Investigation for Clinical Efficacy and Safety of Ipragliflozin 50mg and 100mg on Type II Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

231 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2018-02-28

Brief Summary

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The purpose of this study is to evaluate clinical efficacy and safety of Sodium Glucose Co-transporter 2 (SGLT2) inhibitor, ipragliflozin, at doses of 50mg and 100mg, for Type II Diabetes under usual care. It is also to investigate and analyze the exploratory influential factor of ipragliflozin treatment on clinical efficacy and safety.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ipragliflozin (SGLT2 inhibitor)

Intervention Type DRUG

Interventions

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Ipragliflozin (SGLT2 inhibitor)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Diabetes Mellitus, Type 2 patients poorly-controlled by diet and exercise therapies or additional treatment with various diabetic drugs
2. Patients with changes within +- 0.5% of HbA1c
3. Patients with the variation of 6.5% =\< HbA1C =\<10%
4. Patients with written informed consents
5. Patients whose BMI is =\>20kg/m2

Exclusion Criteria

1. Patients with Diabetes Mellitus, Type 1, other types of diabetes or pregnancy diabetes
2. Patients with history of severe ketoacidosis, diabetic coma or profound coma for the last 6 months
3. Patients with severe infection, in the perioperative period or severe trauma
4. Patients with moderate renal insufficiency (serum creatinine level: male with greater than or equal to 1.5mg/dL、female with greater than or equal to1.3mg/dL)
5. Patients with severe hepatic impairment (judged by the attending doctor)
6. Patients with history of requirement of hospitalization for severe cardiovascular event for the last 6 months of consent
7. Patients in pregnancy, breast-feeding, with childbearing potential or plan of pregnancy
8. Patients with neuropathic bladder or dysuria
9. Patients under treatment with diuretic
10. Patients under SGLT2 treatment at the kickoff point of the study
11. Patients with a history of hypersensitivity to SGLT2 inhibitors
12. Patients who are judged ineligible by the principal investigator

Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No