NCT02738151 - Efficacy and Safety of Toujeo® Versus Tresiba® in Insulin-Naive Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Oral Antihyperglycemic Drug(s) ± GLP-1 Receptor Agonist | Biotech Hunter

Enrollment

929

Participants

Timeline

Start Date

May 19, 2016

Primary Completion Date

August 15, 2017

Study Completion Date

August 15, 2017

Conditions

Diabetes Mellitus, Type 2

Interventions

DRUG

Insulin glargine, 300U/mL

Self-administered by subcutaneous (SC) injection in the evening using a pre-filled pen. Dose titration to achieve fasting self-monitored plasma glucose (SMPG) from 80 to 100 mg/dL (4.4 to 5.6 mmol/L).

DRUG

Insulin degludec, 100 U/mL

"Self-administered by subcutaneous (SC) injection in the evening using a pre-filled pen. Dose titration to achieve fasting self-monitored plasma glucose (SMPG) from 80 to 100 mg/dL (4.4 to 5.6 mmol/L).~Route of administration: subcutaneous"

DRUG

Non-insulin anti-diabetic treatment

Background therapy: Oral Anti diabetics Drugs (OADs), Glucagon-like peptide-1 (GLP-1) receptor agonist.

Trial Locations (158)

1042

Investigational Site Number 348004, Budapest

1083

Investigational Site Number 348002, Budapest

1106

Investigational Site Number 348001, Budapest

1431

Investigational Site Number 100001, Sofia

1505

Investigational Site Number 100002, Sofia

2400

Investigational Site Number 208001, København NV

3200

Investigational Site Number 348003, Gyöngyös

3400

Investigational Site Number 208002, Hillerød

4600

Investigational Site Number 756003, Olten

5000

Investigational Site Number 208004, Odense

8000

Investigational Site Number 208003, Aarhus

9016

Investigational Site Number 756001, Sankt Gallen

10024

Investigational Site Number 380002, Moncalieri

10126

Investigational Site Number 380005, Torino

11000

Investigational Site Number 203007, Prague

Investigational Site Number 688001, Belgrade

12808

Investigational Site Number 203008, Prague

15009

Investigational Site Number 840029, Beaver

17019

Investigational Site Number 250003, La Rochelle

17562

Investigational Site Number 300001, Athens

18100

Investigational Site Number 203002, Prague

19335

Investigational Site Number 840056, Downingtown

20099

Investigational Site Number 380013, Sesto San Giovanni

20132

Investigational Site Number 380014, Milan

20782

Investigational Site Number 840011, Hyattsville

20852

Investigational Site Number 840001, Rockville

22241

Investigational Site Number 752102, Lund

23219

Investigational Site Number 840020, Richmond

25401

Investigational Site Number 203006, Jílové u Prahy

27103

Investigational Site Number 840082, Winston-Salem

28401

Investigational Site Number 840043, Wilmington

28601

Investigational Site Number 840060, Hickory

28655

Investigational Site Number 840064, Morganton

29582

Investigational Site Number 840044, North Myrtle Beach

29605

Investigational Site Number 840097, Greenville

29621

Investigational Site Number 840093, Anderson

29651

Investigational Site Number 840070, Greer

29681

Investigational Site Number 840069, Simpsonville

30029

Investigational Site Number 250006, Nîmes

30046

Investigational Site Number 840071, Lawrenceville

30076

Investigational Site Number 840085, Roswell

30281

Investigational Site Number 840039, Stockbridge

30461

Investigational Site Number 840072, Statesboro

31096

Investigational Site Number 376001, Haifa

33952

Investigational Site Number 840018, Port Charlotte

34201

Investigational Site Number 840075, Bradenton

34652

Investigational Site Number 840076, New Port Richey

34684

Investigational Site Number 840052, Palm Harbor

Investigational Site Number 840080, Palm Harbor

34761

Investigational Site Number 840026, Ocoee

35660

Investigational Site Number 840038, Sheffield

37126

Investigational Site Number 380012, Verona

37404

Investigational Site Number 840006, Chattanooga

37825

Investigational Site Number 840077, New Tazewell

37912

Investigational Site Number 840088, Knoxville

38654

Investigational Site Number 840084, Olive Branch

40361

Investigational Site Number 840061, Paris

44093

Investigational Site Number 250001, Nantes

46001

Investigational Site Number 203005, Liberec

46123

Investigational Site Number 840005, Avon

48085

Investigational Site Number 840033, Troy

48504

Investigational Site Number 840041, Flint

48532

Investigational Site Number 840057, Flint

50134

Investigational Site Number 840098, Des Moines

50266

Investigational Site Number 840096, West Des Moines

50314

Investigational Site Number 840101, Des Moines

51000

Investigational Site Number 191001, Rijeka

Investigational Site Number 191002, Rijeka

51501

Investigational Site Number 840063, Council Bluffs

52621

Investigational Site Number 376003, Tel Litwinsky

53002

Investigational Site Number 203001, Pardubice

54150

Investigational Site Number 752101, Skövde

60005

Investigational Site Number 840036, Arlington Heights

60616

Investigational Site Number 840010, Chicago

63017

Investigational Site Number 840048, Chesterfield

66013

Investigational Site Number 380010, Chieti

68100

Investigational Site Number 300005, Alexandroupoli

69200

Investigational Site Number 250007, Vénissieux

70124

Investigational Site Number 380007, Bari

73104

Investigational Site Number 840025, Oklahoma City

73112

Investigational Site Number 840022, Oklahoma City

75149

Investigational Site Number 840017, Mesquite

75230

Investigational Site Number 840007, Dallas

75231

Investigational Site Number 840086, Dallas

75501

Investigational Site Number 203004, Vsetín

76054

Investigational Site Number 840054, Hurst

76710

Investigational Site Number 840053, Waco

77061

Investigational Site Number 840027, Houston

77090

Investigational Site Number 840040, Houston

77095

Investigational Site Number 840046, Houston

77459

Investigational Site Number 840008, Missouri City

77478

Investigational Site Number 840009, Sugar Land

80131

Investigational Site Number 380011, Napoli

84102

Investigational Site Number 840032, Salt Lake City

84405

Investigational Site Number 840095, Ogden

85020

Investigational Site Number 840066, Phoenix

85025

Investigational Site Number 250002, La Roche-sur-Yon

86021

Investigational Site Number 250005, Poitiers

89117

Investigational Site Number 840023, Las Vegas

89128

Investigational Site Number 840045, Las Vegas

90017

Investigational Site Number 840091, Los Angeles

90255

Investigational Site Number 840016, Huntington Park

90505

Investigational Site Number 840030, Torrance

91324

Investigational Site Number 840058, Northridge

91405

Investigational Site Number 840065, Van Nuys

91710

Investigational Site Number 840081, Chino

92037

Investigational Site Number 840002, La Jolla

92262

Investigational Site Number 840021, Palm Springs

92704

Investigational Site Number 840087, Santa Ana

92801

Investigational Site Number 840051, Anaheim

98055

Investigational Site Number 840012, Renton

400006

Investigational Site Number 642003, Cluj-Napoca

500097

Investigational Site Number 642007, Brasov

500326

Investigational Site Number 642008, Brasov

540015

Investigational Site Number 642010, Târgu Mureş

540142

Investigational Site Number 642004, Târgu Mureş

700547

Investigational Site Number 642014, Iași

900675

Investigational Site Number 642009, Constanța

07036

Investigational Site Number 840031, Linden

Unknown

Investigational Site Number 840079, Bristol

Investigational Site Number 840024, Norfolk

Investigational Site Number 100003, Sofia

Investigational Site Number 191003, Zagreb

Investigational Site Number 203009, Hlučín

Investigational Site Number 300002, Athens

Investigational Site Number 300003, Athens

Investigational Site Number 376004, Haifa

Investigational Site Number 376008, Haifa

Investigational Site Number 376009, Kfar Saba

Investigational Site Number 376002, Petah Tikva

Investigational Site Number 376006, Tel Aviv

Investigational Site Number 376007, Tel Aviv

Investigational Site Number 380009, Catanzaro

Investigational Site Number 380008, Roma

Investigational Site Number 380015, Roma

Investigational Site Number 380016, Roma

Investigational Site Number 642015, Bucharest

Investigational Site Number 642005, Oradea

Investigational Site Number 642012, Oradea

Investigational Site Number 642006, Târgu Mureş

Investigational Site Number 688002, Niš

Investigational Site Number 688003, Niš

77083-4436

Investigational Site Number 840004, Houston

78229-3907

Investigational Site Number 840094, San Antonio

022441

Investigational Site Number 642001, Bucharest

040172

Investigational Site Number 642013, Bucharest

04013

Investigational Site Number 703006, Košice

03491

Investigational Site Number 703002, Ľubochňa

04525

Investigational Site Number 703001, Moldava nad Bodvou

08301

Investigational Site Number 703003, Sabinov

07501

Investigational Site Number 703005, Trebišov

KT160PZ

Investigational Site Number 826001, Chertsey

ME75NY

Investigational Site Number 826005, Gillingham

LN25QY

Investigational Site Number 826008, Lincoln

SW109NH

Investigational Site Number 826002, London

M415SL

Investigational Site Number 826009, Manchester

CT94ANA

Investigational Site Number 826006, Margate

SA66NL

Investigational Site Number 826004, Swansea