The Survey of Ipragliflozin Treatment in Elderly type2 Diabetes Patients

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Suglat®

• Registration Number: NCT02297620
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

The objective of this survey is to confirm the safety of Suglat Tablets when used in the elderly.

Detailed Description

Elderly patients (65 years or older at the time of first administration) with type 2 diabetes who used Suglat Tablets within 3 months from its launch are included in this study. Followings are measured with the patients.

1. Specify incidence rates of adverse drug reactions associated with a decrease in body fluids and their risk factors.

2. Investigate the occurrence of urinary tract infection.

3. Investigate the occurrence of adverse drug reactions in patients at a high risk (those who have poorly controlled blood sugar levels, concurrent organic abnormalities in the urinary system, advanced diabetic neuropathy, etc).

4. Investigate the occurrence of adverse drug reactions other than the above.

5. Factors that may possibly influence the safety of Suglat Tablets.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-11-14
• Study First Submitted QC: 2014-11-19
• Study First Posted: 2014-11-21
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-14
• Last Update Posted: 2015-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8687

Inclusion Criteria

• type 2 diabetes who used Suglat Tablets within 3 months from its launch

Exclusion Criteria

• off-label use patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Suglat group	Suglat®	-

Primary Outcome Measures

Name	Time	Method
Specify incidence rates of adverse drug reactions associated with a decrease in body fluids and their risk factors	Up to 12 months

Secondary Outcome Measures

Name	Time	Method
Investigate the occurrence of urinary tract infection	1-month, 3-month, 6-month, 9-month and 12-month (or at treatment discontinuation time)
Investigate the occurrence of adverse drug reactions in patients at a high risk (those who have poorly controlled blood sugar levels, concurrent organic abnormalities in the urinary system, advanced diabetic neuropathy, etc).	1-month, 3-month, 6-month, 9-month and 12-month (or at treatment discontinuation time)
Investigate the occurrence of adverse drug reactions other than the above	1-month, 3-month, 6-month, 9-month and 12-month (or at treatment discontinuation time)