NCT01388361|CompletedPhase 3Results

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

BEGIN™

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)

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN1250-39482011-001493-25U1111-1120-2782

Study Type

interventional

Target

413

Locations

12 countries

Sites

124

Timeline

RegisteredJul 2011

StartedSep 2011

CompletionJul 2012

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

413

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started Sep 2011

Shorter than P25 for phase_3 diabetes

Geographic Reach

12 countries

124 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10 months study duration

First Submitted

Initial submission to the registry

July 4, 2011

Completed

2 days until next milestone

First Posted

Study publicly available on registry

July 6, 2011

Completed

2 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed

3.4 years until next milestone

Results Posted

Study results publicly available

November 26, 2015

Completed

Last Updated

March 6, 2017

Status Verified

January 1, 2017

Enrollment Period

10 months

First QC Date

July 4, 2011

Results QC Date

October 23, 2015

Last Update Submit

January 20, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

Change From Baseline in Fasting Plasma Glucose (FPG)
week 0, week 26
Change From Baseline in Body Weight
week 0, week 26
Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes
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.

Study Arms (3)

IDeg (non-randomised)

EXPERIMENTAL

Drug: insulin degludec

IDeg + IAsp

EXPERIMENTAL

Drug: insulin degludecDrug: insulin aspart

IDeg + liraglutide

EXPERIMENTAL

Drug: insulin degludecDrug: liraglutide

Interventions

insulin degludecDRUG

Injected s.c. (under the skin) once daily. The doses will be individually adjusted

IDeg (non-randomised)IDeg + IAspIDeg + liraglutide

insulin aspartDRUG

Injected s.c. (under the skin) once daily. The doses will be individually adjusted.

IDeg + IAsp

liraglutideDRUG

Injected s.c. (under the skin) once daily. The doses will be individually adjusted.

IDeg + liraglutide

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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.

Contact the study team to confirm eligibility.