Clinical trial NCT03748810: Head-to-head Comparison of Empagliflozin and Dapagliflozin
Official title: Head-to-head Comparison of Quadruple Combination Therapy With Empagliflozin and Dapagliflozin in Patients With Poorly Controlled Type 2 Diabetes (T2D) Despite Three Existing Oral Antidiabetic Drugs (OAD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type2 Diabetes
Keywords: Empagliflozin
Dapagliflozin
Sodium-glucose cotransporter 2 inhibitors
Quadruple combination antidiabetic drugs
Lead sponsor: Chungbuk National University Hospital
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The targeted population consists of adult patients with type 2 diabetes mellitus treated in outpatient setting by specialists

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in HbA1c from baseline to week 156 (3-year)
timeFrame: Baseline, week 156 (3-year)
measure: Changes in fasting plasma glucose from baseline to week 156 (3-year)
timeFrame: Baseline, week 156 (3-year)
Secondary outcomes:
measure: Changes in HbA1c from baseline to week 104 (2-year)
timeFrame: Baseline, week 104 (2-year)
measure: Changes in HbA1c from baseline to week 52 (1-year)
timeFrame: Baseline, week 52 (1-year)
measure: Changes in HbA1c from baseline to week 24
timeFrame: Baseline, Week 24
measure: Changes in fasting plasma glucose from baseline to week 12
timeFrame: Baseline, Week 12
measure: Changes in fasting plasma glucose from baseline to week 24
timeFrame: Baseline, Week 24
measure: Changes in fasting plasma glucose from baseline to week 56 (1-year)
timeFrame: Baseline, Week 56 (1-year)
measure: Changes in weight between baseline and week 156 (3-year)
timeFrame: Baseline, Week 156 (3-year)
measure: Changes in weight between baseline and week 104 (2-year)
timeFrame: Baseline, Week 104 (2-year)
measure: Changes in weight between baseline and week 52
timeFrame: Baseline, Week 52
measure: Changes in weight between baseline and week 24
timeFrame: Baseline, Week 24
measure: Changes in weight between baseline and week 12
timeFrame: Baseline, Week 12
measure: Changes in systolic blood pressure between baseline and week 156 (3-year)
timeFrame: Baseline, Week 156 (3-year)
measure: Changes in systolic blood pressure between baseline and week 104 (2-year)
timeFrame: Baseline, Week 104 (2-year)
measure: Changes in systolic blood pressure between baseline and week 52
timeFrame: Baseline, Week 52
measure: Changes in systolic blood pressure between baseline and week 24
timeFrame: Baseline, Week 24
measure: Changes in systolic blood pressure between baseline and week 12
timeFrame: Baseline, Week 12
measure: Changes in diastolic blood pressure between baseline and week 156 (3-year)
timeFrame: Baseline, Week 156 (3-year)
measure: Changes in diastolic blood pressure between baseline and week 104 (2-year)
timeFrame: Baseline, Week 104 (2-year)
measure: Changes in diastolic blood pressure between baseline and week 52
timeFrame: Baseline, Week 52
measure: Changes in diastolic blood pressure between baseline and week 24
timeFrame: Baseline, Week 24
measure: Changes in diastolic blood pressure between baseline and week 12
timeFrame: Baseline, Week 12
measure: Changes in total cholesterol between baseline and week 156 (3-year)
timeFrame: Baseline, Week 156 (3-year)
measure: Changes in triglyceride between baseline and week 156 (3-year)
timeFrame: Baseline, Week 156 (3-year)
measure: Changes in LDL-cholesterol between baseline and week 156 (3-year)
timeFrame: Baseline, Week 156 (3-year)
measure: Changes in HDL-cholesterol between baseline and week 156 (3-year)
timeFrame: Baseline, Week 156 (3-year)
measure: Percentage of patients with hypoglycemic episodes between baseline and week 156 (3-year)
timeFrame: Baseline, Week 156 (3-year)
measure: Percentage of patients with at least 1 episode of genitourinary tract infections between baseline and week 156 (3-year)
timeFrame: Baseline, Week 156 (3-year)
Other outcomes:
Locations:
city: Cheonju
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungcheongbuk-do
Study officials:
affiliation: Chungbuk National University Hospital
name: Jae Hyun Ahn
role: STUDY_CHAIR
References:
citation: Ku EJ, Lee DH, Jeon HJ, Oh TK. Long-term effectiveness and safety of quadruple combination therapy with empagliflozin versus dapagliflozin in patients with type 2 diabetes: 3-year prospective observational study. Diabetes Res Clin Pract. 2021 Dec;182:109123. doi: 10.1016/j.diabres.2021.109123. Epub 2021 Nov 3.
citation: Ku EJ, Lee DH, Jeon HJ, Oh TK. Empagliflozin versus dapagliflozin in patients with type 2 diabetes inadequately controlled with metformin, glimepiride and dipeptidyl peptide 4 inhibitors: A 52-week prospective observational study. Diabetes Res Clin Pract. 2019 May;151:65-73. doi: 10.1016/j.diabres.2019.04.008. Epub 2019 Apr 4.