Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01959529
First received: October 8, 2013
Last updated: November 4, 2016
Last verified: November 2016
  Purpose
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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 38 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of severe hypoglycaemic episodes [ Time Frame: Week 0 to the last assessment (38 months) ] [ Designated as safety issue: No ]
  • Change in Glycosylated haemoglobin (HbA1c) [ Time Frame: Week 0 to the last assessment (37 months) ] [ Designated as safety issue: No ]

Enrollment: 7637
Study Start Date: October 2013
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin degludec (IDeg)
All subjects will continue their current antidiabetic therapy except for the basal insulin component (if any) that will be replaced by the investigational product.
Drug: insulin degludec
Injected once daily subcutaneously (s.c., under the skin)
Active Comparator: Insulin glargine (IGlar)
All subjects will continue their current antidiabetic therapy except for the basal insulin component (if any) that will be replaced by the investigational product.
Drug: insulin glargine
Injected once daily subcutaneously (s.c., under the skin)

  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  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: NCT01959529

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Locations
United States, Alabama
Novo Nordisk Investigational Site
Birmingham, Alabama, United States, 35216
Novo Nordisk Investigational Site
Birmingham, Alabama, United States, 35294
Novo Nordisk Investigational Site
Montgomery, Alabama, United States, 36106
Novo Nordisk Investigational Site
Montgomery, Alabama, United States, 36109
United States, Arizona
Novo Nordisk Investigational Site
Gilbert, Arizona, United States, 85295
Novo Nordisk Investigational Site
Glendale, Arizona, United States, 85308
Novo Nordisk Investigational Site
Litchfield Park, Arizona, United States, 85340
Novo Nordisk Investigational Site
Phoenix, Arizona, United States, 85020
Novo Nordisk Investigational Site
Tucson, Arizona, United States, 85704
Novo Nordisk Investigational Site
Tucson, Arizona, United States, 85714
Novo Nordisk Investigational Site
Tuscon, Arizona, United States, 85723
United States, Arkansas
Novo Nordisk Investigational Site
Little Rock, Arkansas, United States, 72205-5446
Novo Nordisk Investigational Site
Little Rock, Arkansas, United States, 72205
Novo Nordisk Investigational Site
Searcy, Arkansas, United States, 72143
United States, California
Novo Nordisk Investigational Site
Chula Vista, California, United States, 91910
Novo Nordisk Investigational Site
Concord, California, United States, 94520
Novo Nordisk Investigational Site
Downey, California, United States, 90242
Novo Nordisk Investigational Site
Duarte, California, United States, 91010
Novo Nordisk Investigational Site
Encino, California, United States, 91436
Novo Nordisk Investigational Site
Fresno, California, United States, 93720
Novo Nordisk Investigational Site
Greenbrae, California, United States, 94904
Novo Nordisk Investigational Site
Huntington Beach, California, United States, 92648
Novo Nordisk Investigational Site
Inglewood, California, United States, 90301
Novo Nordisk Investigational Site
La Jolla, California, United States, 92037
Novo Nordisk Investigational Site
La Mesa, California, United States, 91942
Novo Nordisk Investigational Site
Lancaster, California, United States, 93534
Novo Nordisk Investigational Site
Long Beach, California, United States, 90822
Novo Nordisk Investigational Site
Los Alamitos, California, United States, 90720
Novo Nordisk Investigational Site
Mission Hills, California, United States, 91345
Novo Nordisk Investigational Site
Montclair, California, United States, 91763
Novo Nordisk Investigational Site
Monterey, California, United States, 93940
Novo Nordisk Investigational Site
North Hollywood, California, United States, 91606
Novo Nordisk Investigational Site
Palm Springs, California, United States, 92262-6972
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, 92120
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San Ramon, California, United States, 94583
Novo Nordisk Investigational Site
Santa Ana, California, United States, 92704
Novo Nordisk Investigational Site
Sherman Oaks, California, United States, 91403
Novo Nordisk Investigational Site
Thousand Oaks, California, United States, 91360
Novo Nordisk Investigational Site
Tustin, California, United States, 92780
Novo Nordisk Investigational Site
Ventura, California, United States, 93003
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Vista, California, United States, 92083
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Westminster, California, United States, 92683
United States, Colorado
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Colorado Springs, Colorado, United States, 80909
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Denver, Colorado, United States, 80209
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Denver, Colorado, United States, 80220
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Golden, Colorado, United States, 80401
United States, Connecticut
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Danbury, Connecticut, United States, 06810
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Norwalk, Connecticut, United States, 06851
Novo Nordisk Investigational Site
Waterbury, Connecticut, United States, 06708
United States, Florida
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Boca Raton, Florida, United States, 33433
Novo Nordisk Investigational Site
Boynton Beach, Florida, United States, 33472
Novo Nordisk Investigational Site
Bradenton, Florida, United States, 34201
Novo Nordisk Investigational Site
Brandon, Florida, United States, 33511
Novo Nordisk Investigational Site
Clearwater, Florida, United States, 33756
Novo Nordisk Investigational Site
Cooper City, Florida, United States, 33024
Novo Nordisk Investigational Site
Fleming Island, Florida, United States, 32003
Novo Nordisk Investigational Site
Fort Lauderdale, Florida, United States, 33316-2521
Novo Nordisk Investigational Site
Fort Lauderdale, Florida, United States, 33316
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Gainesville, Florida, United States, 32610
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Green Cove Springs, Florida, United States, 32043
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Hialeah, Florida, United States, 33012
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Jacksonville, Florida, United States, 32207
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Jacksonville, Florida, United States, 32216
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Miami, Florida, United States, 33135
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Miami, Florida, United States, 33136
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Miami, Florida, United States, 33155
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Miami, Florida, United States, 33165
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Miami, Florida, United States, 33183
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Naples, Florida, United States, 34119
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New Port Richey, Florida, United States, 34652
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Orlando, Florida, United States, 32806
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Panama City, Florida, United States, 32401
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Ponte Vedra, Florida, United States, 32081
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Port Charlotte, Florida, United States, 33952
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Port Orange, Florida, United States, 32127
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South Miami, Florida, United States, 33143
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Tampa, Florida, United States, 33619
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Tampa, Florida, United States, 34677
United States, Georgia
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Atlanta, Georgia, United States, 30318
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Decatur, Georgia, United States, 30033
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Dunwoody, Georgia, United States, 30338
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Lawrenceville, Georgia, United States, 30046
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Roswell, Georgia, United States, 30076
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Savannah, Georgia, United States, 31406
United States, Hawaii
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Honolulu, Hawaii, United States, 96814
United States, Idaho
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Idaho Falls, Idaho, United States, 83404-7596
United States, Illinois
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Addison, Illinois, United States, 60101
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Champagne, Illinois, United States, 61822
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Chicago, Illinois, United States, 60607
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Chicago, Illinois, United States, 60616
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Crystal Lake, Illinois, United States, 60012
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Gurnee, Illinois, United States, 60031
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Hines, Illinois, United States, 60141
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Springfield, Illinois, United States, 62702
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Springfield, Illinois, United States, 62711
United States, Indiana
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Brownsburg, Indiana, United States, 46112
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Evansville, Indiana, United States, 47714
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Franklin, Indiana, United States, 46131-9121
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Greenfield, Indiana, United States, 46140
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Indianapolis, Indiana, United States, 46254
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Michigan City, Indiana, United States, 46360
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Muncie, Indiana, United States, 47304
United States, Iowa
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Council Bluffs, Iowa, United States, 51501
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Council Bluffs, Iowa, United States, 51503
United States, Kansas
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Wichita, Kansas, United States, 67203
United States, Kentucky
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Lexington, Kentucky, United States, 40502
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Lexington, Kentucky, United States, 40503
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Louisville, Kentucky, United States, 40206
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Louisville, Kentucky, United States, 40213
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Madisonville, Kentucky, United States, 42431
United States, Louisiana
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Monroe, Louisiana, United States, 71203
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New Orleans, Louisiana, United States, 70119
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Shreveport, Louisiana, United States, 71103
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Slidell, Louisiana, United States, 70461-4231
United States, Maine
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Bangor, Maine, United States, 04401
United States, Maryland
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Hyattsville, Maryland, United States, 20782
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Rockville, Maryland, United States, 20852
United States, Massachusetts
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Watertwon, Massachusetts, United States, 02472
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Worcester, Massachusetts, United States, 01655
United States, Michigan
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Ann Arbor, Michigan, United States, 48106
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Ann Arbor, Michigan, United States, 48109
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Buckley, Michigan, United States, 49620
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Detroit, Michigan, United States, 48201
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Detroit, Michigan, United States, 48202
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Kalamazoo, Michigan, United States, 49009
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Livonia, Michigan, United States, 48152
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Troy, Michigan, United States, 48098
United States, Mississippi
Novo Nordisk Investigational Site
Olive Branch, Mississippi, United States, 38654
United States, Missouri
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Hazelwood, Missouri, United States, 63042
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Jefferson City, Missouri, United States, 65109
Novo Nordisk Investigational Site
Kansas City, Missouri, United States, 64111
United States, Montana
Novo Nordisk Investigational Site
Billings, Montana, United States, 59101
Novo Nordisk Investigational Site
Kalispell, Montana, United States, 59901
United States, Nebraska
Novo Nordisk Investigational Site
Elkhorn, Nebraska, United States, 68022
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Fremont, Nebraska, United States, 68025
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Omaha, Nebraska, United States, 68105
Novo Nordisk Investigational Site
Omaha, Nebraska, United States, 68114
Novo Nordisk Investigational Site
Omaha, Nebraska, United States, 68124
Novo Nordisk Investigational Site
Omaha, Nebraska, United States, 68198-4120
United States, Nevada
Novo Nordisk Investigational Site
Las Vegas, Nevada, United States, 89120
