Phase
Condition
Diabetic Foot Ulcers
Diabetic Gastroparesis
Diabetic Neuropathy
Treatment
N/AClinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects diagnosed with type 2 diabetes with stable diabetes treatment (unchangedmedication and unchanged dose) for 90 days prior to the screening visit including:Monotherapy or any duo-combinations of metformin and/or SUs and/or pioglitazone.Metformin should be used with caution in subjects with moderate renal failure and mustbe used in accordance with local metformin labelling or guidelines. Or Monotherapy orany combinations of metformin and/or pioglitazone and/or basal or premix insulin.Insulin adjustments (total daily dose) below or equal to 10% within 90 days prior tothe screening visit as confirmed by the investigator are acceptable. Metformin shouldbe used with caution in subjects with moderate renal failure and must be used inaccordance with local metformin labelling or guidelines. Combination of pioglitazoneand insulin should be used with caution and according to local labelling or guidelines
HbA1c 7-10% (both inclusive)
Moderate renal impairment diagnosed more than 90 days prior to the screening visit andconfirmed by an eGFR (glomerular filtration rate) of 30-59 mL/min/1.73 m2 per MDRD (modification of diet in renal disease) formula at the screening visit
Body Mass Index (BMI) 20-45 kg/m^2 (both inclusive)
Exclusion
Exclusion Criteria:
Recurrent severe hypoglycaemia or hypoglycaemic unawareness as judged by theinvestigator
Treatment with antidiabetic medication(s) other than stated in the inclusion criteriain a period of 90 days prior to screening. Previous short-term (below or equal to 7days in total) treatment with rapid-or short-acting insulin in connection withintercurrent illness is allowed at the discretion of the investigator
Impaired liver function, defined as ALAT (alanine aminotransferase) above or equal to 2.5 times upper normal limit
History of chronic pancreatitis or idiopathic acute pancreatitis
Within the past 180 days any of the following: Episode of unstable angina, acutecoronary event, cerebral stroke/transient ischemic attack (TIA) or other significantcardiovascular event (including e.g. arrhythmias or conduction delays on ECG (electrocardiogram))
Heart failure defined as New York Heart Association (NYHA) class IV
A systolic blood pressure above or equal to 180 mmHg or a diastolic blood pressureabove or equal to 100 mmHg
Rapidly progressing renal disease (e.g., acute glomerulonephritis) at the discretionof the investigator
Use of immunosuppressive treatment within 90 days prior to screening
Diagnosis or treatment for cancer in the previous 5 years (except basal cell skincancer or squamous cell skin cancer)
Proliferative retinopathy or maculopathy requiring acute treatment as judged by theinvestigator
Study Design
Connect with a study center
Novo Nordisk Investigational Site
Brest, 29609
FranceSite Not Available
empty
Brest Cedex 9, 29240
FranceSite Not Available
Novo Nordisk Investigational Site
LA ROCHE-sur-YON cedex 9, 85295
FranceSite Not Available
Novo Nordisk Investigational Site
LA ROCHELLE cedex, 17019
FranceSite Not Available
Novo Nordisk Investigational Site
Pointe À Pitre, 97159
FranceSite Not Available
Novo Nordisk Investigational Site
Strasbourg, 67000
FranceSite Not Available
Novo Nordisk Investigational Site
Bialystok, 15-435
PolandSite Not Available
Novo Nordisk Investigational Site
Gdansk, 80-546
PolandSite Not Available
Novo Nordisk Investigational Site
Katowice, 40-767
PolandSite Not Available
Novo Nordisk Investigational Site
Krakow, 31-261
PolandSite Not Available
Novo Nordisk Investigational Site
Poznan, 60-569
PolandSite Not Available
Novo Nordisk Investigational Site
Zabrze, 41-800
PolandSite Not Available
Novo Nordisk Investigational Site
Barnaul, 656045
Russian FederationSite Not Available
Novo Nordisk Investigational Site
Kazan, 420043
Russian FederationSite Not Available
Novo Nordisk Investigational Site
Kursk, 305035
Russian FederationSite Not Available
Novo Nordisk Investigational Site
Moscow, 123448
Russian FederationSite Not Available
Novo Nordisk Investigational Site
Nizhniy Novgorod, 603126
Russian FederationSite Not Available
Novo Nordisk Investigational Site
Penza, 440026
Russian FederationSite Not Available
Novo Nordisk Investigational Site
Saint-Petersburg, 194358
Russian FederationSite Not Available
Novo Nordisk Investigational Site
Samara, 443067
Russian FederationSite Not Available
Novo Nordisk Investigational Site
Saratov, 410053
Russian FederationSite Not Available
Novo Nordisk Investigational Site
Smolensk, 214019
Russian FederationSite Not Available
Novo Nordisk Investigational Site
Volgograd, 400138
Russian FederationSite Not Available
Novo Nordisk Investigational Site
Kharkiv, 61000
UkraineSite Not Available
Novo Nordisk Investigational Site
Kiev, 04053
UkraineSite Not Available
Novo Nordisk Investigational Site
Kyiv, 04114
UkraineSite Not Available
Novo Nordisk Investigational Site
Vinnitsa, 21010
UkraineSite Not Available
Novo Nordisk Investigational Site
Vinnytsia, 21010
UkraineSite Not Available
Novo Nordisk Investigational Site
Zaporizhia, 69600
UkraineSite Not Available
Novo Nordisk Investigational Site
Zaporozhye, 69600
UkraineSite Not Available
Novo Nordisk Investigational Site
Bristol, BS10 5NB
United KingdomSite Not Available
Novo Nordisk Investigational Site
Dundee, DD1 9SY
United KingdomSite Not Available
Novo Nordisk Investigational Site
Edinburgh, EH4 2XU
United KingdomSite Not Available
Novo Nordisk Investigational Site
Hull, HU3 2RW
United KingdomSite Not Available
Novo Nordisk Investigational Site
Leicester, LE5 4PW
United KingdomSite Not Available
Novo Nordisk Investigational Site
Letchworth, SG6 4UB
United KingdomSite Not Available
Novo Nordisk Investigational Site
London, SE5 9RT
United KingdomSite Not Available
Novo Nordisk Investigational Site
Swansea, SA6 6NL
United KingdomSite Not Available
Novo Nordisk Investigational Site
Concord, California 94520
United StatesSite Not Available
Novo Nordisk Clinical Trial Call Center
Danville, California 94526
United StatesSite Not Available
Novo Nordisk Clinical Trial Call Center
Encino, California 91436
United StatesSite Not Available
Novo Nordisk Investigational Site
La Jolla, California 92037
United StatesSite Not Available
Novo Nordisk Investigational Site
Los Angeles, California 90057
United StatesSite Not Available
Novo Nordisk Investigational Site
Monterey, California 93940
United StatesSite Not Available
Novo Nordisk Investigational Site
San Diego, California 92111
United StatesSite Not Available
Novo Nordisk Investigational Site
San Ramon, California 94583
United StatesSite Not Available
Novo Nordisk Investigational Site
Torrance, California 90502
United StatesSite Not Available
Novo Nordisk Investigational Site
Tustin, California 92780
United StatesSite Not Available
Novo Nordisk Investigational Site
Ventura, California 93003
United StatesSite Not Available
Novo Nordisk Investigational Site
Golden, Colorado 80401
United StatesSite Not Available
Novo Nordisk Investigational Site
Boynton Beach, Florida 33472
United StatesSite Not Available
Novo Nordisk Investigational Site
Jacksonville, Florida 32216
United StatesSite Not Available
Novo Nordisk Investigational Site
Miami, Florida 33156
United StatesSite Not Available
Novo Nordisk Investigational Site
Pembroke Pines, Florida 33027
United StatesSite Not Available
Novo Nordisk Investigational Site
Plantation, Florida 33324
United StatesSite Not Available
