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

Asan Medical Center

Status and phase

Completed

Phase 4

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Oral administration of Ipragliflozin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02791035

AMC 2016-0100

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

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