Effects of Ipragliflozin on Body Weight in Japanese Patients with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Insulin Therapy

Effects of Ipragliflozin on Body Weight in Japanese Patients with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Insulin Therapy - Effects of Ipragliflozin on Body Weight in Japanese Patients with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Insulin Therapy(SUMS-ADDIT-1)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018839

Enrollment

Registered

2015-09-01

Start date

2015-11-30

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

Oral administration of 50 mg ipragliflozin once daily for 24 weeks Insulin therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Poorly controlled, overweight outpatients with type 2 diabetes who undergoes insulin therapy 1) Aged >= 20, <75 at consent 2) Type 2 diabetes patients undergoing insulin therapy 3) HbA1c > 7.0% and < 10.0% 4) BMI > 23 kg/m2 5) eGFR > 45 ml/min/1.73m2 6) Outpatient 7) Provided written informed consent

Exclusion criteria

Exclusion criteria: 1) Has history of receiving a SGLT-2 inhibitor 2) Contraindication to the use of ipragliflozin (history of hypersensitivity to ipragliflozin, or pregnant, etc.) 3) With severe ketosis, diabetic coma, or precoma 4) Has history of hospitalization for infection, trauma, or surgery within 6 months 5) With history or under treatment of brain infarction or transient ischemic attack 6) With an episode of angina pectoris or myocardial infarction within 6 months 7) Receiving loop diuretics 8) With orthostatic hypotension 9) Considered as inadequate by the investigator

Design outcomes

Primary

Measure	Time frame
Changes in body weight from 0 to 24 weeks	—

Secondary

Measure	Time frame
Changes and percent changes of following parameters from 0 to 24 weeks 1) Physical findings - Systolic/diastolic blood pressure - Pulse 2) Body composition - Fat mass, lean body mass, and bone density measured by DEXA - Subcutaneous fat area at the umbilical level, visceral fat area at the umbilical level, iliopsoas muscle area, and volume of the liver measured by MRI - Intrahepatic fat mass and hepatic glycogen content measured by MRS - Visceral fat mass and subcutaneous fat mass measured by Dual Scan - Fat mass and muscle mass (right and left arms, right and left lower limbs, and body trunk) and water volume measured by weight scale and body composition scale 3) Glucose metabolism HbA1c, Fasting plasma glucose, 1,5 AG, Fasting CPR, Fasting urinary glucose, Glucagon 4) Lipid metabolism Total cholesterol, LDL cholesterol, HDL cholesterol, Blood triglyceride, Blood ketone bodies (total ketone body, ACAC, 3-OHBA), Free fatty acid in the blood, Free glycerol in the blood, RLP cholesterol 5) Liver function tests ALT, AST, Gamma-GTP, ChE, Ferritin 6) Others Albumin in urine, Serum uric acid, Urinary uric acid, Blood amino acid fraction, FGF-21, Cytokeratin-18, Oxidative stress marker (TBARS), Blood lipidomics, PBMC mRNA expression, Erythropoietin, Food preference	—

Measure

Time frame

Changes and percent changes of following parameters from 0 to 24 weeks 1) Physical findings - Systolic/diastolic blood pressure - Pulse 2) Body composition - Fat mass, lean body mass, and bone density measured by DEXA - Subcutaneous fat area at the umbilical level, visceral fat area at the umbilical level, iliopsoas muscle area, and volume of the liver measured by MRI - Intrahepatic fat mass and hepatic glycogen content measured by MRS - Visceral fat mass and subcutaneous fat mass measured by Dual Scan - Fat mass and muscle mass (right and left arms, right and left lower limbs, and body trunk) and water volume measured by weight scale and body composition scale 3) Glucose metabolism HbA1c, Fasting plasma glucose, 1,5 AG, Fasting CPR, Fasting urinary glucose, Glucagon 4) Lipid metabolism Total cholesterol, LDL cholesterol, HDL cholesterol, Blood triglyceride, Blood ketone bodies (total ketone body, ACAC, 3-OHBA), Free fatty acid in the blood, Free glycerol in the blood, RLP cholesterol 5) Liver function tests ALT, AST, Gamma-GTP, ChE, Ferritin 6) Others Albumin in urine, Serum uric acid, Urinary uric acid, Blood amino acid fraction, FGF-21, Cytokeratin-18, Oxidative stress marker (TBARS), Blood lipidomics, PBMC mRNA expression, Erythropoietin, Food preference

—

Countries

Japan

Contacts

Public ContactAkio Tsuji

Shiga University of Medical Science Clinical Reseach and Development Center

hqrec@belle.shiga-med.ac.jp077-548-3576

Outcome results

None listed

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