This study is conducted in Europe. The main objective of the study is to assess the safety of self-titration in type 2 diabetic patients on antidiabetic tablets who are receiving insulin for the first time. The study will also look at the blood glucose control, frequency of dose adjustment, clinic visits, and time spent training patients to self-titrate. The objective of diabetes management is to achieve blood glucose levels as close as possible to normal in order to avoid late stage diabetic complications. Self-titration (where patients adjust insulin dosage themselves) offers the potential for better blood glucose control than titration only at clinic visits. In recent years treatment of type 2 diabetes in the United Kingdom has moved from hospitals to GP surgeries or local clinics. Patients with type 2 diabetes, in general, have not been trained in self-titration to the same degree as patients with type 1 diabetes. Less experience in self-titration could impact the level of blood glucose control and outcome for these patients. Data from this study will be pooled with data from NN304-3714 (NCT00825643) and will be reported in the final study report for NN304-3714.
Study Type
OBSERVATIONAL
Enrollment
882
Start dose and frequency to be prescribed by the physician as a result of a normal clinical evaluation.
Novo Nordisk Investigational Site
Crawley, United Kingdom
Incidence of serious adverse drug reactions including major hypoglycaemic events
Time frame: during treatment
Incidence of serious adverse events and all adverse events
Time frame: during treatment
Incidence of hypoglycaemic events
Time frame: in the 4 weeks preceding the baseline, 12 and 20 week visits
HbA1c
Time frame: at the interim study visit at 12 weeks and the end of the study visit at 20 weeks
Variability and mean of the patient's self-monitored plasma glucose measurements
Time frame: at approximately 12 and 20 weeks
Proportion of patients who achieved equal or greater than 1% HbA1c reduction after initiation of insulin detemir without experiencing hypoglycaemic episodes
Time frame: at approximately 12 and 20 weeks
Proportion of patients achieving FBG below 6.0 mmol/l +/- hypo
Time frame: defined by the average of the last three FBGs
Body weight
Time frame: at approximately 12 and 20 weeks
Frequency of insulin adjustment
Time frame: at approximately 12 and 20 weeks
Total number of visits/contacts to the clinic, related to titration
Time frame: at approximately 12 and 20 weeks
HCP time used on titration training
Time frame: at baseline and approximately 12 and 20 weeks
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