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Las Vegas, Nevada, United States, 89128
Novo Nordisk Investigational Site
Las Vegas, Nevada, United States, 89148
United States, New Hampshire
Novo Nordisk Investigational Site
Nashua, New Hampshire, United States, 03063
United States, New Jersey
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East Brunswick, New Jersey, United States, 08816
Novo Nordisk Investigational Site
Hoboken, New Jersey, United States, 07030
United States, New York
Novo Nordisk Investigational Site
Albany, New York, United States, 12206
Novo Nordisk Investigational Site
Lake Success, New York, United States, 11042
Novo Nordisk Investigational Site
Mineola, New York, United States, 11501
Novo Nordisk Investigational Site
New Windsor, New York, United States, 12553
Novo Nordisk Investigational Site
New York, New York, United States, 10029
Novo Nordisk Investigational Site
North Massapequa, New York, United States, 11758-1802
Novo Nordisk Investigational Site
Northport, New York, United States, 11768
Novo Nordisk Investigational Site
Rochester, New York, United States, 14607
Novo Nordisk Investigational Site
West Seneca, New York, United States, 14224
Novo Nordisk Investigational Site
Westfield, New York, United States, 14787
United States, North Carolina
Novo Nordisk Investigational Site
Asheville, North Carolina, United States, 28801
Novo Nordisk Investigational Site
Asheville, North Carolina, United States, 28803
Novo Nordisk Investigational Site
Burlington, North Carolina, United States, 27215-8700
Novo Nordisk Investigational Site
Cary, North Carolina, United States, 27518-7414
Novo Nordisk Investigational Site
Chapel Hill, North Carolina, United States, 27517
Novo Nordisk Investigational Site
Charlotte, North Carolina, United States, 28209
Novo Nordisk Investigational Site
Greenville, North Carolina, United States, 27834
Novo Nordisk Investigational Site
Lexington, North Carolina, United States, 27292
Novo Nordisk Investigational Site
Morehead City, North Carolina, United States, 28557
Novo Nordisk Investigational Site
New Bern, North Carolina, United States, 28562
Novo Nordisk Investigational Site
Statesville, North Carolina, United States, 28625
Novo Nordisk Investigational Site
Whiteville, North Carolina, United States, 28472
Novo Nordisk Investigational Site
Wilmington, North Carolina, United States, 28401
Novo Nordisk Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
Novo Nordisk Investigational Site
Fargo, North Dakota, United States, 58103
United States, Ohio
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States, 45236
Novo Nordisk Investigational Site
Cleveland, Ohio, United States, 44106-1702
Novo Nordisk Investigational Site
Cleveland, Ohio, United States, 44121-4128
Novo Nordisk Investigational Site
Cleveland, Ohio, United States, 44195
Novo Nordisk Investigational Site
Columbus, Ohio, United States, 43235
Novo Nordisk Investigational Site
Delaware, Ohio, United States, 43015
Novo Nordisk Investigational Site
Franklin, Ohio, United States, 45005
Novo Nordisk Investigational Site
Maumee, Ohio, United States, 43537
Novo Nordisk Investigational Site
Mentor, Ohio, United States, 44060
Novo Nordisk Investigational Site
Perrysburg, Ohio, United States, 43551
United States, Oklahoma
Novo Nordisk Investigational Site
Norman, Oklahoma, United States, 73072
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Novo Nordisk Investigational Site
Portland, Oregon, United States, 97239-3098
United States, Pennsylvania
Novo Nordisk Investigational Site
Altoona, Pennsylvania, United States, 16602
Novo Nordisk Investigational Site
Beaver, Pennsylvania, United States, 15009
Novo Nordisk Investigational Site
Danville, Pennsylvania, United States, 17822
Novo Nordisk Investigational Site
Hermitage, Pennsylvania, United States, 16148
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19107
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19114
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19152
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, United States, 15212
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, United States, 15243
Novo Nordisk Investigational Site
Smithfield, Pennsylvania, United States, 15478
Novo Nordisk Investigational Site
Uniontown, Pennsylvania, United States, 15401
Novo Nordisk Investigational Site
Upper Darby, Pennsylvania, United States, 19082
Novo Nordisk Investigational Site
Wilkes-Barre, Pennsylvania, United States, 18702
United States, South Carolina
Novo Nordisk Investigational Site
Anderson, South Carolina, United States, 29621
Novo Nordisk Investigational Site
Greer, South Carolina, United States, 29651
Novo Nordisk Investigational Site
Moncks Corner, South Carolina, United States, 29461
Novo Nordisk Investigational Site
Murrells Inlet, South Carolina, United States, 29576
Novo Nordisk Investigational Site
Myrtle Beach, South Carolina, United States, 29572
Novo Nordisk Investigational Site
Orangeburg, South Carolina, United States, 29118
Novo Nordisk Investigational Site
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
Novo Nordisk Investigational Site
Chattanooga, Tennessee, United States, 37404-1192
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
Novo Nordisk Investigational Site
Knoxville, Tennessee, United States, 37938
Novo Nordisk Investigational Site
Memphis, Tennessee, United States, 38119
Novo Nordisk Investigational Site
Memphis, Tennessee, United States, 38163
Novo Nordisk Investigational Site
Nashville, Tennessee, United States, 37203
Novo Nordisk Investigational Site
Nashville, Tennessee, United States, 37208
Novo Nordisk Investigational Site
Nashville, Tennessee, United States, 37212
Novo Nordisk Investigational Site
Tullahoma, Tennessee, United States, 37388
United States, Texas
Novo Nordisk Investigational Site
Arlington, Texas, United States, 76012-4637
Novo Nordisk Investigational Site
Austin, Texas, United States, 78705
Novo Nordisk Investigational Site
Austin, Texas, United States, 78731
Novo Nordisk Investigational Site
Austin, Texas, United States, 78749
Novo Nordisk Investigational Site
Carrollton, Texas, United States, 75007
Novo Nordisk Investigational Site
Carrollton, Texas, United States, 75010
Novo Nordisk Investigational Site
Corpus Christi, Texas, United States, 78404
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75230
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75231
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75246
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75390-9302
Novo Nordisk Investigational Site
Fort Worth, Texas, United States, 76117
Novo Nordisk Investigational Site
Fort Worth, Texas, United States, 76132
Novo Nordisk Investigational Site
Houston, Texas, United States, 77008
Novo Nordisk Investigational Site
Houston, Texas, United States, 77024
Novo Nordisk Investigational Site
Houston, Texas, United States, 77029
Novo Nordisk Investigational Site
Houston, Texas, United States, 77060
Novo Nordisk Investigational Site
Houston, Texas, United States, 77070
Novo Nordisk Investigational Site
Houston, Texas, United States, 77081
Novo Nordisk Investigational Site
Houston, Texas, United States, 77093
Novo Nordisk Investigational Site
Humble, Texas, United States, 77338
Novo Nordisk Investigational Site
Hurst, Texas, United States, 76054
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Irving, Texas, United States, 75039
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Lewsiville, Texas, United States, 75067
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Longview, Texas, United States, 75605
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Lubbock, Texas, United States, 79423
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Midland, Texas, United States, 79707
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Odessa, Texas, United States, 79761
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Pearland, Texas, United States, 77584
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Richardson, Texas, United States, 75080
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Round Rock, Texas, United States, 78681
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San Antonio, Texas, United States, 78215
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San Antonio, Texas, United States, 78228-6205
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San Antonio, Texas, United States, 78229
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San Antonio, Texas, United States, 78258
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Splendora, Texas, United States, 77372
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Sugar Land, Texas, United States, 77478
Novo Nordisk Investigational Site
Sugar Land, Texas, United States, 77479
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Sugarland, Texas, United States, 77099
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Sugarland, Texas, United States, 77478
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Waco, Texas, United States, 76710
United States, Utah
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Salt Lake City, Utah, United States, 84102
Novo Nordisk Investigational Site
Salt Lake City, Utah, United States, 84132
United States, Vermont
Novo Nordisk Investigational Site
Bennington, Vermont, United States, 05201
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South Burlington, Vermont, United States, 05403
United States, Virginia
