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

NCT02500186 | Completed

• 2 other identifiers: Kanden-hsp-0001UMIN000017838
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Diabetes Melltius, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in blood glucose level using CGM

  Early morning on 8th and 15th day after the initiation of test meal

  From Day 6 to Day 7, and from Day 13 and Day 14

Secondary Outcomes (57)

• Change of Hematologic test (White blood cell) from baseline (Day 1) to Day 15

  On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose)

• Change of Hematologic test (Ratio of neutrophils) from baseline (Day 1) to Day 15

  On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose)

• Change of Hematologic test (Ratio of lymphocyte) from baseline (Day 1) to Day 15

  On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose)

• Change of Hematologic test (Ratio of monocyte) from baseline (Day 1) to Day 15

  On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose)

• Change of Hematologic test (Ratio of eosinophils) from baseline (Day 1) to Day 15

  On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose)

Study Arms (3)

High GI meal containing 55% carbohydrate

EXPERIMENTAL

The energy intake of study patients is 1800 kcal per day. Study patients in high GI meal containing 55% carbohydrate group take 55% carbohydrate white rice diet.

Drug: Luseogliflozin; Other: Meal containing different carbohydrate ratio and GI value

Low GI meal containing 55% carbohydrate

EXPERIMENTAL

The energy intake of study patients is 1800 kcal per day. Study patients in low GI meal containing 55% carbohydrate group take 55% carbohydrate brown rice diet

Drug: Luseogliflozin; Other: Meal containing different carbohydrate ratio and GI value

High GI meal containing 40% carbohydrate

EXPERIMENTAL

The energy intake of study patients is 1800 kcal per day. Study patients in high GI meal containing 40% carbohydrate group take 40% carbohydrate white rice diet.

Drug: Luseogliflozin; Other: Meal containing different carbohydrate ratio and GI value

Interventions

Luseogliflozin DRUG

Study patients orally receive luseogliflozin 2.5 mg s.i.d. before breakfast for 7 days from the 8th day of starting the study meal to the 14th day.

Also known as: Lusefi tab. 2.5mg

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

Meal containing different carbohydrate ratio and GI value OTHER

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

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

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Japanese patients with type 2 diabetes
• Patients aged 20 to 64, inclusive, when obtaining written informed consent, regardless of sex
• 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)
• Patients with BMI \>= 20 kg/m2 and \< 30 kg/m2
• Outpatients
• 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

You may not qualify if:

• 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
• Patients with complication of severe kidney dysfunction, e.g., nephrotic syndrome, renal failure, dialytic therapy
• Patients with eGFR \< 45mL/min/1.73m2 at screening examination
• Patients with complication of severe hepatic disorder, e.g., hepatocirrhosis
• 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)
• 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
• Patients with diabetic microangiopathy, e.g., retinopathy of diabetes, diabetic neuropathy, or others which cannot be fully controlled regardless of continuing treatment
• Patients who are susceptible to dehydration (Patients with extremely poorly-controlled glycemia)
• Patients with complication of malignancy (Patients who recovered from malignancy are permitted to participate in the clinical study)
• Patients with a history of hypersensitivity to Luseogliflozin
• Patients who is a chronic heavy drinker
• Female patients who are pregnant, possibly pregnant, or breast-feeding
• Other patients who are judged as ineligible for enrollment in the clinical study by the principal investigator or subinvestigat or subinvestigator.

Sponsors & Collaborators

• Kansai Electric Power Hospital: lead
• Medical Corporation Heishinkai OCROM Clinic: collaborator

MeSH Terms

Interventions

1,5-anhydro-1-(5-(4-ethoxybenzyl)-2-methoxy-4-methylphenyl)-1-thioglucitol

Study Officials

• Yutaka Seino, M.D., Ph.D.

  Kansai Electric Power Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2015
• First Posted: July 16, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 11, 2018

Record last verified: 2018-06