohio, United States, 45005
Novo Nordisk Investigational Site
Kettering, Ohio, United States, 45429
Novo Nordisk Investigational Site
Mason, Ohio, United States, 45040-6815
Novo Nordisk Investigational Site
Maumee, Ohio, United States, 43537
United States, Oklahoma
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Novo Nordisk Investigational Site
Beaver, Pennsylvania, United States, 15009
Novo Nordisk Investigational Site
Bridgeville, Pennsylvania, United States, 15017
Novo Nordisk Investigational Site
Norristown, Pennsylvania, United States, 19401
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19107
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19152
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, United States, 15224-2215
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, United States, 15235
United States, Rhode Island
Novo Nordisk Investigational Site
East Providence, Rhode Island, United States, 02914
United States, South Carolina
Novo Nordisk Investigational Site
Columbia, South Carolina, United States, 29201-2970
Novo Nordisk Investigational Site
Greer, South Carolina, United States, 29651
Novo Nordisk Investigational Site
Pelzer, South Carolina, United States, 29669
Novo Nordisk Investigational Site
Simpsonville, South Carolina, United States, 29681
Novo Nordisk Investigational Site
Spartanburg, South Carolina, United States, 29303
Novo Nordisk Investigational Site
Taylors, South Carolina, United States, 29687
United States, Tennessee
Novo Nordisk Investigational Site
Chattanooga, Tennessee, United States, 37404
Novo Nordisk Investigational Site
Chattanooga, Tennessee, United States, 37411
Novo Nordisk Investigational Site
Kingsport, Tennessee, United States, 37660
United States, Texas
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75230
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75246
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75251
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75390-9302
Novo Nordisk Investigational Site
DeSoto, Texas, United States, 75115
Novo Nordisk Investigational Site
Fort Worth, Texas, United States, 76113
Novo Nordisk Investigational Site
Houston, Texas, United States, 77004-7000
Novo Nordisk Investigational Site
Houston, Texas, United States, 77074
Novo Nordisk Investigational Site
Houston, Texas, United States, 77095
Novo Nordisk Investigational Site
Irving, Texas, United States, 75061-2210
Novo Nordisk Investigational Site
Killeen, Texas, United States, 76543-5600
Novo Nordisk Investigational Site
Lubbock, Texas, United States, 79423
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78215
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78224
Novo Nordisk Investigational Site
Sugar Land, Texas, United States, 77478
United States, Utah
Novo Nordisk Investigational Site
Ogden, Utah, United States, 84403
Novo Nordisk Investigational Site
Saint George, Utah, United States, 84790
Novo Nordisk Investigational Site
Salt Lake City, Utah, United States, 84107
United States, Virginia
Novo Nordisk Investigational Site
Burke, Virginia, United States, 22015
Novo Nordisk Investigational Site
Manassas, Virginia, United States, 20110
Novo Nordisk Investigational Site
Newport News, Virginia, United States, 23606
Novo Nordisk Investigational Site
Virginia Beach, Virginia, United States, 23462
United States, Washington
Novo Nordisk Investigational Site
Spokane, Washington, United States, 99208
United States, Wisconsin
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, United States, 53209
Australia, New South Wales
Novo Nordisk Investigational Site
Broadmeadow, New South Wales, Australia, 2292
