Comparison of Basal Plus One vs Biphasic Insulin Regimens - FINAL V1

• Research type

  Research Study

• Full 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

• IRAS ID

  12394

• Sponsor organisation

  Aventis Pharma Ltd trading as sanofi-aventis

• Eudract number

  2008-007026-19

• Research summary

  Controlling diabetes is complex and focuses on controlling blood sugar levels. Treatment tends to start with lifestyle changes (diet and exercise) then treatments such as Oral Anti-diabetic tablets (OADs) and insulin injections.In medical practice, its common to start with long-acting insulin called basal insulin. It controls fasting blood sugar levels and is usually given once a day. An example of a basal insulin is Lantus©. A Basal plus one regimen is where an injection of Ó?fast acting? insulin is added to the regimen before the biggest meal of the day.Alternatively patients may be prescribed a biphasic insulin regimen. Biphasic insulin is a mixture of intermediate and fast acting insulin and it provides a rapid lowering effect on blood glucose levels followed by a prolonged effect that controls the blood glucose levels for the rest of the day and is usually injected before a meal. The aim of this study is to compare two approaches of treating type 2 diabetes. Currently, it is not known which approach is best for patients when their blood sugar control is failing using a basal insulin alone. It is thought that the basal plus one regimen is comparable to the biphasic insulin at controlling blood sugar but may be easier for the patient and so improve quality of life. This study is intended for type 2 diabetics whose blood glucose remains poorly controlled despite treatment with basal insulin. For these people, additional insulin at mealtimes could help to control their diabetes.The patients blood glucose levels will be measured at the start of the study, then 1 week before randomisation (patient will then be randomised to either the basal plus regimen or to the biphasic regimen). Blood glucose levels will be measured again at the end of the study and the two regimens compared. In addition, 4 questionnaires will be done at the start of the treatment period and again at the end of the treatment period in order to compare the change in quality of life between the 2 treatments.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  09/H1008/36

• Date of REC Opinion

  24 Apr 2009

• REC opinion

  Further Information Favourable Opinion