A Trial Investigating the Efficacy and Safety of Insulin Detemir Versus Insulin NPH in Combination With Metformin and Diet/Exercise in Children and Adolescents With Type 2 Diabetes Insufficiently Controlled on Metformin With or Without Other Oral Antidiabetic Drug(s) With or Without Basal Insulin

PHASE3TerminatedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

June 11, 2014

Primary Completion Date

June 14, 2016

Study Completion Date

June 14, 2016

Conditions
DiabetesDiabetes Mellitus, Type 2
Interventions
DRUG

Insulin detemir

Administered subcutaneously (s.c., under the skin) once or twice daily. The subjects' pre-trial OAD's i.e. metformin treatment should continue unchanged during the treatment period.

DRUG

Insulin NPH

Administered subcutaneously (s.c., under the skin) once or twice daily. The subjects' pre-trial OADs i.e. metformin treatment should continue unchanged during the treatment period.

BEHAVIORAL

Diet/exercise

Intervention will be performed through family based changes in eating and activity behaviours.

Trial Locations (82)

333

Novo Nordisk Investigational Site, Taoyuan District

404

Novo Nordisk Investigational Site, Taichung

1023

Novo Nordisk Investigational Site, Budapest

1083

Novo Nordisk Investigational Site, Budapest

1827

Novo Nordisk Investigational Site, Lenasia

3501

Novo Nordisk Investigational Site, Miskolc

7925

Novo Nordisk Investigational Site, Observatory

9611

Novo Nordisk Investigational Site, Lebanon - Beirut

9615

Novo Nordisk Investigational Site, Hazmiyeh

10000

Novo Nordisk Investigational Site, Zagreb

Novo Nordisk Investigational Site, Rabat

11562

Novo Nordisk Investigational Site, Cairo

11628

Novo Nordisk Investigational Site, Cairo

14203

Novo Nordisk Investigational Site, Buffalo

15224

Novo Nordisk Investigational Site, Pittsburgh

17033

Novo Nordisk Investigational Site, Hershey

19104

Novo Nordisk Investigational Site, Philadelphia

20000

Novo Nordisk Investigational Site, Casablanca

20011

Novo Nordisk Investigational Site, Reisterstown

20910

Novo Nordisk Investigational Site, Silver Spring

21131

Novo Nordisk Investigational Site, Alexandria

23507

Novo Nordisk Investigational Site, Norfolk

29203

Novo Nordisk Investigational Site, Columbia

30000

Novo Nordisk Investigational Site, Fes

30322

Novo Nordisk Investigational Site, Atlanta

31096

Novo Nordisk Investigational Site, Haifa

32040

Novo Nordisk Investigational Site, Seri Manjung

32207

Novo Nordisk Investigational Site, Jacksonville

32256

Novo Nordisk Investigational Site, Jacksonville

32308

Novo Nordisk Investigational Site, Tallahassee

33026

Novo Nordisk Investigational Site, Pembroke Pines

34093

Novo Nordisk Investigational Site, Istanbul

34890

Novo Nordisk Investigational Site, Istanbul

38010

Novo Nordisk Investigational Site, Kayseri

38119

Novo Nordisk Investigational Site, Memphis

40000

Novo Nordisk Investigational Site, Marrakesh

43606

Novo Nordisk Investigational Site, Toledo

50139

Novo Nordisk Investigational Site, Florence

53226

Novo Nordisk Investigational Site, Milwaukee

56564

Novo Nordisk Investigational Site, Neuwied

59100

Novo Nordisk Investigational Site, Kuala Lumpur

60123

Novo Nordisk Investigational Site, Ancona

67059

Novo Nordisk Investigational Site, Ludwigshafen

70300

Novo Nordisk Investigational Site, Seremban

72190

Novo Nordisk Investigational Site, Puebla City

78539

Novo Nordisk Investigational Site, Edinburg

79106

Novo Nordisk Investigational Site, Amarillo

84101

Novo Nordisk Investigational Site, Beersheba

85724

Novo Nordisk Investigational Site, Tucson

88996

Novo Nordisk Investigational Site, Kota Kinabalu

89148

Novo Nordisk Investigational Site, Las Vegas

90027

Novo Nordisk Investigational Site, Los Angeles

355017

Novo Nordisk Investigational Site, Stavropol

380007

Novo Nordisk Investigational Site, Ahmedabad

426009

Novo Nordisk Investigational Site, Izhevsk

500072

Novo Nordisk Investigational Site, Hyderabad

500082

Novo Nordisk Investigational Site, Hyderabad

560002

Novo Nordisk Investigational Site, Bangalore

560034

Novo Nordisk Investigational Site, Bangalore

560045

Novo Nordisk Investigational Site, Bangalore

634034

Novo Nordisk Investigational Site, Tomsk

700032

Novo Nordisk Investigational Site, Kolkata

44195-0001

Novo Nordisk Investigational Site, Cleveland

02903

Novo Nordisk Investigational Site, Providence

C1425DUC

Novo Nordisk Investigational Site, CABA

74935-530

Novo Nordisk Investigational Site, Aparecida de Goiânia

91350-250

Novo Nordisk Investigational Site, Porto Alegre

01223-001

Novo Nordisk Investigational Site, São Paulo

01228-000

Novo Nordisk Investigational Site, São Paulo

GR-11527

Novo Nordisk Investigational Site, Goudi/ Athens

GR 54642

Novo Nordisk Investigational Site, Thessaloniki

600 013

Novo Nordisk Investigational Site, Chennai

Unknown

Novo Nordisk Investigational Site, Beirut

50-311

Novo Nordisk Investigational Site, Wroclaw

1250-230

Novo Nordisk Investigational Site, Lisbon

18 000

Novo Nordisk Investigational Site, Niš

0181

Novo Nordisk Investigational Site, Pretoria

05030

Novo Nordisk Investigational Site, Seoul

135-720

Novo Nordisk Investigational Site, Seoul

08950

Novo Nordisk Investigational Site, Esplugues Llobregat(Barcelona)

01130

Novo Nordisk Investigational Site, Adana

06100

Novo Nordisk Investigational Site, Ankara

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY