Phase
Condition
Diabetic Gastroparesis
Diabetic Neuropathy
Diabetic Foot Ulcers
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Informed consent obtained before any trial-related activities. Trial-relatedactivities are any procedures that are carried out as part of the trial, includingactivities to determine suitability for the trial
Male or female, age at least 18 years at the time of signing informed consent Algeria:Male or female, age at least 19 years at the time of signing informed consent
Diagnosed with type 2 diabetes mellitus
Treated with any basal insulin for at least 90 days prior to the day of screening
Subject not on any OAD(s) prior to trial participation OR subjects on stable dailydose(s) of OAD(s) for at least 90 days prior to screening visit (V1). The OAD(s)include any of the following anti-diabetic drug s)/regimen: a. Biguanides (metforminat least 1500 mg or maximum tolerated dose documented in the subject medical record)b. Other OADs (at least half of the maximum approved dose according to local label ormaximum tolerated dose as documented in subject medical record): i. Insulinsecretagogues (SU and glinides) ii. Di-peptidyl-peptidase IV (DPP-4) inhibitors iii. α-glucosidase inhibitors iv. Sodium/glucose co-transporter 2 (SGLT-2) inhibitors v.Oral combination products (of the allowed individual OADs above)
HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive) by central laboratory analysis
Body mass index (BMI) equal to or below 45.0 kg/m^2
Exclusion
Exclusion Criteria:
Participation in any clinical trial of an approved or non-approved investigationalmedicinal product within four weeks prior to the day of screening (V1)
Any chronic disorder or severe disease which, in the opinion of the investigator,might jeopardise subject's safety or compliance with the protocol
Acute decompensation of glycaemic control requiring immediate intensification oftreatment to prevent severe metabolic dysregulation (e.g. diabetes ketoacidosis) equalor below 90 days prior to the day of the screening and between screening andrandomisation
Any of the following: myocardial infarction, stroke or hospitalization for unstableangina or transient ischaemic attack within the past 180 days prior to the day ofscreening and between screening and randomisation
Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value ofbelow 60 ml/min/1.73 m^2 as defined by KDIGO 2012 classification using isotopedilution mass spectrometry (IDMS) for serum creatinine measured at screening
Impaired liver function, defined as alanine aminotransferase (ALT) equal to or above 2.5 times upper normal limit (UNL) at screening.
Subjects presently classified as being in New York Heart Association (NYHA) Class IV
Planned coronary, carotid or peripheral artery revascularisation known on the day ofscreening
Treatment with any medication for the indication of diabetes or obesity other thanstated in the inclusion criteria in a period of 90 days before the day of screening
Anticipated initiation or change in concomitant medications (for more than 14consecutive days) known to affect weight or glucose metabolism (e.g. treatment withorlistat, thyroid hormones, or corticosteroids)
Study Design
Connect with a study center
Novo Nordisk Investigational Site
Constantine, 25000
AlgeriaSite Not Available
Novo Nordisk Investigational Site
Oran, 31000
AlgeriaSite Not Available
Novo Nordisk Investigational Site
Sidi Bel Abbes, 22000
AlgeriaSite Not Available
Novo Nordisk Investigational Site
Broumov, 550 01
CzechiaSite Not Available
Novo Nordisk Investigational Site
Nachod, 547 01
CzechiaSite Not Available
Novo Nordisk Investigational Site
Prague 4, 140 21
CzechiaSite Not Available
Novo Nordisk Investigational Site
Praha 4, 140 46
CzechiaSite Not Available
Novo Nordisk Investigational Site
Trutnov, 541 01
CzechiaSite Not Available
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh 500072
IndiaSite Not Available
Novo Nordisk Investigational Site
Surat, Gujarat 395002
IndiaSite Not Available
Novo Nordisk Investigational Site
Kozhikode, Kerala 673017
IndiaSite Not Available
Novo Nordisk Investigational Site
Aurangabad, Maharashtra 431005
IndiaSite Not Available
