Observational Study on Safety of Self-titration of Once Daily Levemir® (SOLVE™)
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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Evaluation on Safety of Self-titration in Insulin naïve People With Type 2 Diabetes Treated With Levemir® (Insulin Detemir) and Oral Antidiabetic Agents|
- 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 ]
|Study Start Date:||September 2008|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Drug: insulin detemir
Start dose and frequency to be prescribed by the physician as a result of a normal clinical evaluation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00740519
|Novo Nordisk Investigational Site|
|Crawley, United Kingdom, RH11 9RT|
|Study Director:||Global Clinical Registry (GCR, 1452)||Novo Nordisk A/S|