Investigation of the efficacy and safety of ipragliflozin combination therapy in case of insufficient glycemic control by DPP-4 inhibitors

Investigation of the efficacy and safety of ipragliflozin combination therapy in case of insufficient glycemic control by DPP-4 inhibitors - Investigation of the efficacy and safety of ipragliflozin combination therapy in case of insufficient glycemic control by DPP-4 inhibitors

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014790

Enrollment

Registered

2014-08-07

Start date

2014-08-11

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

Orally administration of 50 mg ipragliflozin once a day, pre or post breakfast for 24 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Aged 20 to 80 years at providing consent 2) Poorly glycemic controlled patients nevertheless who undergoes DPP-4 inhibitors at least 12 weeks 3) HbA1c >= 6.5 and < 9.5% 4) BMI >= 22 kg/m2 5) Received informed consent

Exclusion criteria

Exclusion criteria: 1) Type 1 diabetes 2) With severe ketosis, diabetic coma, or precoma 3) With severe infection, pre or post surgery, and serious trauma 4) With severe hepatic dysfunction (Over grade 3 in classification criteria for severity of adverse drug reactions) 5) With moderate or severe renal dysfunction (Serum Creatinine male: >= 1.5mg/dL, female: >= 1.3mg/dL) 6) Has stroke, myocardial infarction, or other serious cardiovascular complications requireing hospitalization within 6 months 7) Is receiving SGLT-2 inhibitors, GLP-1 antagonists, or insulin therapy at consent 8) Is nursing or pregnant or planned to become pregnant 9) With hypersensitivity to ipragliflozin or any other excipient of ipragliflozin 10) Considered as inadequate by the investigator

Design outcomes

Primary

Measure	Time frame
Change in HbA1c from baseline to 24 weeks	—

Secondary

Measure	Time frame
Change in following items from baseline to 12 and 24 weeks 1) HbA1c (Except for 24 week), GA 2) Body weight 3) Fasting plasma glucose 4) Serum insulin (HOMA-beta, HOMA-R) and serum C-peptide 5) Waist circumference (Except for 12 week) 6) Blood pressure and heart rate 7) Uric acid 8) Serum cystatin C (Except for 12 week) 9) Serum lipids (TC, LDL-C, HDL-C, and TG) 10) RLP-C (Remnant like particles cholesterol) (Except for 12 week) 11) ApoB, ApoA-1, ApoB/ApoA-1 ratio (Except for 12 week) 12) Thioredoxin-interacting protein (TXNIP) (Except for 12 week)	—

Measure

Time frame

Change in following items from baseline to 12 and 24 weeks 1) HbA1c (Except for 24 week), GA 2) Body weight 3) Fasting plasma glucose 4) Serum insulin (HOMA-beta, HOMA-R) and serum C-peptide 5) Waist circumference (Except for 12 week) 6) Blood pressure and heart rate 7) Uric acid 8) Serum cystatin C (Except for 12 week) 9) Serum lipids (TC, LDL-C, HDL-C, and TG) 10) RLP-C (Remnant like particles cholesterol) (Except for 12 week) 11) ApoB, ApoA-1, ApoB/ApoA-1 ratio (Except for 12 week) 12) Thioredoxin-interacting protein (TXNIP) (Except for 12 week)

—

Countries

Japan

Contacts

Public ContactKenji Furukawa

Japan Community Health care Organization Kanazawa Hospital internal

kenjif-knz@umin.ac.jp076-252-2200

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026