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: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The objectives of this clinical study is to assess the effect of the amount of carbohydrate intake and meals differing in glycemic index (GI) in patients of type 2 diabetes mellitus treated with an SGLT2 inhibitor (Luseogliflozin), which inhibits glucose reabsorption from renal uriniferous tubule, on glucose variability by using continuous glucose monitoring (CGM), and to establish dietary therapy which reduces the risk of hypoglycemia in patients treated with SGLT2 inhibitors. In addition, blood and urine samples are collected for metabolome analysis that will be performed as an extension study of the clinical study.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kansai Electric Power Hospital
• Collaborator: Medical Corporation Heishinkai OCROM Clinic

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:

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 subinvestigat or subinvestigator.