Observational Study on Levemir® in Obese Diabetic Patients

Study Overview
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Brief Summary
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This study is conducted in Europe. The aim of this observational study is to investigate the effect of switch from other basal insulin treatments to Levemir® on body weight in obese diabetic patients. A local extension will be conducted in Slovenia in order to reach the planned 400 patients for the sub-analysis of Slovenian patients. Included in the study is a retrospective part to evaluate the weight progress since initiation of insulin treatment of another basal insulin and/or oral antidiabetic drugs (OAD) and/or bolus insulin therapy. Retrospective data will be collected at baseline and at approximately 6 and 12 months before starting insulin detemir therapy.

Official Title
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A Prospective, Multicentre, Non-controlled, Observational, 52-weeks Study: the Evaluation of the Body Weight Progress During the Treatment With Insulin Detemir in Type 1 or 2 Diabetes Patients, Previously Treated With Other Basal Insulins

Conditions
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Diabetes, Diabetes Mellitus, Type 1, 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: Diabetes mellitus (Type 1 or type 2) BMI greater than 27 kg/m^2, or more than 3 kg weight increase since start of insulin therapy Exclusion Criteria: Subjects currently being treated with insulin detemir Subjects who were previously enrolled in this study; Subjects with a hypersensitivity to insulin detemir or to any of the excipients. Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months Female patients will be reminded to use adequate contraceptive during the study, where is relevant.

Ages Eligible for Study
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Minimum Age: 6 Years

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>* Safety and effectiveness (weight and HbA1c) data collection in connection with the use of the drug Levemir® in daily clinical practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight and BMI |  | during 12 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight at different BMI subgroups |  | at insulin start, 12 and 6 months before treatment and after 3, 6, 9 and 12 months of treatment | 
| Change in waist perimeter |  | from insulin start and after 6 and 12 months of treatment | 
| Change in FPG (Fasting Plasma Glucose) |  | from 12 and 6 months before treatment after 6 and 12 months of treatment | 
| Change in HbA1C |  | from insulin start and 12 and 6 months before treatment and after 6 and 12 months of treatment | 
| Change in number of hypoglycaemic events during 4 weeks proceeding routine visits |  | after 6 and 12 months of treatment | 
| Number of adverse drug reactions (ADR) |  | after 6 and 12 months of treatment | 
| Change in blood pressure |  | from insulin start and 6 and 12 months after treatment |