Comparison of a Basal Plus One Insulin Regimen With a Biphasic Insulin Regimen in Type 2 Diabetes Patients

Summary

The primary objective is to demonstrate the non-inferiority at six months of a basal plus one insulin regimen (Lantus plus one injection of Apidra) compared with a biphasic insulin regimen (NovoMix 30) at controlling glycosylated haemoglobin (HbA1c) in type 2 diabetes. The secondary objective are: * To compare the proportion of patients in each treatment group reaching HbA1c target (\< 7%) at the end of the treatment period * To compare the rates of hypoglycaemia (total, severe, nocturnal) * To compare the change in body weight from visit 10 to visit 24 * To compare the change in diabetes specific quality of life and other patient reported outcomes from visit 10 to visit 24 * Diabetes Treatment Satisfaction Questionnaire - status and change (DTSQs+c) * Audit of Diabetes-Dependent Quality of Life (ADDQoL) questionnaire * Insulin Treatment Satisfaction Questionnaire (ITSQ) * EuroQoL 5 Dimensions (EQ5D) questionnaire * To record the change in the daily dose of insulin from visit 2 to visit 10 and visit 10 to visit 24

Timeline

Start

2009-07

Primary completion

2012-12

Completion

2012-12

Drugs

Indications