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ADJUNCT TWO™

CompletedPhase 3Results posted

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

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

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

120

Recruiting sites

—

Enrollment

835

actual

Study population

Type 1 diabetes

Key I/E criterion

•HbA1c 7-10%

Primary endpoint

•HbA1c, change

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 IDNCT02098395

Org study IDNN9211-4083

Secondary ID2012-005778-74

Secondary IDNL47705.060.14CCMO

Secondary IDREec-2014-0884Spanish registry

Secondary IDU1111-1138-0619WHO

Timeline

Milestones

Study first posted2014-03-28estimated

Results first posted2016-06-03estimated

Last update posted2017-02-09estimated

Study start2014-05 (month precision)

Primary completion2015-04actual (month precision)

Study completion2015-04actual (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 before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial

•Male or female, aged equal to or greater than 18 years at the time of signing informed consent

•Type 1 diabetes mellitus (as diagnosed clinically) 12 months or longer prior to Visit 1 (i.e. screening)

•Treatment with basal bolus or CSII (continuous subcutaneous insulin infusion, insulin pump) treatment 6 months or longer prior to Visit 1 (i.e. screening)

•Stable insulin treatment 3 months or longer prior to Visit 1 (i.e. screening), as judged and documented by the investigator

•HbA1c 7.0-10.0 percent (Diabetes Control and Complications Trial (DCCT)), both inclusive, by central laboratory analysis (Visit 1, screening) corresponding to 53-86 mmol/mol (International Federation of Clinical Chemistry (IFCC))

Exclusion criteria

•Prior use of glucagon-like peptide-1 (GLP-1) receptor agonist or dipeptidyl peptidase IV (DPPIV) inhibitors

•Use of any medication, which in the investigator's opinion could interfere with the glycaemic control (e.g. systemic corticosteroids, pramlintide (Symlin®)) or affect the subject's safety. Premix insulin is not allowed

•Known proliferative retinopathy or maculopathy requiring acute treatment

•Severe neuropathy, in particular autonomic neuropathy, i.e. gastroparesis, as judged by the investigator

•Uncontrolled/untreated blood pressure at screening (Visit 1) (after resting for 5 minutes) while sitting greater than 160 mmHg for systolic or greater than 100 mmHg for diastolic (repeated measurement at Visit 2 (prior to performing the trial related activities) is allowed to exclude white-coat hypertension)

•History of acute or chronic pancreatitis

•Screening (Visit 1) calcitonin value equal to or greater than 50 ng/L

Endpoints (6)

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

Weight & body composition

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

2 endpoints

Secondary/registry result

Change From Baseline in Body Weight

Time frame:Week 0, Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kg	95% CI
Liraglutide 0.6 mg	-2.37	—
Liraglutide 1.2 mg	-4.03	—
Liraglutide 1.8 mg	-5.1	—
Liraglutide Placebo	-0.26	—

Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Week 0, Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Primary/registry result

Change From Baseline in Glycosylated Haemoglobin (HbA1c)

Time frame:Week 0, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percent (%) glycosylated haemoglobin	95% CI
Liraglutide 0.6 mg	-0.23	—
Liraglutide 1.2 mg	-0.23	—
Liraglutide 1.8 mg	-0.32	—
Liraglutide Placebo	0.01	—

Mean Difference (Final Values)-0.3595% CI-0.5 – -0.2p< 0.0001Mixed Models Analysis

Mean Difference (Final Values)-0.2395% CI-0.38 – -0.08p= 0.0021Mixed Models Analysis

Superiority of liraglutide 1.2 mg was planned to be evaluated only if superiority for liraglutide 1.8 mg was concluded.

Mean Difference (Final Values)-0.2495% CI-0.39 – -0.1p= 0.0011Mixed Models Analysis

Superiority of liraglutide 0.6 mg versus placebo was planned to be evaluated only if superiority of liraglutide 1.2 mg was concluded.

Primary/protocol endpoint

Change From Baseline in Glycosylated Haemoglobin (HbA1c)

Time frame:Week 0, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Safety / tolerability / PK

2 endpoints

Secondary/registry result

Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes

Time frame:Weeks 0-26

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), episodes	95% CI
Liraglutide 0.6 mg	1437	—
Liraglutide 1.2 mg	1943	—
Liraglutide 1.8 mg	1490	—
Liraglutide Placebo	1567	—

Secondary/protocol endpoint

Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes

Time frame:Weeks 0-26

Documented hypoglycemia

event count, event

Publications (4)

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
Theory of mind predicts severity level in autism.
Autism : the international journal of research and practice2017 Feb (month)PMID27493232doi:10.1177/1362361316636758via CT.gov reference
Efficacy and Safety of Liraglutide Added to Capped Insulin Treatment in Subjects With Type 1 Diabetes: The ADJUNCT TWO Randomized Trial.
Diabetes care2016 Oct (month)PMID27493132doi:10.2337/dc16-0690via 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.