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

Type 2 Diabetes Mellitus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02791035
• Other study ID #: AMC 2016-0100
• Status: Completed
• Phase: Phase 4
• First received: May 27, 2016
• Last updated: July 3, 2017
• Start date: June 2016
• Est. completion date: March 2017

Study information

• Verified date: July 2017
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Oral administration of Ipragliflozin

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (5)

Lead Sponsor	Collaborator
Asan Medical Center	Astellas Pharma Korea, Inc., Kyung Hee University Hospital at Gangdong, Samsung Medical Center, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between change of HbA1c and urinary glucose excretion		Baseline and week 12
Secondary	Correlation between reduction in HbA1c and various parameters (HOMA-IR, HOMA-ß, insulinogenic index)		Baseline and week 12
Secondary	Correlation between increase in urinary glucose excretion and various parameters (HOMA-IR, HOMA-ß, insulinogenic index)		Baseline and week 12
Secondary	Change of HbA1c		Baseline and week 12
Secondary	Chang e of fasting glucose		Baseline and week 12
Secondary	Change of waist circumference		Baseline and week 12
Secondary	Percentage of subjects achieving the target HbA1c(<6.5%)		week 12