Phase
Condition
Diabetes Prevention
Diabetic Neuropathy
Diabetic Foot Ulcers
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria: - Male or female, age above or equal to 18 years at the time of signing informed consent. - Subjects fulfilling at least one of the below criteria (For this inclusion criterion the aim is to include minimum 80% of individuals with a previous episode of hypoglycaemia (criterion e). The remaining subjects will have to fulfil at least one of criteria a-d.): - a) Experienced at least one severe hypoglycaemic episode within the last year (according to the ADA definition, April 2013 (An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.). - b) Moderate chronic renal failure, defined as glomerular filtration rate 30 - 59 mL/min/1.73 m^2 per CKD-EPI by central laboratory analysis. - c) Hypoglycaemic symptom unawareness (History of impaired autonomic responses (tremulousness, sweating, palpitations, and hunger) during hypoglycaemia). - d) Treated with insulin for more than 5 years. - e) Episode of hypoglycaemia (defined by symptoms of hypoglycaemia and/or episode with low glucose measurement (equal to or below 70 mg/dL [equal to or below 3.9 mmol/L])) within the last 12 weeks prior to Visit 1 (screening). - Subjects diagnosed (clinically) with type 2 diabetes mellitus. - Treated with basal only insulin (once daily or twice-daily insulin (insulin detemir; insulin glargine 100 U/mL, biosimilar of insulin glargine 100 U/mL or insulin Neutral Protamine Hagedorn)) equal to or above 90 days prior to the day of screening with or without any of the following anti-diabetic drugs with stable doses for equal to or above 90 days prior to screening: - a) Metformin - b) Dipeptidyl peptidase -4 inhibitor - c) Sodium-glucose co-transporter 2 inhibitor - d) Alpha-glucosidase-inhibitors (acarbose) - e) Thiazolidinediones - f) Marketed oral combination products only including the products listed in criteria 5a-5e - HbA1c equal to or below 9.5% (80 mmol/mol) at screening by central laboratory analysis. - BMI equal to or below 45 kg/m^2. Exclusion Criteria: - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening
Study Design
Connect with a study center
Novo Nordisk Investigational Site
Calgary, Alberta T2H 2G4
CanadaSite Not Available
Novo Nordisk Investigational Site
Brampton, Ontario L6S 0C6
CanadaSite Not Available
Novo Nordisk Investigational Site
Etobicoke, Ontario M9R 4E1
CanadaSite Not Available
Novo Nordisk Investigational Site
Hamilton, Ontario L8N 3Z5
CanadaSite Not Available
Novo Nordisk Investigational Site
Markham, Ontario L3P 7P2
CanadaSite Not Available
Novo Nordisk Investigational Site
Oakville, Ontario L6M 1M1
CanadaSite Not Available
Novo Nordisk Investigational Site
Toronto, Ontario M4G 3E8
CanadaSite Not Available
Novo Nordisk Investigational Site
Mirabel, Quebec J7J 2K8
CanadaSite Not Available
Novo Nordisk Investigational Site
Sherbrooke, Quebec J1L 0H8
CanadaSite Not Available
Novo Nordisk Investigational Site
Aarhus N, 8200
DenmarkSite Not Available
Novo Nordisk Investigational Site
Esbjerg, 6700
DenmarkSite Not Available
Novo Nordisk Investigational Site
Hellerup, 2900
DenmarkSite Not Available
Novo Nordisk Investigational Site
Hillerød, 3400
DenmarkSite Not Available
Novo Nordisk Investigational Site
Hvidovre, 2650
DenmarkSite Not Available
Novo Nordisk Investigational Site
Odense, 5000
DenmarkSite Not Available
Novo Nordisk Investigational Site
Århus C, 8000
DenmarkSite Not Available
Novo Nordisk Investigational Site
Pärnu, 80018
EstoniaSite Not Available
Novo Nordisk Investigational Site
Tallinn, 10138
EstoniaSite Not Available
Novo Nordisk Investigational Site
Viljandi, 71024
EstoniaSite Not Available
Novo Nordisk Investigational Site
Bad Mergentheim, 97980
GermanySite Not Available
Novo Nordisk Investigational Site
Berlin, 13597
GermanySite Not Available
Novo Nordisk Investigational Site
Elsterwerda, 04910
GermanySite Not Available
Novo Nordisk Investigational Site
Essen, 45219
GermanySite Not Available
Novo Nordisk Investigational Site
Falkensee, 14612
GermanySite Not Available
Novo Nordisk Investigational Site
Friedrichsthal, 66299
GermanySite Not Available
Novo Nordisk Investigational Site
Hamburg, 22041
GermanySite Not Available
Novo Nordisk Investigational Site
Lingen, 49808
GermanySite Not Available
Novo Nordisk Investigational Site
Rehlingen-Siersburg, 66780
GermanySite Not Available
Novo Nordisk Investigational Site
Saint Ingbert, 66386
GermanySite Not Available
Novo Nordisk Investigational Site
Saint Ingbert-Oberwürzbach, 66386
GermanySite Not Available
Novo Nordisk Investigational Site
St. Ingbert, 66386
GermanySite Not Available
Novo Nordisk Investigational Site
Athens, GR-11527
GreeceSite Not Available
Novo Nordisk Investigational Site
Larissa, GR-41110
GreeceSite Not Available
Novo Nordisk Investigational Site
Nikaia, GR-18454
GreeceSite Not Available
Novo Nordisk Investigational Site
Thessaloniki, GR-57001
GreeceSite Not Available
Novo Nordisk Investigational Site
Budapest, H-1083
HungarySite Not Available
Novo Nordisk Investigational Site
Debrecen, 4043
HungarySite Not Available
Novo Nordisk Investigational Site
Kaposvár, 7400
HungarySite Not Available
Novo Nordisk Investigational Site
Szeged, H-6725
HungarySite Not Available
Novo Nordisk Investigational Site
Szombathely, H-9700
HungarySite Not Available
Novo Nordisk Investigational Site
Hamar, 2318
NorwaySite Not Available
Novo Nordisk Investigational Site
Hoenefoss, 3515
NorwaySite Not Available
Novo Nordisk Investigational Site
Oslo, 0373
NorwaySite Not Available
Novo Nordisk Investigational Site
Skedsmokorset, NO-2020
NorwaySite Not Available
Novo Nordisk Investigational Site
Trondheim, 7030
NorwaySite Not Available
Novo Nordisk Investigational Site
Bialystok, 15-445
PolandSite Not Available
Novo Nordisk Investigational Site
Bytom, 41-902
PolandSite Not Available
Novo Nordisk Investigational Site
Gdansk, 80-858
PolandSite Not Available
Novo Nordisk Investigational Site
Lublin, 20-362
PolandSite Not Available
Novo Nordisk Investigational Site
Szczecin, 70-506
PolandSite Not Available
Novo Nordisk Investigational Site
Warsaw, 00-465
PolandSite Not Available
Novo Nordisk Investigational Site
Warszawa, 00-465
PolandSite Not Available
Novo Nordisk Investigational Site
Zabrze, 41-800
PolandSite Not Available
Novo Nordisk Investigational Site
Manati, 00674
Puerto RicoSite Not Available
Novo Nordisk Investigational Site
Ponce, 00716
Puerto RicoSite Not Available
Novo Nordisk Investigational Site
Oradea, Bihor 410469
RomaniaSite Not Available
Novo Nordisk Investigational Site
Bucharest, 022441
RomaniaSite Not Available
Novo Nordisk Investigational Site
Buzau, 120203
RomaniaSite Not Available
Novo Nordisk Investigational Site
Galati, 800578
RomaniaSite Not Available
Novo Nordisk Investigational Site
Belgrade, 11080
SerbiaSite Not Available
Novo Nordisk Investigational Site
Nis, 18000
SerbiaSite Not Available
Novo Nordisk Investigational Site
Anniston, Alabama 36207
United StatesSite Not Available
Novo Nordisk Investigational Site
Birmingham, Alabama 35211
United StatesSite Not Available
Novo Nordisk Investigational Site
Chandler, Arizona 85224
United StatesSite Not Available
Novo Nordisk Investigational Site
Fountain Hills, Arizona 85268
United StatesSite Not Available
Novo Nordisk Investigational Site
Glendale, Arizona 85306
United StatesSite Not Available
Novo Nordisk Investigational Site
Phoenix, Arizona 85037
United StatesSite Not Available
Novo Nordisk Investigational Site
Tucson, Arizona 85741
United StatesSite Not Available
Novo Nordisk Investigational Site
Buena Park, California 90620
United StatesSite Not Available
Novo Nordisk Investigational Site
Concord, California 94520
United StatesSite Not Available
Novo Nordisk Investigational Site
Downey, California 90242
United StatesSite Not Available
Novo Nordisk Investigational Site
Duarte, California 91010
United StatesSite Not Available
Novo Nordisk Investigational Site
Fresno, California 93720
United StatesSite Not Available
Novo Nordisk Investigational Site
Hawaiian Gardens, California 90716
United StatesSite Not Available
Novo Nordisk Investigational Site
La Jolla, California 92037
United StatesSite Not Available
Novo Nordisk Investigational Site
Lancaster, California 93534
United StatesSite Not Available
Novo Nordisk Investigational Site
Lomita, California 90717
United StatesSite Not Available
Novo Nordisk Investigational Site
Los Alamitos, California 90720
United StatesSite Not Available
Novo Nordisk Investigational Site
Los Angeles, California 90057
United StatesSite Not Available
Novo Nordisk Investigational Site
Moreno Valley, California 92555
United StatesSite Not Available
Novo Nordisk Investigational Site
Northridge, California 91325
United StatesSite Not Available
Novo Nordisk Investigational Site
Palm Springs, California 92262
United StatesSite Not Available
Novo Nordisk Investigational Site
Pomona, California 91766-2007
United StatesSite Not Available
Novo Nordisk Investigational Site
Poway, California 92064
United StatesSite Not Available
Novo Nordisk Investigational Site
Riverside, California 92506
United StatesSite Not Available
Novo Nordisk Investigational Site
Roseville, California 95661
United StatesSite Not Available
Novo Nordisk Investigational Site
Sacramento, California 95821
United StatesSite Not Available
Novo Nordisk Investigational Site
San Mateo, California 94401
United StatesSite Not Available
Novo Nordisk Investigational Site
San Ramon, California 94583
United StatesSite Not Available
Novo Nordisk Investigational Site
Stanford, California 94305
United StatesSite Not Available
Novo Nordisk Investigational Site
Van Nuys, California 91405
United StatesSite Not Available
Novo Nordisk Investigational Site
Vista, California 92083
United StatesSite Not Available
Novo Nordisk Investigational Site
Walnut Creek, California 94598
United StatesSite Not Available
Novo Nordisk Investigational Site
West Hills, California 91304
United StatesSite Not Available
Novo Nordisk Investigational Site
Colorado Springs, Colorado 80918
United StatesSite Not Available
Novo Nordisk Investigational Site
Englewood, Colorado 80113
United StatesSite Not Available
Novo Nordisk Investigational Site
Waterbury, Connecticut 06708
United StatesSite Not Available
Novo Nordisk Investigational Site
Bradenton, Florida 34201
United StatesSite Not Available
Novo Nordisk Investigational Site
Brandon, Florida 33511
United StatesSite Not Available
Novo Nordisk Investigational Site
Clearwater, Florida 33765
United StatesSite Not Available
Novo Nordisk Investigational Site
Cooper City, Florida 33024
United StatesSite Not Available
Novo Nordisk Investigational Site
Jacksonville, Florida 32277
United StatesSite Not Available
Novo Nordisk Investigational Site
Miami, Florida 33175
United StatesSite Not Available
Novo Nordisk Investigational Site
Miami Springs, Florida 33166
United StatesSite Not Available
Novo Nordisk Investigational Site
New Port Richey, Florida 34652
United StatesSite Not Available
Novo Nordisk Investigational Site
Orlando, Florida 32825
United StatesSite Not Available
Novo Nordisk Investigational Site
Ormond Beach, Florida 32174
United StatesSite Not Available
Novo Nordisk Investigational Site
Palm Harbor, Florida 34684-3609
United StatesSite Not Available
Novo Nordisk Investigational Site
Pembroke Pines, Florida 33027
United StatesSite Not Available
Novo Nordisk Investigational Site
Port Charlotte, Florida 33952
United StatesSite Not Available
Novo Nordisk Investigational Site
Tampa, Florida 33606
United StatesSite Not Available
Novo Nordisk Investigational Site
Marietta, Georgia 30067
United StatesSite Not Available
Novo Nordisk Investigational Site
Roswell, Georgia 30076
United StatesSite Not Available
Novo Nordisk Investigational Site
Honolulu, Hawaii 96814
United StatesSite Not Available
Novo Nordisk Investigational Site
Blackfoot, Idaho 83221
United StatesSite Not Available
Novo Nordisk Investigational Site
Chicago, Illinois 60607
United StatesSite Not Available
Novo Nordisk Investigational Site
Gurnee, Illinois 60031
United StatesSite Not Available
