A trial, in which subjects with type 2 diabetes, who qualify for treatment intensification, are given insulin degludec and, additionally, either liraglutide or insulin aspart, both in combination with metformin, with the largest meal. The purpose is to compare efficacy and safety of these two treatments.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001493-25-CZ

Enrollment

420

Registered

2011-05-31

Start date

2011-07-20

Completion date

Unknown

Last updated

2012-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes MedDRA version: 14.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Product Name: IDeg Pharmaceutical Form: Solution for injection INN or Proposed INN: insulin degludec CAS Number: 844439-96-9 Concentration unit: U/ml unit(s)/millilitre Concentration type: equal Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - The subject must have completed the end of treatment visit of NN1250-3643 with IDeg OD + metformin. - Ability and willingness to adhere to the protocol including self measurement of plasma glucose according to the protocol Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120

Exclusion criteria

Exclusion criteria: - Participated in NN1250-3643 and treated with IGlar + metformin +/- DPP-IV inhibitor or IDeg + metformin + DPP-IV inhibitor - Previous treatment with glucacon like peptide 1 (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, at end of treatment in NN1250-3643

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the efficacy of adding liraglutide versus adding IAsp to the largest meal on top of IDeg OD + metformin in controlling glycaemia.;Secondary Objective: To compare the safety of adding liraglutide versus adding IAsp to the largest meal on top of IDeg OD + metformin.;Primary end point(s): Change from baseline in HbA1c (%) after 26 weeks of treatment (analysed by central laboratory).;Timepoint(s) of evaluation of this end point: after 26 weeks of treatment	—

Measure

Time frame

Main Objective: To compare the efficacy of adding liraglutide versus adding IAsp to the largest meal on top of IDeg OD + metformin in controlling glycaemia.;Secondary Objective: To compare the safety of adding liraglutide versus adding IAsp to the largest meal on top of IDeg OD + metformin.;Primary end point(s): Change from baseline in HbA1c (%) after 26 weeks of treatment (analysed by central laboratory).;Timepoint(s) of evaluation of this end point: after 26 weeks of treatment

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Secondary

Measure	Time frame
Secondary end point(s): 1- Change from baseline in fasting plasma glucose (FPG) after 26 weeks 2- Change from baseline in body weight after 26 weeks 3- Number of severe and minor treatment emergent hypoglycaemic episodes that have onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product;Timepoint(s) of evaluation of this end point: 1 - after 26 weeks 2 - after 26 weeks 3 - one week after end of treatment in this trial, week 29 at the latest	—

Measure

Time frame

Secondary end point(s): 1- Change from baseline in fasting plasma glucose (FPG) after 26 weeks 2- Change from baseline in body weight after 26 weeks 3- Number of severe and minor treatment emergent hypoglycaemic episodes that have onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product;Timepoint(s) of evaluation of this end point: 1 - after 26 weeks 2 - after 26 weeks 3 - one week after end of treatment in this trial, week 29 at the latest

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Countries

Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Norway, Serbia, Spain, United States

Contacts

Public ContactGlobal Clinical Registry (GCR,1452)

Novo Nordisk A/S

clinicaltrials@novonordisk.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026