Research Study Comparing a New Medicine Semaglutide to Liraglutide in People With Type 2 Diabetes

Last updated: October 2, 2019
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Diabetic Neuropathy

Diabetic Retinopathy

Diabetic Foot Ulcers

Treatment

N/A

Clinical Study ID

NCT03191396
NN9535-4339
2016-004965-22
U1111-1190-5868
  • Ages > 18
  • All Genders

Study Summary

This study is conducted in Europe. The aim of the study is to compare the effect of semaglutide subcutaneous (s.c., under the skin) 1.0 mg once-weekly to liraglutide s.c.1.2 mg once-daily on blood sugar levels after 30 weeks of treatment in people with type 2 diabetes. The study will last approximately 9 months (37 weeks). Each participant will have 7 visits at the clinic and 3 phone calls with the study doctor. At the visits, participants will have a number of tests, for example: general health checks, blood samples, heart and eye checks etc. Participants will also fill in some forms about their health and satisfaction with their diabetes treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria: - Male or female, age 18 years or older at the time of signing informedconsent - Diagnosed with type 2 diabetes mellitus - HbA1c of 7.0-11.0 % (53 - 97 mmol/mol) (both inclusive) - Stable daily dose(s) including any of the following anti-diabeticdrug(s) or combination regimens 90 days prior to the day of screening: a) Biguanides (metformin above or equal to 1500 mg or maximum tolerated dose documented in the subject'smedical record). b) Sulphonylureas (above or equal to half of the maximum approved doseaccording to local label or maximum tolerated dose as documented in subject medicalrecord). c) SGLT-2 inhibitors (above or equal to half of the maximum approved doseaccording to local label or maximum tolerated dose as documented in subject medical record)

Exclusion

Exclusion Criteria: - Family or personal history of multiple endocrine neoplasia type 2 ormedullary thyroid carcinoma. Family is defined as a first degree relative - History orpresence of pancreatitis (acute or chronic) - History of diabetic ketoacidosis - Any of thefollowing: myocardial infarction, stroke, hospitalization for unstable angina or transientischaemic attack within the past 180 days prior to the day of screening - Subjectspresently classified as being in New York Heart Association (NYHA) Class IV - Plannedcoronary, carotid or peripheral artery revascularisation known on the day of screening -Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of below 30ml/min/1.73 sqm as defined by KDIGO 2012 classification - Impaired liver function, definedas ALT above or equal to 2.5 times upper normal limit at screening - Proliferativeretinopathy or maculopathy requiring acute treatment. Verified by fundus photography ordilated fundoscopy performed within the past 90 days prior to randomisation

Study Design

Total Participants: 577
Study Start date:
June 27, 2017
Estimated Completion Date:
August 13, 2018

Connect with a study center

  • Novo Nordisk Investigational Site

    Burgas, 8000
    Bulgaria

    Site Not Available

  • Novo Nordisk Investigational Site

    Dupnitsa, 2600
    Bulgaria

    Site Not Available

  • Novo Nordisk Investigational Site

    Lukovit, 5770
    Bulgaria

    Site Not Available

  • Novo Nordisk Investigational Site

    Madan, 4900
    Bulgaria

    Site Not Available

  • Novo Nordisk Investigational Site

    Petrich, 2850
    Bulgaria

    Site Not Available

  • Novo Nordisk Investigational Site

    Ruse, 7000
    Bulgaria

    Site Not Available

  • Novo Nordisk Investigational Site

    Sliven, 8800
    Bulgaria

    Site Not Available

  • Novo Nordisk Investigational Site

    Sofia, 1606
    Bulgaria

    Site Not Available

  • Novo Nordisk Investigational Site

    Vratsa, 3001
    Bulgaria

    Site Not Available

  • Novo Nordisk Investigational Site

    Brno, 65691
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Nachod, 547 01
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Praha 10, 100 00
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Praha 4, 140 46
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Helsinki, 00180
    Finland

