Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes

PHASE3CompletedINTERVENTIONAL
Enrollment

135

Participants

Timeline

Start Date

November 13, 2012

Primary Completion Date

November 15, 2017

Study Completion Date

May 20, 2020

Conditions
DiabetesDiabetes Mellitus, Type 2
Interventions
DRUG

liraglutide

Administered subcutaneously (s.c., under the skin) once daily.1.8 mg or maximum tolerated dose (MTD: 0.6 mg, 1.2 mg, 1.8 mg) for 26 weeks. Subjects will continue treatment in a 26 week open-labelled extension. Rescue treatment will be allowed if rescue criteria are met.

DRUG

placebo

Administered subcutaneously (s.c., under the skin) once daily for 26 weeks. Subjects will discontinue placebo treatment in the open-labelled extension. Rescue treatment will be allowed if rescue criteria are met.

DRUG

metformin

Tablets administered for 26 weeks. Maximum tolerated dose (MTD) between 1000-2000 mg at the discretion of the investigator. Subjects will continue treatment in a 26 week open-labelled extension.

Trial Locations (185)

333

Novo Nordisk Investigational Site, Taoyuan District

710

Novo Nordisk Investigational Site, Tainan City

1000

Novo Nordisk Investigational Site, Skopje

1023

Novo Nordisk Investigational Site, Budapest

Novo Nordisk Investigational Site, Grafton

1089

Novo Nordisk Investigational Site, Budapest

1090

Novo Nordisk Investigational Site, Brussels

1094

Novo Nordisk Investigational Site, Budapest

1200

Novo Nordisk Investigational Site, Brussels

2730

Novo Nordisk Investigational Site, Herlev

3000

Novo Nordisk Investigational Site, Leuven

3501

Novo Nordisk Investigational Site, Miskolc

4305

Novo Nordisk Investigational Site, Ipswich

4600

Novo Nordisk Investigational Site, Wels

4700

Novo Nordisk Investigational Site, Næstved

5020

Novo Nordisk Investigational Site, Salzburg

5021

Novo Nordisk Investigational Site, Bergen

6020

Novo Nordisk Investigational Site, Innsbruck

8036

Novo Nordisk Investigational Site, Graz

9611

Novo Nordisk Investigational Site, Lebanon - Beirut

9615

Novo Nordisk Investigational Site, Hazmiyeh

10000

Novo Nordisk Investigational Site, Rabat

10003

Novo Nordisk Investigational Site, New York

10016

Novo Nordisk Investigational Site, New York

10029

Novo Nordisk Investigational Site, New York

10591

Novo Nordisk Investigational Site, Sleepy Hollow

10700

Novo Nordisk Investigational Site, Bangkok

11000

Novo Nordisk Investigational Site, Belgrade

11070

Novo Nordisk Investigational Site, Belgrade

11562

Novo Nordisk Investigational Site, Cairo

11628

Novo Nordisk Investigational Site, Cairo

13006

Novo Nordisk Investigational Site, Marseille

14203

Novo Nordisk Investigational Site, Buffalo

15224

Novo Nordisk Investigational Site, Pittsburgh

17033

Novo Nordisk Investigational Site, Hershey

19104

Novo Nordisk Investigational Site, Philadelphia

19134

Novo Nordisk Investigational Site, Philadelphia

19803

Novo Nordisk Investigational Site, Wilmington

20011

Novo Nordisk Investigational Site, Washington D.C.

20910

Novo Nordisk Investigational Site, Silver Spring

21000

Novo Nordisk Investigational Site, Novi Sad

21131

Novo Nordisk Investigational Site, Alexandria

22908

Novo Nordisk Investigational Site, Charlottesville

23507

Novo Nordisk Investigational Site, Norfolk

25302

Novo Nordisk Investigational Site, Charleston

28009

Novo Nordisk Investigational Site, Madrid

28046

Novo Nordisk Investigational Site, Madrid

28911

Novo Nordisk Investigational Site, Leganés

29615

Novo Nordisk Investigational Site, Greenville

30000

Novo Nordisk Investigational Site, Fes

30318

Novo Nordisk Investigational Site, Atlanta

30322

Novo Nordisk Investigational Site, Atlanta

31096

Novo Nordisk Investigational Site, Haifa

31904

Novo Nordisk Investigational Site, Columbus

32256

Novo Nordisk Investigational Site, Jacksonville

32308

Novo Nordisk Investigational Site, Tallahassee

32901

Novo Nordisk Investigational Site, Melbourne

33126

Novo Nordisk Investigational Site, Miami

33144

Novo Nordisk Investigational Site, Miami

33155

Novo Nordisk Investigational Site, Miami

33612

Novo Nordisk Investigational Site, Tampa

33701

Novo Nordisk Investigational Site, St. Petersburg

34295

Novo Nordisk Investigational Site, Montpellier

34890

Novo Nordisk Investigational Site, Istanbul

35233

Novo Nordisk Investigational Site, Birmingham

35516

Novo Nordisk Investigational Site, Al Mansurah

36312

Novo Nordisk Investigational Site, Vigo

37232

Novo Nordisk Investigational Site, Nashville

37403

Novo Nordisk Investigational Site, Chattanooga

38105

Novo Nordisk Investigational Site, Memphis

38119

Novo Nordisk Investigational Site, Memphis

40503

Novo Nordisk Investigational Site, Lexington

41380

Novo Nordisk Investigational Site, Kocaeli

43606

Novo Nordisk Investigational Site, Toledo

45229

Novo Nordisk Investigational Site, Cincinnati

47401

Novo Nordisk Investigational Site, Bloomington

48201

Novo Nordisk Investigational Site, Detroit

49202

Novo Nordisk Investigational Site, Petah Tikva

49503

Novo Nordisk Investigational Site, Grand Rapids

50200

Novo Nordisk Investigational Site, Chiang Mai

51000

Novo Nordisk Investigational Site, Rijeka

52242

Novo Nordisk Investigational Site, Iowa City

52621

Novo Nordisk Investigational Site, Tel Litwinsky

55102

Novo Nordisk Investigational Site, Saint Paul

56727

Novo Nordisk Investigational Site, Mayen

57701

Novo Nordisk Investigational Site, Rapid City

59100

Novo Nordisk Investigational Site, Kuala Lumpur

63104

Novo Nordisk Investigational Site, St Louis

64111

Novo Nordisk Investigational Site, Kansas City

65201

Novo Nordisk Investigational Site, Columbia

66606

Novo Nordisk Investigational Site, Topeka

67059

Novo Nordisk Investigational Site, Ludwigshafen

72190

Novo Nordisk Investigational Site, Puebla City

75235

Novo Nordisk Investigational Site, Dallas

76104

Novo Nordisk Investigational Site, Fort Worth

77054

Novo Nordisk Investigational Site, Houston

77061

Novo Nordisk Investigational Site, Houston

78028

Novo Nordisk Investigational Site, Kerrville

78233

Novo Nordisk Investigational Site, San Antonio

78539

Novo Nordisk Investigational Site, Edinburg

79106

Novo Nordisk Investigational Site, Amarillo

84101

Novo Nordisk Investigational Site, Beersheba

85053

Novo Nordisk Investigational Site, Phoenix

89128

Novo Nordisk Investigational Site, Las Vegas

89170

Novo Nordisk Investigational Site, Tampico

90027

Novo Nordisk Investigational Site, Los Angeles

90806

Novo Nordisk Investigational Site, Long Beach

91240

Novo Nordisk Investigational Site, Jerusalem

92123

Novo Nordisk Investigational Site, San Diego

92555

Novo Nordisk Investigational Site, Moreno Valley

92626

Novo Nordisk Investigational Site, Costa Mesa

92880

Novo Nordisk Investigational Site, Corona

93003

Novo Nordisk Investigational Site, Ventura

110029

Novo Nordisk Investigational Site, New Dehli

117036

Novo Nordisk Investigational Site, Moscow

125373

Novo Nordisk Investigational Site, Moscow

141001

Novo Nordisk Investigational Site, Ludhiana

160012

Novo Nordisk Investigational Site, Chandigarh

191144

Novo Nordisk Investigational Site, Saint Petersburg

194100

Novo Nordisk Investigational Site, Saint Petersburg

300011

Novo Nordisk Investigational Site, Timișoara

302006

Novo Nordisk Investigational Site, Jaipur

400008

Novo Nordisk Investigational Site, Mumbai

400703

Novo Nordisk Investigational Site, Mumbai

410054

Novo Nordisk Investigational Site, Saratov

411001

Novo Nordisk Investigational Site, Pune

426009

Novo Nordisk Investigational Site, Izhevsk

454087

Novo Nordisk Investigational Site, Chelyabinsk

500072

Novo Nordisk Investigational Site, Hyderabad

522001

Novo Nordisk Investigational Site, Guntur

560041

Novo Nordisk Investigational Site, Bangalore

560052

Novo Nordisk Investigational Site, Bangalore

560054

Novo Nordisk Investigational Site, Bangalore

600086

Novo Nordisk Investigational Site, Chennai

630048

Novo Nordisk Investigational Site, Novosibirsk

634050

Novo Nordisk Investigational Site, Tomsk

660022

Novo Nordisk Investigational Site, Krasnoyarsk

700017

Novo Nordisk Investigational Site, Kolkata

700020

Novo Nordisk Investigational Site, Kolkata

900591

Novo Nordisk Investigational Site, Constanța

85724-0001

Novo Nordisk Investigational Site, Tucson

90048-1869

Novo Nordisk Investigational Site, Los Angeles

94304-1503

Novo Nordisk Investigational Site, Palo Alto

06511

Novo Nordisk Investigational Site, New Haven

40536-0284

Novo Nordisk Investigational Site, Lexington

01655

Novo Nordisk Investigational Site, Worcester

07601

Novo Nordisk Investigational Site, Hackensack

07052

Novo Nordisk Investigational Site, West Orange

38119-3821

Novo Nordisk Investigational Site, Memphis

91350-250

Novo Nordisk Investigational Site, Porto Alegre

T5X 3N5

Novo Nordisk Investigational Site, Edmonton

R3E 3P4

Novo Nordisk Investigational Site, Winnipeg

L6T 0G1

Novo Nordisk Investigational Site, Brampton

H3Z 1E5

Novo Nordisk Investigational Site, Westmount

10 000

Novo Nordisk Investigational Site, Zagreb

151 23

Novo Nordisk Investigational Site, Athens

GR-17562

Novo Nordisk Investigational Site, Athens

GR-11527

Novo Nordisk Investigational Site, Goudi/ Athens

GR-54643

Novo Nordisk Investigational Site, Thessaloniki

H-9700

Novo Nordisk Investigational Site, Szombathely

560 017

Novo Nordisk Investigational Site, Bangalore

500 012

Novo Nordisk Investigational Site, Hyderbad

00165

Novo Nordisk Investigational Site, Roma

5223GZ

Novo Nordisk Investigational Site, 's-Hertogenbosch

40-752

Novo Nordisk Investigational Site, Katowice

04-730

Novo Nordisk Investigational Site, Warsaw

50-311

Novo Nordisk Investigational Site, Wroclaw

4710-243

Novo Nordisk Investigational Site, Braga

1169-045

Novo Nordisk Investigational Site, Lisbon

1649-035

Novo Nordisk Investigational Site, Lisbon

00717

Novo Nordisk Investigational Site, Ponce

020614

Novo Nordisk Investigational Site, Bucharest

041451

Novo Nordisk Investigational Site, Bucharest

18 000

Novo Nordisk Investigational Site, Niš

01009

Novo Nordisk Investigational Site, Vitoria-Gasteiz

416 85

Novo Nordisk Investigational Site, Gothenburg

141 57

Novo Nordisk Investigational Site, Huddinge

751 85

Novo Nordisk Investigational Site, Uppsala

06100

Novo Nordisk Investigational Site, Ankara

06230

Novo Nordisk Investigational Site, Ankara

B4 6NH

Novo Nordisk Investigational Site, Birmingham

SE5 9RS

Novo Nordisk Investigational Site, London

M13 9WL

Novo Nordisk Investigational Site, Manchester

NR4 7TJ

Novo Nordisk Investigational Site, Norwich

SO16 6YD

Novo Nordisk Investigational Site, Southampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY