Comparison of a Basal Plus One Insulin Regimen With a Biphasic Insulin Regimen in Type 2 Diabetes Patients
Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
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