Clinical trial NCT02791035: Correlation Between Change of HbA1c, Urinary Glucose Excretion and Other Factors in Patients Treated With Ipragliflozin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Severance Hospital
name: Samsung Medical Center
name: Kyung Hee University Hospital at Gangdong
name: Astellas Pharma Korea, Inc.
First posted: 2016-06-06
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Correlation between change of HbA1c and urinary glucose excretion
timeFrame: Baseline and week 12
Secondary outcomes:
measure: Correlation between reduction in HbA1c and various parameters (HOMA-IR, HOMA-ß, insulinogenic index)
timeFrame: Baseline and week 12
measure: Correlation between increase in urinary glucose excretion and various parameters (HOMA-IR, HOMA-ß, insulinogenic index)
timeFrame: Baseline and week 12
measure: Change of HbA1c
timeFrame: Baseline and week 12
measure: Chang e of fasting glucose
timeFrame: Baseline and week 12
measure: Change of waist circumference
timeFrame: Baseline and week 12
measure: Percentage of subjects achieving the target HbA1c(<6.5%)
timeFrame: week 12
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References: