The Efficacy and Safety of Liraglutide Adjunct to Insulin Treatment in Type 1 Diabetes

PHASE3CompletedINTERVENTIONAL
Enrollment

835

Participants

Timeline

Start Date

May 31, 2014

Primary Completion Date

April 30, 2015

Study Completion Date

April 30, 2015

Conditions
DiabetesDiabetes Mellitus, Type 1
Interventions
DRUG

liraglutide

Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment will receive 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects will receive 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.

DRUG

liraglutide

Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment will receive 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects will receive 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.

DRUG

liraglutide

Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment will receive 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects will receive 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.

DRUG

placebo

Subjects randomised to 0.3 mL liraglutide placebo as an add-on to their pre-trial insulin treatment will receive 0.1 mL for 2 weeks followed by 0.2 mL for 2 weeks. After 4 weeks of liraglutide placebo, subjects will receive 0.3 mL for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.

DRUG

placebo

Subjects randomised to 0.3 mL liraglutide placebo as an add-on to their pre-trial insulin treatment will receive 0.1 mL for 2 weeks followed by 0.2 mL for 2 weeks. After 4 weeks of liraglutide placebo, subjects will receive 0.3 mL for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.

DRUG

placebo

Subjects randomised to 0.3 mL liraglutide placebo as an add-on to their pre-trial insulin treatment will receive 0.1 mL for 2 weeks followed by 0.2 mL for 2 weeks. After 4 weeks of liraglutide placebo, subjects will receive 0.3 mL for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.

Trial Locations (120)

1090

Novo Nordisk Investigational Site, Brussels

1130

Novo Nordisk Investigational Site, Vienna

1200

Novo Nordisk Investigational Site, Brussels

1431

Novo Nordisk Investigational Site, Sofia

2198

Novo Nordisk Investigational Site, Johannesburg

2400

Novo Nordisk Investigational Site, Copenhagen

2650

Novo Nordisk Investigational Site, Edegem

Novo Nordisk Investigational Site, Hvidovre

2700

Novo Nordisk Investigational Site, Blagoevgrad

2820

Novo Nordisk Investigational Site, Bonheiden

3000

Novo Nordisk Investigational Site, Leuven

4002

Novo Nordisk Investigational Site, Plovdiv

4401

Novo Nordisk Investigational Site, Pazardzhik

5000

Novo Nordisk Investigational Site, Odense

7200

Novo Nordisk Investigational Site, Razgrad

7300

Novo Nordisk Investigational Site, Boussu

7700

Novo Nordisk Investigational Site, Mouscron

7925

Novo Nordisk Investigational Site, Cape Town

8000

Novo Nordisk Investigational Site, Århus C

8036

Novo Nordisk Investigational Site, Graz

8500

Novo Nordisk Investigational Site, Kortrijk

9100

Novo Nordisk Investigational Site, Sint-Niklaas

9300

Novo Nordisk Investigational Site, Aalst

10301

Novo Nordisk Investigational Site, Staten Island

12206

Novo Nordisk Investigational Site, Albany

13285

Novo Nordisk Investigational Site, Marseille

17019

Novo Nordisk Investigational Site, La Rochelle

20099

Novo Nordisk Investigational Site, Sesto San Giovanni (MI)

20852

Novo Nordisk Investigational Site, Rockville

24127

Novo Nordisk Investigational Site, Bergamo

27517

Novo Nordisk Investigational Site, Chapel Hill

28401

Novo Nordisk Investigational Site, Wilmington

28500

Novo Nordisk Investigational Site, Pori

28557

Novo Nordisk Investigational Site, Morehead City

30060

Novo Nordisk Investigational Site, Marietta

30076

Novo Nordisk Investigational Site, Roswell

30318

Novo Nordisk Investigational Site, Atlanta

31054

Novo Nordisk Investigational Site, Toulouse

32751

Novo Nordisk Investigational Site, Maitland

33206

Novo Nordisk Investigational Site, Gijón

34295

Novo Nordisk Investigational Site, Montpellier

37411

Novo Nordisk Investigational Site, Chattanooga

40002

Novo Nordisk Investigational Site, Segovia

40503

Novo Nordisk Investigational Site, Lexington

40620

Novo Nordisk Investigational Site, Jyväskylä

41010

Novo Nordisk Investigational Site, Seville

41014

Novo Nordisk Investigational Site, Seville

50141

Novo Nordisk Investigational Site, Florence

51100

Novo Nordisk Investigational Site, Reims

51501

Novo Nordisk Investigational Site, Council Bluffs

53100

Novo Nordisk Investigational Site, Siena

55416

Novo Nordisk Investigational Site, Minneapolis

58103

Novo Nordisk Investigational Site, Fargo

59101

Novo Nordisk Investigational Site, Billings

59701

Novo Nordisk Investigational Site, Butte

60077

Novo Nordisk Investigational Site, Skokie

60611

Novo Nordisk Investigational Site, Chicago

61821

Novo Nordisk Investigational Site, Champaign

63017

Novo Nordisk Investigational Site, Chesterfield

67098

Novo Nordisk Investigational Site, Strasbourg

69495

Novo Nordisk Investigational Site, Pierre-Bénite

71200

Novo Nordisk Investigational Site, Le Creusot

72205

Novo Nordisk Investigational Site, Little Rock

75014

Novo Nordisk Investigational Site, Paris

75230

Novo Nordisk Investigational Site, Dallas

75231

Novo Nordisk Investigational Site, Dallas

78681

Novo Nordisk Investigational Site, Round Rock

78758

Novo Nordisk Investigational Site, Austin

79106

Novo Nordisk Investigational Site, Amarillo

80045

Novo Nordisk Investigational Site, Aurora

80200

Novo Nordisk Investigational Site, Joensuu

80401

Novo Nordisk Investigational Site, Golden

84123

Novo Nordisk Investigational Site, Murray

84405

Novo Nordisk Investigational Site, Ogden

85032

Novo Nordisk Investigational Site, Phoenix

88100

Novo Nordisk Investigational Site, Catanzaro

89128

Novo Nordisk Investigational Site, Las Vegas

90127

Novo Nordisk Investigational Site, Palermo

91763

Novo Nordisk Investigational Site, Montclair

92025

Novo Nordisk Investigational Site, Escondido

93003

Novo Nordisk Investigational Site, Ventura

93720

Novo Nordisk Investigational Site, Fresno

94401

Novo Nordisk Investigational Site, San Mateo

94520

Novo Nordisk Investigational Site, Concord

94583

Novo Nordisk Investigational Site, San Ramon

94598

Novo Nordisk Investigational Site, Walnut Creek

97235

Novo Nordisk Investigational Site, Trinité - La Martinique

98003

Novo Nordisk Investigational Site, Federal Way

98057

Novo Nordisk Investigational Site, Renton

98195

Novo Nordisk Investigational Site, Seattle

11432-1121

Novo Nordisk Investigational Site, Jamaica

37620-7352

Novo Nordisk Investigational Site, Bristol

05201

Novo Nordisk Investigational Site, Bennington

T2V 4J2

Novo Nordisk Investigational Site, Calgary

B3H 2Y9

Novo Nordisk Investigational Site, Halifax

K6H 4M4

Novo Nordisk Investigational Site, Cornwall

L8N 3Z5

Novo Nordisk Investigational Site, Hamilton

L5M 2V8

Novo Nordisk Investigational Site, Mississauga

L4J 8L7

Novo Nordisk Investigational Site, Thornhill

H7T 2P5

Novo Nordisk Investigational Site, Laval

H2X 0A9

Novo Nordisk Investigational Site, Montreal

J1H 5N4

Novo Nordisk Investigational Site, Sherbrooke

00250

Novo Nordisk Investigational Site, Helsinki

FI-90220

Novo Nordisk Investigational Site, Oulu

FI-20520

Novo Nordisk Investigational Site, Turku

00133

Novo Nordisk Investigational Site, Roma

00168

Novo Nordisk Investigational Site, Roma

5223GZ

Novo Nordisk Investigational Site, 's-Hertogenbosch

3813 TZ

Novo Nordisk Investigational Site, Amersfoort

7334 DZ

Novo Nordisk Investigational Site, Apeldoorn

5631 BM

Novo Nordisk Investigational Site, Eindhoven

2597 AX

Novo Nordisk Investigational Site, The Hague

3584 CX

Novo Nordisk Investigational Site, Utrecht

04001

Novo Nordisk Investigational Site, Almería

262 91

Novo Nordisk Investigational Site, Ängelholm

582 16

Novo Nordisk Investigational Site, Linköping

205 02

Novo Nordisk Investigational Site, Malmo

701 85

Novo Nordisk Investigational Site, Örebro

112 81

Novo Nordisk Investigational Site, Stockholm

901 85

Novo Nordisk Investigational Site, Umeå

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY

NCT02098395 - The Efficacy and Safety of Liraglutide Adjunct to Insulin Treatment in Type 1 Diabetes | Biotech Hunter | Biotech Hunter