DiabetesPhase 3ADJUNCT ONE™NCT01836523

The Efficacy and Safety of Liraglutide as Adjunct Therapy to Insulin in the Treatment of 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 182 sites in 17 countries.

Completed

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

Official record

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Trial 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. 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: 1,398 participants
Where: 182 sitesin 17 countries
Study dates: Nov 2013to Jun 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
- 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

Who cannot join

- 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

Show all 9Show fewer

- 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)

Trial locations and contacts

182 sites in 17 countries.

Country

City, postcode or hospital

182 sites in 17 countries

United States70 sites

Novo Nordisk Investigational Site
Albany, New York, 12206
Novo Nordisk Investigational Site
Amarillo, Texas, 79106
Novo Nordisk Investigational Site
Atlanta, Georgia, 30308-2253
Novo Nordisk Investigational Site
Atlanta, Georgia, 30318
Novo Nordisk Investigational Site
Baltimore, Maryland, 21229
Novo Nordisk Investigational Site
Bennington, Vermont, 05201
Novo Nordisk Investigational Site
Billings, Montana, 59101
Novo Nordisk Investigational Site
Butte, Montana, 59701
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37404-1192
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37411
Novo Nordisk Investigational Site
Chesterfield, Missouri, 63017
Novo Nordisk Investigational Site
City of Saint Peters, Missouri, 63376
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
Dallas, Texas, 75246
Novo Nordisk Investigational Site
Denver, Colorado, 80209
Novo Nordisk Investigational Site
El Paso, Texas, 79912
Novo Nordisk Investigational Site
Encino, California, 91436
Novo Nordisk Investigational Site
Escondido, California, 92025
Novo Nordisk Investigational Site
Federal Way, Washington, 98003
Novo Nordisk Investigational Site
Fort Lauderdale, Florida, 33312
Novo Nordisk Investigational Site
Greensboro, North Carolina, 27408
Novo Nordisk Investigational Site
Greer, South Carolina, 29651
Novo Nordisk Investigational Site
Hialeah, Florida, 33012
Novo Nordisk Investigational Site
Huntington Beach, California, 92648
Novo Nordisk Investigational Site
Idaho Falls, Idaho, 83404-7596
Novo Nordisk Investigational Site
Indianapolis, Indiana, 46254
Novo Nordisk Investigational Site
Iowa City, Iowa, 52242
Novo Nordisk Investigational Site
Jacksonville, Florida, 32258
Novo Nordisk Investigational Site
La Mesa, California, 91942
Novo Nordisk Investigational Site
Lancaster, California, 93534
Novo Nordisk Investigational Site
Lawrenceville, New Jersey, 08648
Novo Nordisk Investigational Site
Little Rock, Arkansas, 72205
Novo Nordisk Investigational Site
Marietta, Georgia, 30060
Novo Nordisk Investigational Site
Memphis, Tennessee, 38119-3821
Novo Nordisk Investigational Site
Mentor, Ohio, 44060
Novo Nordisk Investigational Site
Metarie, Louisiana, 70006
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, 53209
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, 53226
Novo Nordisk Investigational Site
Mineola, New York, 11501
Novo Nordisk Investigational Site
Minneapolis, Minnesota, 55416
Novo Nordisk Investigational Site
Monterey, California, 93940
Novo Nordisk Investigational Site
Morehead City, North Carolina, 28557
Novo Nordisk Investigational Site
Myrtle Beach, South Carolina, 29572
Novo Nordisk Investigational Site
Nashville, Tennessee, 37203
Novo Nordisk Investigational Site
Nashville, Tennessee, 37212
Novo Nordisk Investigational Site
New York, New York, 10029
Novo Nordisk Investigational Site
New York, New York, 10032
Novo Nordisk Investigational Site
Norfolk, Virginia, 23510
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, 15224-2215
Novo Nordisk Investigational Site
Roswell, Georgia, 30076
Novo Nordisk Investigational Site
Round Rock, Texas, 78681
Novo Nordisk Investigational Site
Saint Charles, Missouri, 63303
Novo Nordisk Investigational Site
Salt Lake City, Utah, 84102
Novo Nordisk Investigational Site
San Mateo, California, 94401
Novo Nordisk Investigational Site
San Ramon, California, 94583
Novo Nordisk Investigational Site
Savannah, Georgia, 31405
Novo Nordisk Investigational Site
Spokane, Washington, 99208
Novo Nordisk Investigational Site
Springfield, Missouri, 65807
Novo Nordisk Investigational Site
St Louis, Missouri, 63110-1020
Novo Nordisk Investigational Site
Staten Island, New York, 10301
Novo Nordisk Investigational Site
Sugar Land, Texas, 77478
Novo Nordisk Investigational Site
Summerville, South Carolina, 29485
Novo Nordisk Investigational Site
Syracuse, New York, 13210
Novo Nordisk Investigational Site
Tampa, Florida, 33619
Novo Nordisk Investigational Site
Topeka, Kansas, 66606
Novo Nordisk Investigational Site
Upper Darby, Pennsylvania, 19082
Novo Nordisk Investigational Site
Walnut Creek, California, 94598

Other trials in United States

Canada15 sites

Novo Nordisk Investigational Site
Barrie, Ontario, L4M 7G1
Novo Nordisk Investigational Site
Cambridge, Ontario, N1R 7L6
Novo Nordisk Investigational Site
Edmonton, Alberta, T6G 2E1
Novo Nordisk Investigational Site
London, Ontario, N6A 4V2
Novo Nordisk Investigational Site
Mississauga, Ontario, L5M 2V8
Novo Nordisk Investigational Site
Montreal, Quebec, H2W 1R7
Novo Nordisk Investigational Site
Oakville, Ontario, L6M 1M1
Novo Nordisk Investigational Site
Québec, Quebec, G1V 4G2
Novo Nordisk Investigational Site
Québec, Quebec, G1V 4G5
Novo Nordisk Investigational Site
Sherbrooke, Quebec, J1G 5K2
Novo Nordisk Investigational Site
Thornhill, Ontario, L4J 8L7
Novo Nordisk Investigational Site
Toronto, Ontario, M4G 3E8
Novo Nordisk Investigational Site
Toronto, Ontario, M5C 2T2
Novo Nordisk Investigational Site
Toronto, Ontario, M5T 3L9
Novo Nordisk Investigational Site
Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

France13 sites

Novo Nordisk Investigational Site
Besançon, 25030
Novo Nordisk Investigational Site
Brest, 29609
Novo Nordisk Investigational Site
Caen, 14033
Novo Nordisk Investigational Site
Corbeil-Essonnes, 91106
Novo Nordisk Investigational Site
Dijon, 21079
Novo Nordisk Investigational Site
Le Creusot, 71200
Novo Nordisk Investigational Site
Narbonne, 11108
Novo Nordisk Investigational Site
Paris, 75877
Novo Nordisk Investigational Site
Pointe à Pitre, 97159
Novo Nordisk Investigational Site
Poitiers, 86000
Novo Nordisk Investigational Site
Saint-Herblain, 44800
Novo Nordisk Investigational Site
Saint-Priest-en-Jarez, 42270
Novo Nordisk Investigational Site
Vénissieux, 69200

Other trials in France

Germany10 sites

Novo Nordisk Investigational Site
Eisenach, 99817
Novo Nordisk Investigational Site
Essen, 45219
Novo Nordisk Investigational Site
Hamburg, 21073
Novo Nordisk Investigational Site
Hamburg, 22607
Novo Nordisk Investigational Site
Hohenmölsen, 06679
Novo Nordisk Investigational Site
Marburg, 35039
Novo Nordisk Investigational Site
Münster, 48145
Novo Nordisk Investigational Site
Pohlheim, 35415
Novo Nordisk Investigational Site
Rehlingen-Siersburg, 66780
Novo Nordisk Investigational Site
Saint Ingbert, 66386

