A Trial Investigating the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily Plus Insulin Aspart for the Remaining Meals Versus Insulin Detemir Once or Twice Daily Plus Meal Time Insulin Aspart in Children and Adolescents With Type 1 Diabetes Mellitus

PHASE3CompletedINTERVENTIONAL
Enrollment

362

Participants

Timeline

Start Date

October 17, 2013

Primary Completion Date

November 7, 2014

Study Completion Date

November 7, 2014

Conditions
DiabetesDiabetes Mellitus, Type 1
Interventions
DRUG

insulin degludec/insulin aspart

Administered subcutaneously (s.c., under the skin) once daily with a main meal. Dose individually adjusted.

DRUG

insulin aspart

Administered s.c. with the remaining meals. Dose individually adjusted.

DRUG

insulin detemir

Administered s.c. once or twice daily. Dose individually adjusted. Subjects will continue with their pre-trial dosing scheme (once (OD) or twice daily (BID)) and will be allowed to switch from OD to BID dosing.

DRUG

insulin aspart

Administered s.c. at meal-times. Dose individually adjusted.

Trial Locations (73)

1000

Novo Nordisk Investigational Site, Skopje

1090

Novo Nordisk Investigational Site, Brussels

1200

Novo Nordisk Investigational Site, Brussels

1525

Novo Nordisk Investigational Site, Ljubljana

2193

Novo Nordisk Investigational Site, Johannesburg

3000

Novo Nordisk Investigational Site, Leuven

4058

Novo Nordisk Investigational Site, Mayville

10000

Novo Nordisk Investigational Site, Zagreb

11070

Novo Nordisk Investigational Site, Belgrade

14203

Novo Nordisk Investigational Site, Buffalo

15018

Novo Nordisk Investigational Site, Prague

19104

Novo Nordisk Investigational Site, Philadelphia

19107

Novo Nordisk Investigational Site, Philadelphia

21000

Novo Nordisk Investigational Site, Novi Sad

21229

Novo Nordisk Investigational Site, Baltimore

28034

Novo Nordisk Investigational Site, Madrid

28046

Novo Nordisk Investigational Site, Madrid

28911

Novo Nordisk Investigational Site, Leganés

30322

Novo Nordisk Investigational Site, Atlanta

30339

Novo Nordisk Investigational Site, Atlanta

31096

Novo Nordisk Investigational Site, Haifa

32207

Novo Nordisk Investigational Site, Jacksonville

32308

Novo Nordisk Investigational Site, Tallahassee

32751

Novo Nordisk Investigational Site, Maitland

32901

Novo Nordisk Investigational Site, Melbourne

33612

Novo Nordisk Investigational Site, Tampa

40503

Novo Nordisk Investigational Site, Lexington

46202

Novo Nordisk Investigational Site, Indianapolis

49202

Novo Nordisk Investigational Site, Petah Tikva

52242

Novo Nordisk Investigational Site, Iowa City

52621

Novo Nordisk Investigational Site, Tel Litwinsky

53203

Novo Nordisk Investigational Site, Pardubice

62703

Novo Nordisk Investigational Site, Springfield

64111

Novo Nordisk Investigational Site, Kansas City

70300

Novo Nordisk Investigational Site, Ẕerifin

74135

Novo Nordisk Investigational Site, Tulsa

75231

Novo Nordisk Investigational Site, Dallas

80045

Novo Nordisk Investigational Site, Aurora

84101

Novo Nordisk Investigational Site, Beersheba

85053

Novo Nordisk Investigational Site, Phoenix

85724

Novo Nordisk Investigational Site, Tucson

95816

Novo Nordisk Investigational Site, Sacramento

110029

Novo Nordisk Investigational Site, New Dehli

125373

Novo Nordisk Investigational Site, Moscow

191144

Novo Nordisk Investigational Site, Saint Petersburg

400008

Novo Nordisk Investigational Site, Mumbai

400012

Novo Nordisk Investigational Site, Mumbai

450106

Novo Nordisk Investigational Site, Ufa

500034

Novo Nordisk Investigational Site, Hyderabad

560034

Novo Nordisk Investigational Site, Bangalore

600086

Novo Nordisk Investigational Site, Chennai

630048

Novo Nordisk Investigational Site, Novosibirsk

634050

Novo Nordisk Investigational Site, Tomsk

83404-7596

Novo Nordisk Investigational Site, Idaho Falls

01655

Novo Nordisk Investigational Site, Worcester

80810-040

Novo Nordisk Investigational Site, Curitiba

91350-250

Novo Nordisk Investigational Site, Porto Alegre

01228-200

Novo Nordisk Investigational Site, São Paulo

V6H 3V4

Novo Nordisk Investigational Site, Vancouver

N6A 5W9

Novo Nordisk Investigational Site, London

L5B 1B8

Novo Nordisk Investigational Site, Mississauga

H3T 1C5

Novo Nordisk Investigational Site, Montreal

HIT 2M4

Novo Nordisk Investigational Site, Montreal

10 000

Novo Nordisk Investigational Site, Zagreb

779 00

Novo Nordisk Investigational Site, Olomouc

Unknown

Novo Nordisk Investigational Site, Tel Aviv

80-952

Novo Nordisk Investigational Site, Gdansk

04-730

Novo Nordisk Investigational Site, Warsaw

04-736

Novo Nordisk Investigational Site, Warsaw

18 000

Novo Nordisk Investigational Site, Niš

0181

Novo Nordisk Investigational Site, Pretoria

08035

Novo Nordisk Investigational Site, Barcelona

08950

Novo Nordisk Investigational Site, Esplugues Llobregat(Barcelona)

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY