Clinical trial NCT03078478: A Trial Comparing the Efficacy and Safety of Insulin Degludec and Insulin Glargine 300 Units/mL in Subjects With Type 2 Diabetes Mellitus Inadequately Treated With Basal Insulin With or Without Oral Antidiabetic Drugs
Official title: A Trial Comparing the Efficacy and Safety of Insulin Degludec and Insulin Glargine 300 Units/mL in Subjects With Type 2 Diabetes Mellitus Inadequately Treated With Basal Insulin With or Without Oral Antidiabetic Drugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2017-03-13
Enrollment: 1609
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe and North America. The aim of the trial is to compare the efficacy and safety of insulin degludec and insulin glargine 300 units/mL in subjects with type 2 diabetes mellitus inadequately treated with basal insulin with or without oral antidiabetic drugs. Due to change in glycaemic data collection process, this trial is amended to allow for a full 36 weeks (maintenance 2 period) of the use of the new process.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks)
timeFrame: 36 Weeks
Secondary outcomes:
measure: Basal Insulin Dose (U) at End of Treatment (up to 88 Weeks)
timeFrame: 88 weeks
measure: Number of Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks)
timeFrame: 36 weeks
measure: Number of Severe Hypoglycaemic Episodes During Maintenance 2 (36 Weeks)
timeFrame: 36 weeks (maintenance 2)
measure: Change in HbA1c From Baseline to End of Treatment (up to 88 Weeks)
timeFrame: Week 0, week 88
measure: Change in Fasting Plasma Glucose (FPG) From Baseline to End of Treatment (up to 88 Weeks)
timeFrame: Week 0, week 88
measure: Percentage of Participants With FPG ≤ 7.2 mmol/L (130 mg/dL) at End of Treatment (up to 88 Weeks) (Yes/no)
timeFrame: At 88 weeks
measure: Percentage of Participants With FPG ≤ 5.0 mmol/L (90 mg/dL) at End of Treatment (up to 88 Weeks) (Yes/no)
timeFrame: At 88 weeks
measure: Percentage of Participants With HbA1c < 7.0% (53 mmol/Mol) at End of Treatment (up to 88 Weeks) and no Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) (Yes/no)
timeFrame: End of Treatment (up to 88 Weeks)
measure: Percentage of Participants With HbA1c < 7.0% (53 mmol/Mol) at End of Treatment (up to 88 Weeks) and no Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) (Yes/no)
timeFrame: At 88 weeks
measure: Change in Mean Pre-breakfast Self-measured Plasma Glucose Used for Titration From Baseline to End of Treatment (up to 88 Weeks)
timeFrame: Week 0, week 88
measure: Number of Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Treatment (up to 88 Weeks)
timeFrame: 88 weeks
measure: Number of Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Treatment (up to 88 Weeks)
timeFrame: 88 weeks
measure: Number of Severe Hypoglycaemic Episodes During Treatment (up to 88 Weeks)
timeFrame: 88 weeks
measure: Number of Adverse Events From Randomisation to End of Maintenance Period 2 (up to 88 Weeks)
timeFrame: 88 weeks
measure: Change in Body Weight From Baseline to End of Treatment (up to 88 Weeks)
timeFrame: Week 0, week 88
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Chandler
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state: Arizona
city: Fountain Hills
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facility: Novo Nordisk Investigational Site
state: Arizona
city: Glendale
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facility: Novo Nordisk Investigational Site
state: Arizona
city: Glendale
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state: Arizona
city: Glendale
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state: Arizona
city: Phoenix
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state: Arizona
city: Tucson
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state: Arizona
city: Buena Park
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state: California
city: Concord
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state: California
city: Downey
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state: California
city: Duarte
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state: California
city: Fresno
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state: California
city: La Jolla
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state: California
city: Lancaster
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state: California
city: Lomita
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facility: Novo Nordisk Investigational Site
state: California
city: Los Alamitos
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facility: Novo Nordisk Investigational Site
state: California
city: Los Angeles
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facility: Novo Nordisk Investigational Site
state: California
city: Moreno Valley
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state: California
city: Northridge
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state: California
city: Palm Springs
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facility: Novo Nordisk Investigational Site
state: California
city: Pomona
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Poway
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state: California
city: Riverside
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Roseville
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Sacramento
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: San Mateo
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: San Ramon
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Stanford
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state: California
city: Vista
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state: California
city: Walnut Creek
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city: West Hills
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state: California
city: Colorado Springs
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state: Colorado
city: Englewood
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state: Colorado
city: Waterbury
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facility: Novo Nordisk Investigational Site
state: Connecticut
city: Bradenton
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facility: Novo Nordisk Investigational Site
state: Florida
city: Brandon
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facility: Novo Nordisk Investigational Site
state: Florida
city: Clearwater
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facility: Novo Nordisk Investigational Site
state: Florida
city: Cooper City
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Jacksonville
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facility: Novo Nordisk Investigational Site
state: Florida
city: Miami Springs
