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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Oral administration of Ipragliflozin

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ipragliflozin; Ipragliflozin 50 mg/tablet, orally, 1 tablet once daily for 12 weeks	Drug: Oral administration of Ipragliflozin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Correlation between change of HbA1c and urinary glucose excretion	Baseline and week 12

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Collaborators: Samsung Medical Center; Astellas Pharma Korea, Inc.; Severance Hospital; Kyung Hee University Hospital at Gangdong

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: May 27, 2016
• First Submitted That Met QC Criteria: June 1, 2016
• First Posted (Estimate): June 6, 2016

Study Record Updates

• Last Update Posted (Actual): July 5, 2017
• Last Update Submitted That Met QC Criteria: July 3, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Ipragliflozin
• Other Study ID Numbers: AMC 2016-0100