A Study to Compare Insulin Intensification of Biphasic Insulin Aspart 30 and Insulin Analogues (Insulin Glargine and Insulin Aspart) in Insulin naïve Type 2 Diabetic Patients

Phase 4 Completed 335 enrolled Novo Nordisk A/S

RandomizedParallel-groupOpen-labelTreatment

Summary

This trial is conducted globally. The aim of this trial is to compare stepwise insulin intensification of biphasic insulin aspart (BIAsp) 30 and basal-bolus therapy with insulin glargine and insulin aspart in insulin naïve type 2 diabetic patients inadequately controlled on oral anti-diabetic therapy.

Timeline

Start: 2015-08-31
Primary completion: 2016-09-20
Completion: 2016-09-20

Outcome

Missed primary endpoint

registry analysis (superiority or other test); BIAsp 30 vs Basal-bolus; p = 0.0435; Treatment difference at week 32 0.18 (95% CI 0.01 to 0.36); Mixed Models Analysis NCT02453685 ↗

Publications

Results Linjawi S, Lee BW, Tabak O, Lovdahl S, Werther S, Abusnana S. A 32-Week Randomized Comparison of Stepwise Insulin Intensification of Biphasic Insulin Aspart (BIAsp 30) Versus Basal-Bolus Therapy in Insulin-Naive Patients with Type 2 Diabetes. Diabetes Ther. 2018 Feb;9(1):1-11. doi: 10.1007/s13300-017-0334-8. Epub 2017 Nov 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	biphasic insulin aspart 30	Protein / enzyme biologic	—	Subcutaneous
Subject	insulin aspart	Protein / enzyme biologic	—	Subcutaneous
Comparator	insulin glargine	Protein / enzyme biologic	—	Subcutaneous