ADJUNCT ONE™

CompletedPhase 3Results posted

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

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

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

182

Recruiting sites

—

Enrollment

1,398

actual

Study population

Type 1 diabetes

Key I/E criterion

•HbA1c 7-10%

Primary endpoints

•HbA1c, change•Body weight, absolute change (kg)•Total Daily Insulin Dose

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01836523

Org study IDNN9211-3919

Secondary ID2012-003580-21

Secondary IDU1111-1133-0590WHO

Timeline

Milestones

Study first posted2013-04-22estimated

Last update posted2017-03-06actual

Results first posted2017-03-06actual

Study start2013-11 (month precision)

Primary completion2015-06actual (month precision)

Study completion2015-06actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

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)

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Weight & body composition

Safety / tolerability / PK

Weight & body composition

2 endpoints

Primary/registry result

Change From Baseline in Body Weight

Time frame:Week 0, week 52

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kg	95% CI
Liraglutide 0.6 mg	-1.34	—
Liraglutide 1.2 mg	-2.73	—
Liraglutide 1.8 mg	-4.02	—
Placebo	0.94	—

Treatment difference-4.9095% CI-5.65 – -4.16p<0.0001Mixed Models Analysis

Treatment difference-3.5595% CI-4.29 – -2.81p<0.0001Mixed Models Analysis

Treatment difference-2.1995% CI-2.91 – -1.47p<0.0001Mixed Models Analysis

Primary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Week 0, week 52

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

4 endpoints

Primary/registry result

Change From Baseline in HbA1c (Glycosylated Haemoglobin)

Time frame:Week 0, week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percentage of glycosylated haemoglobin	95% CI
Liraglutide 0.6 mg	-0.45	—
Liraglutide 1.2 mg	-0.50	—
Liraglutide 1.8 mg	-0.54	—
Placebo	-0.34	—

Treatment difference-0.2095% CI-0.32 – -0.07

Treatment difference-0.1595% CI-0.27 – -0.03

Treatment difference-0.0995% CI-0.21 – 0.03

Primary/registry result/low confidence

Change From Baseline in Total Daily Insulin Dose

Time frame:Week 0, week 52

ratio, improvement

Posted result

Group	Value (geometric_mean), ratio	95% CI
Liraglutide 0.6 mg	1.04	—
Liraglutide 1.2 mg	0.98	—
Liraglutide 1.8 mg	0.95	—
Placebo	1.04	—

Treatment ratio0.9295% CI0.88 – 0.96p<0.0001Mixed Models Analysis

Treatment ratio0.9595% CI0.91 – 0.99p0.0148Mixed Models Analysis

Treatment ratio1.0095% CI0.96 – 1.04p0.9615Mixed Models Analysis

Primary/protocol endpoint

Change From Baseline in HbA1c (Glycosylated Haemoglobin)

Time frame:Week 0, week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Primary/protocol endpoint/low confidence

Change From Baseline in Total Daily Insulin Dose

Time frame:Week 0, week 52

ratio, improvement

Safety / tolerability / PK

2 endpoints

Secondary/registry result

Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes

Time frame:Weeks 0-52

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), episodes	95% CI
Liraglutide 0.6 mg	4954	—
Liraglutide 1.2 mg	4602	—
Liraglutide 1.8 mg	4614	—
Placebo	3654	—

Rate ratio1.3195% CI1.07 – 1.59p0.0081Negative binomial regression

Rate ratio1.2795% CI1.03 – 1.55p0.0219Negative binomial regression

Rate ratio1.1795% CI0.97 – 1.43p0.1079Negative binomial regression

Secondary/protocol endpoint

Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes

Time frame:Weeks 0-52

Documented hypoglycemia

event count, event

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Determinants of Liraglutide Treatment Discontinuation in Type 1 Diabetes: A Post Hoc Analysis of ADJUNCT ONE and ADJUNCT TWO Randomized Placebo-Controlled Clinical Studies.
Journal of diabetes science and technology2025 Mar (month)PMID39717993doi:10.1177/19322968241305647via clinicaltrials gov reference derived + pubmed nct search
Efficacy and safety of liraglutide in type 1 diabetes by baseline characteristics in the ADJUNCT ONE and ADJUNCT TWO randomized controlled trials.
Diabetes, obesity & metabolism2021 Dec (month)PMID34463425doi:10.1111/dom.14532via clinicaltrials gov reference derived + pubmed nct search
Efficacy and Safety of Liraglutide Added to Insulin Treatment in Type 1 Diabetes: The ADJUNCT ONE Treat-To-Target Randomized Trial.
Diabetes care2016 Oct (month)PMID27506222doi:10.2337/dc16-0691via CT.gov reference + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.