Head-to-head Comparison of Empagliflozin and Dapagliflozin

Type2 Diabetes Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03748810
• Other study ID #: SGLT2 inhibitor 2018
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2022
• Source: Chungbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Drug:
• Empagliflozin
Empagliflozin 25 mg once daily add on the background OADs for 3 years
• Dapagliflozin
Dapagliflozin 25 mg once daily add on the background OADs for 3 years

Locations

Country	Name	City	State
Korea, Republic of	Chungbuk National University Hospital	Cheonju	Chungcheongbuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chungbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in HbA1c from baseline to week 156 (3-year)	Changes in HbA1c from baseline to week 156 (3-year)	Baseline, week 156 (3-year)
Primary	Changes in fasting plasma glucose from baseline to week 156 (3-year)	Changes in fasting plasma glucose from baseline to week 156 (3-year)	Baseline, week 156 (3-year)
Secondary	Changes in HbA1c from baseline to week 104 (2-year)	Changes in HbA1c from baseline to week 104 (2-year)	Baseline, week 104 (2-year)
Secondary	Changes in HbA1c from baseline to week 52 (1-year)	Changes in HbA1c from baseline to week 52 (1-year)	Baseline, week 52 (1-year)
Secondary	Changes in HbA1c from baseline to week 24	Changes in HbA1c from baseline to week 24	Baseline, Week 24
Secondary	Changes in fasting plasma glucose from baseline to week 12	Changes in fasting plasma glucose from baseline to week 12	Baseline, Week 12
Secondary	Changes in fasting plasma glucose from baseline to week 24	Changes in fasting plasma glucose from baseline to week 24	Baseline, Week 24
Secondary	Changes in fasting plasma glucose from baseline to week 56 (1-year)	Changes in fasting plasma glucose from baseline to week 56 (1-year)	Baseline, Week 56 (1-year)
Secondary	Changes in weight between baseline and week 156 (3-year)	Changes in weight between baseline and week 156 (3-year)	Baseline, Week 156 (3-year)
Secondary	Changes in weight between baseline and week 104 (2-year)	Changes in weight between baseline and week 104 (2-year)	Baseline, Week 104 (2-year)
Secondary	Changes in weight between baseline and week 52	Changes in weight between baseline and week 52	Baseline, Week 52
Secondary	Changes in weight between baseline and week 24	Changes in weight between baseline and week 24	Baseline, Week 24
Secondary	Changes in weight between baseline and week 12	Changes in weight between baseline and week 12	Baseline, Week 12
Secondary	Changes in systolic blood pressure between baseline and week 156 (3-year)	Changes in systolic blood pressure between baseline and week 156 (3-year)	Baseline, Week 156 (3-year)
Secondary	Changes in systolic blood pressure between baseline and week 104 (2-year)	Changes in systolic blood pressure between baseline and week 104 (2-year)	Baseline, Week 104 (2-year)
Secondary	Changes in systolic blood pressure between baseline and week 52	Changes in systolic blood pressure between baseline and week 52	Baseline, Week 52
Secondary	Changes in systolic blood pressure between baseline and week 24	Changes in systolic blood pressure between baseline and week 24	Baseline, Week 24
Secondary	Changes in systolic blood pressure between baseline and week 12	Changes in systolic blood pressure between baseline and week 12	Baseline, Week 12
Secondary	Changes in diastolic blood pressure between baseline and week 156 (3-year)	Changes in diastolic blood pressure between baseline and week 156 (3-year)	Baseline, Week 156 (3-year)
Secondary	Changes in diastolic blood pressure between baseline and week 104 (2-year)	Changes in diastolic blood pressure between baseline and week 104 (2-year)	Baseline, Week 104 (2-year)
Secondary	Changes in diastolic blood pressure between baseline and week 52	Changes in diastolic blood pressure between baseline and week 52	Baseline, Week 52
Secondary	Changes in diastolic blood pressure between baseline and week 24	Changes in diastolic blood pressure between baseline and week 24	Baseline, Week 24
Secondary	Changes in diastolic blood pressure between baseline and week 12	Changes in diastolic blood pressure between baseline and week 12	Baseline, Week 12
Secondary	Changes in total cholesterol between baseline and week 156 (3-year)	Changes in total cholesterol between baseline and week 156 (3-year)	Baseline, Week 156 (3-year)
Secondary	Changes in triglyceride between baseline and week 156 (3-year)	Changes in triglyceride between baseline and week 156 (3-year)	Baseline, Week 156 (3-year)
Secondary	Changes in LDL-cholesterol between baseline and week 156 (3-year)	Changes in LDL-cholesterol between baseline and week 156 (3-year)	Baseline, Week 156 (3-year)
Secondary	Changes in HDL-cholesterol between baseline and week 156 (3-year)	Changes in HDL-cholesterol between baseline and week 156 (3-year)	Baseline, Week 156 (3-year)
Secondary	Percentage of patients with hypoglycemic episodes between baseline and week 156 (3-year)	All episodes consistent with hypoglycemic episodes with or without a confirmatory blood glucose reading were collected	Baseline, Week 156 (3-year)
Secondary	Percentage of patients with at least 1 episode of genitourinary tract infections between baseline and week 156 (3-year)	Percentage of patients with at least 1 episode of genitourinary tract infections	Baseline, Week 156 (3-year)