    Site Not Available

  • Novo Nordisk Investigational Site

    Jyväskylä, 40100
    Finland

    Site Not Available

  • Novo Nordisk Investigational Site

    Kuusamo, 93600
    Finland

    Site Not Available

  • Novo Nordisk Investigational Site

    Lahti, 15110
    Finland

    Site Not Available

  • Novo Nordisk Investigational Site

    Oulu, 90220
    Finland

    Site Not Available

  • Novo Nordisk Investigational Site

    Rauma, 26100
    Finland

    Site Not Available

  • Novo Nordisk Investigational Site

    Turku, 20100
    Finland

    Site Not Available

  • Novo Nordisk Investigational Site

    Varkaus, 78300
    Finland

    Site Not Available

  • Novo Nordisk Investigational Site

    Béziers, 34500
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    DIJON cedex, 21079
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Dambach-la-ville, 67650
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    LA ROCHELLE cedex, 17019
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Le Coudray, 28630
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Le Creusot, 71200
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Nantes, 44200
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Obernai, 67210
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    PERPIGNAN cedex, 66046
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Paris, 75877
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Schiltigheim, 67300
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Strasbourg, 67000
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Vandoeuvre Les Nancy, 54511
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Venissieux, 69200
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Dresden, 01219
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Essen, 45136
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Falkensee, 14612
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Hamburg, 22607
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint Ingbert, 66386
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint Ingbert-Oberwürzbach, 66386
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    St. Ingbert, 66386
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Stuttgart, 70378
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Budapest, 1033
    Hungary

    Site Not Available

  • Novo Nordisk Investigational Site

    Nagykanizsa, 8800
    Hungary

    Site Not Available

  • Novo Nordisk Investigational Site

    Pécs, 7623
    Hungary

    Site Not Available

  • Novo Nordisk Investigational Site

    Siófok, 8600
    Hungary

    Site Not Available

  • Novo Nordisk Investigational Site

    Szolnok, 5004
    Hungary

    Site Not Available

  • Novo Nordisk Investigational Site

    Tatabánya, 2800
    Hungary

    Site Not Available

  • Novo Nordisk Investigational Site

    Zalaegerszeg, 8900
    Hungary

    Site Not Available

  • Novo Nordisk Investigational Site

    Bergamo, 24127
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Como, 22042
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Milano, 20132
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Pavia, 27100
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Roma, 00168
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Rome, 00168
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Lublin, 20-044
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Szczecin, 70-506
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Celje, SI-3000
    Slovenia

    Site Not Available

  • Novo Nordisk Investigational Site

    Jesenice, SI-4270
    Slovenia

    Site Not Available

  • Novo Nordisk Investigational Site

    Koper, SI-6000
    Slovenia

    Site Not Available

  • Novo Nordisk Investigational Site

    Ljubljana, 1525
    Slovenia

    Site Not Available

  • Novo Nordisk Investigational Site

    Alcorcón, 28922
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Almería, 04001
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    La Roca del Vallés, 08430
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Palma de Mallorca, 07014
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Valladolid, 47010
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Vic (Barcelona), 08500
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Kristianstad, 291 85
    Sweden

    Site Not Available

  • Novo Nordisk Investigational Site

    Lund, 222 22
    Sweden

    Site Not Available

  • Novo Nordisk Investigational Site

    Stockholm, 112 81
    Sweden

    Site Not Available

  • Novo Nordisk Investigational Site

    Ängelholm, 262 81
    Sweden

    Site Not Available

  • Novo Nordisk Investigational Site

    Örebro, 701 85
    Sweden

    Site Not Available

  • Novo Nordisk Investigational Site

    Blackpool, FY3 7EN
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Bristol, BS10 5NB
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Coventry, CV2 2DX
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Crewe, CW5 5NX
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Faringdon, SN7 7YU.
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Hinckley, LE10 2SE
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    London, SW17 0QT
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Northwood, HA6 2RN
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Norwich, NR4 7TJ
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Nuneaton, CV10 7DJ
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Rhyl, LL18 1DA
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Rotherham, S65 1DA
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Sidcup, DA14 6LT
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Southampton, SO30 3JB
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    St Helens, WA9 3DA
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Truro, TR1 3LJ
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Watford, WD25 7NL
    United Kingdom

    Site Not Available

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