Novo Nordisk Investigational Site
Camperdown, New South Wales, Australia, 2050
Novo Nordisk Investigational Site
Coffs Harbour, New South Wales, Australia, 2450
Novo Nordisk Investigational Site
Penrith, New South Wales, Australia, 2751
Australia, Queensland
Novo Nordisk Investigational Site
Meadowbrook, Queensland, Australia, 4131
Australia, South Australia
Novo Nordisk Investigational Site
Keswick, South Australia, Australia, 5035
Australia, Victoria
Novo Nordisk Investigational Site
East Ringwood, Victoria, Australia, 3135
Novo Nordisk Investigational Site
Melbourne, Victoria, Australia, 3004
Canada, Alberta
Novo Nordisk Investigational Site
Edmonton, Alberta, Canada, T5J 3N4
Canada, British Columbia
Novo Nordisk Investigational Site
Chilliwack, British Columbia, Canada, V2P 4M9
Novo Nordisk Investigational Site
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Manitoba
Novo Nordisk Investigational Site
Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Ontario
Novo Nordisk Investigational Site
Brampton, Ontario, Canada, L6T 0G1
Novo Nordisk Investigational Site
Burlington, Ontario, Canada, L7R 1E2
Novo Nordisk Investigational Site
Cornwall, Ontario, Canada, K6H 4M4
Novo Nordisk Investigational Site
Hamilton, Ontario, Canada, L8L 5G8
Novo Nordisk Investigational Site
Hamilton, Ontario, Canada, L8M 1K7
Novo Nordisk Investigational Site
Mississauga, Ontario, Canada, L5M 2V8
Novo Nordisk Investigational Site
Toronto, Ontario, Canada, M3J 1N2
Canada, Quebec
Novo Nordisk Investigational Site
Drummondville, Quebec, Canada, J2B 7T1
Novo Nordisk Investigational Site
Laval, Quebec, Canada, H7T 2P5
Canada
Novo Nordisk Investigational Site
Quebec, Canada, G1G 3Y8
Novo Nordisk Investigational Site
Quebec, Canada, G1N 4V3
Finland
Novo Nordisk Investigational Site
Hanko, Finland, 10900
Novo Nordisk Investigational Site
Helsinki, Finland, 00180
Novo Nordisk Investigational Site
Imatra, Finland, FI-55120
Novo Nordisk Investigational Site
Kokkola, Finland, FI-67100
Novo Nordisk Investigational Site
Oulu, Finland, 90100
Germany
Novo Nordisk Investigational Site
Bad Neuenahr-Ahrweiler, Germany, 53474
Novo Nordisk Investigational Site
Eisenach, Germany, 99817
Novo Nordisk Investigational Site
Esslingen, Germany, 73728
Novo Nordisk Investigational Site
Frankfurt, Germany, 60388
Novo Nordisk Investigational Site
Grevenbroich, Germany, 41515
Novo Nordisk Investigational Site
Hamburg, Germany, 21073
Novo Nordisk Investigational Site
Herrenberg, Germany, 71083
Novo Nordisk Investigational Site
Hohenmölsen, Germany, 06679
Novo Nordisk Investigational Site
Münster, Germany, 48145
Novo Nordisk Investigational Site
Oldenburg, Germany, 23758
Novo Nordisk Investigational Site
Pohlheim, Germany, 35415
Novo Nordisk Investigational Site
Rehburg-Loccum, Germany, 31547
Novo Nordisk Investigational Site
Rehlingen-Siersburg, Germany, 66780
Novo Nordisk Investigational Site
Stuttgart, Germany, 70378
Hungary
Novo Nordisk Investigational Site
Budapest, Hungary, 1041
Novo Nordisk Investigational Site
Budapest, Hungary, H-1212
Novo Nordisk Investigational Site
Debrecen, Hungary, 4043
Novo Nordisk Investigational Site
Eger, Hungary, 3300
Novo Nordisk Investigational Site
Gyula, Hungary, 5700
Novo Nordisk Investigational Site
Pécs, Hungary, 7623
Novo Nordisk Investigational Site
Szeged, Hungary, H-6720
India
Novo Nordisk Investigational Site
Ahmedabad, Gujarat, India, 380006
Novo Nordisk Investigational Site
Gurgaon, Haryana, India, 122001
Novo Nordisk Investigational Site
Bangalore, Karnataka, India, 560034
Novo Nordisk Investigational Site
Bangalore, Karnataka, India, 560092
Novo Nordisk Investigational Site
