A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes

PHASE3CompletedINTERVENTIONAL
Enrollment

2,274

Participants

Timeline

Start Date

October 1, 2018

Primary Completion Date

February 22, 2021

Study Completion Date

February 22, 2021

Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG

Semaglutide

Subjects will receive subcutaneous (s.c., under the skin) injections of semaglutide once weekly (OW) with a dose of 0.25 mg. The dose should be increased after four weeks to 0.5 mg semaglutide. After 4 more weeks the dose can be increased to 1.0 mg semaglutide if the study doctor decides and further dose adjusted throughout the study.

DRUG

Insulin aspart

Subjects should initiate treatment with 4U of Insulin aspart (s.c. injections) before each main meal, three times daily (TID). The dose will be adjusted individually based on pre-prandial and bedtime self measured plasma glucose (SMPG) from the preceding 3 days

DRUG

Insulin glargine U100

Run-in period: Subjects will receive s.c. injections of IGlar U100 OD in accordance with the approved local label of IGlar U100. The dose will be adjusted based on the mean of three pre-breakfast SMPG values (target SMPG: 4.0-6.9 mmol/L)

Trial Locations (210)

1000

Novo Nordisk Investigational Site, Skopje

1033

Novo Nordisk Investigational Site, Budapest

1042

Novo Nordisk Investigational Site, Budapest

1089

Novo Nordisk Investigational Site, Budapest

1501

Novo Nordisk Investigational Site, Benoni

1632

Novo Nordisk Investigational Site, Sofia

1818

Novo Nordisk Investigational Site, Johannesburg

1827

Novo Nordisk Investigational Site, Lenasia

2188

Novo Nordisk Investigational Site, Cosmo City

2198

Novo Nordisk Investigational Site, Johannesburg

3100

Novo Nordisk Investigational Site, Salgótarján

4002

Novo Nordisk Investigational Site, Plovdiv

4092

Novo Nordisk Investigational Site, Durban

4170

Novo Nordisk Investigational Site, eMkhomazi

4450

Novo Nordisk Investigational Site, Durban

5700

Novo Nordisk Investigational Site, Gyula

6000

Novo Nordisk Investigational Site, Stara Zagora

6001

Novo Nordisk Investigational Site, Stara Zagora

6400

Novo Nordisk Investigational Site, Dimitrovgrad

7000

Novo Nordisk Investigational Site, Rousse

7100

Novo Nordisk Investigational Site, Byala

7623

Novo Nordisk Investigational Site, Pécs

8000

Novo Nordisk Investigational Site, Burgas

8250

Novo Nordisk Investigational Site, Brežice

8800

Novo Nordisk Investigational Site, Nagykanizsa

8900

Novo Nordisk Investigational Site, Zalaegerszeg

9010

Novo Nordisk Investigational Site, Varna

10138

Novo Nordisk Investigational Site, Tallinn

10437

Novo Nordisk Investigational Site, Berlin

10617

Novo Nordisk Investigational Site, Tallinn

10629

Novo Nordisk Investigational Site, Berlin

10787

Novo Nordisk Investigational Site, Berlin

11000

Novo Nordisk Investigational Site, Belgrade

11080

Novo Nordisk Investigational Site, Belgrade

11522

Novo Nordisk Investigational Site, Athens

13419

Novo Nordisk Investigational Site, Tallinn

13597

Novo Nordisk Investigational Site, Berlin

14004

Novo Nordisk Investigational Site, Córdoba

14612

Novo Nordisk Investigational Site, Falkensee

18000

Novo Nordisk Investigational Site, Niš

19000

Novo Nordisk Investigational Site, Zaječar

20070

Novo Nordisk Investigational Site, Denizli

21000

Novo Nordisk Investigational Site, Novi Sad

22041

Novo Nordisk Investigational Site, Hamburg

22607

Novo Nordisk Investigational Site, Hamburg

23758

Novo Nordisk Investigational Site, Oldenburg I. Holst

24119

Novo Nordisk Investigational Site, Kiel Kronshagen

25240

Novo Nordisk Investigational Site, Erzurum

26601

Novo Nordisk Investigational Site, Beroun

28006

Novo Nordisk Investigational Site, Madrid

28816

Novo Nordisk Investigational Site, Stuhr

28942

Novo Nordisk Investigational Site, Fuenlabrada - Madrid

29006

Novo Nordisk Investigational Site, Málaga

29200

Novo Nordisk Investigational Site, Antequera

34000

Novo Nordisk Investigational Site, Kragujevac

34303

Novo Nordisk Investigational Site, Istanbul

34390

Novo Nordisk Investigational Site, Istanbul

34400

Novo Nordisk Investigational Site, Istanbul

34722

Novo Nordisk Investigational Site, Istanbul

34760

Novo Nordisk Investigational Site, Istanbul

34899

Novo Nordisk Investigational Site, Istanbul

35100

Novo Nordisk Investigational Site, Izmir

35340

Novo Nordisk Investigational Site, Izmir

35415

Novo Nordisk Investigational Site, Pohlheim

37355

Novo Nordisk Investigational Site, Panevezys

39319

Novo Nordisk Investigational Site, Jerichow

40002

Novo Nordisk Investigational Site, Segovia

41003

Novo Nordisk Investigational Site, Seville

45136

Novo Nordisk Investigational Site, Essen

45355

Novo Nordisk Investigational Site, Essen

45359

Novo Nordisk Investigational Site, Essen

47000

Novo Nordisk Investigational Site, Karlovac

48145

Novo Nordisk Investigational Site, Münster

48153

Novo Nordisk Investigational Site, Münster

48259

Novo Nordisk Investigational Site, Kaunas

49449

Novo Nordisk Investigational Site, Kaunas

50009

Novo Nordisk Investigational Site, Kaunas

52100

Novo Nordisk Investigational Site, Pula

54701

Novo Nordisk Investigational Site, Náchod

55270

Novo Nordisk Investigational Site, Schwabenheim

55545

Novo Nordisk Investigational Site, Bad Kreuznach

61080

Novo Nordisk Investigational Site, Trabzon

66299

Novo Nordisk Investigational Site, Friedrichsthal

66386

Novo Nordisk Investigational Site, Saint Ingbert-Oberwürzbach

66780

Novo Nordisk Investigational Site, Rehlingen-Siersburg

70199

Novo Nordisk Investigational Site, Stuttgart

70378

Novo Nordisk Investigational Site, Stuttgart

71000

Novo Nordisk Investigational Site, Sarajevo

71024

Novo Nordisk Investigational Site, Viljandi

73728

Novo Nordisk Investigational Site, Esslingen am Neckar

75000

Novo Nordisk Investigational Site, Tuzla

77900

Novo Nordisk Investigational Site, Olomouc

78000

Novo Nordisk Investigational Site, Banja Luka

78048

Novo Nordisk Investigational Site, Villingen-Schwenningen

79601

Novo Nordisk Investigational Site, Prostějov

80018

Novo Nordisk Investigational Site, Pärnu

81108

Novo Nordisk Investigational Site, Bratislava

82606

Novo Nordisk Investigational Site, Bratislava

93401

Novo Nordisk Investigational Site, Levice

97101

Novo Nordisk Investigational Site, Prievidza

97421

Novo Nordisk Investigational Site, Schweinfurt

97980

Novo Nordisk Investigational Site, Bad Mergentheim

99817

Novo Nordisk Investigational Site, Eisenach

100018

Novo Nordisk Investigational Site, Ploieşti

110001

Novo Nordisk Investigational Site, New Delhi

110002

Novo Nordisk Investigational Site, Delhi

110029

Novo Nordisk Investigational Site, New Dehli

130086

Novo Nordisk Investigational Site, Târgovişte

141001

Novo Nordisk Investigational Site, Ludhiana

160012

Novo Nordisk Investigational Site, Chandigarh

160062

Novo Nordisk Investigational Site, Mohali

302006

Novo Nordisk Investigational Site, Jaipur

400006

Novo Nordisk Investigational Site, Cluj-Napoca

400012

Novo Nordisk Investigational Site, Mumbai

400058

Novo Nordisk Investigational Site, Mumbai

411040

Novo Nordisk Investigational Site, Pune

440010

Novo Nordisk Investigational Site, Nagpur

452010

Novo Nordisk Investigational Site, Indore

500003

Novo Nordisk Investigational Site, Hyderabad

500072

Novo Nordisk Investigational Site, Hyderabad

500101

Novo Nordisk Investigational Site, Brasov

500283

Novo Nordisk Investigational Site, Brasov

540098

Novo Nordisk Investigational Site, Târgu Mureş

560034

Novo Nordisk Investigational Site, Bangalore

560092

Novo Nordisk Investigational Site, Bangalore

700054

Novo Nordisk Investigational Site, Kolkata

751005

Novo Nordisk Investigational Site, Bhubaneswar

751019

Novo Nordisk Investigational Site, Bhubaneswar

800578

Novo Nordisk Investigational Site, Galati

31 000

Novo Nordisk Investigational Site, Osijek

51 000

Novo Nordisk Investigational Site, Rijeka

42 000

Novo Nordisk Investigational Site, Varaždin

10 000

Novo Nordisk Investigational Site, Zagreb

602 00

Novo Nordisk Investigational Site, Brno

272 01

Novo Nordisk Investigational Site, Kladno - Krocehlavy

293 50

Novo Nordisk Investigational Site, Mladá Boleslav

301 00

Novo Nordisk Investigational Site, Pilsen

06679

Novo Nordisk Investigational Site, Hohenmölsen

04249

Novo Nordisk Investigational Site, Leipzig

GR-68100

Novo Nordisk Investigational Site, Alexandroupoli

115 21

Novo Nordisk Investigational Site, Athens

115 25

Novo Nordisk Investigational Site, Athens

GR-115 27

Novo Nordisk Investigational Site, Athens

GR-11521

Novo Nordisk Investigational Site, Athens

GR-11526

Novo Nordisk Investigational Site, Athens

GR-11527

Novo Nordisk Investigational Site, Athens

GR-41110

Novo Nordisk Investigational Site, Larissa

GR-18536

Novo Nordisk Investigational Site, Piraeus

GR-54642

Novo Nordisk Investigational Site, Thessaloniki

GR-54643

Novo Nordisk Investigational Site, Thessaloniki

GR-57001

Novo Nordisk Investigational Site, Thessaloniki

GR-57010

Novo Nordisk Investigational Site, Thessaloniki

H-6725

Novo Nordisk Investigational Site, Szeged

Unknown

Novo Nordisk Investigational Site, Ahmedabad

625 020

Novo Nordisk Investigational Site, Madurai

500 012

Novo Nordisk Investigational Site, Hyderbad

LV-3001

Novo Nordisk Investigational Site, Jelgava

LV-5001

Novo Nordisk Investigational Site, Ogre

LV-1002

Novo Nordisk Investigational Site, Riga

LV-1024

Novo Nordisk Investigational Site, Riga

LV-2150

Novo Nordisk Investigational Site, Sigulda

LV-3201

Novo Nordisk Investigational Site, Talsi

04318

Novo Nordisk Investigational Site, Vilnius

08661

Novo Nordisk Investigational Site, Vilnius

15-276

Novo Nordisk Investigational Site, Bialystok

15-351

Novo Nordisk Investigational Site, Bialystok

15-704

Novo Nordisk Investigational Site, Bialystok

66-400

Novo Nordisk Investigational Site, Gorzów Wielkopolski

94-074 LODZ

Novo Nordisk Investigational Site, Lodz

20-044

Novo Nordisk Investigational Site, Lublin

20-090

Novo Nordisk Investigational Site, Lublin

20-538

Novo Nordisk Investigational Site, Lublin

60-589

Novo Nordisk Investigational Site, Poznan

61-251

Novo Nordisk Investigational Site, Poznan

61-853

Novo Nordisk Investigational Site, Poznan

24-100

Novo Nordisk Investigational Site, Puławy

41-709

Novo Nordisk Investigational Site, Ruda Śląska

08-110

Novo Nordisk Investigational Site, Siedlce

60-185

Novo Nordisk Investigational Site, Skorzewo

00-465

Novo Nordisk Investigational Site, Warsaw

33-122

Novo Nordisk Investigational Site, Wierzchosławice

50-127

Novo Nordisk Investigational Site, Wroclaw

51-685

Novo Nordisk Investigational Site, Wroclaw

41-800

Novo Nordisk Investigational Site, Zabrze

2805-267

Novo Nordisk Investigational Site, Almada

4710-243

Novo Nordisk Investigational Site, Braga

3000-561

Novo Nordisk Investigational Site, Coimbra

1250-230

Novo Nordisk Investigational Site, Lisbon

2674-514

Novo Nordisk Investigational Site, Loures

4200-319

Novo Nordisk Investigational Site, Porto

2910-446

Novo Nordisk Investigational Site, Setúbal

08501

Novo Nordisk Investigational Site, Bardejov

811 08

Novo Nordisk Investigational Site, Bratislava

02601

Novo Nordisk Investigational Site, Dolný Kubín

03491

Novo Nordisk Investigational Site, Ľubochňa

03601

Novo Nordisk Investigational Site, Martin

080 01

Novo Nordisk Investigational Site, Prešov

08301

Novo Nordisk Investigational Site, Sabinov

SI-4270

Novo Nordisk Investigational Site, Jesenice

SI-6000

Novo Nordisk Investigational Site, Koper

SI-9000

Novo Nordisk Investigational Site, Murska Sobota

SI-5000

Novo Nordisk Investigational Site, Nova Gorica

SI-5290

Novo Nordisk Investigational Site, Nova Gorica

0002

Novo Nordisk Investigational Site, Pretoria

0122

Novo Nordisk Investigational Site, Pretoria

04009

Novo Nordisk Investigational Site, Almería

07010

Novo Nordisk Investigational Site, Palma de Mallorca

01130

Novo Nordisk Investigational Site, Adana

06500

Novo Nordisk Investigational Site, Ankara

07058

Novo Nordisk Investigational Site, Antalya

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY