Primary outcome
What BEGIN measured first
| IDegn=236 | IDeg + Liraglutiden=88 | IDeg + IAsp ODn=89 |
|---|---|---|
| 0.10(0.40) | -0.74(0.73) | -0.39(0.72) |
Phase 3 · Liraglutide
BEGIN trial results
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)
Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin) (percentage of glycosylated haemoglobin), week 0, week 26. IDeg: 0.10; IDeg + Liraglutide: -0.74; IDeg + IAsp OD: -0.39.
- Participants
- 413
- Status
- completed
- Completed
- 2012-07
- Sponsor
- Novo Nordisk A/S
As posted on ClinicalTrials.gov (NCT01388361), updated at source Mar 6, 2017. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Side effects by arm
Side effects in BEGIN
Percent of participants affected, Treatment emergent adverse events were collected during 26 week treatment period + 7 days follow up.. The most common events the registry lists.
| Event | IDeg | IDeg + Liraglutide | IDeg + IAsp OD |
|---|---|---|---|
| Any serious event | 4.7% | 4.6% | 5.8% |
| Nausea | 1.3% | 20.7% | 1.2% |
| Nasopharyngitis | 18.2% | 10.3% | 12.8% |
| Diarrhoea | 3.4% | 10.3% | 1.2% |
| Lipase increased | 0% | 6.9% | 0% |
| Vomiting | 1.7% | 5.7% | 0% |
| Pain in extremity | 0.8% | 5.7% | 1.2% |
| Bronchitis | 5.5% | 1.1% | 2.3% |
| Upper respiratory tract infection | 5.1% | 4.6% | 3.5% |
Secondary outcomes
What else it measured
| IDegn=226 | IDeg + Liraglutiden=86 | IDeg + IAsp ODn=84 |
|---|---|---|
| -1.23(2.03) | -0.14(2.52) | -0.04(2.84) |
| IDegn=233 | IDeg + Liraglutiden=87 | IDeg + IAsp ODn=89 |
|---|---|---|
| 0.1(2.7) | -1.0(1.3) | 0.3(0.9) |
| Measure | IDegn=236 | IDeg + Liraglutiden=87 | IDeg + IAsp ODn=86 |
|---|---|---|---|
| Confirmed(severe+minor) | 313 | 40 | 330 |
| Severe | 1 | 0 | 0 |
The trial
How BEGIN was run
This trial is conducted in Europe and North America. The aim of this trial is to compare the efficacy and safety of adding liraglutide versus addition of insulin aspart with the largest meal to insulin degludec in subjects with type 2 diabetes. Eligible subjects with an HbA1c equal to or above 7% at end of treatment in NN1250-3643 (NCT01193309) trial will be randomised to receive treatment intensification while subjects with an HbA1c below 7% at end of treatment in NN1250-3643 (NCT01193309) may continue to receive insulin degludec treatment. Subjects are to continue their pre-trial metformin treatment.
- IDeg (non-randomised)
- IDeg + IAsp
- IDeg + liraglutide
Who could join the trial
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.
Published papers
Papers from BEGIN
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
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