An observational study in Diabetes Mellitus, Type 2, sponsored by Chungbuk National University Hospital. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-07-20.
Sponsored by Chungbuk National University Hospital · Observational
This study aimed to evaluate the long-term effectiveness and safety of the empagliflozin as add-on thearpy compared to basal insulin-based antidiabetic agents (OADs) combination therapy in patients with type 2 diabetes inadequately controlled on triple OADs in a real clinical practice.
This study aimed to evaluate the long-term effectiveness and safety of the empagliflozin as add-on thearpy compared to basal insulin-based antidiabetic agents (OADs) combination therapy in patients with type 2 diabetes inadequately controlled on triple OADs in a real clinical practice.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 300 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Chungbuk National University Hospital is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Type 2 diabetes, uncontrolled with triple OADs
Exclusion Criteria:
Inadequatelly controlled type 2 diabetes patients despite triple combination therapy with metformin, glimepiride, and DPP-4 inhibitor
Drug: Empagliflozin 25 MG · Drug: INS
Empagliflozin 25mg/day add-on to triple combination oral antidiabetic agents consisted with metformin, glimepiride, and DPP4 inhibitor
Basal insulin add on the background OADs
Also known as: Basal insulin
Changes in HbA1c From Baseline to months 36
Changes in HbA1c From Baseline to months 36 (3-year)
Time frame: Baseline, month 36 (3-year)
Achievement of target HbA1c
Percentage of Patients Who Achieved Glycemic Target of HbA1c at month 36
Time frame: Baseline, month 36
Changes in HbA1c
Changes in HbA1c From Baseline to each time frame
Time frame: Baseline, month 3, 6, 12, 18, 24, 30
Changes in FPG
Changes in fasting plasma glucose level from baseline to each month
Time frame: Baseline, month 3, 6, 12, 18, 24, 30, 36
Changes in lipid profiles
Changes in total cholesterol, triglyceride, HDL-cholesterol and LDL cholesterol from baseline to month 36
Time frame: Baseline, month 36
Changes in body weight
Changes in body weight from baseline to month 36
Time frame: Baseline, month 36
Changes in blood pressure
Changes in systolic and diastolic blood pressure from baseline to month 36
Time frame: Baseline, month 36
Percentage of patients with hypoglycemic episodes
All episodes consistent with hypoglycemia with or without a confirmatory blood glucose reading were collected.
Time frame: Baseline, month 36
Percentage of patients with at least 1 episode of genitourinary tract infections
Percentage of Patients With At Least 1 Episode of Genitourinary Tract Infections
Time frame: Baseline, month 36
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Chungbuk National University Hospital