Primary objective: * To determine the optimal treatment algorithm for the clinical use of insulin glargine based on the incidence of severe hypoglycaemia. Secondary objectives: * To determine for each treatment algorithm the incidence of asymptomatic, symptomatic and nocturnal hypoglycaemia. * To determine the difference in glycaemic control as measured by HbA1c and fasting blood glucose between the treatment algorithms. * To determine the difference in glycaemic control as measured by HbA1c and fasting blood glucose between baseline and end of treatment. * To obtain safety data on the use of insulin glargine in each treatment algorithm. * To measure change in subject weight and insulin dose between baseline and end of treatment. * To determine subject quality of life and treatment satisfaction (sub-study)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7,376
Incidence of severe hypoglycaemia
Incidence of any hypoglycaemia
Incidence of symptomatic hypoglycaemia
Incidence of nocturnal hypoglycaemia
Incidence of asymptomatic hypoglycaemia
Adjusted mean change in Hb1Ac (%)
Adjusted mean change in fasting blood glucose (FBG) (mg/dl)
Adjusted mean change in nocturnal blood glucose (NBG) (mg/dl)
Adjusted mean change in mean daily blood glucose (MBG) (mg/dl)
% of subjects at v12 with Hb1Ac < or = 6.5 %
% of subjects at v12 with Hb1Ac < or = 7.0 %
% of subjects at v12 with FBG < or = 100 mg/dl
Weight change (kg)
Change in insulin glargine dose v2 - v12 (IU)
Safety data
Quality of Life and treatment satisfaction before, during and at the end of treatment using the Diabetes Treatment Satisfaction Questionnaire
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.