BEGIN™

CompletedPhase 3Results posted

Comparison of the Efficacy and Safety of Two Intensification Strategies in Subjects With Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin

A Trial Comparing the Efficacy and Safety of Adding Liraglutide Versus Addition of Insulin Aspart With the Largest Meal to Insulin Degludec, Both in Combination With Metformin, in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification (BEGIN™: VICTOZA® ADD-ON)

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

124

Recruiting sites

—

Enrollment

413

actual

Study population

Type 2 diabetes

Key I/E criterion

—

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 IDNCT01388361

Org study IDNN1250-3948

Secondary ID2011-001493-25

Secondary IDU1111-1120-2782WHO

Timeline

Milestones

Study first posted2011-07-06estimated

Results first posted2015-11-26estimated

Last update posted2017-03-06actual

Study start2011-09 (month precision)

Primary completion2012-07actual (month precision)

Study completion2012-07actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

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

•The subject must have completed the end of treatment visit of NN1250-3643 with Insulin degludec once daily + metformin.

•Ability and willingness to adhere to the protocol including self measurement of plasma glucose according to the protocol

Exclusion criteria

•Participated in NN1250-3643 and treated with insulin glargine

•Previous treatment with glucacon like peptide (GLP-1) receptor agonists (e.g. exenatide, liraglutide)

•Impaired liver function, defined as alanine aminotransferase (ALAT) 2.5 times the upper limit of normal at end of treatment in NN1250-3643

•Impaired renal function defined as serum-creatinine = 125 µmol/l (= 1.4 mg/dl) for males and = 110 µmol/L (= 1.3 mg/dl) for females or according to local label for metformin [For France: glomerular filtration rate below 60 ml/min, calculated by the Cockroft \& Gault formula] at end of treatment in NN1250-3643.

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

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
IDeg	0.1	—
IDeg + Liraglutide	-1.0	—
IDeg + IAsp OD	0.3	—

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

4 endpoints

Primary/registry result

Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin)

Time frame:week 0, week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percentage of glycosylated haemoglobin	95% CI
IDeg	0.10	—
IDeg + Liraglutide	-0.74	—
IDeg + IAsp OD	-0.39	—

Primary/protocol endpoint

Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin)

Time frame:week 0, week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change From Baseline in Fasting Plasma Glucose (FPG)

Time frame:week 0, week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mmol/L	95% CI
IDeg	-1.23	—
IDeg + Liraglutide	-0.14	—
IDeg + IAsp OD	-0.04	—

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose (FPG)

Time frame:week 0, week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Safety / tolerability / PK

2 endpoints

Secondary/registry result

Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes

Time frame:Onset on or after the first day of exposure to investigational product for 26 weeks of treatment period and no later than 7 days after last exposure to investigational product.

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), events	95% CI
IDegConfirmed(severe+minor)	313	—
Severe	1	—
IDeg + LiraglutideConfirmed(severe+minor)	40	—
Severe	0	—
IDeg + IAsp ODConfirmed(severe+minor)	330	—
Severe	0	—

Secondary/protocol endpoint

Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes

Time frame:Onset on or after the first day of exposure to investigational product for 26 weeks of treatment period and no later than 7 days after last exposure to investigational product.

Documented hypoglycemia

event count, event

Publications (1)

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

A comparison of adding liraglutide versus a single daily dose of insulin aspart to insulin degludec in subjects with type 2 diabetes (BEGIN: VICTOZA ADD-ON).
Diabetes, obesity & metabolism2014 Jul (month)PMID24443830doi:10.1111/dom.12262via CT.gov reference

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.