Comparison of the effects of insulin monotherapy and combination therapy with ipragliflozin and insulin on glucose toxicity in type 2 diabetes mellitus : a randomized controlled trial

Comparison of the effects of insulin monotherapy and combination therapy with ipragliflozin and insulin on glucose toxicity in type 2 diabetes mellitus : a randomized controlled trial - Comparison of the effects of insulin monotherapy and combination therapy with ipragliflozin and insulin on glucose toxicity in type 2 diabetes mellitus : a randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018784

Enrollment

Registered

2015-09-01

Start date

2015-09-01

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

Combination therapy with ipragliflozin and insulin group Oral administration of 50mg ipragliflozin (Suglat) once a day, after breakfast Multiple injection of rapid acting insulin (Novorapid flexpen)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) HbA1c<=8.0% at the entry of the study 2) Patients treated with diet therapy only or drugs except for SGLT2 inhibitor 3) Patients provided written informed consent to participate in the study with their own will

Exclusion criteria

Exclusion criteria: 1) Patients less than 20 years old or 75 years or older, and without consent 2) BMI<20kg/m2 3) Patients with severe diabetic complication (pre-proliferative retinopathy/proliferative retinopathy, eGFR<45ml/min/1.73m2, cardiovascular/cerebrovascular disease) 4) Patiens severe liver dysfunction (AST or ALT 100 IU/L or more, or T-Bil 2.0 mg/dl or more) 5) Patients who have malignant neoplasm 6) Patients taking glucocorticoid medicine 7) Patines with malnutrition or dehydration 8) Patients who correspond to the administration contraindication of ipragliflozin or insulin 9) Woman who are pregnant, nursing or possibly pregnant 10) Patients who considered not eligible for the study by the attending doctor due to other reasons

Design outcomes

Primary

Measure	Time frame
Period to achieve target blood glucose levels	—

Secondary

Measure	Time frame
1. Changes in parameters of glucose metabolism Total daily insulin dose, daily profile of blood glucose, plasma glucose, serum insulin and C-peptide and plasma glucagon levels during mixed-meal tolerance test 2. Changes in body weight and parameters of body fluid volume Body weight, waist circumstance, serum ketone body fraction, Hematocrit, serum ureanitrogen, uric acid and BNP, urinary ketone body 3. Changes in parameters of lipid metabolism Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride 4. Changes in parameters of renal function Serum creatinine, urinary albumin and beta 2 microglobulin 5. Changes in parameters of bone metabolism Serum Ca, P, Mg, PTH, 25(OH)VD, BAP, TRACP-5b, FGF23, urinary Ca, urinary P, urinary Mg 6. Incidence rate and severity of adverse events	—

Measure

Time frame

1. Changes in parameters of glucose metabolism Total daily insulin dose, daily profile of blood glucose, plasma glucose, serum insulin and C-peptide and plasma glucagon levels during mixed-meal tolerance test 2. Changes in body weight and parameters of body fluid volume Body weight, waist circumstance, serum ketone body fraction, Hematocrit, serum ureanitrogen, uric acid and BNP, urinary ketone body 3. Changes in parameters of lipid metabolism Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride 4. Changes in parameters of renal function Serum creatinine, urinary albumin and beta 2 microglobulin 5. Changes in parameters of bone metabolism Serum Ca, P, Mg, PTH, 25(OH)VD, BAP, TRACP-5b, FGF23, urinary Ca, urinary P, urinary Mg 6. Incidence rate and severity of adverse events

—

Countries

Japan

Contacts

Public ContactFumie Sakamoto

Osaka University Graduate School of Medicine Department of Metabolic Medicine

sakamoto131@endmet.med.osaka-u.ac.jp06-6879-3743

Outcome results

None listed

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