Cochin, Kerala, India, 695010
Novo Nordisk Investigational Site
Kochi, Kerala, India, 682041
Novo Nordisk Investigational Site
Thiruvanathapuram, Kerala, India, 695010
Novo Nordisk Investigational Site
Trivandrum, Kerala, India, 695011
Novo Nordisk Investigational Site
Indore, Madhya Pradesh, India, 452010
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India, 400008
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India, 400012
Novo Nordisk Investigational Site
Pune, Maharashtra, India, 411 037
Novo Nordisk Investigational Site
Bhubaneswar, Orissa, India, 751019
Novo Nordisk Investigational Site
Jaipur, Rajasthan, India, 302006
Novo Nordisk Investigational Site
Jaipur, Rajasthan, India, 302017
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, India, 600 013
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, India, 600028
Novo Nordisk Investigational Site
Trichy, Tamil Nadu, India, 620018
Novo Nordisk Investigational Site
Kolkatta, West Bengal, India, 700031
Novo Nordisk Investigational Site
Hyderabad, India, 600034
Novo Nordisk Investigational Site
Kolkata, India, 700017
Novo Nordisk Investigational Site
Patna, India, 800020
Novo Nordisk Investigational Site
Pune, India, 411011
Ireland
Novo Nordisk Investigational Site
Dublin, Ireland, DUBLIN 7
Novo Nordisk Investigational Site
Galway, Ireland, H91 YR71
Italy
Novo Nordisk Investigational Site
Cosenza, Italy, 87100
Novo Nordisk Investigational Site
Forlì, Italy, 47100
Novo Nordisk Investigational Site
Monserrato, Cagliari, Italy, 09042
Novo Nordisk Investigational Site
Novara, Italy, 28100
Novo Nordisk Investigational Site
Olbia, Italy, 07026
Novo Nordisk Investigational Site
Palermo, Italy, 90127
Novo Nordisk Investigational Site
Siena, Italy, 53100
Novo Nordisk Investigational Site
Torino, Italy, 10126
Malaysia
Novo Nordisk Investigational Site
Cheras, Malaysia, 56000
Novo Nordisk Investigational Site
Kota Bharu, Kelantan, Malaysia, 16150
Novo Nordisk Investigational Site
Penang, Malaysia, 10459
Novo Nordisk Investigational Site
Pulau Pinang, Malaysia, 10990
Novo Nordisk Investigational Site
Putrajaya, Malaysia, 62250
Novo Nordisk Investigational Site
Seremban, Malaysia, 70300
Mexico
Novo Nordisk Investigational Site
Guadalajara, Jalisco, Mexico, 44600
Novo Nordisk Investigational Site
Monterrey, Nuevo León, Mexico, 64460
Puerto Rico
Novo Nordisk Investigational Site
San Juan, Puerto Rico, 00921
Russian Federation
Novo Nordisk Investigational Site
Kursk, Russian Federation, 305035
Novo Nordisk Investigational Site
Moscow, Russian Federation, 119435
Novo Nordisk Investigational Site
Moscow, Russian Federation, 127411
Novo Nordisk Investigational Site
Penza, Russian Federation, 440026
Novo Nordisk Investigational Site
Saint-Petersburg, Russian Federation, 194156
Novo Nordisk Investigational Site
Saint-Petersburg, Russian Federation, 195257
Novo Nordisk Investigational Site
Saint-Petersburg, Russian Federation, 199034
Novo Nordisk Investigational Site
Saratov, Russian Federation, 410053
Novo Nordisk Investigational Site
Stavropol, Russian Federation, 355017
Novo Nordisk Investigational Site
Voronezh, Russian Federation, 394018
Novo Nordisk Investigational Site
Vsevolozhsk, Russian Federation, 188643
Singapore
Novo Nordisk Investigational Site
Singapore, Singapore, 119228
Novo Nordisk Investigational Site
Singapore, Singapore, 308433
Novo Nordisk Investigational Site
Singapore, Singapore, 768828
Slovakia
Novo Nordisk Investigational Site
Bratislava, Slovakia, 821 03
Novo Nordisk Investigational Site
Lucenec, Slovakia, 984 01
Novo Nordisk Investigational Site
Moldava nad Bodvou, Slovakia, 045 01
Novo Nordisk Investigational Site
