A Trial Investigating the Efficacy and Safety of Flexible vs. Fixed Dosing and Simple vs. Stepwise Titration With Once Daily (OD) Insulin Degludec in Inadequately Treated Subjects With Type 2 Diabetes

Summary

This trial is conducted in Asia. The aim of the trial is to investigate the efficacy and safety of flexible versus fixed dosing and simple versus stepwise titration with OD insulin degludec in inadequately treated subjects with type 2 diabetes.

Timeline

Start

2013-06

Primary completion

2014-04

Completion

2014-04

Outcome

Met primary endpoint

paper IDeg flexible was non-inferior to IDeg fixed with respect to change in glycated hemoglobin from baseline PMID 27182031 ↗

paper Dosing of IDeg at a time convenient to the patient was non-inferior, with respect to glycated hemoglobin, to dosing at the same time each day. PMID 27182031 ↗

Publications

• Results Kadowaki T, Jinnouchi H, Kaku K, Herslov ML, Hyllested-Winge J, Nakamura S. Insulin degludec in a simple or stepwise titration algorithm in a Japanese population of patients with type 2 diabetes: a randomized, 26-week, treat-to-target trial. Diabetol Int. 2016 Sep 2;8(1):87-94. doi: 10.1007/s13340-016-0284-9. eCollection 2017 Mar.
• Results Kadowaki T, Jinnouchi H, Kaku K, Herslov ML, Hyllested-Winge J, Nakamura S. Efficacy and safety of once-daily insulin degludec dosed flexibly at convenient times vs fixed dosing at the same time each day in a Japanese cohort with type 2 diabetes: A randomized, 26-week, treat-to-target trial. J Diabetes Investig. 2016 Sep;7(5):711-7. doi: 10.1111/jdi.12502. Epub 2016 Apr 1.

Drugs

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

Indications