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Midlothian, Virginia, United States, 23114
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Norfolk, Virginia, United States, 23510
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Richmond, Virginia, United States, 23249
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Winchester, Virginia, United States, 22601-3834
United States, Washington
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Richland, Washington, United States, 99352
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Spokane, Washington, United States, 99208
United States, Wisconsin
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Kenosha, Wisconsin, United States, 53142
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Milwaukee, Wisconsin, United States, 53209
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Milwaukee, Wisconsin, United States, 53295
Algeria
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Algiers, Algeria, 16000
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Constantine, Algeria, 25000
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Oran, Algeria, 31000
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Sidi Bel Abbes, Algeria, 22000
Argentina
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Caba, Argentina, C1440AAD
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Cordoba, Argentina, 5000
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Mar del Plata, Argentina, B7600FZN
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Rosario, Argentina, S2000CUD
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Zarate, Argentina, B2800DGH
Brazil
Novo Nordisk Investigational Site
Fortaleza, Ceara, Brazil, 60115-282
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Aparecida de Goiania, Goias, Brazil, 74935-530
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Belém, Para, Brazil, 66073-000
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São Paulo, Sao Paulo, Brazil, 01223-001
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São Paulo, Sao Paulo, Brazil, 01228-000
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São Paulo, Sao Paulo, Brazil, 01244-030
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São Paulo, Sao Paulo, Brazil, 05403-900
Novo Nordisk Investigational Site
Brasília, Brazil, 71625-009
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Fortaleza, Brazil, 60430-350
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Mogi Das Cruzes, Brazil, 08780-090
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Porto Alegre, Brazil, 90035-170
Canada, Alberta
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Edmonton, Alberta, Canada, T5J 3N4
Canada, Manitoba
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Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Ontario
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Chatham, Ontario, Canada, N7L 1C1
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Ottawa, Ontario, Canada, K1K 4L2
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Sarnia, Ontario, Canada, N7T 4X3
Canada, Quebec
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Laval, Quebec, Canada, H7T 2P5
Croatia
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Bjelovar, Croatia, 43000
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Osijek, Croatia, 31 000
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Slavonski Brod, Croatia, 35 000
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Zagreb, Croatia, 10 000
Novo Nordisk Investigational Site
Zagreb, Croatia, 10000
Greece
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Athens, Greece, GR-10552
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Athens, Greece, GR-115 27
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Athens, Greece, GR-11527
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Athens, Greece, GR-17562
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Thessaloniki, Greece, GR-54642
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Thessaloniki, Greece, GR-57001
India
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, India, 500034
Novo Nordisk Investigational Site
Hyderbad, Andhra Pradesh, India, 500 012
Novo Nordisk Investigational Site
Ahmedabad, Gujarat, India, 380006
Novo Nordisk Investigational Site
Ahmedabad, Gujarat, India, 380007
Novo Nordisk Investigational Site
Ahmedabad, Gujarat, India, 380016
Novo Nordisk Investigational Site
Ahmedabad, Gujarat, India, 380052
Novo Nordisk Investigational Site
Gurgaon, Haryana, India, 122001
Novo Nordisk Investigational Site
Bangalore, Karnataka, India, 560 017
Novo Nordisk Investigational Site
Bangalore, Karnataka, India, 560034
Novo Nordisk Investigational Site
Kozhikode, Kerala, India, 673017
Novo Nordisk Investigational Site
