Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Comparison of a Basal Plus One Insulin Regimen (Insulin Glargine/Insulin Glulisine) With a Biphasic Insulin Regimen (Insulin Aspart/Insulin Aspart Protamine 30/70) in Type 2 Diabetes Patients Following Basal Insulin Optimisation
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
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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