The Survey of Ipragliflozin Treatment in Elderly type2 Diabetes Patients

NCT ID: NCT02297620

Last Updated: 2015-10-15

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

8687 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Type 2 Diabetes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Suglat group

Suglat®

Intervention Type DRUG

oral

Interventions

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Suglat®

oral

Intervention Type DRUG

Other Intervention Names

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ipragliflozin

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* off-label use patients
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

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Chugoku, , Japan

Site Status

Chūbu, , Japan

Site Status

Hokkaido, , Japan

Site Status

Kansai, , Japan

Site Status

Kantou, , Japan

Site Status

Kyusyu, , Japan

Site Status

Shikoku, , Japan

Site Status

Tōhoku, , Japan

Site Status

Countries

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Japan

References

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Terauchi Y, Yokote K, Nakamura I, Sugamori H. Safety of ipragliflozin in elderly Japanese patients with type 2 diabetes mellitus (STELLA-ELDER): Interim results of a post-marketing surveillance study. Expert Opin Pharmacother. 2016;17(4):463-71. doi: 10.1517/14656566.2016.1145668. Epub 2016 Feb 5.

Reference Type DERIVED
PMID: 26800061 (View on PubMed)

Other Identifiers

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SGL001

Identifier Type: -

Identifier Source: org_study_id

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