Observational Study on Safety of Self-titration of Once Daily Levemir®

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation on Safety of Self-titration in Insulin naïve People With Type 2 Diabetes Treated With Levemir® (Insulin Detemir) and Oral Antidiabetic Agents

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: insulin detemir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: After the participating physician/nurse's decision has been made to initiate once daily Levemir® therapy (within the license of the product), any patient with type 2 diabetes of 18 years or older who is currently treated with diet, exercise and one or more OADs can be offered to participate Exclusion Criteria: Patients unable to give written informed consent Current treatment with insulin Patient deemed unable or unwilling to self-titrate Known or suspected allergy to study product or related products Pregnancy or breastfeeding or intention of becoming pregnant within the next 6 months
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | Drug: insulin detemir<br>* Start dose and frequency to be prescribed by the physician as a result of a normal clinical evaluation.<br>* Other names: Levemir®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of serious adverse drug reactions including major hypoglycaemic events |  | during treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of serious adverse events and all adverse events |  | during treatment | 
| Incidence of hypoglycaemic events |  | in the 4 weeks preceding the baseline, 12 and 20 week visits | 
| HbA1c |  | 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 |  | 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 |  | at approximately 12 and 20 weeks | 
| Proportion of patients achieving FBG below 6.0 mmol/l +/- hypo |  | defined by the average of the last three FBGs | 
| Body weight |  | at approximately 12 and 20 weeks | 
| Frequency of insulin adjustment |  | at approximately 12 and 20 weeks | 
| Total number of visits/contacts to the clinic, related to titration |  | at approximately 12 and 20 weeks | 
| HCP time used on titration training |  | at baseline and approximately 12 and 20 weeks |