Observational, Safety Study of NovoNorm® (Repaglinide) and Insulin Analogue Combination Therapy in Type 2 Diabetes in Korea

Study Overview
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Brief Summary
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This trial is conducted in Asia. The primary objective of this study is to evaluate the clinical safety profile during 26 weeks of NovoNorm® (repaglinide) and insulin analogue combination therapy in type 2 diabetes under normal clinical practice conditions in Korea while the secondary objective is to evaluate the safety and efficacy after 13 and 26 weeks of NovoNorm® and insulin analogue combination therapy in type 2 diabetes under normal clinical practice conditions in Korea.

Official Title
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A 26-week, Multicentre, Open-labelled, Non-randomised, Non-interventional, Observational, Safety Study of NovoNorm® (Repaglinide) and Insulin Analogue Combination Therapy in Type 2 Diabetes in Korea

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: repaglinide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol.) Patients with type 2 diabetes mellitus Patients who are currently treated with NovoNorm® alone or in combination with metformin or TZD Age: at least 18 years old Patients who will be prescribed with insulin analogue in addition to current NovoNorm® (with/without metformin/TZD) treatment at the discretion by the Physician Exclusion Criteria: Known or suspected allergy to study product(s) or related products Previous participation in this study. Participation is defined as screened Patients who have been treated with insulin preparations (including insulin analogues) previously Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice) Patients who are unlikely to comply with protocol requirements, e.g. uncooperative attitude, inability to return for the final visit Any other disease or condition that the Physician feels would interfere with study participation or evaluation of results

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 |
| --- | --- |
| Repaglinide<br> | Drug: repaglinide<br>* The dosage and frequency, as well as later changes to either dose, frequency or add-on medication (if applicable), will be determined by the physician, according to the patient's requirements.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of serious Adverse Drug Reactions (SADRs) including major (serious) hypoglycaemic episodes |  | weeks 0-26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Drug Reactions (ADRs) |  | week 13 and 26 | 
| Incidence of Adverse Events (AEs) |  | week 13 and 26 | 
| Incidence of Serious Adverse Event (SAEs) |  | week 13 and 26 | 
| Change in HbA1c |  | after 13 and 26 weeks of NovoNorm® and insulin analogue combination therapy |