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This is a local, prospective, non-interventional, regulatory postmarketing surveillance study. Adult patients with type 2 diabetes mellitus who are initiating Xigduo XR as indicated by the Ministry of Food and Drug Safety (MFDS) will be included.
To evaluate the safety and tolerability of Xigduo XR in patients with type 2 diabetes mellitus based on conducted laboratory test (Laboratory tests are not mandatory because of the non-interventional nature of this study)
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| Measure | Description | Time Frame |
|---|---|---|
| Descriptive analysis of the percentage (%) of adverse events (AEs), serious adverse events (SAEs), unexpected adverse events∙adverse drug reactions and AEs of special interest (AESI) |
| 12 or 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c (HbA1c) | Change in HbA1c in % during the observation period to evaluate effectivenss | 12 or 24 weeks |
| Fasting plasma glucose (FPG) | Change in FPG in mg/dL during the observation period to evaluate effectivenss |
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Inclusion Criteria:
-Patients will be enrolled by a continuous registration method. Investigators should enroll adult patients who are diagnosed with T2DM and who initiate treatment with Xigduo XR for the first time. Patients (or a legally acceptable representative) who has been informed of all pertinent aspects of the study will sign the Informed Consent Form for use of data. Discontinuation of treatment will be determined by a patient's willingness to continue treatment and the investigator's discretion. The reason for discontinued treatment will be documented.
Exclusion Criteria:
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Adult patients who are diagnosed with type 2 diabetes mellitus (T2DM) eligible for the treatment with Xigduo XR according to prescription information approved by MFDS and as decided by the investigator
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| Name | Affiliation | Role |
|---|---|---|
| JiSeong Yoon, PhD | YoungNam University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Busan | South Korea | ||||
| Research Site |
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| Label | URL |
|---|---|
| D1691R00001 CSR synopsis | View source |
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| 12 or 24 weeks |
| 2-hr post-prandial glucose (PPG-2hr) | Change of PPG-2hr in mg/dL during the observation period to evaluate effectivenss | 12 or 24 weeks |
| Blood pressure | Change in blood pressure in mmHg during the observation period to evaluate effectivenss | 12 or 24 weeks |
| Abdominal circumference | Change in abdominal circumference in cm during the observation period to evaluate effectiveness | 12 or 24 weeks |
| Body weight | Change in body weight in Kg during the observation period to evaluate effectiveness | 12 or 24 weeks |
| Overall investigator's assessment on the outcome of the treatment | Overall investigator's assessment on the outcome of the treatment: "Improved", "Unchanged", "Worsened", "Assessment impossible" | 12 or 24 weeks |
| Number of Participants With Abnormal Laboratory Values | Laboratory measures (chemistry/hematology/ urinalysis) during the observation period to evaluate the safety and tolerability of Xigduo XR based on conducted laboratory test (Laboratory tests are not mandatory because of the non-interventional nature of this study).
| 12 or 24 weeks |
| ChungCheong |
| South Korea |
| Research Site | Daegu | South Korea |
| Research Site | Daejeon | South Korea |
| Research Site | Gyeonggi-do | South Korea |
| Research Site | Seoul | South Korea |
| Research Site | Suncheon | South Korea |
| Research Site | Wŏnju | South Korea |