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 is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Novo Nordisk A/S
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01959529
First received: October 8, 2013
Last updated: July 10, 2014
Last verified: July 2014
  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 60 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of severe hypoglycaemic episodes [ Time Frame: Week 0 to the last assessment (60 months) ] [ Designated as safety issue: No ]
  • Change in Glycosylated haemoglobin (HbA1c) [ Time Frame: Week 0 to the last assessment (59 months) ] [ Designated as safety issue: No ]

Estimated Enrollment: 7500
Study Start Date: October 2013
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (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
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

Contacts
Contact: Novo Nordisk clinicaltrials@novonordisk.com

  Hide Study Locations
Locations
United States, Alabama
Novo Nordisk Clinical Trial Call Center Recruiting
Birmingham, Alabama, United States, 35216
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Birmingham, Alabama, United States, 35233-2110
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Montgomery, Alabama, United States, 36109
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Montgomery, Alabama, United States, 36106-1509
United States, Arizona
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Gilbert, Arizona, United States, 85295-6683
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Glendale, Arizona, United States, 85308
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Goodyear, Arizona, United States, 85395
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Phoenix, Arizona, United States, 85020
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Tucson, Arizona, United States, 85704
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Tucson, Arizona, United States, 85724
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Tuscon, Arizona, United States, 85732
United States, Arkansas
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Little Rock, Arkansas, United States, 72205-5446
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Little Rock, Arkansas, United States, 72205
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Searcy, Arkansas, United States, 72143
United States, California
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Chino, California, United States, 91710
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Chula Vista, California, United States, 91910
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Concord, California, United States, 94520
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Downey, California, United States, 90242
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Duarte, California, United States, 91010
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Encino, California, United States, 91436
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Fountain Valley, California, United States, 92708
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Fresno, California, United States, 93720
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Greenbrae, California, United States, 94904
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Huntington Beach, California, United States, 92648
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Inglewood, California, United States, 90301-4106
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La Jolla, California, United States, 92037
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La Mesa, California, United States, 91942
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Lancaster, California, United States, 93534
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Long Beach, California, United States, 90822
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Los Alamitos, California, United States, 90720
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Mission Hills, California, United States, 91345
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Monterey, California, United States, 93940
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North Hollywood, California, United States, 91606
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Palm Springs, California, United States, 92262-6972
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Poway, California, United States, 92064
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San Diego, California, United States, 92120
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San Diego, California, United States, 92111
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San Ramon, California, United States, 94583
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Santa Ana, California, United States, 92704
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Tustin, California, United States, 92780
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Ventura, California, United States, 93003-2824
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Vista, California, United States, 92803
United States, Colorado
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Colorado Springs, Colorado, United States, 80922
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Denver, Colorado, United States, 80220-3808
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Denver, Colorado, United States, 80209-3806
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Golden, Colorado, United States, 80401
United States, Connecticut
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Danbury, Connecticut, United States, 06810-5013
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Norwalk, Connecticut, United States, 06851-4697
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Waterbury, Connecticut, United States, 06708
United States, Florida
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Boca Raton, Florida, United States, 33433
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Boynton Beach, Florida, United States, 33472
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Bradenton, Florida, United States, 34208
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Clearwater, Florida, United States, 33756
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Cooper City, Florida, United States, 33024
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Doral, Florida, United States, 33172
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Fort Lauderdale, Florida, United States, 33316-2521
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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, 32204
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Jacksonville, Florida, United States, 32216
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Jacksonville, Florida, United States, 32207
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Miami, Florida, United States, 33155
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Miami, Florida, United States, 33135-1687
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Miami, Florida, United States, 33183
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Miami, Florida, United States, 33136
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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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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
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Honolulu, Hawaii, United States, 96813
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Idaho Falls, Idaho, United States, 83404-7542
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Addison, Illinois, United States, 60101
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Champaign, Illinois, United States, 61820
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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, 62704-1433
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Springfield, Illinois, United States, 62703
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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, 51501-3605
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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, 40503
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Lexington, Kentucky, United States, 40502
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Louisville, Kentucky, United States, 40213
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Louisville, Kentucky, United States, 40206
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Madisonville, Kentucky, United States, 42431-1661
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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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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College Park, Maryland, United States, 20740
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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, 48202-2608
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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
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Olive Branch, Mississippi, United States, 38654-3573
United States, Missouri
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Hazelwood, Missouri, United States, 63042
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Jefferson City, Missouri, United States, 65109-6001
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Kansas City, Missouri, United States, 64111
United States, Montana
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Billings, Montana, United States, 59101
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Kalispell, Montana, United States, 59901
United States, Nebraska
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Elkhorn, Nebraska, United States, 68022
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Fremont, Nebraska, United States, 68025
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Omaha, Nebraska, United States, 68105
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Omaha, Nebraska, United States, 68114
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Omaha, Nebraska, United States, 68124
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Omaha, Nebraska, United States, 68198-3020
United States, Nevada
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Las Vegas, Nevada, United States, 89101
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Las Vegas, Nevada, United States, 89148
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Las Vegas, Nevada, United States, 89128
United States, New Hampshire
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Nashua, New Hampshire, United States, 03063
United States, New Jersey
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East Brunswick, New Jersey, United States, 08816
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Hoboken, New Jersey, United States, 07030
United States, New York
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Albany, New York, United States, 12206
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Mineola, New York, United States, 11501
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New Windsor, New York, United States, 12553
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New York, New York, United States, 10032-3729
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North Massapequa, New York, United States, 11758-1802
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Northport, New York, United States, 11768
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Rochester, New York, United States, 14607-4083
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Roslyn, New York, United States, 11576
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West Seneca, New York, United States, 14224
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Westfield, New York, United States, 14787
United States, North Carolina
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Asheville, North Carolina, United States, 28803
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Burlington, North Carolina, United States, 27215-8700
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Cary, North Carolina, United States, 27518-7414
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Charlotte, North Carolina, United States, 28209
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Durham, North Carolina, United States, 27713
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Greenville, North Carolina, United States, 27834
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Lexington, North Carolina, United States, 27292
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Morehead City, North Carolina, United States, 28557
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New Bern, North Carolina, United States, 28562
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Statesville, North Carolina, United States, 28625-1916
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Whiteville, North Carolina, United States, 28472
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Wilmington, North Carolina, United States, 28401
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Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
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Fargo, North Dakota, United States, 58103-6413
United States, Ohio
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Cincinnati, Ohio, United States, 45236
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Cleveland, Ohio, United States, 44195
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Cleveland, Ohio, United States, 44106-1702
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Cleveland, Ohio, United States, 44121-4128
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Columbus, Ohio, United States, 43235
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Delaware, Ohio, United States, 43015
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Franklin, Ohio, United States, 45005
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Maumee, Ohio, United States, 43537
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Mentor, Ohio, United States, 44060
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Perrysburg, Ohio, United States, 43551
United States, Oklahoma
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Norman, Oklahoma, United States, 73069
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Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
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Portland, Oregon, United States, 97239-3011
United States, Pennsylvania
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Altoona, Pennsylvania, United States, 16602-2415
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Beaver, Pennsylvania, United States, 15009
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Danville, Pennsylvania, United States, 17822
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Hermitage, Pennsylvania, United States, 16148
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Philadelphia, Pennsylvania, United States, 19107
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Philadelphia, Pennsylvania, United States, 19152
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Philadelphia, Pennsylvania, United States, 19114
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Pittsburgh, Pennsylvania, United States, 15243
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Pittsburgh, Pennsylvania, United States, 15212
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Smithfield, Pennsylvania, United States, 15478
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Uniontown, Pennsylvania, United States, 15401-2686
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Upper Darby, Pennsylvania, United States, 19082-2513
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Willkes Barre, Pennsylvania, United States, 18702
United States, South Carolina
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Anderson, South Carolina, United States, 29621
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Greer, South Carolina, United States, 29651
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Moncks Corner, South Carolina, United States, 29461
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Murrells Inlet, South Carolina, United States, 29576
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Myrtle Beach, South Carolina, United States, 29572-4610
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Orangeburg, South Carolina, United States, 29118
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Spartanburg, South Carolina, United States, 29303
United States, Tennessee
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Chattanooga, Tennessee, United States, 37404
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Chattanooga, Tennessee, United States, 37411
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Kingsport, Tennessee, United States, 37660
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Knoxville, Tennessee, United States, 37938
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Memphis, Tennessee, United States, 38119
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Nashville, Tennessee, United States, 37208
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Nashville, Tennessee, United States, 37203
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Nashville, Tennessee, United States, 37212
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Tullahoma, Tennessee, United States, 37388
United States, Texas
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Arlington, Texas, United States, 76012-4637
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Austin, Texas, United States, 78731
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Austin, Texas, United States, 78705
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Carrollton, Texas, United States, 75010
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Carrollton, Texas, United States, 75007
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Corpus Christi, Texas, United States, 78404
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Dallas, Texas, United States, 75231
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Dallas, Texas, United States, 75390-8858
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Dallas, Texas, United States, 75230
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Dallas, Texas, United States, 75246
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Fort Worth, Texas, United States, 76104
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Fort Worth, Texas, United States, 76117
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Houston, Texas, United States, 77093
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Houston, Texas, United States, 77070
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Houston, Texas, United States, 77036
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Houston, Texas, United States, 77008
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Houston, Texas, United States, 77024
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Houston, Texas, United States, 77060
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Houston, Texas, United States, 77025
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Houston, Texas, United States, 77029
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Humble, Texas, United States, 77338
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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, 79761-5100
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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, 78229
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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, 78229-6014
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San Antonio, Texas, United States, 78258
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Sugar Land, Texas, United States, 77479
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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
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Salt Lake City, Utah, United States, 84108-1239
United States, Vermont
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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
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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, 53142-7884
Novo Nordisk Clinical Trial Call Center Recruiting
Milwaukee, Wisconsin, United States, 53209
Novo Nordisk Clinical Trial Call Center Recruiting
Milwaukee, Wisconsin, United States, 53226
Algeria
Recruiting
Constantine, Algeria, 25000
Argentina
Recruiting
Buenos Aires, Argentina, C1449AAD
Brazil
Recruiting
Aparecida de Goiania, Goias, Brazil, 74935-530
Canada, Ontario
Recruiting
Sarnia, Ontario, Canada, N7T 4X3
Croatia
Recruiting
Slavonski Brod, Croatia, 35 000
Greece
Recruiting
Athens, Greece, GR-115 27
India
Recruiting
Bangalore, Karnataka, India, 560 017
Italy
Recruiting
Milano, Italy, 20132
Japan
Recruiting
Miyazaki-shi, Japan, 880 0034
Korea, Republic of
Recruiting
Seoul, Korea, Republic of, 110-744
Malaysia
Recruiting
Seremban, Malaysia, 70300
Mexico
Recruiting
Guadalajara, Jalisco, Mexico, 44150
Poland
Recruiting
Bytom, Poland, 41-902
Romania
Recruiting
Alba Iulia, Alba, Romania, 510053
Russian Federation
Recruiting
Saratov, Russian Federation, 410012
South Africa
Recruiting
Johannesburg, Gauteng, South Africa, 2198
Spain
Recruiting
Madrid, Spain, 28046
Thailand
Recruiting
Bangkoknoi, Bangkok, Thailand, 10700
United Kingdom
Recruiting
Bristol, United Kingdom, BS10 5NB
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

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
Study First Received: October 8, 2013
Last Updated: July 10, 2014
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
Serbia: Agency for Drugs and Medicinal Devices
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Ministry of Health
Thailand: Ministry of Public Health
Ukraine: Ministry of 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
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014