Open, randomized, active-controlled insulin resistance outcome trial of safety and efficacy with empagliflozin in type 2 diabetic patients

Open, randomized, active-controlled insulin resistance outcome trial of safety and efficacy with empagliflozin in type 2 diabetic patients - Insulin resistance outcomes with empagliflozin in type2 diabetic patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021552

Enrollment

100

Registered

2016-03-30

Start date

2016-03-30

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

Active treatment with empagliflozin 10mg/day for 12 months Active treatment without all of SGLT-2 inhibition drugs for 12 months

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Type 2 diabetic patients with insulin resistance

Exclusion criteria

Exclusion criteria: 1)BMI <20 2)eGFR <30 3)Both of reduced insulin secretion and no use of insulin 4)Having had side effects of another SGLT -2I drugs before

Design outcomes

Primary

Measure	Time frame
Fasting blood glucose and IRI are set to be measured at baseline, 3, 6, 9, 12 months. And HOMA-IR will be estimated.	—

Secondary

Measure	Time frame
Body mass index (BMI), blood pressure, brain natriuretic peptide (BNP), albumin -creatinine ratio (ACR), lipid and liver function are set to be measured at baseline, 3, 6, 9, 12 months.	—

Countries

Japan

Contacts

Public ContactSachiko Hattori

Foundation Health Medicine Association Tohto Clinic Diabetes Internal Medicine

s-hattori@kenkoigaku.or.jp03-3239-0301

Outcome results

None listed

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