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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 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-06-11

No results posted yet for this study

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

Interventions

DRUG

Luseogliflozin

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.

OTHER

Meal containing different carbohydrate ratio and GI value

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

Sponsors & Collaborators

  • Medical Corporation Heishinkai OCROM Clinic

    collaborator UNKNOWN

  • Kansai Electric Power Hospital

    lead OTHER

Principal Investigators

  • Yutaka Seino, M.D., Ph.D. · Kansai Electric Power Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2015-12-31
Completion
2015-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02500186 on ClinicalTrials.gov