Novo Nordisk Investigational Site
Mumbai, Maharashtra 400058
IndiaSite Not Available
Novo Nordisk Investigational Site
New Dehli, New Delhi 110029
IndiaSite Not Available
Novo Nordisk Investigational Site
Chennai, Tamil Nadu 600086
IndiaSite Not Available
Novo Nordisk Investigational Site
Coimbatore, Tamil Nadu 641018
IndiaSite Not Available
Novo Nordisk Investigational Site
Kolkata, West Bengal 700054
IndiaSite Not Available
Novo Nordisk Investigational Site
New Delhi, 110001
IndiaSite Not Available
Novo Nordisk Investigational Site
Arkhangelsk, 163045
Russian FederationSite Not Available
Novo Nordisk Investigational Site
Cheboksary, 428009
Russian FederationSite Not Available
Novo Nordisk Investigational Site
Moscow, 127486
Russian FederationSite Not Available
Novo Nordisk Investigational Site
Saint-Petersburg, 195213
Russian FederationSite Not Available
Novo Nordisk Investigational Site
Saratov, 410053
Russian FederationSite Not Available
Novo Nordisk Investigational Site
Syktyvkar, 167981
Russian FederationSite Not Available
Novo Nordisk Investigational Site
Tumen, 625023
Russian FederationSite Not Available
Novo Nordisk Investigational Site
Belgrade, 11080
SerbiaSite Not Available
Novo Nordisk Investigational Site
Nis, 18000
SerbiaSite Not Available
Novo Nordisk Investigational Site
Adana, 01250
TurkeySite Not Available
Novo Nordisk Investigational Site
Ankara, 06100
TurkeySite Not Available
Novo Nordisk Investigational Site
Istanbul, 34718
TurkeySite Not Available
Novo Nordisk Investigational Site
Izmir, 35340
TurkeySite Not Available
Novo Nordisk Investigational Site
Glendale, Arizona 85306-4652
United StatesSite Not Available
Novo Nordisk Investigational Site
Phoenix, Arizona 85050
United StatesSite Not Available
Novo Nordisk Investigational Site
Anaheim, California 92801
United StatesSite Not Available
Novo Nordisk Investigational Site
Concord, California 94520
United StatesSite Not Available
Novo Nordisk Investigational Site
Fresno, California 93720
United StatesSite Not Available
Novo Nordisk Investigational Site
La Jolla, California 92037
United StatesSite Not Available
Novo Nordisk Investigational Site
Northridge, California 91325
United StatesSite Not Available
Novo Nordisk Investigational Site
Danbury, Connecticut 06810
United StatesSite Not Available
Novo Nordisk Investigational Site
Fort Lauderdale, Florida 33312
United StatesSite Not Available
Novo Nordisk Investigational Site
Ft. Lauderdale, Florida 33312
United StatesSite Not Available
Novo Nordisk Investigational Site
Jacksonville, Florida 32205
United StatesSite Not Available
Novo Nordisk Investigational Site
Kissimmee, Florida 34744
United StatesSite Not Available
Novo Nordisk Investigational Site
Roswell, Georgia 30076
United StatesSite Not Available
Novo Nordisk Investigational Site
Louisville, Kentucky 40213
United StatesSite Not Available
Novo Nordisk Investigational Site
Chesterfield, Missouri 63017
United StatesSite Not Available
Novo Nordisk Investigational Site
New York, New York 10029
United StatesSite Not Available
Novo Nordisk Investigational Site
Westfield, New York 14787
United StatesSite Not Available
Novo Nordisk Investigational Site
Wilmington, North Carolina 28401
United StatesSite Not Available
Novo Nordisk Investigational Site
Franklin, Ohio 45005
United StatesSite Not Available
Novo Nordisk Investigational Site
Bartlett, Tennessee 38133
United StatesSite Not Available
Novo Nordisk Investigational Site
Chattanooga, Tennessee 37411
United StatesSite Not Available
Novo Nordisk Investigational Site
Kingsport, Tennessee 37660
United StatesSite Not Available
Novo Nordisk Investigational Site
Knoxville, Tennessee 37938
United StatesSite Not Available
Novo Nordisk Investigational Site
Nashville, Tennessee 37228
United StatesSite Not Available
Novo Nordisk Investigational Site
Austin, Texas 78758
United StatesSite Not Available
Novo Nordisk Investigational Site
Dallas, Texas 75390-9302
United StatesSite Not Available
Novo Nordisk Investigational Site
San Antonio, Texas 78230
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
Winchester, Virginia 22601-3834
United StatesSite Not Available
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