Novo Nordisk Investigational Site
Peoria, Illinois 61603
United StatesSite Not Available
Novo Nordisk Investigational Site
Skokie, Illinois 60077
United StatesSite Not Available
Novo Nordisk Investigational Site
Springfield, Illinois 62711
United StatesSite Not Available
Novo Nordisk Investigational Site
Wauconda, Illinois 60084
United StatesSite Not Available
Novo Nordisk Investigational Site
Evansville, Indiana 47713
United StatesSite Not Available
Novo Nordisk Investigational Site
Mishawaka, Indiana 46544
United StatesSite Not Available
Novo Nordisk Investigational Site
Valparaiso, Indiana 46383
United StatesSite Not Available
Novo Nordisk Investigational Site
Council Bluffs, Iowa 51501
United StatesSite Not Available
Novo Nordisk Investigational Site
Des Moines, Iowa 50314-2610
United StatesSite Not Available
Novo Nordisk Investigational Site
West Des Moines, Iowa 50265
United StatesSite Not Available
Novo Nordisk Investigational Site
Topeka, Kansas 66606
United StatesSite Not Available
Novo Nordisk Investigational Site
Lexington, Kentucky 40503
United StatesSite Not Available
Novo Nordisk Investigational Site
Louisville, Kentucky 40213
United StatesSite Not Available
Novo Nordisk Investigational Site
Paducah, Kentucky 42001
United StatesSite Not Available
Novo Nordisk Investigational Site
New Orleans, Louisiana 70119
United StatesSite Not Available
Novo Nordisk Investigational Site
Rockville, Maryland 20852
United StatesSite Not Available
Novo Nordisk Investigational Site
Bloomfield Hills, Michigan 48302
United StatesSite Not Available
Novo Nordisk Investigational Site
Edina, Minnesota 55435
United StatesSite Not Available
Novo Nordisk Investigational Site
Richfield, Minnesota 55432
United StatesSite Not Available
Novo Nordisk Investigational Site
Chesterfield, Missouri 63017
United StatesSite Not Available
Novo Nordisk Investigational Site
Kalispell, Montana 59901
United StatesSite Not Available
Novo Nordisk Investigational Site
Elkhorn, Nebraska 68022
United StatesSite Not Available
Novo Nordisk Investigational Site
Fremont, Nebraska 68025
United StatesSite Not Available
Novo Nordisk Investigational Site
Omaha, Nebraska 68144
United StatesSite Not Available
Novo Nordisk Investigational Site
Henderson, Nevada 89052
United StatesSite Not Available
Novo Nordisk Investigational Site
Las Vegas, Nevada 89109
United StatesSite Not Available
Novo Nordisk Investigational Site
Nashua, New Hampshire 03063
United StatesSite Not Available
Novo Nordisk Investigational Site
East Brunswick, New Jersey 08816
United StatesSite Not Available
Novo Nordisk Investigational Site
Lawrenceville, New Jersey 08648
United StatesSite Not Available
Novo Nordisk Investigational Site
Albuquerque, New Mexico 87109-2134
United StatesSite Not Available
Novo Nordisk Investigational Site
Albany, New York 12203
United StatesSite Not Available
Novo Nordisk Investigational Site
New Windsor, New York 12553
United StatesSite Not Available
Novo Nordisk Investigational Site
New York, New York 10016
United StatesSite Not Available
Novo Nordisk Investigational Site
Northport, New York 11768
United StatesSite Not Available
Novo Nordisk Investigational Site
West Seneca, New York 14224
United StatesSite Not Available
Novo Nordisk Investigational Site
Charlotte, North Carolina 28210
United StatesSite Not Available
Novo Nordisk Investigational Site
Greensboro, North Carolina 27408
United StatesSite Not Available
Novo Nordisk Investigational Site
Greenville, North Carolina 27858
United StatesSite Not Available
Novo Nordisk Investigational Site
Morehead City, North Carolina 28557-4346
United StatesSite Not Available
Novo Nordisk Investigational Site
Statesville, North Carolina 28625
United StatesSite Not Available
Novo Nordisk Investigational Site
Wilmington, North Carolina 28401
United StatesSite Not Available
Novo Nordisk Investigational Site
Colombus, Ohio 43213
United StatesSite Not Available
Novo Nordisk Investigational Site
Columbus, Ohio 43213
United StatesSite Not Available
Novo Nordisk Investigational Site
Maumee, Ohio 43537
United StatesSite Not Available
Novo Nordisk Investigational Site
Toledo, Ohio 43614
United StatesSite Not Available
Novo Nordisk Investigational Site
Norman, Oklahoma 73069
United StatesSite Not Available
Novo Nordisk Investigational Site
Beaver, Pennsylvania 15009
United StatesSite Not Available
Novo Nordisk Investigational Site
McMurray, Pennsylvania 15317
United StatesSite Not Available
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania 19114
United StatesSite Not Available
Novo Nordisk Investigational Site
Anderson, South Carolina 29621
United StatesSite Not Available
Novo Nordisk Investigational Site
Gaffney, South Carolina 29341
United StatesSite Not Available
Novo Nordisk Investigational Site
Greer, South Carolina 29651
United StatesSite Not Available
Novo Nordisk Investigational Site
Mount Pleasant, South Carolina 29464
United StatesSite Not Available
Novo Nordisk Investigational Site
Pelzer, South Carolina 29669
United StatesSite Not Available
Novo Nordisk Investigational Site
West Columbia, South Carolina 29169
United StatesSite Not Available
Novo Nordisk Investigational Site
Dakota Dunes, South Dakota 57049
United StatesSite Not Available
Novo Nordisk Investigational Site
Bristol, Tennessee 37620-7352
United StatesSite Not Available
Novo Nordisk Investigational Site
Chattanooga, Tennessee 37404
United StatesSite Not Available
Novo Nordisk Investigational Site
Kingsport, Tennessee 37660
United StatesSite Not Available
Novo Nordisk Investigational Site
Knoxville, Tennessee 37909
United StatesSite Not Available
Novo Nordisk Investigational Site
Nashville, Tennessee 37232
United StatesSite Not Available
Novo Nordisk Investigational Site
Amarillo, Texas 79106
United StatesSite Not Available
Novo Nordisk Investigational Site
Arlington, Texas 76012-4637
United StatesSite Not Available
Novo Nordisk Investigational Site
Austin, Texas 78731
United StatesSite Not Available
Novo Nordisk Investigational Site
Dallas, Texas 75226
United StatesSite Not Available
Novo Nordisk Investigational Site
Fort Worth, Texas 76132
United StatesSite Not Available
Novo Nordisk Investigational Site
Houston, Texas 77024
United StatesSite Not Available
Novo Nordisk Investigational Site
Humble, Texas 77338
United StatesSite Not Available
Novo Nordisk Investigational Site
Kerrville, Texas 78028
United StatesSite Not Available
Novo Nordisk Investigational Site
New Braunfels, Texas 78130
United StatesSite Not Available
Novo Nordisk Investigational Site
Plano, Texas 75075
United StatesSite Not Available
Novo Nordisk Investigational Site
Round Rock, Texas 78681
United StatesSite Not Available
Novo Nordisk Investigational Site
San Antonio, Texas 78215
United StatesSite Not Available
Novo Nordisk Investigational Site
Waco, Texas 76710
United StatesSite Not Available
Novo Nordisk Investigational Site
Bountiful, Utah 84010
United StatesSite Not Available
Novo Nordisk Investigational Site
Murray, Utah 84123
United StatesSite Not Available
Novo Nordisk Investigational Site
Ogden, Utah 84405
United StatesSite Not Available
Novo Nordisk Investigational Site
Bennington, Vermont 05201
United StatesSite Not Available
Novo Nordisk Investigational Site
Chesapeake, Virginia 23321
United StatesSite Not Available
Novo Nordisk Investigational Site
Midlothian, Virginia 23114
United StatesSite Not Available
Novo Nordisk Investigational Site
Norfolk, Virginia 23510-2015
United StatesSite Not Available
Novo Nordisk Investigational Site
Richmond, Virginia 23219
United StatesSite Not Available
Novo Nordisk Investigational Site
Virginia Beach, Virginia 23454
United StatesSite Not Available
Novo Nordisk Investigational Site
Olympia, Washington 98502
United StatesSite Not Available
Novo Nordisk Investigational Site
Spokane, Washington 99201
United StatesSite Not Available
Novo Nordisk Investigational Site
Kenosha, Wisconsin 53144
United StatesSite Not Available
Novo Nordisk Investigational Site
West Allis, Wisconsin 53227
United StatesSite Not Available
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