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

Not Applicable

• Conditions: Type 2 diabetes mellitus

• Registration Number: JPRN-UMIN000017838
• Lead Sponsor: Kansai Electric Power Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-09
• Study Completion: 2015-07-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified