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The Efficacy and Safety of Liraglutide Adjunct to Insulin Treatment in Type 1 Diabetes (ADJUNCT TWO™)

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
liraglutide
liraglutide
liraglutide
placebo
placebo
placebo
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
  • Male or female, aged equal to or greater than 18 years at the time of signing informed consent
  • Type 1 diabetes mellitus (as diagnosed clinically) 12 months or longer prior to Visit 1 (i.e. screening)
  • Treatment with basal bolus or CSII (continuous subcutaneous insulin infusion, insulin pump) treatment 6 months or longer prior to Visit 1 (i.e. screening)
  • Stable insulin treatment 3 months or longer prior to Visit 1 (i.e. screening), as judged and documented by the investigator
  • HbA1c 7.0-10.0 percent (Diabetes Control and Complications Trial (DCCT)), both inclusive, by central laboratory analysis (Visit 1, screening) corresponding to 53-86 mmol/mol (International Federation of Clinical Chemistry (IFCC))

Exclusion Criteria:

  • Prior use of glucagon-like peptide-1 (GLP-1) receptor agonist or dipeptidyl peptidase IV (DPPIV) inhibitors
  • Use of any medication, which in the investigator's opinion could interfere with the glycaemic control (e.g. systemic corticosteroids, pramlintide (Symlin®)) or affect the subject's safety. Premix insulin is not allowed
  • Known proliferative retinopathy or maculopathy requiring acute treatment
  • Severe neuropathy, in particular autonomic neuropathy, i.e. gastroparesis, as judged by the investigator
  • Uncontrolled/untreated blood pressure at screening (Visit 1) (after resting for 5 minutes) while sitting greater than 160 mmHg for systolic or greater than 100 mmHg for diastolic (repeated measurement at Visit 2 (prior to performing the trial related activities) is allowed to exclude white-coat hypertension)
  • History of acute or chronic pancreatitis
  • Screening (Visit 1) calcitonin value equal to or greater than 50 ng/L

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Placebo Comparator

Arm Label

Liraglutide 1.8 mg + insulin

Liraglutide 1.2 mg + insulin

Liraglutide 0.6 mg + insulin

Liraglutide placebo 0.3 ml + insulin

Liraglutide placebo 0.2 ml + insulin

Liraglutide placebo 0.1 ml + insulin

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Glycosylated Haemoglobin (HbA1c)
Change from baseline in glycosylated haemoglobin (HbA1c), after 26 weeks of treatment. Full analysis set (FAS = 831) included all randomised subjects who had received at least one dose and had any post-randomisation data.

Secondary Outcome Measures

Change From Baseline in Body Weight
Change from baseline body weight, after 26 weeks of treatment. Full analysis set (FAS = 831) included all randomised subjects who had received at least one dose and had any post-randomisation data.
Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes
Number of treatment-emergent symptomatic hypoglycaemic episodes during 26 weeks of treatment. Symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or a self-measured plasma glucose (SMPG) value of <3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA classification is defined as an episode that required assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions.

Full Information

First Posted
March 25, 2014
Last Updated
December 15, 2016
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT02098395
Brief Title
The Efficacy and Safety of Liraglutide Adjunct to Insulin Treatment in Type 1 Diabetes
Acronym
ADJUNCT TWO™
Official Title
A 26-weeks Randomised, Insulin Capped, Placebo-controlled, Double-blind, Parallel Group, Multinational, Multi-centre Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial is conducted in Africa, Europe and North America. The purpose of the trial is to investigate the efficacy and safety of liraglutide adjunct to insulin treatment in type 1 diabetes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
835 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liraglutide 1.8 mg + insulin
Arm Type
Experimental
Arm Title
Liraglutide 1.2 mg + insulin
Arm Type
Experimental
Arm Title
Liraglutide 0.6 mg + insulin
Arm Type
Experimental
Arm Title
Liraglutide placebo 0.3 ml + insulin
Arm Type
Placebo Comparator
Arm Title
Liraglutide placebo 0.2 ml + insulin
Arm Type
Placebo Comparator
Arm Title
Liraglutide placebo 0.1 ml + insulin
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Glycosylated Haemoglobin (HbA1c)
Description
Change from baseline in glycosylated haemoglobin (HbA1c), after 26 weeks of treatment. Full analysis set (FAS = 831) included all randomised subjects who had received at least one dose and had any post-randomisation data.
Time Frame
Week 0, Week 26
Secondary Outcome Measure Information:
Title
Change From Baseline in Body Weight
Description
Change from baseline body weight, after 26 weeks of treatment. Full analysis set (FAS = 831) included all randomised subjects who had received at least one dose and had any post-randomisation data.
Time Frame
Week 0, Week 26
Title
Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes
Description
Number of treatment-emergent symptomatic hypoglycaemic episodes during 26 weeks of treatment. Symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or a self-measured plasma glucose (SMPG) value of <3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA classification is defined as an episode that required assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions.
Time Frame
Weeks 0-26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial Male or female, aged equal to or greater than 18 years at the time of signing informed consent Type 1 diabetes mellitus (as diagnosed clinically) 12 months or longer prior to Visit 1 (i.e. screening) Treatment with basal bolus or CSII (continuous subcutaneous insulin infusion, insulin pump) treatment 6 months or longer prior to Visit 1 (i.e. screening) Stable insulin treatment 3 months or longer prior to Visit 1 (i.e. screening), as judged and documented by the investigator HbA1c 7.0-10.0 percent (Diabetes Control and Complications Trial (DCCT)), both inclusive, by central laboratory analysis (Visit 1, screening) corresponding to 53-86 mmol/mol (International Federation of Clinical Chemistry (IFCC)) Exclusion Criteria: Prior use of glucagon-like peptide-1 (GLP-1) receptor agonist or dipeptidyl peptidase IV (DPPIV) inhibitors Use of any medication, which in the investigator's opinion could interfere with the glycaemic control (e.g. systemic corticosteroids, pramlintide (Symlin®)) or affect the subject's safety. Premix insulin is not allowed Known proliferative retinopathy or maculopathy requiring acute treatment Severe neuropathy, in particular autonomic neuropathy, i.e. gastroparesis, as judged by the investigator Uncontrolled/untreated blood pressure at screening (Visit 1) (after resting for 5 minutes) while sitting greater than 160 mmHg for systolic or greater than 100 mmHg for diastolic (repeated measurement at Visit 2 (prior to performing the trial related activities) is allowed to exclude white-coat hypertension) History of acute or chronic pancreatitis Screening (Visit 1) calcitonin value equal to or greater than 50 ng/L
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Mateo
State/Province
California
ZIP/Postal Code
94401
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Ramon
State/Province
California
ZIP/Postal Code
94583
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61821
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Council Bluffs
State/Province
Iowa
ZIP/Postal Code
51501
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432-1121
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Staten Island
State/Province
New York
ZIP/Postal Code
10301
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620-7352
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37411
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Federal Way
State/Province
Washington
ZIP/Postal Code
98003
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Wien
ZIP/Postal Code
1130
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Boussu
ZIP/Postal Code
7300
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Mouscron
ZIP/Postal Code
7700
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Sint-Niklaas
ZIP/Postal Code
9100
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Blagoevgrad
ZIP/Postal Code
2700
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Pazardzhik
ZIP/Postal Code
4401
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Razgrad
ZIP/Postal Code
7200
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2V 4J2
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Cornwall
State/Province
Ontario
ZIP/Postal Code
K6H 4M4
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 2V8
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Thornhill
State/Province
Ontario
ZIP/Postal Code
L4J 8L7
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7T 2P5
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
København
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Århus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Helsinki
ZIP/Postal Code
00250
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Joensuu
ZIP/Postal Code
80200
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Jyväskylä
ZIP/Postal Code
40620
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Oulu
ZIP/Postal Code
FI-90220
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Pori
ZIP/Postal Code
28500
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Turku
ZIP/Postal Code
FI-20520
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
LA ROCHELLE cedex
ZIP/Postal Code
17019
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Le Creusot
ZIP/Postal Code
71200
Country
France
Facility Name
Novo Nordisk Investigational Site
City
MARSEILLE cedex 08
ZIP/Postal Code
13285
Country
France
Facility Name
Novo Nordisk Investigational Site
City
MONTPELLIER cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Novo Nordisk Investigational Site
City
TOULOUSE cedex
ZIP/Postal Code
31054
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Trinité - La Martinique
ZIP/Postal Code
97235
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Firenze
ZIP/Postal Code
50141
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
sesto san giovanni (MI)
ZIP/Postal Code
20099
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Amersfoort
ZIP/Postal Code
3813 TZ
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Apeldoorn
ZIP/Postal Code
7334 DZ
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Den Bosch
ZIP/Postal Code
5223GZ
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Den Haag
ZIP/Postal Code
2597 AX
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Eindhoven
ZIP/Postal Code
5631 BM
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2198
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Almería
ZIP/Postal Code
04001
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Gijón
ZIP/Postal Code
33206
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Segovia
ZIP/Postal Code
40002
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Sevilla
ZIP/Postal Code
41010
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Linköping
ZIP/Postal Code
582 16
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Malmö
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Stockholm
ZIP/Postal Code
112 81
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Umeå
ZIP/Postal Code
901 85
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Ängelholm
ZIP/Postal Code
262 91
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Örebro
ZIP/Postal Code
701 85
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
27493132
Citation
Ahren B, Hirsch IB, Pieber TR, Mathieu C, Gomez-Peralta F, Hansen TK, Philotheou A, Birch S, Christiansen E, Jensen TJ, Buse JB; ADJUNCT TWO Investigators. Efficacy and Safety of Liraglutide Added to Capped Insulin Treatment in Subjects With Type 1 Diabetes: The ADJUNCT TWO Randomized Trial. Diabetes Care. 2016 Oct;39(10):1693-701. doi: 10.2337/dc16-0690. Epub 2016 Aug 4.
Results Reference
result
PubMed Identifier
27493232
Citation
Hoogenhout M, Malcolm-Smith S. Theory of mind predicts severity level in autism. Autism. 2017 Feb;21(2):242-252. doi: 10.1177/1362361316636758. Epub 2016 Aug 19.
Results Reference
result
PubMed Identifier
34463425
Citation
Dejgaard TF, von Scholten BJ, Christiansen E, Kreiner FF, Bardtrum L, von Herrath M, Mathieu C, Madsbad S; ADJUNCT ONE and ADJUNCT TWO Investigators. Efficacy and safety of liraglutide in type 1 diabetes by baseline characteristics in the ADJUNCT ONE and ADJUNCT TWO randomized controlled trials. Diabetes Obes Metab. 2021 Dec;23(12):2752-2762. doi: 10.1111/dom.14532. Epub 2021 Sep 28. Erratum In: Diabetes Obes Metab. 2022 Nov;24(11):2280.
Results Reference
derived
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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