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Type 2 DiabetesSTELLA-ELDERNCT02297620

The Survey of Ipragliflozin Treatment in Elderly type2 Diabetes Patients

An observational study of Type 2 Diabetes, run by Astellas Pharma Inc at 8 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 65 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
Suglat®
Type of treatment
Pill or oral medicine
How many people
8,687 participants
Where
8 sitesJapan
Study dates
Apr 2014to Jul 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

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

Who may be able to join

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

Who cannot join

  • off-label use patients

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Japan8 sites

  • Study site

    Chūbu

  • Study site

    Chugoku

  • Study site

    Hokkaido

  • Study site

    Kansai

  • Study site

    Kantou

  • Study site

    Kyusyu

  • Study site

    Shikoku

  • Study site

    Tōhoku

Other trials in Japan

About this study

Official title: 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.

Read the 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.
Conditions
Type 2 Diabetes
Being tested
Suglat®
Keywords
SGLT-2 inhibitor, Elderly patients, ASP1941
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Suglat®Drug

    Also called ipragliflozin

    oral

Study groups in NCT02297620
Study groupRoleWhat they receive
Suglat groupNot described
Receives: Drug: Suglat®

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 12 months

Secondary outcomes (3)

  1. Investigate the occurrence of urinary tract infection

    Measured: 1-month, 3-month, 6-month, 9-month and 12-month (or at treatment discontinuation time)

  2. 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).

    Measured: 1-month, 3-month, 6-month, 9-month and 12-month (or at treatment discontinuation time)

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

    Measured: 1-month, 3-month, 6-month, 9-month and 12-month (or at treatment discontinuation time)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionJul 2015
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
8,687 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02297620
Sponsor's protocol ID
SGL001
Acronym
STELLA-ELDER
Status last verified
Oct 2015
First submitted
14 Nov 2014
Last updated
15 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 26800061

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes, run by Astellas Pharma Inc at 8 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Specify incidence rates of adverse drug reactions associated with a decrease in body fluids and their risk factors (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02297620, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2015.

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