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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Oral administration of Ipragliflozin
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 2 Diabetes Mellitus

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ipragliflozin

Arm Description

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

Outcomes

Primary Outcome Measures

Correlation between change of HbA1c and urinary glucose excretion

Secondary Outcome Measures

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

Full Information

First Posted
May 27, 2016
Last Updated
July 3, 2017
Sponsor
Asan Medical Center
Collaborators
Severance Hospital, Samsung Medical Center, Kyung Hee University Hospital at Gangdong, Astellas Pharma Korea, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02791035
Brief Title
Correlation Between Change of HbA1c, Urinary Glucose Excretion and Other Factors in Patients Treated With Ipragliflozin
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
Collaborators
Severance Hospital, Samsung Medical Center, Kyung Hee University Hospital at Gangdong, Astellas Pharma Korea, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ipragliflozin
Arm Type
Experimental
Arm Description
Ipragliflozin 50 mg/tablet, orally, 1 tablet once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Oral administration of Ipragliflozin
Primary Outcome Measure Information:
Title
Correlation between change of HbA1c and urinary glucose excretion
Time Frame
Baseline and week 12
Secondary Outcome Measure Information:
Title
Correlation between reduction in HbA1c and various parameters (HOMA-IR, HOMA-ß, insulinogenic index)
Time Frame
Baseline and week 12
Title
Correlation between increase in urinary glucose excretion and various parameters (HOMA-IR, HOMA-ß, insulinogenic index)
Time Frame
Baseline and week 12
Title
Change of HbA1c
Time Frame
Baseline and week 12
Title
Chang e of fasting glucose
Time Frame
Baseline and week 12
Title
Change of waist circumference
Time Frame
Baseline and week 12
Title
Percentage of subjects achieving the target HbA1c(<6.5%)
Time Frame
week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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