Clinical trial NCT02128932: Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as add-on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes
Official title: Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as Add on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes
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: 2014-05-01
Enrollment: 1089
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 Africa, North and South America, Asia and Europe. The purpose of the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in insulin-naïve subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Male or female, 18 years or older at the time of signing informed consent
* Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin 1500 mg or higher or maximum tolerated dose and SU half of maximum allowed dose according to national label or higher) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose
* HbA1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or of childbearing potential not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period
* Any disorder which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol
* Treatment with any glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (7 days or less in total) with insulin in connection with intercurrent illness
* History of chronic or idiopathic acute pancreatitis
* Screening calcitonin value greater than or equal to 50 ng/L
* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome 2
* Severe renal impairment defined as estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m\^2 per modification of diet in renal disease (MDRD) formula (4 variable version)
* Acute coronary or cerebrovascular event within 90 days before randomisation
* Heart failure, New York Heart Association Class IV
* Known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator
* Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
* Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures

Primary outcomes:
measure: Change in HbA1c From Baseline
timeFrame: Week 0, week 30
Secondary outcomes:
measure: Change in Body Weight From Baseline
timeFrame: Week 0, week 30
measure: Change in Fasting Plasma Glucose From Baseline
timeFrame: Week 0, week 30
measure: Change in Diastolic Blood Pressure.
timeFrame: Week 0, week 30
measure: Change in Systolic Blood Pressure.
timeFrame: Week 0, week 30
measure: Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™
timeFrame: Week 0, week 30
measure: Change in Patient Reported Outcome Questionnaires. (PROs), Diabetes Treatment Satisfaction Questionnaire (DTSQs)
timeFrame: Week 0, week 30
measure: Subjects Who Achieve HbA1c ≤6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE)
timeFrame: After 30 weeks treatment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Ozark
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Tuscumbia
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Gilbert
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Anaheim
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Carmichael
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Chula Vista
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Elk Grove
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Inglewood
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: La Mesa
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Long Beach
country: United States
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state: California
city: Los Angeles
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Oceanside
country: United States
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state: California
city: Orange
country: United States
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state: California
city: Pomona
country: United States
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state: California
city: Rialto
country: United States
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state: California
city: Rolling Hills Estates
country: United States
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state: California
city: Roseville
country: United States
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state: California
city: San Diego
country: United States
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state: California
city: San Mateo
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Sherman Oaks
country: United States
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state: California
city: Spring Valley
country: United States
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state: California
city: Tustin
country: United States
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state: California
city: Walnut Creek
country: United States
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state: California
city: Colorado Springs
country: United States
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state: Colorado
city: Denver
country: United States
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state: Colorado
city: Denver
country: United States
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state: Colorado
city: Clearwater
country: United States
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state: Florida
city: Cooper City
country: United States
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state: Florida
city: Hialeah
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Jacksonville
country: United States
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state: Florida
city: Jacksonville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Jacksonville
country: United States
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state: Florida
city: Kissimmee
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Lakeland
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Miami Lakes
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Miami
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Miami
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Spring Hill
country: United States
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state: Florida
city: Winter Haven
country: United States
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state: Florida
city: Winter Park
country: United States
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state: Florida
city: Conyers
country: United States
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state: Georgia
city: Johns Creek
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Marietta
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Norcross
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Roswell
country: United States
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state: Georgia
city: Meridian
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state: Idaho
city: Chicago
country: United States
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state: Illinois
city: Gurnee
country: United States
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city: Peoria
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city: Avon
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state: Indiana
city: Indianapolis
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city: Council Bluffs
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state: Iowa
city: Park City
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state: Kansas
city: Lexington
country: United States
