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

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.

Timeline

Start

2011-09

Primary completion

2012-07

Completion

2012-07

Outcome

Met primary endpoint

paper IDeg+Lira reduced HbA1c (-0.74%-points) significantly more than IDeg+IAsp (-0.39%-points); PMID 24443830 ↗

paper estimated treatment difference (ETD) (IDeg+Lira-IDeg+IAsp) -0.32%-points (95% CI -0.53; -0.12); p = 0.0024. PMID 24443830 ↗

Publications

• Results Mathieu C, Rodbard HW, Cariou B, Handelsman Y, Philis-Tsimikas A, Ocampo Francisco AM, Rana A, Zinman B; BEGIN: VICTOZA ADD-ON (NN1250-3948) study group. 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). Diabetes Obes Metab. 2014 Jul;16(7):636-44. doi: 10.1111/dom.12262. Epub 2014 Feb 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Liraglutide	Peptide	—	Subcutaneous
Subject	insulin aspart	Protein / enzyme biologic	—	Subcutaneous
Subject	insulin degludec	Protein / enzyme biologic	—	Subcutaneous

Indications