Clinical effects of empagliflozin dose increase in patients with type 2 diabetes: a retrospective observational study

Clinical effects of empagliflozin dose increase in patients with type 2 diabetes: a retrospective observational study - CLENDEIN study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000041543

Enrollment

100

Registered

2020-09-01

Start date

2020-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The selection criteria for the subjects is as follow. 1. Patients who have been diagnosed as type 2 diabetes. 2. Patients who were taking empagliflozin 10mg orally and then increased the dose to 25mg. 3. Patients who have not received new therapeutic intervention (new administration or dose increase) with other drugs during the period from 3 months before empagliflozin dose increase to 6 months after dose increase. 4. Patients who have not received inpatient treatment from 3 months before empagliflozin dose increase to 6 months after dose increase.

Exclusion criteria

Exclusion criteria: The exclusion criteria for the subjects are as follow. 1. Subjects with acute and/or chronic inflammation 2. Subjects with fresh cardiovascular and/or cerebrovascular diseases 3. Subjects with liver cirrhosis. 4. Subjects with severe respiratory disease or severe heart failure 5. Subjects with alcoholicsm or medicinal intoxication 6. Subjects with psychosis 7. Subjects who doctors judge as unfitness

Design outcomes

Primary

Measure	Time frame
Comparing the change in HbA1c between before and after dose-increasing of empagliflozin.	—

Secondary

Measure	Time frame
1: Comparing the change in body weight between before and after dose-increasing of empagliflozin. 2: Comparing the change before and after dose-increasing of empagliflozin. 1.GA 2.FPG (mg/dL) 3.systolic blood pressure (mmHg) 4.diastolic blood pressure (mmHg) 5.lipid profile 6.renal function: eGFR (ml/min/1.73m2) 7.liver function: AST, ALT, GGT 8.FIB-4 index 9.body weight (kg), BMI (kg/mm2) 10.hematocrit 3: Association the change of HbA1c. 1.GA 2.FPG (mg/dL) 3.systolic blood pressure (mmHg) 4.diastolic blood pressure (mmHg) 5.lipid profile 6.renal function: eGFR (ml/min/1.73m2) 7.liver function: AST, ALT, GGT 8.FIB-4 index 9.body weight (kg), BMI (kg/mm2) 10.hematocrit 11.detail of medication and number of medication 12. nutrition counselling 4: Association the change of body weight. 1.GA 2.FPG (mg/dL) 3.systolic blood pressure (mmHg) 4.diastolic blood pressure (mmHg) 5.lipid profile 6.renal function: eGFR (ml/min/1.73m2) 7.liver function: AST, ALT, GGT 8.FIB-4 index 9.HbA1c (%) 10.hematocrit 11.detail of medication and number of medication 12. nutrition counselling	—

Measure

Time frame

1: Comparing the change in body weight between before and after dose-increasing of empagliflozin. 2: Comparing the change before and after dose-increasing of empagliflozin. 1.GA 2.FPG (mg/dL) 3.systolic blood pressure (mmHg) 4.diastolic blood pressure (mmHg) 5.lipid profile 6.renal function: eGFR (ml/min/1.73m2) 7.liver function: AST, ALT, GGT 8.FIB-4 index 9.body weight (kg), BMI (kg/mm2) 10.hematocrit 3: Association the change of HbA1c. 1.GA 2.FPG (mg/dL) 3.systolic blood pressure (mmHg) 4.diastolic blood pressure (mmHg) 5.lipid profile 6.renal function: eGFR (ml/min/1.73m2) 7.liver function: AST, ALT, GGT 8.FIB-4 index 9.body weight (kg), BMI (kg/mm2) 10.hematocrit 11.detail of medication and number of medication 12. nutrition counselling 4: Association the change of body weight. 1.GA 2.FPG (mg/dL) 3.systolic blood pressure (mmHg) 4.diastolic blood pressure (mmHg) 5.lipid profile 6.renal function: eGFR (ml/min/1.73m2) 7.liver function: AST, ALT, GGT 8.FIB-4 index 9.HbA1c (%) 10.hematocrit 11.detail of medication and number of medication 12. nutrition counselling

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Countries

Japan

Contacts

Public ContactTanaka Tomoko

Nishinihon Hospital Department of Pharmacy

kusuri@nishinihon.or.jp096-380-1111

Outcome results