Clinical trial NCT02461589: Dose-finding of Semaglutide Administered Subcutaneously Once Daily Versus Placebo and Liraglutide in Subjects With Type 2 Diabetes
Official title: Dose-finding of Semaglutide Administered Subcutaneously Once Daily Versus Placebo and Liraglutide in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2015-06-03
Enrollment: 706
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 globally. The aim of this trial is to investigate dose-finding of semaglutide administered subcutaneously once daily versus placebo and liraglutide in subjects with type 2 diabetes


Eligibility criteria: Inclusion Criteria:

* Male or female, age at least 18 years at the time of signing informed consent.
* Subjects should be on stable diabetes treatment consisting of diet and exercise with or without metformin (at least 1500 mg daily or maximum tolerated dose documented in the patient medical record) for at least 90 days prior to screening
* HbA1c (glycosylated haemoglobin): 53-86 mmol/mol (7.0-10.0%) (both inclusive)
* BMI: 25.0 - 40.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Simultaneous participation in any other clinical trial of an investigational medicinal product
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods throughout the trial including the 7 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice). Germany: Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner. United Kingdom: Adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), female sterilisation, male sterilisation (where partner is sole partner of subject), or true abstinence (when in line with preferred and usual lifestyle)
* 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 screening (an exception is short-term insulin treatment for acute illnesses for a total of below or equal to 14 days)
* Anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on an frequent basis) known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
* History of pancreatitis (acute or chronic)
* Screening calcitonin above or equal to 50 ng/L
* Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)
* Severe to moderate renal impairment defined as GFR, estimated below 60 ml/min/1.73 m\^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology)
* Within the past 180 days before screening any of the following: Myocardial infarction, stroke or hospitalisation for unstable angina and/or transient ischemic attack
* Currently planned coronary, carotid or peripheral artery revascularisation
* Patients presently classified as being in New York Heart Association (NYHA) Class III or IV

Primary outcomes:
measure: Change in HbA1c (Glycosylated Haemoglobin)
timeFrame: Week 0, week 26
Secondary outcomes:
measure: Change in Fasting Plasma Glucose (FPG)
timeFrame: Week 0, Week 26
measure: Body Weight Change
timeFrame: Week 0, Week 26
measure: Change in Systolic and Diastolic Blood Pressure
timeFrame: Week 0, Week 26
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Coronado
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Lancaster
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Riverside
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Tustin
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facility: Novo Nordisk Investigational Site
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city: Van Nuys
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city: Vista
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state: California
city: Walnut Creek
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city: Gainesville
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city: Boston
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city: Buckley
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state: Michigan
city: Belzoni
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state: Mississippi
city: Bridgeton
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state: Missouri
city: Kalispell
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city: Elkhorn
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state: Nebraska
city: Las Vegas
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state: Nevada
city: Lawrenceville
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state: New Jersey
city: Hopewell Junction
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city: Statesville
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state: North Carolina
city: Cincinnati
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state: Ohio
city: Cincinnati
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state: Ohio
city: Cincinnati
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city: Delaware
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city: Dublin
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city: Kettering
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city: Mason
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city: Oklahoma City
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city: Corvallis
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city: Downingtown
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state: Pennsylvania
city: Media
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state: Pennsylvania
city: Smithfield
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city: Uniontown
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city: Charleston
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state: South Carolina
city: Hodges
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facility: Novo Nordisk Investigational Site
state: South Carolina
city: Indian Land
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facility: Novo Nordisk Investigational Site
state: South Carolina
city: Mount Pleasant
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facility: Novo Nordisk Investigational Site
state: South Carolina
city: Bristol
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facility: Novo Nordisk Investigational Site
state: Tennessee
city: Chattanooga
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Johnson City
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facility: Novo Nordisk Investigational Site
state: Tennessee
city: Kingsport
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city: Memphis
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city: Nashville
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city: Arlington
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city: Austin
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state: Texas
city: Carrollton
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state: Texas
city: Dallas
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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: Dallas
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facility: Novo Nordisk Investigational Site
state: Texas
city: Houston
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state: Texas
city: Missouri City
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city: New Braunfels
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city: San Antonio
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state: Texas
city: San Antonio
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city: Clinton
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city: Riverton
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city: Virginia Beach
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city: Renton
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country: Austria
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city: Coquitlam
country: Canada
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state: British Columbia
city: Moncton
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state: New Brunswick
city: Hamilton
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state: Ontario
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city: Strathroy
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city: Benesov
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country: Germany
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facility: Novo Nordisk Investigational Site
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country: Germany
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country: Malaysia
facility: Novo Nordisk Investigational Site
city: Kota Bharu
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Penang
country: Malaysia
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city: Seremban
country: Malaysia
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city: Seri Manjung
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Dzerzhinskiy
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Kazan
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saratov
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saratov
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Smolensk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Syktyvkar
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Voronezh
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Belgrade
country: Serbia
facility: Novo Nordisk Investigational Site
city: Kragujevac
country: Serbia
facility: Novo Nordisk Investigational Site
city: Nis
country: Serbia
facility: Novo Nordisk Investigational Site
city: Novi Sad
country: Serbia
facility: Novo Nordisk Investigational Site
city: Zajecar
country: Serbia
facility: Novo Nordisk Investigational Site
city: Bloemfontein
country: South Africa
facility: Novo Nordisk Investigational Site
state: Free State
city: Johannesburg
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Midrand
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Durban
country: South Africa
facility: Novo Nordisk Investigational Site
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Novo Nordisk Investigational Site
state: KwaZulu-Natal
city: Middleburg
country: South Africa
facility: Novo Nordisk Investigational Site
state: Mpumalanga
city: Basingstoke
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Belfast
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Bexhill-on-Sea
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Blackburn
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Bristol
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Chesterfield, Derbyshire
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Devon
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Harrogate, North Yorkshire
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Hinckley
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Oxford
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Plymouth
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Sidcup
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Truro
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: Lingvay I, Desouza CV, Lalic KS, Rose L, Hansen T, Zacho J, Pieber TR. A 26-Week Randomized Controlled Trial of Semaglutide Once Daily Versus Liraglutide and Placebo in Patients With Type 2 Diabetes Suboptimally Controlled on Diet and Exercise With or Without Metformin. Diabetes Care. 2018 Sep;41(9):1926-1937. doi: 10.2337/dc17-2381. Epub 2018 Jul 19.