CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 413 enrolled
Drug / intervention
insulin degludec +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01388361
NCT01388361Phase 3Completed
CompareCT.gov

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·interventional·Posted Jul 6, 2011·Updated Mar 6, 2017

In Brief

A Phase 3 clinical trial evaluating insulin degludec, insulin aspart, and 1 other intervention for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 413 participants across 124 sites in 12 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesAustria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Norway, Serbia, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 6, 2011
Enrollment StartSep 1, 2011
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 15.0 years ago

Interventions

insulin degludecdrug

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

insulin aspartdrug

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

liraglutidedrug

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