NCT03473262
Completed
Not Applicable
Efficacy and Safety of Empagliflozin vs. Insulin Glargine add-on Therapy in Patients With Inadequately Controlled Type 2 Diabetes Under Triple Combination Therapy
ConditionsDiabetes Mellitus, Type 2
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Chungbuk National University Hospital
- Enrollment
- 200
- Primary Endpoint
- Changes in HbA1c From Baseline to Week 24
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eu Jeong Ku
ChungbukNUH
Chungbuk National University Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Changes in HbA1c From Baseline to Week 24
Time Frame: Baseline, Week 24
Changes in Fasting Plasma Glucose From Baseline to Week 24
Time Frame: Baseline, Week 24
Secondary Outcomes
- 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)
- Percentage of Patients With At Least 1 Episode of Genitourinary Tract Infections Between Baseline and Week 24(Baseline, Week 24)
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