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The Efficacy and Safety of Liraglutide as Adjunct Therapy to Insulin in the Treatment of Type 1 Diabetes (ADJUNCT ONE™)

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
liraglutide
placebo
liraglutide
placebo
liraglutide
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
  • - Type 1 diabetes mellitus for 12 months or longer
  • - Basal bolus or CSII (Continuous Subcutaneous Insulin Infusion, insulin pump) treatment for 6 months or longer
  • - Stable insulin treatment for the last 3 months prior to Screening, as judged and documented by the investigator
  • - HbA1c 7.0-10% (Diabetes Control and Complications Trial (DCCT)), both inclusive, (corresponding to 53-86 mmol/mol (International Federation of Clinical Chemistry (IFCC))
  • - Ability and willingness to comply with all protocol procedures e.g. correct handling of trial product, complete trial related questionnaires, diaries, self-monitoring of plasma glucose, self titration of insulin and attend all scheduled visits

Exclusion Criteria:

  • - Prior use of glucagon-like peptide-1 (GLP-1) receptor agonist or dipeptidyl peptidase IV (DPP-4) inhibitors
  • - Use of any medication, which in the investigator's opinion could interfere with the glycaemic control 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 above 160 mmHg for systolic or above 100 mmHg for diastolic
  • - History of acute or chronic pancreatitis
  • - Screening calcitonin value equal to or above 50 ng/L
  • - Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2 (MEN2)
  • - Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)

Sites / Locations

  • 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 0.6 mg + insulin

Liraglutide 1.2 mg + insulin

Liraglutide 1.8 mg + insulin

Liraglutide placebo 0.6 mg + insulin

Liraglutide placebo 1.2 mg + insulin

Liraglutide placebo 1.8 mg + insulin

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Change from baseline in HbA1c at week 52. Missing values were handled by using a mixed model for repeated measurements (MMRM).
Change From Baseline in Body Weight
Change from baseline in body weight at week 52. Missing values were handled by using a MMRM.
Change From Baseline in Total Daily Insulin Dose
Change from baseline in total daily insulin dose at week 52. Change from baseline was represented in terms of ratio to baseline for insulin dose i.e. Total daily insulin dose at week 52/total daily insulin dose at baseline. Missing values were handled by using a MMRM.

Secondary Outcome Measures

Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes
This is a confirmatory secondary endpoint. Symptomatic hypoglycaemic episodes were defined as: 1) Severe according to the American Diabetes Association (ADA) classification: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. OR 2) Self-monitoring of plasma glucose value of <3.1 mmol/L, with symptoms consistent with hypoglycaemia. A treatment emergent episode is defined as an episode with onset date (or increase in severity) on or after first day of exposure to randomised treatment and up to last dose + 7 days.

Full Information

First Posted
April 17, 2013
Last Updated
January 16, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01836523
Brief Title
The Efficacy and Safety of Liraglutide as Adjunct Therapy to Insulin in the Treatment of Type 1 Diabetes
Acronym
ADJUNCT ONE™
Official Title
The Efficacy and Safety of Liraglutide as Adjunct Therapy to Insulin in the Treatment of Type 1 Diabetes. A 52-week Randomised, Treat-to-target, Placebo-controlled, Double Blinded, Parallel Group, Multinational, Multi-centre Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 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 globally. The aim of the trial is to confirm the efficacy and safety of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetes. The total trial duration per subject is approximately 58 weeks.

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
1398 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liraglutide 0.6 mg + insulin
Arm Type
Experimental
Arm Title
Liraglutide 1.2 mg + insulin
Arm Type
Experimental
Arm Title
Liraglutide 1.8 mg + insulin
Arm Type
Experimental
Arm Title
Liraglutide placebo 0.6 mg + insulin
Arm Type
Placebo Comparator
Arm Title
Liraglutide placebo 1.2 mg + insulin
Arm Type
Placebo Comparator
Arm Title
Liraglutide placebo 1.8 mg + insulin
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.
Primary Outcome Measure Information:
Title
Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Description
Change from baseline in HbA1c at week 52. Missing values were handled by using a mixed model for repeated measurements (MMRM).
Time Frame
Week 0, week 52
Title
Change From Baseline in Body Weight
Description
Change from baseline in body weight at week 52. Missing values were handled by using a MMRM.
Time Frame
Week 0, week 52
Title
Change From Baseline in Total Daily Insulin Dose
Description
Change from baseline in total daily insulin dose at week 52. Change from baseline was represented in terms of ratio to baseline for insulin dose i.e. Total daily insulin dose at week 52/total daily insulin dose at baseline. Missing values were handled by using a MMRM.
Time Frame
Week 0, week 52
Secondary Outcome Measure Information:
Title
Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes
Description
This is a confirmatory secondary endpoint. Symptomatic hypoglycaemic episodes were defined as: 1) Severe according to the American Diabetes Association (ADA) classification: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. OR 2) Self-monitoring of plasma glucose value of <3.1 mmol/L, with symptoms consistent with hypoglycaemia. A treatment emergent episode is defined as an episode with onset date (or increase in severity) on or after first day of exposure to randomised treatment and up to last dose + 7 days.
Time Frame
Weeks 0-52

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 - Type 1 diabetes mellitus for 12 months or longer - Basal bolus or CSII (Continuous Subcutaneous Insulin Infusion, insulin pump) treatment for 6 months or longer - Stable insulin treatment for the last 3 months prior to Screening, as judged and documented by the investigator - HbA1c 7.0-10% (Diabetes Control and Complications Trial (DCCT)), both inclusive, (corresponding to 53-86 mmol/mol (International Federation of Clinical Chemistry (IFCC)) - Ability and willingness to comply with all protocol procedures e.g. correct handling of trial product, complete trial related questionnaires, diaries, self-monitoring of plasma glucose, self titration of insulin and attend all scheduled visits Exclusion Criteria: - Prior use of glucagon-like peptide-1 (GLP-1) receptor agonist or dipeptidyl peptidase IV (DPP-4) inhibitors - Use of any medication, which in the investigator's opinion could interfere with the glycaemic control 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 above 160 mmHg for systolic or above 100 mmHg for diastolic - History of acute or chronic pancreatitis - Screening calcitonin value equal to or above 50 ng/L - Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2 (MEN2) - Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
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
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
Encino
State/Province
California
ZIP/Postal Code
91436
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
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Monterey
State/Province
California
ZIP/Postal Code
93940
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
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33312
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32258
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33619
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308-2253
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
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404-7596
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46254
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
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Metarie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
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
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
St. Charles
State/Province
Missouri
ZIP/Postal Code
63303
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110-1020
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
St. Peters
State/Province
Missouri
ZIP/Postal Code
63376
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
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
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
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
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
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
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
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224-2215
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Upper Darby
State/Province
Pennsylvania
ZIP/Postal Code
19082
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404-1192
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
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119-3821
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
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
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
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79912
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
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
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
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
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
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Caba
ZIP/Postal Code
C1118AAT
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Caba
ZIP/Postal Code
C1440AAD
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Capital Federal
ZIP/Postal Code
1405
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Córdoba
ZIP/Postal Code
X5016KEH
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Mendoza
ZIP/Postal Code
5500
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Morón
ZIP/Postal Code
B1708IFF
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Broadmeadow
State/Province
New South Wales
ZIP/Postal Code
2292
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Elizabeth Vale
State/Province
South Australia
ZIP/Postal Code
5112
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Keswick
State/Province
South Australia
ZIP/Postal Code
5035
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Arlon
ZIP/Postal Code
6700
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2E1
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3P4
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N1R 7L6
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
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
Oakville
State/Province
Ontario
ZIP/Postal Code
L6M 1M1
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
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3E8
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 2T2
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3L9
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1R7
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1G 5K2
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Helsinki
ZIP/Postal Code
00250
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Pori
ZIP/Postal Code
28500
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Seinäjoki
ZIP/Postal Code
60220
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Seinäjoki
ZIP/Postal Code
60510
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Turku
ZIP/Postal Code
FI-20520
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Corbeil Essonnes
ZIP/Postal Code
91106
Country
France
Facility Name
Novo Nordisk Investigational Site
City
DIJON cedex
ZIP/Postal Code
21079
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Le Creusot
ZIP/Postal Code
71200
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Narbonne
ZIP/Postal Code
11108
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Paris
ZIP/Postal Code
75877
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Pointe à Pitre
ZIP/Postal Code
97159
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Saint Herblain
ZIP/Postal Code
44800
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Saint Priest en Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Venissieux
ZIP/Postal Code
69200
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Eisenach
ZIP/Postal Code
99817
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Essen
ZIP/Postal Code
45219
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hamburg
ZIP/Postal Code
21073
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hamburg
ZIP/Postal Code
22607
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hohenmölsen
ZIP/Postal Code
06679
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Marburg
ZIP/Postal Code
35039
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Münster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Pohlheim
ZIP/Postal Code
35415
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Rehlingen-Siersburg
ZIP/Postal Code
66780
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
St. Ingbert
ZIP/Postal Code
66386
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Dublin 9
Country
Ireland
Facility Name
Novo Nordisk Investigational Site
City
Dublin
ZIP/Postal Code
DUBLIN 15
Country
Ireland
Facility Name
Novo Nordisk Investigational Site
City
Dublin
ZIP/Postal Code
DUBLIN 4
Country
Ireland
Facility Name
Novo Nordisk Investigational Site
City
Dublin
ZIP/Postal Code
DUBLIN 7
Country
Ireland
Facility Name
Novo Nordisk Investigational Site
City
Galway
Country
Ireland
Facility Name
Novo Nordisk Investigational Site
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Jerusalem
ZIP/Postal Code
93106
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Petah Tikva
ZIP/Postal Code
49202
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Rishon Le Zion
ZIP/Postal Code
75650
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Den Haag
ZIP/Postal Code
2512 VA
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Hoogeveen
ZIP/Postal Code
7909 AA
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Rotterdam
ZIP/Postal Code
3011 TA
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Venlo
ZIP/Postal Code
5912 BL
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Gjettum
ZIP/Postal Code
1346
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Hamar
ZIP/Postal Code
2318
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Kongsvinger
ZIP/Postal Code
2226
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Stavanger
ZIP/Postal Code
4011
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Lublin
ZIP/Postal Code
20-044
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Pulawy
ZIP/Postal Code
24-100
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Warszawa
ZIP/Postal Code
00-911
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Warszawa
ZIP/Postal Code
03-242
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Kazan
ZIP/Postal Code
420073
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Penza
ZIP/Postal Code
440026
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saratov
ZIP/Postal Code
410012
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Volgograd
ZIP/Postal Code
400138
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Göteborg
ZIP/Postal Code
413 45
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
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Kharkov
ZIP/Postal Code
61058
Country
Ukraine
Facility Name
Novo Nordisk Investigational Site
City
Kharkov
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Novo Nordisk Investigational Site
City
Kiev
ZIP/Postal Code
04114
Country
Ukraine
Facility Name
Novo Nordisk Investigational Site
City
Poltava
ZIP/Postal Code
36011
Country
Ukraine
Facility Name
Novo Nordisk Investigational Site
City
Zhytomir
ZIP/Postal Code
10002
Country
Ukraine
Facility Name
Novo Nordisk Investigational Site
City
Blackburn
ZIP/Postal Code
BB2 3HH
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Durham
ZIP/Postal Code
DH11 5TW
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Edgbaston, Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Middlesbrough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Plymouth
ZIP/Postal Code
PL6 8BQ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Southall
ZIP/Postal Code
UB1 3HW
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
St Helens
ZIP/Postal Code
WA9 3DA
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Stevenage
ZIP/Postal Code
SG1 4AB
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27506222
Citation
Mathieu C, Zinman B, Hemmingsson JU, Woo V, Colman P, Christiansen E, Linder M, Bode B; ADJUNCT ONE Investigators. Efficacy and Safety of Liraglutide Added to Insulin Treatment in Type 1 Diabetes: The ADJUNCT ONE Treat-To-Target Randomized Trial. Diabetes Care. 2016 Oct;39(10):1702-10. doi: 10.2337/dc16-0691. Epub 2016 Aug 9.
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 as Adjunct Therapy to Insulin in the Treatment of Type 1 Diabetes

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