Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name BEGIN™

NCTNCT01388361Other idNN1250-3948Other id2011-001493-25Other idU1111-1120-2782

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 413 participants (actual)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Open label (no masking)
Countries: 12 countries
United States, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Norway, Serbia, Spain
Start: Sept 2011
Primary completion: Jul 2012
Completion: Jul 2012
First posted: 6 Jul 2011 (estimated)
Last update posted: 6 Mar 2017
Conditions: Diabetes · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201120122013

Ph 3
BEGIN™
NCT01388361
Sept 2011 to Jul 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

insulin degludecDrug
insulin aspartDrug
liraglutideDrug

Arms3

Experimental
IDeg (non-randomised)
Experimental
IDeg + IAsp
Experimental
IDeg + liraglutide

Primary outcomes1

Outcomes the sponsor listed as primary.

Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin)
Time frame · week 0, week 26
Registry description
Values for change in HbA1c from baseline to 26 weeks of treatment period.

Secondary outcomes(3)

Change From Baseline in Fasting Plasma Glucose (FPG)
Time frame · week 0, week 26
Registry description
Values for change in FPG in mmol/L from baseline to week 26 of randomised period.
Change From Baseline in Body Weight
Time frame · week 0, week 26
Registry description
Corresponds to the values of change in body weight in kilograms from baseline to week 26.
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.
Registry description
Corresponds to number of treatment emergent hypoglycaemic events from onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product. Confirmed hypoglycaemia was defined as the pool of severe hypoglycaemic episodes and minor episodes with a plasma glucose (PG) value \< 3.1 mmol/L (56 mg/dL).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· week 0, week 26

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

Group	Value (percentage of glycosylated haemoglobin)	Spread
IDeg	0.10	0.40
IDeg + Liraglutide	-0.74	0.73
IDeg + IAsp OD	-0.39	0.72

Secondary and other outcome results(3)

Secondary outcomeMean· week 0, week 26

Change From Baseline in Fasting Plasma Glucose (FPG)

Group	Value (mmol/L)	Spread
IDeg	-1.23	2.03
IDeg + Liraglutide	-0.14	2.52
IDeg + IAsp OD	-0.04	2.84

Secondary outcomeMean· week 0, week 26

Change From Baseline in Body Weight

Group	Value (kg)	Spread
IDeg	0.1	2.7
IDeg + Liraglutide	-1.0	1.3
IDeg + IAsp OD	0.3	0.9

Secondary outcomeNumber· 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.

Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes

Group	Value (events)
IDeg	313
IDeg + Liraglutide	40
IDeg + IAsp OD	330

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
IDegThis non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) \< 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen's ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms.	–	11 / 236	64 / 236
IDeg + LiraglutideAll subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.	–	4 / 87	40 / 87
IDeg + IAsp ODSubjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.	–	5 / 86	18 / 86

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2014

7 results

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).

Mathieu et al. 2014Diabetes, obesity & metabolismcited by 121

PMID 24443830DOI 10.1111/dom.12262PUB-24443830

Free to read · publisher termsCC BY-NC-ND7 results

Read at source See results (7)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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