Nove Zamky, Slovakia, 940 59
South Africa
Novo Nordisk Investigational Site
Port Elizabeth, Eastern Cape, South Africa, 6014
Novo Nordisk Investigational Site
Bloemfontein, Free State, South Africa, 9301
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa, 1812
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa, 1827
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa, 2001
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa, 2198
Novo Nordisk Investigational Site
Vaderbijlpark, Gauteng, South Africa, 1900
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, South Africa, 4001
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, South Africa, 4091
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, South Africa, 4126
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, South Africa, 4450
Novo Nordisk Investigational Site
Umkomaas, KwaZulu-Natal, South Africa, 4170
Novo Nordisk Investigational Site
Brits, North West, South Africa, 0250
Novo Nordisk Investigational Site
Cape Town, Western Cape, South Africa, 7572
Spain
Novo Nordisk Investigational Site
Almería, Spain, 04001
Novo Nordisk Investigational Site
Granada, Spain, 18012
Novo Nordisk Investigational Site
La Coruña, Spain, 15006
Novo Nordisk Investigational Site
Partida de Bacarot, Spain, 03114
Novo Nordisk Investigational Site
Sevilla, Spain, 41003
Novo Nordisk Investigational Site
Sevilla, Spain, 41010
Novo Nordisk Investigational Site
Valencia, Spain, 46026
Novo Nordisk Investigational Site
Valladolid, Spain, 47005
Taiwan
Novo Nordisk Investigational Site
Taichung City, Taiwan, 407
Novo Nordisk Investigational Site
Tainan city, Taiwan, 710
Novo Nordisk Investigational Site
Taipei, Taiwan, 100
Novo Nordisk Investigational Site
Taoyuan, Taiwan, 333
Thailand
Novo Nordisk Investigational Site
Bangkoknoi, Bangkok, Thailand, 10700
Novo Nordisk Investigational Site
Bangkok, Thailand, 10330
Novo Nordisk Investigational Site
Bangkok, Thailand, 10400
Novo Nordisk Investigational Site
Chiang Mai, Thailand, 50200
United Kingdom
Novo Nordisk Investigational Site
Belfast, United Kingdom, BT16 1RH
Novo Nordisk Investigational Site
Bury St Edmunds, United Kingdom, IP33 2QZ
Novo Nordisk Investigational Site
Carmarthen, United Kingdom, SA31 2AF
Novo Nordisk Investigational Site
Dundee, United Kingdom, DD1 9SY
Novo Nordisk Investigational Site
Edgbaston, Birmingham, United Kingdom, B15 2TH
Novo Nordisk Investigational Site
Fife, United Kingdom, KY2 5AH
Novo Nordisk Investigational Site
Glasgow, United Kingdom, G45 9AW
Novo Nordisk Investigational Site
Gloucester, United Kingdom, GL1 3NN
Novo Nordisk Investigational Site
Headington, United Kingdom, OX3 7LE
Novo Nordisk Investigational Site
Lancaster, United Kingdom, LA1 4RP
Novo Nordisk Investigational Site
Letchworth, United Kingdom, SG6 4UB
Novo Nordisk Investigational Site
Llantrisant, United Kingdom, CF72 8XR
Novo Nordisk Investigational Site
London, United Kingdom, W6 7HY
Novo Nordisk Investigational Site
St Helens, United Kingdom, WA9 3DA
Novo Nordisk Investigational Site
Stevenage, United Kingdom, SG1 4AB
Novo Nordisk Investigational Site
Weston Super Mare, United Kingdom, BS23 4TQ
Novo Nordisk Investigational Site
Wrexham, United Kingdom, LL13 7TD
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01336023     History of Changes
Other Study ID Numbers: NN9068-3697
U1111-1119-1174 ( Other Identifier: WHO )
2010-021560-15 ( EudraCT Number )
Study First Received: April 13, 2011
Results First Received: December 12, 2016
Last Updated: April 26, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Liraglutide
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 27, 2017