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facility: Novo Nordisk Investigational Site
state: Florida
city: Miami
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state: Florida
city: New Port Richey
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state: Florida
city: Orlando
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facility: Novo Nordisk Investigational Site
state: Florida
city: Ormond Beach
country: United States
facility: Novo Nordisk Investigational Site
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city: Palm Harbor
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city: Pembroke Pines
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city: Port Charlotte
country: United States
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state: Florida
city: Tampa
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state: Florida
city: Marietta
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Roswell
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Honolulu
country: United States
facility: Novo Nordisk Investigational Site
state: Hawaii
city: Blackfoot
country: United States
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state: Idaho
city: Chicago
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Gurnee
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Peoria
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Skokie
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Springfield
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Wauconda
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Evansville
country: United States
facility: Novo Nordisk Investigational Site
state: Indiana
city: Mishawaka
country: United States
facility: Novo Nordisk Investigational Site
state: Indiana
city: Valparaiso
country: United States
facility: Novo Nordisk Investigational Site
state: Indiana
city: Council Bluffs
country: United States
facility: Novo Nordisk Investigational Site
state: Iowa
city: West Des Moines
country: United States
facility: Novo Nordisk Investigational Site
state: Iowa
city: Topeka
country: United States
facility: Novo Nordisk Investigational Site
state: Kansas
city: Lexington
country: United States
facility: Novo Nordisk Investigational Site
state: Kentucky
city: Lexington
country: United States
facility: Novo Nordisk Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Novo Nordisk Investigational Site
state: Kentucky
city: Paducah
country: United States
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state: Kentucky
city: New Orleans
country: United States
facility: Novo Nordisk Investigational Site
state: Louisiana
city: Rockville
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: Bloomfield Hills
country: United States
facility: Novo Nordisk Investigational Site
state: Michigan
city: Richfield
country: United States
facility: Novo Nordisk Investigational Site
state: Minnesota
city: Chesterfield
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Kalispell
country: United States
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state: Montana
city: Elkhorn
country: United States
facility: Novo Nordisk Investigational Site
state: Nebraska
city: Fremont
country: United States
facility: Novo Nordisk Investigational Site
state: Nebraska
city: Omaha
country: United States
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state: Nebraska
city: Henderson
country: United States
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state: Nevada
city: Las Vegas
country: United States
facility: Novo Nordisk Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Novo Nordisk Investigational Site
state: Nevada
city: Las Vegas
country: United States
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state: Nevada
city: Nashua
country: United States
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state: New Hampshire
city: East Brunswick
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Lawrenceville
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Novo Nordisk Investigational Site
state: New Mexico
city: Albuquerque
country: United States
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state: New Mexico
city: Albany
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: New Windsor
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: New York
country: United States
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state: New York
city: Northport
country: United States
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state: New York
city: West Seneca
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Charlotte
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Greensboro
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Greenville
country: United States
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state: North Carolina
city: Greenville
country: United States
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state: North Carolina
city: Morehead City
country: United States
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state: North Carolina
city: Statesville
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Maumee
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Toledo
country: United States
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state: Ohio
city: Norman
country: United States
facility: Novo Nordisk Investigational Site
state: Oklahoma
city: Beaver
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: McMurray
country: United States
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state: Pennsylvania
city: Philadelphia
country: United States
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state: Pennsylvania
city: Anderson
country: United States
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state: South Carolina
city: Gaffney
country: United States
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state: South Carolina
city: Greenville
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Greer
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Mount Pleasant
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Pelzer
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: West Columbia
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Dakota Dunes
country: United States
facility: Novo Nordisk Investigational Site
state: South Dakota
city: Bristol
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Chattanooga
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Chattanooga
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Kingsport
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Knoxville
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Amarillo
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Arlington
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Austin
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Humble
