Correlation Between Change of HbA1c, Urinary Glucose Excretion and Other Factors in Patients Treated With Ipragliflozin

NCT ID: NCT02791035

Last Updated: 2017-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-03-31

Brief Summary

The purpose of this study is to examine the correlation between change of HbA1c, urinary glucose excretion and other factors when ipragliflozin is added to preexisting therapy in subjects with type 2 diabetes.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Ipragliflozin

Ipragliflozin 50 mg/tablet, orally, 1 tablet once daily for 12 weeks

Group Type: EXPERIMENTAL

Oral administration of Ipragliflozin

Intervention Type: DRUG

Interventions

Oral administration of Ipragliflozin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subject who has written informed consent
• Subjects who are diagnosed as type 2 diabetes mellitus
• Subjects who are 20 to 70 years old
• Subjects on a stable diet and exercise at least 8 weeks prior to the study participation
• Stable doses of the following medications for 8 weeks or more but, HbA1c level of 7.0 to 9.5% (Metformin, Metformin + SU, Metformin + DPP-4 inhibitor, Metformin + TZD, TZD, TZD + SU, TZD + DPP-4 inhibitor, SU, SU + DPP-4 inhibitor, DPP-4 inhibitor)

Exclusion Criteria

• Type 1 DM
• Gestational DM
• Diabetic ketoacidosis
• CKD stage 3B-5 (eGFR 45)
• Severe infection, serious trauma, or perioperative period
• Known or suspected hypersensitivity to ipragliflozin
• Symptomatic urogenital infection
• Chemotherapy or radiation therapy for malignant tumor or diagnosis of malignant tumor within 5 years (except for thyroid cancer)
• Under the therapeutic intervention and/or another clinical study using IP drug
• Hepatic disease ( 3 times of upper normal limit of AST or ALT)
• Serious voiding difficulty due to neurogenic bladder or prostate hyperplasia
• Drugs not allowed for concomitant use

• Alpha glucosidase inhibitor or meglitinide within 60 days prior to screening
• Insulin within 60 days prior to screening
• Systemic steroid use (PO, IV or IM) over 2 weeks within 3 months prior to screening
• Inhalation or pleural intracavitary injection of steroid known as having high systemic absorption rate
• GLP-1 agonist (except for exenatide) within 60 days prior to screening
• Heart failure (NYHA class III-IV) or uncontrolled arrhythmia within 6 months prior to screening
• Cardiovascular diseases (unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass graft, or percutaneous coronary intervention) within 3 months prior to screening
• Subjects who are not eligible to the study according to an investigator's decision
• Inability to read the consent form
• Pregnancy, lactation, or plan to get pregnant during the study period

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Severance Hospital

OTHER

Sponsor Role: collaborator

Samsung Medical Center

OTHER

Sponsor Role: collaborator

Kyung Hee University Hospital at Gangdong

OTHER

Sponsor Role: collaborator

Astellas Pharma Korea, Inc.

INDUSTRY

Sponsor Role: collaborator

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

WOO JE LEE

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

AMC 2016-0100

Identifier Type: -

Identifier Source: org_study_id