The Survey of Ipragliflozin Treatment in Elderly type2 Diabetes Patients (STELLA-ELDER)

October 14, 2015 updated by: Astellas Pharma Inc

Specified Drug Use resulTs survEy of IpragLifLozin treAtment in ELDERly type2 Diabetes Patients (STELLA-ELDER)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

8687

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chubu, Japan
      • Chugoku, Japan
      • Hokkaido, Japan
      • Kansai, Japan
      • Kantou, Japan
      • Kyusyu, Japan
      • Shikoku, Japan
      • Tohoku, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Elderly patients with type 2 diabetes who used Suglat Tablets within 3 months from its launch

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • off-label use patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Suglat group
Drug: Suglat®
oral
Other Names:
  • ipragliflozin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Specify incidence rates of adverse drug reactions associated with a decrease in body fluids and their risk factors
Time Frame: Up to 12 months
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Investigate the occurrence of urinary tract infection
Time Frame: 1-month, 3-month, 6-month, 9-month and 12-month (or at treatment discontinuation time)
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).
Time Frame: 1-month, 3-month, 6-month, 9-month and 12-month (or at treatment discontinuation time)
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
Time Frame: 1-month, 3-month, 6-month, 9-month and 12-month (or at treatment discontinuation time)
1-month, 3-month, 6-month, 9-month and 12-month (or at treatment discontinuation time)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

November 14, 2014

First Submitted That Met QC Criteria

November 19, 2014

First Posted (Estimate)

November 21, 2014

Study Record Updates

Last Update Posted (Estimate)

October 15, 2015

Last Update Submitted That Met QC Criteria

October 14, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGL001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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