A Trial Investigating the Efficacy and Safety of Insulin Degludec in Children and Adolescents With Type 1 Diabetes Mellitus

PHASE3CompletedINTERVENTIONAL
Enrollment

350

Participants

Timeline

Start Date

January 16, 2012

Primary Completion Date

July 30, 2013

Study Completion Date

July 30, 2013

Conditions
DiabetesDiabetes Mellitus, Type 1
Interventions
DRUG

insulin degludec

Injected subcutaneously (under the skin) once daily. Dose individually adjusted.

DRUG

insulin detemir

Injected subcutaneously (under the skin) once or twice daily. Dose individually adjusted.

DRUG

insulin aspart

Injected subcutaneously (under the skin) as mealtime bolus insulin. Dose individually adjusted.

Trial Locations (81)

1000

Novo Nordisk Investigational Site, Skopje

1606

Novo Nordisk Investigational Site, Sofia

2193

Novo Nordisk Investigational Site, Johannesburg

7925

Novo Nordisk Investigational Site, Cape Town

9010

Novo Nordisk Investigational Site, Varna

13353

Novo Nordisk Investigational Site, Berlin

14203

Novo Nordisk Investigational Site, Buffalo

15224

Novo Nordisk Investigational Site, Pittsburgh

16147

Novo Nordisk Investigational Site, Genova

17033

Novo Nordisk Investigational Site, Hershey

19104

Novo Nordisk Investigational Site, Philadelphia

21201

Novo Nordisk Investigational Site, Baltimore

21229

Novo Nordisk Investigational Site, Baltimore

23235

Novo Nordisk Investigational Site, Richmond

23507

Novo Nordisk Investigational Site, Norfolk

28500

Novo Nordisk Investigational Site, Pori

30173

Novo Nordisk Investigational Site, Hanover

30322

Novo Nordisk Investigational Site, Atlanta

30339

Novo Nordisk Investigational Site, Atlanta

31059

Novo Nordisk Investigational Site, Toulouse

32207

Novo Nordisk Investigational Site, Jacksonville

32308

Novo Nordisk Investigational Site, Tallahassee

32608

Novo Nordisk Investigational Site, Gainesville

32751

Novo Nordisk Investigational Site, Maitland

32901

Novo Nordisk Investigational Site, Melbourne

35056

Novo Nordisk Investigational Site, Rennes

40202

Novo Nordisk Investigational Site, Louisville

40503

Novo Nordisk Investigational Site, Lexington

44308

Novo Nordisk Investigational Site, Akron

45229

Novo Nordisk Investigational Site, Cincinnati

48155

Novo Nordisk Investigational Site, Münster

50100

Novo Nordisk Investigational Site, Mikkeli

66100

Novo Nordisk Investigational Site, Chieti

67059

Novo Nordisk Investigational Site, Ludwigshafen

69677

Novo Nordisk Investigational Site, Bron

70210

Novo Nordisk Investigational Site, Kuopio

72202

Novo Nordisk Investigational Site, Little Rock

75015

Novo Nordisk Investigational Site, Paris

75235

Novo Nordisk Investigational Site, Dallas

78207

Novo Nordisk Investigational Site, San Antonio

80045

Novo Nordisk Investigational Site, Aurora

90029

Novo Nordisk Investigational Site, OYS

92123

Novo Nordisk Investigational Site, San Diego

92868

Novo Nordisk Investigational Site, Orange

117036

Novo Nordisk Investigational Site, Moscow

119049

Novo Nordisk Investigational Site, Moscow

125373

Novo Nordisk Investigational Site, Moscow

191144

Novo Nordisk Investigational Site, Saint Petersburg

410028

Novo Nordisk Investigational Site, Saratov

410054

Novo Nordisk Investigational Site, Saratov

630048

Novo Nordisk Investigational Site, Novosibirsk

06511

Novo Nordisk Investigational Site, New Haven

02215

Novo Nordisk Investigational Site, Boston

01655

Novo Nordisk Investigational Site, Worcester

02740

Novo Nordisk Investigational Site, Espoo

00165

Novo Nordisk Investigational Site, Roma

409 3898

Novo Nordisk Investigational Site, Chuo-shi, Yamanashi

963-8851

Novo Nordisk Investigational Site, Fukushima

350 0495

Novo Nordisk Investigational Site, Iruma-gun, Saitama

657-0846

Novo Nordisk Investigational Site, Kobe-shi, Hyogo

780 0952

Novo Nordisk Investigational Site, Kochi-shi, Kochi

860 8556

Novo Nordisk Investigational Site, Kumamoto-shi, Kumamoto

371-8511

Novo Nordisk Investigational Site, Maebashi-shi, Gunma

180 0023

Novo Nordisk Investigational Site, Musashino-shi, Tokyo

951 8520

Novo Nordisk Investigational Site, Niigata-shi, Niigata

545 8586

Novo Nordisk Investigational Site, Osaka-shi, Osaka

980 8574

Novo Nordisk Investigational Site, Sendai-shi, Miyagi

157 8535

Novo Nordisk Investigational Site, Tokyo

162 8666

Novo Nordisk Investigational Site, Tokyo

560 0004

Novo Nordisk Investigational Site, Toyonaka-city, Osaka

514 0125

Novo Nordisk Investigational Site, Tsu-shi, Mie

1315 RA

Novo Nordisk Investigational Site, Almere Stad

3816 CP

Novo Nordisk Investigational Site, Amersfoort

5623 EJ

Novo Nordisk Investigational Site, Eindhoven

6532 CL

Novo Nordisk Investigational Site, Nijmegen

3011 TA

Novo Nordisk Investigational Site, Rotterdam

AB25 2ZG

Novo Nordisk Investigational Site, Aberdeen

B4 6NH

Novo Nordisk Investigational Site, Birmingham

M13 9WL

Novo Nordisk Investigational Site, Manchester

NR4 7UY

Novo Nordisk Investigational Site, Norwich

S102TH

Novo Nordisk Investigational Site, Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY

NCT01513473 - A Trial Investigating the Efficacy and Safety of Insulin Degludec in Children and Adolescents With Type 1 Diabetes Mellitus | Biotech Hunter | Biotech Hunter