Diabetes Mellitus, Type 2
Conditions
Keywords
Type 2 diabetes, Sodium glucose cotransporter 2 inhibitor, Empagliflozin, Insulin glargine
Brief summary
This study evaluates the efficacy and safety of the empagliflozin as add-on thearpy compared to insulin glargine-based antidiabetic agents (OADs) combination thearpy in patients with type 2 diabetes inadequately controlled on triple OADs in a real clinical practice.
Interventions
None listed
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
* Are inadequately controlled with triple OADs (metformin, sulfonylurea, dipeptidyl peptidase inhibitor) as evidenced by HbA1c \>7.5% and \<12.0%
Exclusion criteria
* Type 1 diabetes * Gestional 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 the study * Have been treated with any type of insulin for more than 7 consecutive days within 3 months before entering the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in HbA1c From Baseline to Week 24 | Baseline, Week 24 |
| Changes in Fasting Plasma Glucose From Baseline to Week 24 | Baseline, Week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Fasting Plasma Glucose From Baseline to Week 12 | Baseline, Week 24 | — |
| Changes in Weight Between Baseline and Week 24 | Baseline, Week 24 | — |
| Changes in Body Mass Index Between Baseline and Week 24 | Baseline, Week 24 | — |
| Changes in Total Cholesterol Between Baseline and Week 24 | Baseline, Week 24 | — |
| Changes in HDL Cholesterol Between Baseline and Week 24 | Baseline, Week 24 | — |
| Percentage of Patients Who Achieved Glycemic Target of HbA1c ≤7.0% at Week 24 | Baseline, Week 24 | — |
| Changes in Triglycerides Between Baseline and Week 24 | Baseline, Week 24 | — |
| Changes in Systolic Blood Pressure Between Baseline and Week 24 | Baseline, Week 24 | — |
| Changes in Dystolic Blood Pressure Between Baseline and Week 24 | Baseline, Week 24 | — |
| Percentage of Patients With Hypoglycemia Episodes Between Baseline and Week 24 | Baseline, Week 24 | All episodes consistent with hypoglycemia with or without a confirmatory blood glucose reading were collected. |
| Percentage of Patients With At Least 1 Episode of Genitourinary Tract Infections Between Baseline and Week 24 | Baseline, Week 24 | — |
| Changes in LDL Cholesterol Between Baseline and Week 24 | Baseline, Week 24 | — |
| Changes in HbA1c From Baseline to Week 12 | Baseline, Week 12 | — |
Outcome results
None listed