Comparing Patient-adjusted Versus Physician-adjusted Titration of BIAsp 30 Combined With Metformin in Type 2 Diabetes Patients

Phase 4 Completed 155 enrolled Novo Nordisk A/S

RandomizedParallel-groupOpen-labelTreatment

Summary

This trial is conducted in Africa and Asia. The aim of the trial is to compare patient-adjusted versus physician-adjusted titration of BIAsp 30 combined with metformin in type 2 diabetes patients uncontrolled on NPH insulin.

Timeline

Start: 2012-05-26
Primary completion: 2015-07-09
Completion: 2015-07-09

Outcome

Met primary endpoint

paper The noninferiority of patient-driven compared to physician-driven titration with respect to the reduction in HbA1c was confirmed. PMID 28523482 ↗

Publications

Results Chraibi A, Al-Herz S, Nguyen BD, Soeatmadji DW, Shinde A, Lakshmivenkataraman B, Assaad-Khalil SH. An RCT Investigating Patient-Driven Versus Physician-Driven Titration of BIAsp 30 in Patients with Type 2 Diabetes Uncontrolled Using NPH Insulin. Diabetes Ther. 2017 Aug;8(4):767-780. doi: 10.1007/s13300-017-0268-1. Epub 2017 May 18.

Drugs

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