A retrospective comparative study of the clinical efficacy of SGLT2 inhibitors and biguanides as additional treatment for patients with type 2 diabetes treated with DPP-4 inhibitors

Comparison of clinical efficacy between SGLT2 inhibitors and biguanides as additional treatment for patients with type 2 diabetes treated with DPP-4 inhibitors: a retrospective comparative study - ADDED study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000047481

Enrollment

Registered

2022-04-14

Start date

2022-06-01

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 mellitus

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The selection criteria for the subjects are as follow. 1. Patients who have been diagnosed as type 2 diabetes. 2. Over 20 years old.

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
The difference in glucose metabolism marker, such as fasting plasma glucose and HbA1c between the addition of SGLT2 inhibitors and the addition of biguanides will be evaluated after 1, 3 and 6 months.	—

Secondary

Measure	Time frame
1: Comparing the difference in body weight and/or BMI between the addition of SGLT2 inhibitors and the addition of biguanides will be evaluated after 1, 3 and 6 months. 2: Comparing the difference in several factors as follow between the addition of SGLT2 inhibitors and the addition of biguanides will be evaluated after 1, 3 and 6 months. 1.Ht 2.systolic blood pressure (mmHg) 3.diastolic blood pressure (mmHg) 4.lipid profile 5.renal function: eGFR (ml/min/1.73m2) 6.liver function: AST, ALT, GGT 7.FIB-4 index 8.UA 3: Association the change of HbA1c and several factors as follow between two groups. 1.Ht 2.systolic blood pressure (mmHg) 3.diastolic blood pressure (mmHg) 4.lipid profile 5.renal function: eGFR (ml/min/1.73m2) 6.liver function: AST, ALT, GGT 7.FIB-4 index 8.UA 9.body weight (kg), BMI (kg/mm2) 10.detail of medication and number of take medicine 11.detail of the diabetic macro- or micro-vascular complication and number of complications. 4: Association the change of body weight and several factors as follow between two groups. 1.Ht 2.FPG (mg/dL) 3.HbA1c 4.systolic blood pressure (mmHg) 5.diastolic blood pressure (mmHg) 6.lipid profile 7.renal function: eGFR (ml/min/1.73m2) 8.liver function: AST, ALT, GGT 9.FIB-4 index 10.UA 11.detail of medication and number of take medicine 12.detail of the diabetic macro- or micro-vascular complication and number of complications.	—

Measure

Time frame

1: Comparing the difference in body weight and/or BMI between the addition of SGLT2 inhibitors and the addition of biguanides will be evaluated after 1, 3 and 6 months. 2: Comparing the difference in several factors as follow between the addition of SGLT2 inhibitors and the addition of biguanides will be evaluated after 1, 3 and 6 months. 1.Ht 2.systolic blood pressure (mmHg) 3.diastolic blood pressure (mmHg) 4.lipid profile 5.renal function: eGFR (ml/min/1.73m2) 6.liver function: AST, ALT, GGT 7.FIB-4 index 8.UA 3: Association the change of HbA1c and several factors as follow between two groups. 1.Ht 2.systolic blood pressure (mmHg) 3.diastolic blood pressure (mmHg) 4.lipid profile 5.renal function: eGFR (ml/min/1.73m2) 6.liver function: AST, ALT, GGT 7.FIB-4 index 8.UA 9.body weight (kg), BMI (kg/mm2) 10.detail of medication and number of take medicine 11.detail of the diabetic macro- or micro-vascular complication and number of complications. 4: Association the change of body weight and several factors as follow between two groups. 1.Ht 2.FPG (mg/dL) 3.HbA1c 4.systolic blood pressure (mmHg) 5.diastolic blood pressure (mmHg) 6.lipid profile 7.renal function: eGFR (ml/min/1.73m2) 8.liver function: AST, ALT, GGT 9.FIB-4 index 10.UA 11.detail of medication and number of take medicine 12.detail of the diabetic macro- or micro-vascular complication and number of complications.

—

Countries

Japan

Contacts

Public ContactTakeshi Matsumura

Nishinihon Hospital Metabolic Medicine

takeshim@gpo.kumamoto-u.ac.jp096-380-1111

Outcome results