Other trials in Germany

United Kingdom10 sites

Novo Nordisk Investigational Site
Blackburn, BB2 3HH
Novo Nordisk Investigational Site
Bristol, BS10 5NB
Novo Nordisk Investigational Site
Durham, DH11 5TW
Novo Nordisk Investigational Site
Edgbaston, Birmingham, B15 2TH
Novo Nordisk Investigational Site
Edinburgh, EH4 2XU
Novo Nordisk Investigational Site
Middlesbrough, TS4 3BW
Novo Nordisk Investigational Site
Plymouth, PL6 8BQ
Novo Nordisk Investigational Site
Southall, UB1 3HW
Novo Nordisk Investigational Site
St Helens, WA9 3DA
Novo Nordisk Investigational Site
Stevenage, SG1 4AB

Other trials in United Kingdom

Finland7 sites

Novo Nordisk Investigational Site
Helsinki, 00029
Novo Nordisk Investigational Site
Helsinki, 00250
Novo Nordisk Investigational Site
Pori, 28500
Novo Nordisk Investigational Site
Seinäjoki, 60220
Novo Nordisk Investigational Site
Seinäjoki, 60510
Novo Nordisk Investigational Site
Tampere, 33520
Novo Nordisk Investigational Site
Turku, FI-20520

Other trials in Finland

Netherlands7 sites

Novo Nordisk Investigational Site
Amsterdam, 1105 AZ
Novo Nordisk Investigational Site
Hoogeveen, 7909 AA
Novo Nordisk Investigational Site
Leiden, 2333 ZA
Novo Nordisk Investigational Site
Nijmegen, 6525 GA
Novo Nordisk Investigational Site
Rotterdam, 3011 TA
Novo Nordisk Investigational Site
The Hague, 2512 VA
Novo Nordisk Investigational Site
Venlo, 5912 BL

Other trials in Netherlands

Argentina6 sites

Novo Nordisk Investigational Site
Caba, C1118AAT
Novo Nordisk Investigational Site
Caba, C1440AAD
Novo Nordisk Investigational Site
Capital Federal, 1405
Novo Nordisk Investigational Site
Córdoba, X5016KEH
Novo Nordisk Investigational Site
Mendoza, 5500
Novo Nordisk Investigational Site
Morón, B1708IFF

Other trials in Argentina

Israel6 sites

Novo Nordisk Investigational Site
Haifa, 31096
Novo Nordisk Investigational Site
Holon, 58100
Novo Nordisk Investigational Site
Jerusalem, 91120
Novo Nordisk Investigational Site
Jerusalem, 93106
Novo Nordisk Investigational Site
Petah Tikva, 49202
Novo Nordisk Investigational Site
Rishon LeZiyyon, 75650

Other trials in Israel

Australia5 sites

Novo Nordisk Investigational Site
Broadmeadow, New South Wales, 2292
Novo Nordisk Investigational Site
Elizabeth Vale, South Australia, 5112
Novo Nordisk Investigational Site
Keswick, South Australia, 5035
Novo Nordisk Investigational Site
Melbourne, Victoria, 3004
Novo Nordisk Investigational Site
Parkville, Victoria, 3050

Other trials in Australia

Ireland5 sites

Novo Nordisk Investigational Site
Dublin, DUBLIN 15
Novo Nordisk Investigational Site
Dublin, DUBLIN 4
Novo Nordisk Investigational Site
Dublin, DUBLIN 7
Novo Nordisk Investigational Site
Dublin
Novo Nordisk Investigational Site
Galway

Other trials in Ireland

Norway5 sites

Novo Nordisk Investigational Site
Bergen, 5021
Novo Nordisk Investigational Site
Gjettum, 1346
Novo Nordisk Investigational Site
Hamar, 2318
Novo Nordisk Investigational Site
Kongsvinger, 2226
Novo Nordisk Investigational Site
Stavanger, 4011

Other trials in Norway

Poland5 sites

Novo Nordisk Investigational Site
Lublin, 20-044
Novo Nordisk Investigational Site
Puławy, 24-100
Novo Nordisk Investigational Site
Warsaw, 00-911
Novo Nordisk Investigational Site
Warsaw, 03-242
Novo Nordisk Investigational Site
Zabrze, 41-800

Other trials in Poland

Russia5 sites

Novo Nordisk Investigational Site
Kazan', 420012
Novo Nordisk Investigational Site
Kazan', 420073
Novo Nordisk Investigational Site
Penza, 440026
Novo Nordisk Investigational Site
Saratov, 410012
Novo Nordisk Investigational Site
Volgograd, 400138

Other trials in Russia

Ukraine5 sites

Novo Nordisk Investigational Site
Kharkiv, 61058
Novo Nordisk Investigational Site
Kharkiv, 61070
Novo Nordisk Investigational Site
Kiev, 04114
Novo Nordisk Investigational Site
Poltava, 36011
Novo Nordisk Investigational Site
Zhytomyr, 10002

Other trials in Ukraine

Belgium4 sites

Novo Nordisk Investigational Site
Arlon, 6700
Novo Nordisk Investigational Site
Edegem, 2650
Novo Nordisk Investigational Site
Leuven, 3000
Novo Nordisk Investigational Site
Liège, 4000

Other trials in Belgium

Sweden4 sites

Novo Nordisk Investigational Site
Gothenburg, 413 45
Novo Nordisk Investigational Site
Malmö, 205 02
Novo Nordisk Investigational Site
Stockholm, 112 81
Novo Nordisk Investigational Site
Stockholm, 141 86

Other trials in Sweden

About this study

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

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 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.
placeboDrug
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.
liraglutideDrug
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.
placeboDrug
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.
liraglutideDrug
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.
placeboDrug
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.

Study groups in NCT01836523
Study group	Role	What they receive
Liraglutide 0.6 mg + insulin	Experimental	Not described Receives: Drug: liraglutide
Liraglutide 1.2 mg + insulin	Experimental	Not described Receives: Drug: liraglutide
Liraglutide 1.8 mg + insulin	Experimental	Not described Receives: Drug: liraglutide
Liraglutide placebo 0.6 mg + insulin	Placebo comparator	Not described Receives: Drug: placebo
Liraglutide placebo 1.2 mg + insulin	Placebo comparator	Not described Receives: Drug: placebo
Liraglutide placebo 1.8 mg + 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 HbA1c (Glycosylated Haemoglobin)
Change from baseline in HbA1c at week 52. Missing values were handled by using a mixed model for repeated measurements (MMRM).
Measured: Week 0, week 52
Change From Baseline in Body Weight
Change from baseline in body weight at week 52. Missing values were handled by using a MMRM.
Measured: Week 0, week 52
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.
Measured: Week 0, week 52

Secondary outcomes (1)

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.
Measured: Weeks 0-52

Timeline

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

Nov 2013Jun 2015

First posted22 Apr 2013 (estimated)
Study startNov 2013
Primary completionJun 2015
Study completionJun 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 (3)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: 1,398 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01836523
Sponsor's protocol ID: NN9211-3919
Other IDs: 2012-003580-21, U1111-1133-0590
Acronym: ADJUNCT ONE™
Status last verified: Jan 2017
First submitted: 17 Apr 2013
Last updated: 6 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 27506222
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 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01836523
Acronym / sponsor ID: ADJUNCT ONE™ / NN9211-3919
Conditions: Diabetes, Diabetes Mellitus, Type 1
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,398 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Nov 2013
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 22 Apr 2013 (estimated)
Results: Posted 6 Mar 2017

Clinical summary

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

Study design

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

Arm	Type	Receives
Liraglutide 0.6 mg + insulin	Experimental	Drug: liraglutide
Liraglutide 1.2 mg + insulin	Experimental	Drug: liraglutide
Liraglutide 1.8 mg + insulin	Experimental	Drug: liraglutide
Liraglutide placebo 0.6 mg + insulin	Placebo comparator	Drug: placebo
Liraglutide placebo 1.2 mg + insulin	Placebo comparator	Drug: placebo
Liraglutide placebo 1.8 mg + 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
- 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))

Key exclusion criteria (9 listed)

- 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

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 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.	Drug	Liraglutide 0.6 mg + insulin
placeboSubjects 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.	Drug	Liraglutide placebo 0.6 mg + insulin
liraglutideSubjects 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.	Drug	Liraglutide 1.2 mg + insulin
placeboSubjects 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.	Drug	Liraglutide placebo 1.2 mg + insulin
liraglutideSubjects 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.	Drug	Liraglutide 1.8 mg + insulin
placeboSubjects 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.	Drug	Liraglutide placebo 1.8 mg + insulin

Primary outcome

Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Time frame: Week 0, week 52
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
Time frame: Week 0, week 52
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
Time frame: Week 0, week 52
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.

1 secondary outcome

Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes
Time frame: Weeks 0-52

Results and safety

Results posted to the registry on 6 Mar 2017, 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	351	300
Liraglutide 1.2 mg	350	265
Liraglutide 1.8 mg	349	258
Placebo	348	274

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

Time frame: Week 0, week 52. Mean (Standard Deviation). Unit: percentage of glycosylated haemoglobin

Measure	Liraglutide 0.6 mg n = 334	Liraglutide 1.2 mg n = 312	Liraglutide 1.8 mg n = 305	Placebo n = 324
Value	-0.45 (0.741)	-0.50 (0.767)	-0.54 (0.729)	-0.34 (0.707)

Liraglutide 1.8 mg vs Placebo: Treatment difference: -0.20 (95% CI -0.32 to -0.07)
Liraglutide 1.2 mg vs Placebo: Treatment difference: -0.15 (95% CI -0.27 to -0.03)
Liraglutide 0.6 mg vs Placebo: Treatment difference: -0.09 (95% CI -0.21 to 0.03)

Population analysed: Full analysis set. Number of subjects analysed=subjects with any post-baseline HbA1c data.

Primary outcome: Change From Baseline in Body Weight

Time frame: Week 0, week 52. Mean (Standard Deviation). Unit: kg

Measure	Liraglutide 0.6 mg n = 324	Liraglutide 1.2 mg n = 300	Liraglutide 1.8 mg n = 298	Placebo n = 311
Value	-1.34 (4.183)	-2.73 (4.524)	-4.02 (4.873)	0.94 (3.828)

Liraglutide 1.8 mg vs Placebo: Treatment difference: -4.90 (95% CI -5.65 to -4.16), p <0.0001, Mixed Models Analysis
Liraglutide 1.2 mg vs Placebo: Treatment difference: -3.55 (95% CI -4.29 to -2.81), p <0.0001, Mixed Models Analysis
Liraglutide 0.6 mg vs Placebo: Treatment difference: -2.19 (95% CI -2.91 to -1.47), p <0.0001, Mixed Models Analysis

Population analysed: Full analysis set. Number of subjects analysed=subjects with any post-baseline body weight data.

Primary outcome: Change From Baseline in Total Daily Insulin Dose

Time frame: Week 0, week 52. Geometric mean (Geometric Coefficient of Variation). Unit: ratio

Measure	Liraglutide 0.6 mg n = 337	Liraglutide 1.2 mg n = 328	Liraglutide 1.8 mg n = 331	Placebo n = 341
Value	1.04 (23.75)	0.98 (26.66)	0.95 (24.21)	1.04 (26.69)

Liraglutide 1.8 mg vs Placebo: Treatment ratio: 0.92 (95% CI 0.88 to 0.96), p <0.0001, Mixed Models Analysis
Liraglutide 1.2 mg vs Placebo: Treatment ratio: 0.95 (95% CI 0.91 to 0.99), p = 0.0148, Mixed Models Analysis
Liraglutide 0.6 mg vs Placebo: Treatment ratio: 1.00 (95% CI 0.96 to 1.04), p = 0.9615, Mixed Models Analysis

Population analysed: Full analysis set. Number of subjects analysed=subjects with any post-baseline total insulin daily dose data.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 52 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Liraglutide 0.6 mg	35 of 350 (10%)	259 of 350 (74%)	Not reported
Liraglutide 1.2 mg	36 of 348 (10.3%)	263 of 348 (75.6%)	Not reported
Liraglutide 1.8 mg	29 of 347 (8.4%)	282 of 347 (81.3%)	Not reported
Placebo	38 of 348 (10.9%)	224 of 348 (64.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27506222Mathieu 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.
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

182 sites in 17 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 182 sites in 17 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 9 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 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 182 sites in United States, Canada, France, Germany, United Kingdom and 12 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 6 Mar 2017). 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 HbA1c (Glycosylated Haemoglobin) (time frame: Week 0, week 52). The study lists 3 primary outcomes in all. 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 NCT01836523, which also lists 3 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 6 Mar 2017.