GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Alone

A 52-week, Multi-centre, Open-labelled, Randomised (2:1), Parallel-group Trial With an Active Control (Two OADs Combination Therapy) to Evaluate the Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Monotherapy

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

363

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≤40•HbA1c 7-10%

Primary endpoint

•Treatment-emergent AEs (any)

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 IDNCT01512108

Org study IDNN2211-3924

Secondary IDJapicCTI-121744JAPIC

Secondary IDU1111-1121-3457WHO

Timeline

Milestones

Study start2012-01-10actual

Study first posted2012-01-19estimated

Primary completion2013-04-26actual

Study completion2013-04-26actual

Results first posted2014-05-28estimated

Last update posted2017-12-18actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Informed consent obtained before any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the subject.)

•Japanese subjects with type 2 diabetes on monotherapy with an OAD (either glinide, metformin, a-glucosidase inhibitor or thiazolidinedione) within approved Japanese labelling in addition to diet and exercise therapy. Total daily dose and type of drug should have remained unchanged for at least 8 weeks prior to Visit 1

•Type 2 diabetes mellitus (clinically diagnosed) for at least 6 months

•HbA1c between 7.0-10.0% (both inclusive)

•Body Mass Index (BMI) below 40.0 kg/m^2

•Outpatients who have no plans for an educational hospitalisation for the purpose of glycaemic control. However, hospitalisation for training of self-injection from Visit 2 that is for no longer than one week is allowed

•Subjects able and willing to perform self-monitoring of plasma glucose (SMPG)

Exclusion criteria

•Subjects with known or previous malignant tumor and are strongly suspected of recurrence (except basal cell skin cancer or squamous cell skin cancer)

•Calcitonin above or equal to 160 pg/mL

•Personal history of non-familial medullary thyroid carcinoma

•Family or personal history of multiple endocrine neoplasia type 2 (MEN-2) or familial medullary thyroid carcinoma (FMTC)

•History of chronic pancreatitis or idiopathic acute pancreatitis

•Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months

•Treatment with GLP-1 receptor agonist or dipeptidyl peptidase 4 (DPP-4) inhibitor within 12 weeks prior to Visit 1

•Having contraindications to liraglutide and any of the OADs (according to Japanese labelling)

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

Safety / tolerability / PK

Glycemic / diabetes

4 endpoints

Secondary/registry result

Change in HbA1c From Baseline to Week 52

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 0.9 mg/Day	-1.21	—
Additional OAD	-0.94	—

Estimated treatment difference, Mean-0.2795% CI-0.44 – -0.09p0.0026ANOVA

Secondary/registry result

Change in FPG From Baseline to Week 52

Time frame:Week 0, week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide 0.9 mg/Day	-1.55	—
Additional OAD	-1.24	—

Estimated treatment difference, Mean-0.3095% CI-0.60 – -0.01p0.0458ANOVA

Secondary/protocol endpoint

Change in HbA1c From Baseline to Week 52

Time frame:Week 0, week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in FPG From Baseline to Week 52

Time frame:Week 0, week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Safety / tolerability / PK

4 endpoints

Primary/registry result

Incidence of Treatment Emergent Adverse Events (AEs)

Time frame:Week 0 to Week 52 + 7 days

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Events/100 years of patient exposure	95% CI
Liraglutide 0.9 mg/DayAll AEs	361	—
Mild AEs	345	—
Moderate AEs	14	—
Severe AEs	2	—
Serious AEs	5	—
Additional OADAll AEs	331	—
Mild AEs	321	—
Moderate AEs	9	—
Severe AEs	2	—
Serious AEs	9	—

Primary/protocol endpoint

Incidence of Treatment Emergent Adverse Events (AEs)

Time frame:Week 0 to Week 52 + 7 days

Treatment-emergent AEs (any)

event count, event

Secondary/registry result

Number of Confirmed Hypoglycaemic Episodes

Time frame:Week 0 to Week 52

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), episodes	95% CI
Liraglutide 0.9 mg/Day	7	—
Additional OAD	2	—

Secondary/protocol endpoint

Number of Confirmed Hypoglycaemic Episodes

Time frame:Week 0 to Week 52

Documented hypoglycemia

event count, event

Publications (2)

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

Safety and efficacy of the combination of the glucagon-like peptide-1 receptor agonist liraglutide with an oral antidiabetic drug in Japanese patients with type 2 diabetes: Post-hoc analysis of a randomized, 52-week, open-label, parallel-group trial.
Journal of diabetes investigation2018 Jul (month)PMID28984041doi:10.1111/jdi.12759via CT.gov reference
Liraglutide is effective and well tolerated in combination with an oral antidiabetic drug in Japanese patients with type 2 diabetes: A randomized, 52-week, open-label, parallel-group trial.
Journal of diabetes investigation2016 Jan (month)PMID26816604doi:10.1111/jdi.12367via 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.