Observational Study to Evaluate Safety and Efficacy of Insulin Therapy in Type 2 Diabetes Mellitus Subjects Failing on Oral Anti-diabetic Agents

Study Overview
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Brief Summary
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This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of major hypoglycaemic episodes and other adverse events, and to evaluate efficacy while using insulin under normal clinical practice conditions. The switch from OAD treatment to insulin therapy will be determined by physician.

Official Title
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Observational Safety and Efficacy Study in Subjects Using Insulin for the Treatment of Type 2 Diabetes Mellitus Failing on Oral Anti-diabetic Agents

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: soluble human insulin
* Drug: biphasic human insulin
* Drug: insulin NPH
* Drug: insulin aspart
* Drug: biphasic insulin aspart
* Drug: insulin detemir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes for at least 12 months and currently receiving oral anti-diabetic (OAD) treatment, whether single or combination, for at least 3 months before this study Insulin naive Poor glycaemic control on OADs and decided by the physician to start insulin therapy Exclusion Criteria: Type 1 diabetes patients Patients who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit Patients with a hypersensitivity to insulin or to any of the excipients Patient groups not approved in the product label

Ages Eligible for Study
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Minimum Age: 18 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: soluble human insulin<br>* Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation<br>* Other names: Actrapid®;Drug: biphasic human insulin<br>* Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation<br>Drug: insulin NPH<br>* Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation<br>Drug: insulin aspart<br>* Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation<br>Drug: biphasic insulin aspart<br>* Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation<br>Drug: insulin detemir<br>* Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of major hypoglycaemic episodes |  | during 26 weeks of insulin therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and type of hypoglycaemic episodes |  | during 26 weeks of insulin therapy | 
| Frequency and type of adverse events |  | during 26 weeks of insulin therapy | 
| Frequency and type of adverse drug reactions |  | during 26 weeks of insulin therapy | 
| Change in HbA1c from baseline |  | during 26 weeks of insulin therapy | 
| Change in PPG from baseline |  | during 26 weeks of insulin therapy | 
| Change in FPG from baseline |  | during 26 weeks of insulin therapy | 
| Subjects' insulin treatment satisfaction |  | during 26 weeks of insulin therapy | 
| Physicians' satisfaction with insulin therapy |  | during 26 weeks of insulin therapy | 
| Weight change |  | at the end of the study | 
| Percentage of patients reaching the target of HbA1c less than 7.5% |  | at the end of the study | 
| Percentage of patients reaching the target of HbA1c less than 7% |  | at the end of the study | 
| Percentage of patients reaching the target of HbA1c less than 6.5% |  | at the end of the study |