DiabetesPhase 3ADJUNCT TWO™NCT02098395

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

A Phase 3 study testing liraglutide in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 120 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 1
What is being tested?: liraglutide
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 835 participants
Where: 120 sitesin 13 countries
Study dates: May 2014to Apr 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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))

Who cannot join

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

Trial locations and contacts

120 sites in 13 countries.

Country

City, postcode or hospital

120 sites in 13 countries

United States47 sites

Novo Nordisk Investigational Site
Albany, New York, 12206
Novo Nordisk Investigational Site
Amarillo, Texas, 79106
Novo Nordisk Investigational Site
Atlanta, Georgia, 30318
Novo Nordisk Investigational Site
Aurora, Colorado, 80045
Novo Nordisk Investigational Site
Austin, Texas, 78758
Novo Nordisk Investigational Site
Bennington, Vermont, 05201
Novo Nordisk Investigational Site
Billings, Montana, 59101
Novo Nordisk Investigational Site
Bristol, Tennessee, 37620-7352
Novo Nordisk Investigational Site
Butte, Montana, 59701
Novo Nordisk Investigational Site
Champaign, Illinois, 61821
Novo Nordisk Investigational Site
Chapel Hill, North Carolina, 27517
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37411
Novo Nordisk Investigational Site
Chesterfield, Missouri, 63017
Novo Nordisk Investigational Site
Chicago, Illinois, 60611
Novo Nordisk Investigational Site
Concord, California, 94520
Novo Nordisk Investigational Site
Council Bluffs, Iowa, 51501
Novo Nordisk Investigational Site
Dallas, Texas, 75230
Novo Nordisk Investigational Site
Dallas, Texas, 75231
Novo Nordisk Investigational Site
Escondido, California, 92025
Novo Nordisk Investigational Site
Fargo, North Dakota, 58103
Novo Nordisk Investigational Site
Federal Way, Washington, 98003
Novo Nordisk Investigational Site
Fresno, California, 93720
Novo Nordisk Investigational Site
Golden, Colorado, 80401
Novo Nordisk Investigational Site
Jamaica, New York, 11432-1121
Novo Nordisk Investigational Site
Las Vegas, Nevada, 89128
Novo Nordisk Investigational Site
Lexington, Kentucky, 40503
Novo Nordisk Investigational Site
Little Rock, Arkansas, 72205
Novo Nordisk Investigational Site
Maitland, Florida, 32751
Novo Nordisk Investigational Site
Marietta, Georgia, 30060
Novo Nordisk Investigational Site
Minneapolis, Minnesota, 55416
Novo Nordisk Investigational Site
Montclair, California, 91763
Novo Nordisk Investigational Site
Morehead City, North Carolina, 28557
Novo Nordisk Investigational Site
Murray, Utah, 84123
Novo Nordisk Investigational Site
Ogden, Utah, 84405
Novo Nordisk Investigational Site
Phoenix, Arizona, 85032
Novo Nordisk Investigational Site
Renton, Washington, 98057
Novo Nordisk Investigational Site
Rockville, Maryland, 20852
Novo Nordisk Investigational Site
Roswell, Georgia, 30076
Novo Nordisk Investigational Site
Round Rock, Texas, 78681
Novo Nordisk Investigational Site
San Mateo, California, 94401
Novo Nordisk Investigational Site
San Ramon, California, 94583
Novo Nordisk Investigational Site
Seattle, Washington, 98195
Novo Nordisk Investigational Site
Skokie, Illinois, 60077
Novo Nordisk Investigational Site
Staten Island, New York, 10301
Novo Nordisk Investigational Site
Ventura, California, 93003
Novo Nordisk Investigational Site
Walnut Creek, California, 94598
Novo Nordisk Investigational Site
Wilmington, North Carolina, 28401

Other trials in United States

Belgium10 sites

Novo Nordisk Investigational Site
Aalst, 9300
Novo Nordisk Investigational Site
Bonheiden, 2820
Novo Nordisk Investigational Site
Boussu, 7300
Novo Nordisk Investigational Site
Brussels, 1090
Novo Nordisk Investigational Site
Brussels, 1200
Novo Nordisk Investigational Site
Edegem, 2650
Novo Nordisk Investigational Site
Kortrijk, 8500
Novo Nordisk Investigational Site
Leuven, 3000
Novo Nordisk Investigational Site
Mouscron, 7700
Novo Nordisk Investigational Site
Sint-Niklaas, 9100

Other trials in Belgium

France10 sites

Novo Nordisk Investigational Site
La Rochelle, 17019
Novo Nordisk Investigational Site
Le Creusot, 71200
Novo Nordisk Investigational Site
Marseille, 13285
Novo Nordisk Investigational Site
Montpellier, 34295
Novo Nordisk Investigational Site
Paris, 75014
Novo Nordisk Investigational Site
Pierre-Bénite, 69495
Novo Nordisk Investigational Site
Reims, 51100
Novo Nordisk Investigational Site
Strasbourg, 67098
Novo Nordisk Investigational Site
Toulouse, 31054
Novo Nordisk Investigational Site
Trinité - La Martinique, 97235

Other trials in France

Canada9 sites

Novo Nordisk Investigational Site
Calgary, Alberta, T2V 4J2
Novo Nordisk Investigational Site
Cornwall, Ontario, K6H 4M4
Novo Nordisk Investigational Site
Halifax, Nova Scotia, B3H 2Y9
Novo Nordisk Investigational Site
Hamilton, Ontario, L8N 3Z5
Novo Nordisk Investigational Site
Laval, Quebec, H7T 2P5
Novo Nordisk Investigational Site
Mississauga, Ontario, L5M 2V8
Novo Nordisk Investigational Site
Montreal, Quebec, H2X 0A9
Novo Nordisk Investigational Site
Sherbrooke, Quebec, J1H 5N4
Novo Nordisk Investigational Site
Thornhill, Ontario, L4J 8L7

Other trials in Canada

Italy8 sites

Novo Nordisk Investigational Site
Bergamo, 24127
Novo Nordisk Investigational Site
Catanzaro, 88100
Novo Nordisk Investigational Site
Florence, 50141
Novo Nordisk Investigational Site
Palermo, 90127
Novo Nordisk Investigational Site
Roma, 00133
Novo Nordisk Investigational Site
Roma, 00168
Novo Nordisk Investigational Site
Sesto San Giovanni (MI), 20099
Novo Nordisk Investigational Site
Siena, 53100

Other trials in Italy

Finland6 sites

Novo Nordisk Investigational Site
Helsinki, 00250
Novo Nordisk Investigational Site
Joensuu, 80200
Novo Nordisk Investigational Site
Jyväskylä, 40620
Novo Nordisk Investigational Site
Oulu, FI-90220
Novo Nordisk Investigational Site
Pori, 28500
Novo Nordisk Investigational Site
Turku, FI-20520

Other trials in Finland

Netherlands6 sites

Novo Nordisk Investigational Site
's-Hertogenbosch, 5223GZ
Novo Nordisk Investigational Site
Amersfoort, 3813 TZ
Novo Nordisk Investigational Site
Apeldoorn, 7334 DZ
Novo Nordisk Investigational Site
Eindhoven, 5631 BM
Novo Nordisk Investigational Site
The Hague, 2597 AX
Novo Nordisk Investigational Site
Utrecht, 3584 CX

Other trials in Netherlands

Sweden6 sites

Novo Nordisk Investigational Site
Ängelholm, 262 91
Novo Nordisk Investigational Site
Linköping, 582 16
Novo Nordisk Investigational Site
Malmö, 205 02
Novo Nordisk Investigational Site
Örebro, 701 85
Novo Nordisk Investigational Site
Stockholm, 112 81
Novo Nordisk Investigational Site
Umeå, 901 85

Other trials in Sweden

Bulgaria5 sites

Novo Nordisk Investigational Site
Blagoevgrad, 2700
Novo Nordisk Investigational Site
Pazardzhik, 4401
Novo Nordisk Investigational Site
Plovdiv, 4002
Novo Nordisk Investigational Site
Razgrad, 7200
Novo Nordisk Investigational Site
Sofia, 1431

Other trials in Bulgaria

Spain5 sites

Novo Nordisk Investigational Site
Almería, 04001
Novo Nordisk Investigational Site
Gijón, 33206
Novo Nordisk Investigational Site
Segovia, 40002
Novo Nordisk Investigational Site
Seville, 41010
Novo Nordisk Investigational Site
Seville, 41014

Other trials in Spain

Denmark4 sites

Novo Nordisk Investigational Site
Århus C, 8000
Novo Nordisk Investigational Site
Copenhagen, 2400
Novo Nordisk Investigational Site
Hvidovre, 2650
Novo Nordisk Investigational Site
Odense, 5000

Other trials in Denmark

Austria2 sites

Novo Nordisk Investigational Site
Graz, 8036
Novo Nordisk Investigational Site
Vienna, 1130

Other trials in Austria

South Africa2 sites

Novo Nordisk Investigational Site
Cape Town, Western Cape, 7925
Novo Nordisk Investigational Site
Johannesburg, Gauteng, 2198

Other trials in South Africa

About this study

Official title: A 26-weeks Randomised, Insulin Capped, Placebo-controlled, Double-blind, Parallel Group, Multinational, Multi-centre Trial

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.

Conditions: Diabetes, Diabetes Mellitus, Type 1
Being tested: liraglutide, placebo
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

liraglutideDrug
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.
liraglutideDrug
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.
liraglutideDrug
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.
placeboDrug
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.
placeboDrug
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.
placeboDrug
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.

Study groups in NCT02098395
Study group	Role	What they receive
Liraglutide 1.8 mg + insulin	Experimental	Not described Receives: Drug: liraglutide
Liraglutide 1.2 mg + insulin	Experimental	Not described Receives: Drug: liraglutide
Liraglutide 0.6 mg + insulin	Experimental	Not described Receives: Drug: liraglutide
Liraglutide placebo 0.3 ml + insulin	Placebo comparator	Not described Receives: Drug: placebo
Liraglutide placebo 0.2 ml + insulin	Placebo comparator	Not described Receives: Drug: placebo
Liraglutide placebo 0.1 ml + insulin	Placebo comparator	Not described Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Week 0, Week 26

Secondary outcomes (2)

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.
Measured: Week 0, Week 26
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.
Measured: Weeks 0-26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2014Apr 2015

First posted28 Mar 2014 (estimated)
Study startMay 2014
Primary completionApr 2015
Study completionApr 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 835 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02098395
Sponsor's protocol ID: NN9211-4083
Other IDs: 2012-005778-74, U1111-1138-0619, NL47705.060.14, REec-2014-0884
Acronym: ADJUNCT TWO™
Status last verified: Dec 2016
First submitted: 25 Mar 2014
Last updated: 9 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 27493132
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.
PubMed 27493232
Shah VN, Agesen RM, Bardtrum L, Christiansen E, Snaith J, Greenfield JR. Determinants of Liraglutide Treatment Discontinuation in Type 1 Diabetes: A Post Hoc Analysis of ADJUNCT ONE and ADJUNCT TWO Randomized Placebo-Controlled Clinical Studies. J Diabetes Sci Technol. 2025 Mar;19(2):321-331. doi: 10.1177/19322968241305647. Epub 2024 Dec 24.
PubMed 39717993
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.
PubMed 34463425

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 26-weeks Randomised, Insulin Capped, Placebo-controlled, Double-blind, Parallel Group, Multinational, Multi-centre Trial
ClinicalTrials.gov ID: NCT02098395
Acronym / sponsor ID: ADJUNCT TWO™ / NN9211-4083
Conditions: Diabetes, Diabetes Mellitus, Type 1
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 835 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: May 2014
Primary completion: Apr 2015 (actual)
Study completion: Apr 2015 (actual)
First posted: 28 Mar 2014 (estimated)
Results: Posted 3 Jun 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Liraglutide 1.8 mg + insulin	Experimental	Drug: liraglutide
Liraglutide 1.2 mg + insulin	Experimental	Drug: liraglutide
Liraglutide 0.6 mg + insulin	Experimental	Drug: liraglutide
Liraglutide placebo 0.3 ml + insulin	Placebo comparator	Drug: placebo
Liraglutide placebo 0.2 ml + insulin	Placebo comparator	Drug: placebo
Liraglutide placebo 0.1 ml + insulin	Placebo comparator	Drug: placebo

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (7 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
liraglutideSubjects 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 1.8 mg + insulin
liraglutideSubjects 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 1.2 mg + insulin
liraglutideSubjects 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 0.6 mg + insulin
placeboSubjects 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	Liraglutide placebo 0.3 ml + insulin
placeboSubjects 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	Liraglutide placebo 0.2 ml + insulin
placeboSubjects 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	Liraglutide placebo 0.1 ml + insulin

Primary outcome

Change From Baseline in Glycosylated Haemoglobin (HbA1c)
Time frame: Week 0, Week 26
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.

2 secondary outcomes

Change From Baseline in Body Weight
Time frame: Week 0, Week 26
Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes
Time frame: Weeks 0-26

Results and safety

Results posted to the registry on 3 Jun 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Liraglutide 0.6 mg	212	186
Liraglutide 1.2 mg	209	177
Liraglutide 1.8 mg	207	165
Liraglutide Placebo	207	180

Primary outcome: Change From Baseline in Glycosylated Haemoglobin (HbA1c)

Time frame: Week 0, Week 26. Mean (Standard Deviation). Unit: Percent (%) glycosylated haemoglobin

Measure	Liraglutide 0.6 mg n = 189	Liraglutide 1.2 mg n = 176	Liraglutide 1.8 mg n = 170	Liraglutide Placebo n = 190
Value	-0.23 (0.744)	-0.23 (0.731)	-0.32 (0.73)	0.01 (0.674)

Liraglutide 1.8 mg vs Liraglutide Placebo: Mean Difference (Final Values): -0.35 (95% CI -0.5 to -0.2), p < 0.0001, Mixed Models Analysis
Liraglutide 1.2 mg vs Liraglutide Placebo: Mean Difference (Final Values): -0.23 (95% CI -0.38 to -0.08), p = 0.0021, Mixed Models Analysis
Liraglutide 0.6 mg vs Liraglutide Placebo: Mean Difference (Final Values): -0.24 (95% CI -0.39 to -0.1), p = 0.0011, Mixed Models Analysis

Population analysed: Out of the 831 subjects in FAS, 22 subjects in lira 0.6 mg arm, 33 subjects in lira 1.2 mg arm, 35 subjects in lira 1.8 mg arm and 16 in placebo arm did not contribute to this analysis. Missing data imputed from a mixed model for repeated measurements (MMRM) method.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Liraglutide 0.6 mg	20 of 211 (9.5%)	137 of 211 (64.9%)	Not reported
Liraglutide 1.2 mg	21 of 209 (10%)	164 of 209 (78.5%)	Not reported
Liraglutide 1.8 mg	14 of 206 (6.8%)	162 of 206 (78.6%)	Not reported
Liraglutide Placebo	14 of 206 (6.8%)	125 of 206 (60.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27493132Ahren 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 publication: PubMed 27493232Hoogenhout 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.
Derived from this study: PubMed 39717993Shah VN, Agesen RM, Bardtrum L, Christiansen E, Snaith J, Greenfield JR. Determinants of Liraglutide Treatment Discontinuation in Type 1 Diabetes: A Post Hoc Analysis of ADJUNCT ONE and ADJUNCT TWO Randomized Placebo-Controlled Clinical Studies. J Diabetes Sci Technol. 2025 Mar;19(2):321-331. doi: 10.1177/19322968241305647. Epub 2024 Dec 24.
Derived from this study: PubMed 34463425Dejgaard 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.
Clinical Trials at Novo NordiskLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Registry (GCR, 1452) study director

Novo Nordisk A/S

120 sites in 13 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing liraglutide in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 120 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 120 sites in United States, Belgium, France, Canada, Italy and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Glycosylated Haemoglobin (HbA1c) (time frame: Week 0, Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02098395, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.