Novo Nordisk Investigational Site
Saint Petersburg, Florida 33711
United StatesSite Not Available
Novo Nordisk Investigational Site
St. Petersburg, Florida 33711
United StatesSite Not Available
Novo Nordisk Investigational Site
Atlanta, Georgia 30303
United StatesSite Not Available
Novo Nordisk Investigational Site
Roswell, Georgia 30076
United StatesSite Not Available
Novo Nordisk Investigational Site
Avon, Indiana 46123
United StatesSite Not Available
Novo Nordisk Investigational Site
Franklin, Indiana 46131
United StatesSite Not Available
Novo Nordisk Investigational Site
Greenfield, Indiana 46140
United StatesSite Not Available
Novo Nordisk Investigational Site
Muncie, Indiana 47304
United StatesSite Not Available
Novo Nordisk Investigational Site
Slidell, Louisiana 70461-4231
United StatesSite Not Available
Novo Nordisk Investigational Site
Rockville, Maryland 20852
United StatesSite Not Available
Novo Nordisk Investigational Site
Springfield, Massachusetts 01199
United StatesSite Not Available
Novo Nordisk Investigational Site
Buckley, Michigan 49620
United StatesSite Not Available
Novo Nordisk Investigational Site
Southfield, Michigan 48034-7661
United StatesSite Not Available
Novo Nordisk Investigational Site
Great Falls, Montana 59405
United StatesSite Not Available
Novo Nordisk Investigational Site
Nashua, New Hampshire 03063
United StatesSite Not Available
Novo Nordisk Investigational Site
Rosedale, New York 11422
United StatesSite Not Available
Novo Nordisk Investigational Site
Staten Island, New York 10301
United StatesSite Not Available
Novo Nordisk Investigational Site
Greenville, North Carolina 27834
United StatesSite Not Available
Novo Nordisk Investigational Site
Mooresville, North Carolina 28117
United StatesSite Not Available
Novo Nordisk Clinical Trial Call Center
Statesville, North Carolina 28625
United StatesSite Not Available
Novo Nordisk Investigational Site
Mason, Ohio 45040-6815
United StatesSite Not Available
Novo Nordisk Investigational Site
Wadsworth, Ohio 44281-9236
United StatesSite Not Available
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Novo Nordisk Investigational Site
McMurray, Pennsylvania 15317
United StatesSite Not Available
Novo Nordisk Investigational Site
Norristown, Pennsylvania 19401
United StatesSite Not Available
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Novo Nordisk Clinical Trial Call Center
Upper St Clair, Pennsylvania 15241
United StatesSite Not Available
Novo Nordisk Investigational Site
East Providence, Rhode Island 02914
United StatesSite Not Available
Novo Nordisk Investigational Site
Chattanooga, Tennessee 37404-1192
United StatesSite Not Available
Novo Nordisk Investigational Site
Kingsport, Tennessee 37660
United StatesSite Not Available
Novo Nordisk Investigational Site
Amarillo, Texas 79106
United StatesSite Not Available
Novo Nordisk Clinical Trial Call Center
Houston, Texas 77054
United StatesSite Not Available
Novo Nordisk Investigational Site
Lubbock, Texas 79423
United StatesSite Not Available
Novo Nordisk Investigational Site
Sugar Land, Texas 77479
United StatesSite Not Available
Novo Nordisk Investigational Site
Newport News, Virginia 23606
United StatesSite Not Available
Novo Nordisk Clinical Trial Call Center
Norfolk, Virginia 23502
United StatesSite Not Available
Novo Nordisk Investigational Site
Richmond, Virginia 23298
United StatesSite Not Available
Novo Nordisk Investigational Site
Winchester, Virginia 22601
United StatesSite Not Available
Novo Nordisk Clinical Trial Call Center
Olympia, Washington 98502-5010
United StatesSite Not Available
Novo Nordisk Investigational Site
Milwaukee, Wisconsin 53209
United StatesSite Not Available
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