Empagliflozin-based Quadruple Combination vs Insulin Glarine-based Combination Therapy in Patients With Type 2 Diabetes
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT03473262
- Lead Sponsor
- Chungbuk National University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Percentage of Patients Who Achieved Glycemic Target of HbA1c ≤7.0% at Week 24 Baseline, Week 24 Changes in HbA1c From Baseline to Week 12 Baseline, Week 12 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 Changes in LDL Cholesterol Between Baseline and 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