The clinical study to assess the effect of the amount of carbohydrate intake and meals differing in glycemic index (GI) in patients treated with a sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor

The clinical study to assess the effect of the amount of carbohydrate intake and meals differing in glycemic index (GI) in patients treated with a sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor - The clinical study to assess the effect of the amount of carbohydrate intake and meals differing in glycemic index (GI) in patients treated with a sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000017838

Enrollment

Registered

2015-06-09

Start date

2015-05-20

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 mellitus

Interventions

High GI meal containing 55% carbohydrate Low GI meal containing 55% carbohydrate High GI meal containing 40% carbohydrate

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Japanese patients with type 2 diabetes (2) Patients aged 20 to 64, inclusive, when obtaining written informed consent, regardless of sex (3) Patients with HbA1c (NGSP) between 7.0 and 10.0 % at screening examination or patients with HbA1c (NGSP) <= 10.0 % (no lower limit) at screening examination if they receive one kind of hypoglycemic drug (oral hypoglycemic drug or GLP-1 receptor agonist) (4) Patients with BMI >= 20 kg/m2 and < 30 kg/m2 (5) Outpatients (6) Patients who was explained about the clinical study, understood the content of the study, and gave written informed consent before participating in the clinical study

Exclusion criteria

Exclusion criteria: (1)Patients who are diagnosed as diabetes mellitus other than type 2 diabetes, e.g., type 1 diabetes, diabetes with specific mechanism or disease except for type 2 diabetes, pregnancy diabetes (2) Patients with complication of severe kidney dysfunction, e.g., nephrotic syndrome, renal failure, dialytic therapy (3) Patients with eGFR < 45mL/min/1.73m2 at screening examination (4) Patients with complication of severe hepatic disorder, e.g., hepatocirrhosis (5) Patients with complication of severe heart disease, e.g., cardiac infarction, cardiac failure, or of cerebral infarction, or patients with medical history of those within 6 months prior to the initiation of the clinical study (obtaining informed consent) (6) Patients who have serious complication of gastrointestinal disorders or who underwent a surgical operation that is known to affect the absorption of a drug by digestive tract (7) Patients with diabetic microangiopathy, e.g., retinopathy of diabetes, diabetic neuropathy, or others which cannot be fully controlled regardless of continuing treatment (8) Patients who are susceptible to dehydration (Patients with extremely poorly-controlled glycemia) (9) Patients with complication of malignancy (Patients who recovered from malignancy are permitted to participate in the clinical study) (10) Patients with a history of hypersensitivity to Luseogliflozin (11) Patients who is a chronic heavy drinker (12) Female patients who are pregnant, possibly pregnant, or breast-feeding (13) Other patients who are judged as ineligible for enrollment in the clinical study by the principal investigator or subinvestigator

Design outcomes

Primary

Measure	Time frame
Comparison of profile of blood glucose level using CGM	—

Secondary

Measure	Time frame
Clinical laboratory tests Vital signs Adverse events	—

Countries

Japan

Contacts

Public ContactDaisuke Yabe

Kansai Electric Power Hospital Center for Metabolism and Clinical Nutrition

ydaisuke-kyoto@umin.ac.jp06-6458-5821

Outcome results

None listed

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