Prospective and randomized study on the efficacy of novel hypoglycemic type 2 diabetes agent ipragliflozin to serum glycemic control and cardiovascular risk factors

Prospective and randomized study on the efficacy of novel hypoglycemic type 2 diabetes agent ipragliflozin to serum glycemic control and cardiovascular risk factors - Prospective and randomized study on the efficacy of novel hypoglycemic type 2 diabetes agent ipragliflozin to serum glycemic control and cardiovascular risk factors

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014422

Enrollment

100

Registered

2014-06-30

Start date

2014-07-01

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

Orally administration of 50 mg ipragliflozin once a day, pre or post breakfast for 12 weeks Ipragliflozin non-administrated group (Continuation of conventional therapy)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Aged from 20 to less than 65 years at providing consent 2) Type 2 diabetes patients with BMI >= 24 kg/m2 3) HbA1c (NGSP) was from 7% to less than 10% for 3 months or more, under conventional thrapy (HbA1c >= 7.5% in case of having sulfonylureas and glinides)

Exclusion criteria

Exclusion criteria: 1) With receiving insulin therapy 2) With a history of ischemic heart disease (angina pectoris, myocardial infarction) and ischemic stroke 3) Serum Creatinine >= 1.2 mg/dL 4) Fasting serum triglycerides levels >= 400 mg/dL 5) HbA1c was changed 2% or more within 3 months 6) With unconscious thirst (impossible self-judgement water intake) 7) With contraindication for ipragliflozin a) History of hypersensitivity to ipragliflozin b) Severe ketosis, diabetic or precoma c) Severe infection, pre or post surgery, and severe trauma 8) Considered as inadequate by the investigator

Design outcomes

Primary

Measure	Time frame
1) Improving effects of sd-LDL, IDL, LDL and HDL using by Lipofo-AS 2) TC, TG, HDL-C, LDL-C, LDL/HDL-C rate and non HDL-C	—

Secondary

Measure	Time frame
1) Lowering effects of body weight and blood pressure 2) Improving effects of hsCRP, HOMA-beta and HOMA-R 3) Lowering effects of HbA1c and GA	—

Countries

Japan

Contacts

Public ContactYukihiro Bando

Fukui-ken Saiseikai Hospital internal

Y-BANDO@fukui.saiseikai.or.jp0776-23-1111

Outcome results

None listed

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