Impact of Switching from Twice-Daily Basal Insulin to Once-Daily Insulin Glargine 300 U/mL in People with Type 1 Diabetes on Basal-Bolus Insulin: Phase 4 OPTIMIZE Study.

ABSTRACT:

Introduction

OPTIMIZE evaluated the efficacy, safety and treatment satisfaction of insulin glargine 300 U/mL once daily (Gla-300 OD) in people with type 1 diabetes mellitus (T1DM) previously uncontrolled on basal insulin twice daily (BID) as part of basal-bolus therapy.

Methods

OPTIMIZE was a 28-week, prospective, interventional, single-arm phase 4 trial in adults with T1DM. At baseline, basal insulin BID treatment was switched to Gla-300 OD titrated to a fasting self-monitored blood glucose target of 4.4-7.2 mmol/L (80-130 mg/dL). The primary endpoint was the mean glycated haemoglobin (HbA_1c) change from baseline to week 24. Secondary endpoints included self-monitored blood glucose, fasting-plasma glucose, hypoglycaemia and patient-reported outcomes including the

SUBMITTER: Mathieu C 

PROVIDER: S-EPMC6995801 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature