Type2 Diabetes
Conditions
Keywords
Empagliflozin, Dapagliflozin, Sodium-glucose cotransporter 2 inhibitors, Quadruple combination antidiabetic drugs
Brief summary
This open-labeled, prospective, observational, 3-year, clinical study was conducted to compare the effectiveness and safety between empagliflozin (25 mg once daily) and dapagliflozin (10 mg once daily) in patients with inadequately controlled type 2 diabetes despite preexisting triple OAD combination.
Detailed description
All participants included in this study were initially requested to initiate therapy with insulin, but they insisted on another form of OAD. When participants declined insulin injection and requested another OAD, they were not randomly assigned to each groups. It is fairly common among participants with T2D to decline insulin therapy, despite being aware of its importance and the benefits in controlling blood glucose. Their lack of willingness to use insulin is explained by their avoidance of painful injections, the potential for body weight gain and their fear of hypoglycemia. The investigators conducted a regimen consisting of four OADs, including empagliflozin or dapagliflozin, to confirm which regimen would be effective and safe.
Interventions
DRUGEmpagliflozin
Empagliflozin 25 mg once daily add on the background OADs for 3 years
DRUGDapagliflozin
Dapagliflozin 25 mg once daily add on the background OADs for 3 years
Sponsors
Chungbuk National University Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Inadequately controlled under triple OADs (metformin, glimepiride, dipeptidyl peptidase inhibitor) as evidenced by HbA1c 7.5-12%
Exclusion criteria
* Type 1 diabetes * Gestational diabetes * Diabetes due to secondary causes * Receiving anticancer treatment * Receiving glucocorticoids or immune-suppressants * have been treated with sodium-glucose co-transporter 2 inhibitors for more than 7 consecutive days within 3 months before entering this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in HbA1c from baseline to week 156 (3-year) | Baseline, week 156 (3-year) | Changes in HbA1c from baseline to week 156 (3-year) |
| Changes in fasting plasma glucose from baseline to week 156 (3-year) | Baseline, week 156 (3-year) | Changes in fasting plasma glucose from baseline to week 156 (3-year) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in HbA1c from baseline to week 52 (1-year) | Baseline, week 52 (1-year) | Changes in HbA1c from baseline to week 52 (1-year) |
| Changes in HbA1c from baseline to week 24 | Baseline, Week 24 | Changes in HbA1c from baseline to week 24 |
| Changes in fasting plasma glucose from baseline to week 12 | Baseline, Week 12 | Changes in fasting plasma glucose from baseline to week 12 |
| Changes in fasting plasma glucose from baseline to week 24 | Baseline, Week 24 | Changes in fasting plasma glucose from baseline to week 24 |
| Changes in fasting plasma glucose from baseline to week 56 (1-year) | Baseline, Week 56 (1-year) | Changes in fasting plasma glucose from baseline to week 56 (1-year) |
| Changes in weight between baseline and week 156 (3-year) | Baseline, Week 156 (3-year) | Changes in weight between baseline and week 156 (3-year) |
| Changes in weight between baseline and week 104 (2-year) | Baseline, Week 104 (2-year) | Changes in weight between baseline and week 104 (2-year) |
| Changes in weight between baseline and week 52 | Baseline, Week 52 | Changes in weight between baseline and week 52 |
| Changes in weight between baseline and week 24 | Baseline, Week 24 | Changes in weight between baseline and week 24 |
| Changes in weight between baseline and week 12 | Baseline, Week 12 | Changes in weight between baseline and week 12 |
| Changes in systolic blood pressure between baseline and week 156 (3-year) | Baseline, Week 156 (3-year) | Changes in systolic blood pressure between baseline and week 156 (3-year) |
| Changes in systolic blood pressure between baseline and week 104 (2-year) | Baseline, Week 104 (2-year) | Changes in systolic blood pressure between baseline and week 104 (2-year) |
| Percentage of patients with at least 1 episode of genitourinary tract infections between baseline and week 156 (3-year) | Baseline, Week 156 (3-year) | Percentage of patients with at least 1 episode of genitourinary tract infections |
| Changes in systolic blood pressure between baseline and week 24 | Baseline, Week 24 | Changes in systolic blood pressure between baseline and week 24 |
| Changes in systolic blood pressure between baseline and week 12 | Baseline, Week 12 | Changes in systolic blood pressure between baseline and week 12 |
| Changes in diastolic blood pressure between baseline and week 156 (3-year) | Baseline, Week 156 (3-year) | Changes in diastolic blood pressure between baseline and week 156 (3-year) |
| Changes in diastolic blood pressure between baseline and week 104 (2-year) | Baseline, Week 104 (2-year) | Changes in diastolic blood pressure between baseline and week 104 (2-year) |
| Changes in diastolic blood pressure between baseline and week 52 | Baseline, Week 52 | Changes in diastolic blood pressure between baseline and week 52 |
| Changes in diastolic blood pressure between baseline and week 24 | Baseline, Week 24 | Changes in diastolic blood pressure between baseline and week 24 |
| Changes in diastolic blood pressure between baseline and week 12 | Baseline, Week 12 | Changes in diastolic blood pressure between baseline and week 12 |
| Changes in total cholesterol between baseline and week 156 (3-year) | Baseline, Week 156 (3-year) | Changes in total cholesterol between baseline and week 156 (3-year) |
| Changes in triglyceride between baseline and week 156 (3-year) | Baseline, Week 156 (3-year) | Changes in triglyceride between baseline and week 156 (3-year) |
| Changes in LDL-cholesterol between baseline and week 156 (3-year) | Baseline, Week 156 (3-year) | Changes in LDL-cholesterol between baseline and week 156 (3-year) |
| Changes in HDL-cholesterol between baseline and week 156 (3-year) | Baseline, Week 156 (3-year) | Changes in HDL-cholesterol between baseline and week 156 (3-year) |
| Percentage of patients with hypoglycemic episodes between baseline and week 156 (3-year) | Baseline, Week 156 (3-year) | All episodes consistent with hypoglycemic episodes with or without a confirmatory blood glucose reading were collected |
| Changes in systolic blood pressure between baseline and week 52 | Baseline, Week 52 | Changes in systolic blood pressure between baseline and week 52 |
| Changes in HbA1c from baseline to week 104 (2-year) | Baseline, week 104 (2-year) | Changes in HbA1c from baseline to week 104 (2-year) |
Countries
South Korea
Outcome results
None listed