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

NCT01388361 · Completed

Last updated 2026-05-28

This clinical trial compares two different treatment approaches to improve blood sugar control in adults with type 2 diabetes who are already taking basal insulin and metformin.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 413 people

Who can join Ages 18+ · all sexes

Timeline Started 2011-09 · est. completion 2012-07

Where 124 sites · Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Norway, Serbia, Spain, United States

What this study is testing ClinicalTrials.gov NCT01388361 ↗

Description as written by the study sponsor.

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.

Treatments tested

insulin degludec Drug

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

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

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

Main thing measured	Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin)
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes, Diabetes Mellitus, Type 2
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01388361 ↗