Observational Study in Japanese Type 2 Diabetes Patients

Study Overview
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Brief Summary
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This study is designed to address the gap in the literature related to changing treatment regimen or formulation between different types of insulin, and how this change impacts quality of life, adherence, individual patient treatment satisfaction and glycemic control.

Detailed Description
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To measure changes in Health Related Quality of Life (as measured by the Insulin Therapy Related-Quality of Life: ITR-QOL) in insulin treated type 2 diabetes over a 12 weeks period following a significant change in insulin treatment regimen. Definition of significant change is a) increase or decrease the in number of injections per day, or/and b) change in formulation of insulin (human or analog insulin, basal or bolus, rapid or mix insulin), and/or c) change in administration method (syringe or pen, disposal or re-usable).

Official Title
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A Prospective, Non-safety Observational Study in Japanese Type 2 Diabetes Patients(INSIGHTS)

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Insulins


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inpatients or outpatients with type 2 diabetes, aged 20 years or older, on insulin therapy who have planned to change insulin therapy during the registration period of the study Patients who have provided written informed consent to participation in the study after receiving explanations about the objective and other details of the study Patients who have received the same insulin therapy for 3 months or longer before informed consent. (i.e. receiving the same type of insulin preparation at the same dosing frequency regardless of insulin dose) Exclusion Criteria: Patients who have planned to discontinue insulin therapy Patients incapable of completing the ITR-QOL, DTSQ and patient's questionnaire based on their self-ratings Patients with type 1 diabetes Patients who have used CSII or have planned to switch to CSII(continuous subcutaneous insulin infusion ) Patients with poor treatment compliance as determined by their investigators based on the treatment history

Ages Eligible for Study
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Minimum Age: 20 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 |
| --- | --- |
| Type 2 diabetes treated with insulin<br> | Drug: Insulins<br>* Individual dose and frequency and duration as determined by the treating physician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Health Related Quality of Life (ITR-QOL) in insulin treated type 2 diabetes at baseline and 12 weeks after a significant change in insulin treatment regimen |  | Baseline, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summarize by occurrence the reason for insulin treatment change at study entry |  | Baseline | 
| Change in HbA1c at baseline and 12 weeks after a significant change in insulin treatment regimen |  | Baseline, 12 weeks | 
| Change in treatment adherence at baseline and 12 weeks after a significant change in insulin treatment regimen |  | Baseline, 12 weeks | 
| Change in DTSQ (Diabetes treatment satisfaction questionnaire) at baseline and 12 weeks after a significant change in insulin treatment regimen |  | Baseline, 12 weeks | 
| Total daily dose of insulin |  | Baseline, over 12 weeks | 
| Change in type of insulin product |  | Baseline, 12 weeks | 
| Change from baseline in use of concomitant oral hypoglycemic drugs |  | Baseline, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin, ITR-QOL, DTSQ, Diabetes Mellitus, Type 2