To Evaluate Clinical Outcome and Injection Compliance of Scilin

Study Overview
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Brief Summary
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This is a prospective, multi-center, open-label, non-interventional, 12-week study in people with type 2 diabetes mellitus who are treated with recombinant human insulin-SciLin N, SciLin R and SciLin M30 (alone or in combination) in routine clinical practice. The term study insulins will be used in this protocol for these drugs and combinations.

Official Title
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A Prospective Multi-centre, Non-randomized, Open-label, Non-interventional Study to Evaluate the Safety, Efficacy and Injection Compliance of Scilin N, Scilin R or Scilin M30 in Chinese Type 2 Diabetes Mellitus (T2DM)

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Insulin (Scilin N, BAY81-9924)
* Drug: Insulin (Scilin R _BAY81-9924
* Drug: Insulin(Scilin M30_BAY81-9924)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Based on physicians' clinical judgement, subjects who are treated with SciLin N, SciLin R and SciLin M30 ( alone or in combination) will be eligible to be included in this clinical study. Exclusion Criteria: Subjects with one of the conditions listed below will be excluded: Women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 6 months Subjects who have to be treated with other insulins simultaneously Subjects who are participating in other diabetes clinical studies at the same time
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 |
| --- | --- |
| Group 1<br> | Drug: Insulin (Scilin N, BAY81-9924)<br>* Subjects are treated with recombinant human insulin-SciLin N, SciLin R and SciLin M30 (alone or in combination) in routine clinical practice.<br>Drug: Insulin (Scilin R _BAY81-9924<br>* Subjects are treated with recombinant human insulin-SciLin N, SciLin R and SciLin M30 (alone or in combination) in routine clinical practice<br>Drug: Insulin(Scilin M30_BAY81-9924)<br>* Subjects are treated with recombinant human insulin-SciLin N, SciLin R and SciLin M30 (alone or in combination) in routine clinical practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence rate of serious adverse drug reactions including severe hypoglycaemic events |  | up to 12 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence rate of hypoglycemic events |  | up to 12 weeks | 
| Change in HbA1c |  | Baseline and week 12 | 
| Change in FPG (Fasting Plasma Glucose) |  | Baseline and week 12 | 
| Change in PPG (Postprandial Glucose) |  | Baseline and week 12 | 
| The ratio of compliance injection (following physician's advice) |  | up to 12 weeks | 
| Number and ratio of missed injections |  | up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recombinant human insulin, T2DM, Safety, Efficacy