Effects of Dapagliflozin on Body Weight in Japanese Patients with Type 2 Diabetes Mellitus. SUMS-ADDIT-2

Effects of Dapagliflozin on Body Weight in Japanese Patients with Type 2 Diabetes Mellitus. SUMS-ADDIT-2 - Effects of Dapagliflozin on Body Weight in Japanese Patients with Type 2 Diabetes Mellitus. SUMS-ADDIT-2 (Shiga University of Medical Science Anti-Diabetic Drugs Intervention Study-2)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020239

Enrollment

Registered

2015-12-21

Start date

2016-01-05

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 5 mg dapagliflozin once a day after breakfast Antidiabetic agent except for insulin and GLP-1 agonist

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Aged >= 20, <75 at consent 2) Type 2 diabetes patients undergoing oral antidiabetic agent 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) History of receiving a SGLT-2 inhibitor 2) Receiving insulin or GLP-1 agonist 3) With severe ketosis, diabetic coma, or precoma 4) Contraindication to the use of dapagliflozin (history of hypersensitivity to dapagliflozin, or pregnant, etc.) 5) History of hospitalization for infection, trauma, or surgery within 6 months 6) History or under treatment of brain infarction, transient ischemic attack 7) With an episode of angina pectoris or myocardial infarction within 6 months 8) Receiving loop diuretics 9) With orthostatic hypotension 10) Considered 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 - Subcutaneous fat area at the umbilical level, visceral fat area at the umbilical level 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 plasma insulin, Fasting urinary glucose, Glucagon 4) Lipid metabolism Total cholesterol, LDL cholesterol, HDL cholesterol, Triacylglycerol, Blood ketone bodies (total ketone body, ACAC, 3-OHBA), Free fatty acid, Free glycerol, RLP cholesterol 5) Liver function tests ALT, AST, Gamma-GTP, ChE, Ferritin 6) Others Urinary albumin, Serum uric acid, Urinary uric acid, Blood amino acid fraction, FGF-21, Cytokeratin-18, Oxidative stress marker (TBARS), lipid metabolites majored by lipidomics, mRNA expression in PBMC, Erythropoietin, Food preference questionary	—

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 - Subcutaneous fat area at the umbilical level, visceral fat area at the umbilical level 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 plasma insulin, Fasting urinary glucose, Glucagon 4) Lipid metabolism Total cholesterol, LDL cholesterol, HDL cholesterol, Triacylglycerol, Blood ketone bodies (total ketone body, ACAC, 3-OHBA), Free fatty acid, Free glycerol, RLP cholesterol 5) Liver function tests ALT, AST, Gamma-GTP, ChE, Ferritin 6) Others Urinary albumin, Serum uric acid, Urinary uric acid, Blood amino acid fraction, FGF-21, Cytokeratin-18, Oxidative stress marker (TBARS), lipid metabolites majored by lipidomics, mRNA expression in PBMC, Erythropoietin, Food preference questionary

—

Countries

Japan

Contacts

Public ContactMitsuru Kawanishi

Shiga University of Medical Science Clinical Reseach and Development Center

hqchiken@belle.shiga-med.ac.jp077-548-3619

Outcome results

None listed

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