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state: Kentucky
city: Madisonville
country: United States
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state: Kentucky
city: Paducah
country: United States
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state: Kentucky
city: Lake Charles
country: United States
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state: Louisiana
city: Metairie
country: United States
facility: Novo Nordisk Investigational Site
state: Louisiana
city: Natchitoches
country: United States
facility: Novo Nordisk Investigational Site
state: Louisiana
city: Shreveport
country: United States
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state: Louisiana
city: Hyattsville
country: United States
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state: Maryland
city: Buckley
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state: Michigan
city: Flint
country: United States
facility: Novo Nordisk Investigational Site
state: Michigan
city: Sterling Heights
country: United States
facility: Novo Nordisk Investigational Site
state: Michigan
city: Troy
country: United States
facility: Novo Nordisk Investigational Site
state: Michigan
city: Saint Louis
country: United States
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state: Missouri
city: Saint Louis
country: United States
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state: Missouri
city: Butte
country: United States
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state: Montana
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: Las Vegas
country: United States
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state: Nevada
city: Berlin
country: United States
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state: New Jersey
city: Toms River
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Trenton
country: United States
facility: Novo Nordisk Investigational Site
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city: Albuquerque
country: United States
facility: Novo Nordisk Investigational Site
state: New Mexico
city: Brooklyn
country: United States
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state: New York
city: New Windsor
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: West Seneca
country: United States
facility: Novo Nordisk Investigational Site
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city: Greensboro
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Morehead City
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Morganton
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Shelby
country: United States
facility: Novo Nordisk Investigational Site
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: Fargo
country: United States
facility: Novo Nordisk Investigational Site
state: North Dakota
city: Canal Fulton
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Carlisle
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Cincinnati
country: United States
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state: Ohio
city: Cincinnati
country: United States
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state: Ohio
city: Cincinnati
country: United States
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state: Ohio
city: Cleveland
country: United States
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state: Ohio
city: Kettering
country: United States
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state: Ohio
city: Mason
country: United States
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state: Ohio
city: Maumee
country: United States
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state: Ohio
city: Toledo
country: United States
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state: Ohio
city: Corvallis
country: United States
facility: Novo Nordisk Investigational Site
state: Oregon
city: Altoona
country: United States
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state: Pennsylvania
city: Beaver
country: United States
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state: Pennsylvania
city: Clairton
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Jersey Shore
country: United States
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city: Lansdale
country: United States
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state: Pennsylvania
city: Philadelphia
country: United States
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state: Pennsylvania
city: Gaffney
country: United States
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state: South Carolina
city: Murrells Inlet
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Rapid City
country: United States
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state: South Dakota
city: Chattanooga
country: United States
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state: Tennessee
city: Knoxville
country: United States
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state: Tennessee
city: Amarillo
country: United States
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state: Texas
city: Austin
country: United States
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state: Texas
city: Dallas
country: United States
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state: Texas
city: Fort Worth
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: Humble
country: United States
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state: Texas
city: Hurst
country: United States
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state: Texas
city: Irving
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Longview
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Marshall
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
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state: Texas
city: Saint George
country: United States
facility: Novo Nordisk Investigational Site
state: Utah
city: Salt Lake City
country: United States
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state: Utah
city: Arlington
country: United States
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state: Virginia
city: Winchester
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Olympia
country: United States
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state: Washington
city: Renton
country: United States
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city: Wenatchee
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Kenosha
country: United States
facility: Novo Nordisk Investigational Site
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Novo Nordisk Investigational Site
city: Caba
country: Argentina
facility: Novo Nordisk Investigational Site
city: Capital Federal
country: Argentina
facility: Novo Nordisk Investigational Site
city: Godoy Cruz
country: Argentina
facility: Novo Nordisk Investigational Site
city: Cakovec
country: Croatia
facility: Novo Nordisk Investigational Site
city: Karlovac
country: Croatia
facility: Novo Nordisk Investigational Site
city: Krapinske Toplice
country: Croatia
facility: Novo Nordisk Investigational Site
city: Zagreb
country: Croatia
facility: Novo Nordisk Investigational Site
city: Bobigny
country: France
facility: Novo Nordisk Investigational Site
city: Bois-Guillaume
country: France
facility: Novo Nordisk Investigational Site
city: Bourgoin-jallieu
country: France
facility: Novo Nordisk Investigational Site
city: LA ROCHE-sur-YON cedex 9
country: France
facility: Novo Nordisk Investigational Site
city: Le Creusot
country: France
facility: Novo Nordisk Investigational Site
city: MARSEILLE cedex 08
country: France
facility: Novo Nordisk Investigational Site
city: MARSEILLE Cédex 05
country: France
facility: Novo Nordisk Investigational Site
city: Nanterre
country: France
facility: Novo Nordisk Investigational Site
city: Narbonne
country: France
facility: Novo Nordisk Investigational Site
city: NICE cedex 3
country: France
facility: Novo Nordisk Investigational Site
city: Paris
country: France
facility: Novo Nordisk Investigational Site
city: Pierre-Bénite
country: France
facility: Novo Nordisk Investigational Site
city: Pointe À Pitre
country: France
facility: Novo Nordisk Investigational Site
city: Rang-du-fliers
country: France
facility: Novo Nordisk Investigational Site
city: Saint Herblain
country: France
facility: Novo Nordisk Investigational Site
city: Saint Nazaire
country: France
facility: Novo Nordisk Investigational Site
city: Strasbourg
country: France
facility: Novo Nordisk Investigational Site
city: Trinité - La Martinique
country: France
facility: Novo Nordisk Investigational Site
city: Venissieux
country: France
facility: Novo Nordisk Investigational Site
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Essen
country: Germany
facility: Novo Nordisk Investigational Site
city: Jerichow
country: Germany
facility: Novo Nordisk Investigational Site
city: Lampertheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Ludwigshafen
country: Germany
facility: Novo Nordisk Investigational Site
city: Münster
country: Germany
facility: Novo Nordisk Investigational Site
city: Neuwied
country: Germany
facility: Novo Nordisk Investigational Site
city: Rehlingen-Siersburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Rostock
country: Germany
facility: Novo Nordisk Investigational Site
city: Saint Ingbert-Oberwürzbach
country: Germany
facility: Novo Nordisk Investigational Site
city: Stuttgart
country: Germany
facility: Novo Nordisk Investigational Site
city: Wangen
country: Germany
facility: Novo Nordisk Investigational Site
city: Ahmedabad
country: India
facility: Novo Nordisk Investigational Site
state: Gujarat
city: Ahmedabad
country: India
facility: Novo Nordisk Investigational Site
state: Gujarat
city: Bangalore
country: India
facility: Novo Nordisk Investigational Site
state: Karnataka
city: Mysore
country: India
facility: Novo Nordisk Investigational Site
state: Karnataka
city: Mysore
country: India
facility: Novo Nordisk Investigational Site
state: Karnataka
city: Indore
country: India
facility: Novo Nordisk Investigational Site
state: Madhya Pradesh
city: Mumbai
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: Mumbai
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: Mumbai
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: Mumbai
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: New Dehli
country: India
facility: Novo Nordisk Investigational Site
state: New Delhi
city: Chennai
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Kolkata
country: India
facility: Novo Nordisk Investigational Site
state: West Bengal
city: Kolkata
country: India
facility: Novo Nordisk Investigational Site
city: New Delhi
country: India
facility: Novo Nordisk Investigational Site
city: Guadalajara
country: Mexico
facility: Novo Nordisk Investigational Site
state: Jalisco
city: Distrito Federal
country: Mexico
facility: Novo Nordisk Investigational Site
state: México, D.F.
city: México D.F.
country: Mexico
facility: Novo Nordisk Investigational Site
state: México, D.F.
city: Aguascalientes
country: Mexico
facility: Novo Nordisk Investigational Site
city: Amsterdam
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Hoofddorp
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Rotterdam
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Skopje
country: North Macedonia
facility: Novo Nordisk Investigational Site
city: Tetovo
country: North Macedonia
facility: Novo Nordisk Investigational Site
city: Ponce
country: Puerto Rico
facility: Novo Nordisk Investigational Site
city: Pitesti
country: Romania
facility: Novo Nordisk Investigational Site
state: Arges
city: Oradea
country: Romania
facility: Novo Nordisk Investigational Site
state: Bihor
city: Cluj Napoca
country: Romania
facility: Novo Nordisk Investigational Site
state: Cluj
city: Bucharest
country: Romania
facility: Novo Nordisk Investigational Site
city: Iasi
country: Romania
facility: Novo Nordisk Investigational Site
city: Kosice
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Moldava nad Bodvou
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Piestany
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Puchov
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Trencin
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Koper
country: Slovenia
facility: Novo Nordisk Investigational Site
city: Ljubljana
country: Slovenia
facility: Novo Nordisk Investigational Site
city: Novo mesto
country: Slovenia
facility: Novo Nordisk Investigational Site
city: Johannesburg
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Johannesburg
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Pretoria
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Durban
country: South Africa
facility: Novo Nordisk Investigational Site
state: KwaZulu-Natal
city: Cape Town
country: South Africa
facility: Novo Nordisk Investigational Site
state: Western Cape
city: Basingstoke
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Bristol
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Harrogate, North Yorkshire
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Haxey
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Hull
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Ipswich
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Northwood
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Plymouth
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Salford
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Sidcup
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Soham
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Swansea
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Taunton
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Rodbard HW, Bellary S, Hramiak I, Seino Y, Silver R, Damgaard LH, Nayak G, Zacho J, Aroda VR. GREATER COMBINED REDUCTIONS IN HbA1C >/=1.0% AND WEIGHT >/=5.0% WITH SEMAGLUTIDE VERSUS COMPARATORS IN TYPE 2 DIABETES. Endocr Pract. 2019 Jun;25(6):589-597. doi: 10.4158/EP-2018-0444. Epub 2019 Mar 13.
citation: Aroda VR, Bain SC, Cariou B, Piletic M, Rose L, Axelsen M, Rowe E, DeVries JH. Efficacy and safety of once-weekly semaglutide versus once-daily insulin glargine as add-on to metformin (with or without sulfonylureas) in insulin-naive patients with type 2 diabetes (SUSTAIN 4): a randomised, open-label, parallel-group, multicentre, multinational, phase 3a trial. Lancet Diabetes Endocrinol. 2017 May;5(5):355-366. doi: 10.1016/S2213-8587(17)30085-2. Epub 2017 Mar 23.
citation: Kapitza C, Dahl K, Jacobsen JB, Axelsen MB, Flint A. Effects of semaglutide on beta cell function and glycaemic control in participants with type 2 diabetes: a randomised, double-blind, placebo-controlled trial. Diabetologia. 2017 Aug;60(8):1390-1399. doi: 10.1007/s00125-017-4289-0. Epub 2017 May 19.
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