Indore, Madhya Pradesh, India, 452010
Novo Nordisk Investigational Site
Goa, Maharashtra, India, 403 202
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India, 400007
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India, 400008
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India, 400010
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India, 400012
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India, 400022
Novo Nordisk Investigational Site
Pune, Maharashtra, India, 411001
Novo Nordisk Investigational Site
Pune, Maharashtra, India, 411040
Novo Nordisk Investigational Site
New Dehli, New Delhi, India, 110029
Novo Nordisk Investigational Site
Bhubaneswar, Orissa, India, 751005
Novo Nordisk Investigational Site
Mohali, Punjab, India, 160062
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, India, 600031
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, India, 600086
Novo Nordisk Investigational Site
Coimbatore, Tamil Nadu, India, 641018
Novo Nordisk Investigational Site
Lucknow, Uttar Pradesh, India, 226014
Novo Nordisk Investigational Site
Kolkata, West Bengal, India, 700020
Novo Nordisk Investigational Site
Kolkata, West Bengal, India, 700054
Novo Nordisk Investigational Site
Ludhiana, India, 141001
Novo Nordisk Investigational Site
New Delhi, India, 110001
Italy
Novo Nordisk Investigational Site
Bari, Italy, 70124
Novo Nordisk Investigational Site
Bergamo, Italy, 24127
Novo Nordisk Investigational Site
Catanzaro, Italy, 88100
Novo Nordisk Investigational Site
Chieti Scalo, Italy, 66100
Novo Nordisk Investigational Site
Milano (mi), Italy, 20132
Novo Nordisk Investigational Site
Milano, Italy, 20100
Novo Nordisk Investigational Site
Milano, Italy, 20162
Novo Nordisk Investigational Site
Olbia, Italy, 07026
Novo Nordisk Investigational Site
Padova, Italy, 35143
Novo Nordisk Investigational Site
Palermo, Italy, 90127
Novo Nordisk Investigational Site
Ravenna, Italy, 48121
Novo Nordisk Investigational Site
Roma, Italy, 00133
Novo Nordisk Investigational Site
Roma, Italy, 00161
Novo Nordisk Investigational Site
sesto san giovanni (MI), Italy, 20099
Japan
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, Japan, 103 0002
Novo Nordisk Investigational Site
Kumamoto-shi,Kumamoto, Japan, 862 0976
Novo Nordisk Investigational Site
Matsumoto-shi, Nagano, Japan, 390-8621
Novo Nordisk Investigational Site
Miyazaki-shi, Japan, 880 0034
Novo Nordisk Investigational Site
Ota-ku, Tokyo, Japan, 1430015
Novo Nordisk Investigational Site
Ota-ku, Japan, 144 0035
Novo Nordisk Investigational Site
Tokyo, Japan, 162-8655
Novo Nordisk Investigational Site
Yokohama-shi, Japan, 235 0045
Korea, Republic of
Novo Nordisk Investigational Site
Goyang, Korea, Republic of, 10380
Novo Nordisk Investigational Site
Seoul, Korea, Republic of, 02841
Novo Nordisk Investigational Site
Seoul, Korea, Republic of, 03080
Novo Nordisk Investigational Site
Suwon, Korea, Republic of, 16247
Malaysia
Novo Nordisk Investigational Site
Kedah, Malaysia, 05460
Novo Nordisk Investigational Site
Kota Samarahan, Malaysia, 94300
Novo Nordisk Investigational Site
Kuala Lumpur, Malaysia, 59100
Novo Nordisk Investigational Site
Kuantan, Malaysia, 25100
Novo Nordisk Investigational Site
Melaka, Malaysia, 75400
Novo Nordisk Investigational Site
Serdang, Malaysia, 43000
Novo Nordisk Investigational Site
Seremban, Malaysia, 70300
Mexico
Novo Nordisk Investigational Site
Guadalajara, Jalisco, Mexico, 44130
Novo Nordisk Investigational Site
Guadalajara, Jalisco, Mexico, 44150
Novo Nordisk Investigational Site
Guadalajara, Jalisco, Mexico, 44600
Novo Nordisk Investigational Site
Guadalajara, Jalisco, Mexico, 44650
Novo Nordisk Investigational Site
Guadalajara, Jalisco, Mexico, 44670
Novo Nordisk Investigational Site
Cuernavaca, Morelos, Mexico, 62250
Novo Nordisk Investigational Site
Distrito Federal, México, D.F., Mexico, 14000
Novo Nordisk Investigational Site
Aguascalientes, Mexico, 20230
Novo Nordisk Investigational Site
Chihuahua, Mexico, 31200
Novo Nordisk Investigational Site
San Luis Potosi, Mexico, 78200
Poland
Novo Nordisk Investigational Site
Bytom, Poland, 41-902
Novo Nordisk Investigational Site
Gdansk, Poland, 80-546
Novo Nordisk Investigational Site
Krakow, Poland, 31-455
Novo Nordisk Investigational Site
Oswiecim, Poland, 32-600
Novo Nordisk Investigational Site
Poznan, Poland, 60-592
Novo Nordisk Investigational Site
Szczecin, Poland, 70-506
Novo Nordisk Investigational Site
Warszawa, Poland, 02-507
Novo Nordisk Investigational Site
Zamosc, Poland, 22-400
Romania
Novo Nordisk Investigational Site
Alba Iulia, Alba, Romania, 510053
Novo Nordisk Investigational Site
Baia Mare, Maramures, Romania, 430222
Novo Nordisk Investigational Site
Targu Mures, Mures, Romania, 540142
Novo Nordisk Investigational Site
Ploiesti, Prahova, Romania, 100163
Russian Federation
Novo Nordisk Investigational Site
Ekaterinburg, Russian Federation, 620102
Novo Nordisk Investigational Site
Kemerovo, Russian Federation, 650002
Novo Nordisk Investigational Site
Kirov, Russian Federation, 610014
Novo Nordisk Investigational Site
Krasnodar, Russian Federation, 350012
Novo Nordisk Investigational Site
Krasnodar, Russian Federation, 350086
Novo Nordisk Investigational Site
Moscow, Russian Federation, 111539
Novo Nordisk Investigational Site
Moscow, Russian Federation, 123423
Novo Nordisk Investigational Site
Nizhny Novgorod, Russian Federation, 603018
Novo Nordisk Investigational Site
Rostov-on-Don, Russian Federation, 344068
Novo Nordisk Investigational Site
Saint-Petersburg, Russian Federation, 190103
Novo Nordisk Investigational Site
Saint-Petersburg, Russian Federation, 191119
Novo Nordisk Investigational Site
Saint-Petersburg, Russian Federation, 195213
Novo Nordisk Investigational Site
Saratov, Russian Federation, 410012
Novo Nordisk Investigational Site
Saratov, Russian Federation, 410053
Novo Nordisk Investigational Site
St. Petersburg, Russian Federation, 194354
Novo Nordisk Investigational Site
St. Petersburg, Russian Federation, 195257
Novo Nordisk Investigational Site
Syktyvkar, Russian Federation, 167981
Novo Nordisk Investigational Site
Tumen, Russian Federation, 625023
Novo Nordisk Investigational Site
Tver, Russian Federation, 170036
Novo Nordisk Investigational Site
Ulianovsk, Russian Federation, 432063
Novo Nordisk Investigational Site
Volgograd, Russian Federation, 400131
Novo Nordisk Investigational Site
Yaroslavl, Russian Federation, 150010
South Africa
Novo Nordisk Investigational Site
Port Elizabeth, Eastern Cape, South Africa, 6014
Novo Nordisk Investigational Site
Port Elizabeth, Eastern Cape, South Africa, 6045
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa, 1818
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa, 2193
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa, 2198
Novo Nordisk Investigational Site
Pretoria, Gauteng, South Africa, 0001
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, South Africa, 4000
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, South Africa, 4001
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, South Africa, 4170
Novo Nordisk Investigational Site
Middleburg, Mpumalanga, South Africa, 1055
Novo Nordisk Investigational Site
Brits, North West, South Africa, 0250
Novo Nordisk Investigational Site
Cape Town, Western Cape, South Africa, 7130
Novo Nordisk Investigational Site
Cape Town, Western Cape, South Africa, 7460
Novo Nordisk Investigational Site
Cape Town, Western Cape, South Africa, 7500
Novo Nordisk Investigational Site
Cape Town, Western Cape, South Africa, 7708
Spain
Novo Nordisk Investigational Site
Granada, Spain, 18003
Novo Nordisk Investigational Site
Granada, Spain, 18012
Novo Nordisk Investigational Site
Madrid, Spain, 28046
Novo Nordisk Investigational Site
Málaga, Spain, 29006
Novo Nordisk Investigational Site
Sevilla, Spain, 41009
Novo Nordisk Investigational Site
Valencia, Spain, 46014
Novo Nordisk Investigational Site
Valencia, Spain, 46015
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
Novo Nordisk Investigational Site
Nakhon Ratchasima, Thailand, 30000
United Kingdom
Novo Nordisk Investigational Site
Bristol, United Kingdom, BS10 5NB
Novo Nordisk Investigational Site
Dundee, United Kingdom, DD1 9SY
Novo Nordisk Investigational Site
Edinburgh, United Kingdom, EH4 2XU
Novo Nordisk Investigational Site
Guildford, United Kingdom, GU2 7XX
Novo Nordisk Investigational Site
Norwich, United Kingdom, NR4 7TJ
Novo Nordisk Investigational Site
Nuneaton, United Kingdom, CV10 7DJ
Novo Nordisk Investigational Site
Stevenage, United Kingdom, SG1 4AB
Novo Nordisk Investigational Site
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01959529     History of Changes
Other Study ID Numbers: EX1250-4080  2013-002371-17  U1111-1141-7614  JapicCTI-142464 
Study First Received: October 8, 2013
Last Updated: November 4, 2016
Health Authority: Algeria: Ministry of Health
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
Canada: Health Canada
Croatia: Ministry of Health and Social Care
Greece: National Organization of Medicines
India: Ministry of Health
Italy: Ministry of Health
Japan: Ministry of Health, Labor and Welfare
Malaysia: Ministry of Health
Mexico: Federal Commission for Protection Against Health Risks
Poland: Ministry of Health
Romania: National Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Ministry of Health
Thailand: Ministry of Public Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Glargine
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016