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Kerrville
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: New Braunfels
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Plano
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Waco
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Bountiful
country: United States
facility: Novo Nordisk Investigational Site
state: Utah
city: Murray
country: United States
facility: Novo Nordisk Investigational Site
state: Utah
city: Ogden
country: United States
facility: Novo Nordisk Investigational Site
state: Utah
city: Bennington
country: United States
facility: Novo Nordisk Investigational Site
state: Vermont
city: Chesapeake
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Midlothian
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Virginia Beach
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Olympia
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Spokane
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Kenosha
country: United States
facility: Novo Nordisk Investigational Site
state: Wisconsin
city: West Allis
country: United States
facility: Novo Nordisk Investigational Site
state: Wisconsin
city: Calgary
country: Canada
facility: Novo Nordisk Investigational Site
state: Alberta
city: Brampton
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Etobicoke
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Markham
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Oakville
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Mirabel
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: Aarhus N
country: Denmark
facility: Novo Nordisk Investigational Site
city: Esbjerg
country: Denmark
facility: Novo Nordisk Investigational Site
city: Hellerup
country: Denmark
facility: Novo Nordisk Investigational Site
city: Hillerød
country: Denmark
facility: Novo Nordisk Investigational Site
city: Hvidovre
country: Denmark
facility: Novo Nordisk Investigational Site
city: Odense
country: Denmark
facility: Novo Nordisk Investigational Site
city: Pärnu
country: Estonia
facility: Novo Nordisk Investigational Site
city: Tallinn
country: Estonia
facility: Novo Nordisk Investigational Site
city: Tallinn
country: Estonia
facility: Novo Nordisk Investigational Site
city: Viljandi
country: Estonia
facility: Novo Nordisk Investigational Site
city: Bad Mergentheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Elsterwerda
country: Germany
facility: Novo Nordisk Investigational Site
city: Essen
country: Germany
facility: Novo Nordisk Investigational Site
city: Essen
country: Germany
facility: Novo Nordisk Investigational Site
city: Falkensee
country: Germany
facility: Novo Nordisk Investigational Site
city: Friedrichsthal
country: Germany
facility: Novo Nordisk Investigational Site
city: Hamburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Hamburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Lingen
country: Germany
facility: Novo Nordisk Investigational Site
city: Rehlingen-Siersburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Saint Ingbert-Oberwürzbach
country: Germany
facility: Novo Nordisk Investigational Site
city: Athens
country: Greece
facility: Novo Nordisk Investigational Site
city: Athens
country: Greece
facility: Novo Nordisk Investigational Site
city: Larissa
country: Greece
facility: Novo Nordisk Investigational Site
city: Nikaia
country: Greece
facility: Novo Nordisk Investigational Site
city: Thessaloniki
country: Greece
facility: Novo Nordisk Investigational Site
city: Thessaloniki
country: Greece
facility: Novo Nordisk Investigational Site
city: Thessaloniki
country: Greece
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Debrecen
country: Hungary
facility: Novo Nordisk Investigational Site
city: Debrecen
country: Hungary
facility: Novo Nordisk Investigational Site
city: Kaposvár
country: Hungary
facility: Novo Nordisk Investigational Site
city: Szeged
country: Hungary
facility: Novo Nordisk Investigational Site
city: Szombathely
country: Hungary
facility: Novo Nordisk Investigational Site
city: Hamar
country: Norway
facility: Novo Nordisk Investigational Site
city: Hoenefoss
country: Norway
facility: Novo Nordisk Investigational Site
city: Oslo
country: Norway
facility: Novo Nordisk Investigational Site
city: Oslo
country: Norway
facility: Novo Nordisk Investigational Site
city: Oslo
country: Norway
facility: Novo Nordisk Investigational Site
city: Skedsmokorset
country: Norway
facility: Novo Nordisk Investigational Site
city: Trondheim
country: Norway
facility: Novo Nordisk Investigational Site
city: Bialystok
country: Poland
facility: Novo Nordisk Investigational Site
city: Bytom
country: Poland
facility: Novo Nordisk Investigational Site
city: Gdansk
country: Poland
facility: Novo Nordisk Investigational Site
city: Gdansk
country: Poland
facility: Novo Nordisk Investigational Site
city: Lublin
country: Poland
facility: Novo Nordisk Investigational Site
city: Lublin
country: Poland
facility: Novo Nordisk Investigational Site
city: Szczecin
country: Poland
facility: Novo Nordisk Investigational Site
city: Warsaw
country: Poland
facility: Novo Nordisk Investigational Site
city: Zabrze
country: Poland
facility: Novo Nordisk Investigational Site
city: Manati
country: Puerto Rico
facility: Novo Nordisk Investigational Site
city: Ponce
country: Puerto Rico
facility: Novo Nordisk Investigational Site
city: Oradea
country: Romania
facility: Novo Nordisk Investigational Site
state: Bihor
city: Bucharest
country: Romania
facility: Novo Nordisk Investigational Site
city: Bucharest
country: Romania
facility: Novo Nordisk Investigational Site
city: Buzau
country: Romania
facility: Novo Nordisk Investigational Site
city: Galati
country: Romania
facility: Novo Nordisk Investigational Site
city: Belgrade
country: Serbia
facility: Novo Nordisk Investigational Site
city: Belgrade
country: Serbia
facility: Novo Nordisk Investigational Site
city: Nis
country: Serbia
facility: Novo Nordisk Investigational Site
Study officials:
References:
citation: Philis-Tsimikas A, Stratton I, Norgard Troelsen L, Anker Bak B, Leiter LA. Efficacy and Safety of Degludec Compared to Glargine 300 Units/mL in Insulin-Experienced Patients With Type 2 Diabetes: Trial Protocol Amendment (NCT03078478). J Diabetes Sci Technol. 2019 May;13(3):498-506. doi: 10.1177/1932296819841585. Epub 2019 Apr 11.
citation: Philis-Tsimikas A, Klonoff DC, Khunti K, Bajaj HS, Leiter LA, Hansen MV, Troelsen LN, Ladelund S, Heller S, Pieber TR; CONCLUDE Study Group. Risk of hypoglycaemia with insulin degludec versus insulin glargine U300 in insulin-treated patients with type 2 diabetes: the randomised, head-to-head CONCLUDE trial. Diabetologia. 2020 Apr;63(4):698-710. doi: 10.1007/s00125-019-05080-9. Epub 2020 Jan 27.
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