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Type 2 DiabetesSTELLALONGTERMNCT02479399

Specified Drug Use Results Survey of Ipragliflozin Treatment in 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 Read more about this study

Who is it for?
Any age
Conditions the study is for
Type 2 Diabetes
What is being tested?
ipragliflozin
Type of treatment
Pill or oral medicine
How many people
11,412 participants
Where
8 sitesJapan
Study dates
17 Jul 2014to 16 Oct 2018
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients with type 2 diabetes who first use Suglat Tablets during the period from July 17, 2014 to July 16, 2015

Who may be able to join

  • Patients with type 2 diabetes who first use Suglat Tablets during the period from July 17, 2014 to July 16, 2015

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

    Kyushu

  • Study site

    Shikoku

  • Study site

    Tōhoku

Other trials in Japan

About this study

Official title: Specified Drug Use resulTs survEy of lpragLifLozin treAtment in type2 Diabetes Patients: LONG-TERM (STELLA-LONG TERM)

The objective of this survey is to confirm the safety of Suglat Tablets

Read the detailed description

The objective of this survey is to confirm the safety and efficacy of Suglat Tablets for long-term use over 3 years.

Specify the effects of Suglat Tablets on the cardiovascular system, incidence rates of malignant tumor, and their risk factors.

Investigate the occurrence of adverse drug reactions. Specify factors that may possibly influence the safety and efficacy of Suglat Tablets.

<Items of interest>

  • Hypoglycemia
  • Genital infection
  • Urinary tract infection
  • Polyuria and pollakiuria
  • Adverse events related to a decrease in body fluids (dehydration, etc.)
  • Malignant tumor
  • Cardiovascular diseases
Conditions
Type 2 Diabetes
Being tested
ipragliflozin
Keywords
Suglat, SGLT-2 inhibitor, Ipragliflozin L-Proline, ASP1941 long-term use
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.

  • ipragliflozinDrug

    Also called ASP1941, Suglat

    Tablets

Study groups in NCT02479399
Study groupRoleWhat they receive
Suglat groupTablets
Receives: Drug: ipragliflozin

What is being measured

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

  1. Incidence of cardiovascular adverse events

    Measured: Up to 3 years

  2. Incidence of malignant tumor

    Measured: Up to 3 years

Secondary outcomes (1)

  1. Safety developed by adverse events and laboratory tests

    Measured: Up to 3 years

Timeline

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

  1. First posted24 Jun 2015 (estimated)
  2. Study start17 Jul 2014
  3. Primary completion16 Oct 2018
  4. Study completion16 Oct 2018

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
11,412 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02479399
Sponsor's protocol ID
SGL002
Acronym
STELLALONGTERM
Status last verified
Dec 2018
First submitted
15 Jun 2015
Last updated
22 Oct 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Publications

  • Maegawa H, Tobe K, Nakamura I, Uno S. Real-world evidence for long-term safety and effectiveness of ipragliflozin in treatment-naive versus non-naive Japanese patients with type 2 diabetes mellitus: subgroup analysis of a 3-year post-marketing surveillance study (STELLA-LONG TERM). Diabetol Int. 2021 Mar 24;12(4):430-444. doi: 10.1007/s13340-021-00501-w. eCollection 2021 Oct.

    PubMed 34567926

  • Nakamura I, Maegawa H, Tobe K, Uno S. Safety and Effectiveness of Ipragliflozin in Elderly Versus Non-elderly Japanese Patients with Type 2 Diabetes: Subgroup Analysis of STELLA-LONG TERM. Diabetes Ther. 2021 May;12(5):1359-1378. doi: 10.1007/s13300-021-01042-w. Epub 2021 Mar 17.

    PubMed 33730336

  • Maegawa H, Tobe K, Nakamura I, Uno S. Safety and effectiveness of ipragliflozin in elderly versus non-elderly Japanese type 2 diabetes mellitus patients: 12 month interim results of the STELLA-LONG TERM study. Curr Med Res Opin. 2019 Nov;35(11):1901-1910. doi: 10.1080/03007995.2019.1647503. Epub 2019 Aug 29.

    PubMed 31347926

  • Nakamura I, Maegawa H, Tobe K, Uno S. Safety and Effectiveness of Ipragliflozin for Type 2 Diabetes in Japan: 12-Month Interim Results of the STELLA-LONG TERM Post-Marketing Surveillance Study. Adv Ther. 2019 Apr;36(4):923-949. doi: 10.1007/s12325-019-0895-1. Epub 2019 Feb 14.

    PubMed 30767112

  • Maegawa H, Tobe K, Tabuchi H, Nakamura I. Baseline characteristics and interim (3-month) efficacy and safety data from STELLA-LONG TERM, a long-term post-marketing surveillance study of ipragliflozin in Japanese patients with type 2 diabetes in real-world clinical practice. Expert Opin Pharmacother. 2016 Oct;17(15):1985-94. doi: 10.1080/14656566.2016.1217994. Epub 2016 Aug 12.

    PubMed 27463414

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 22 Oct 2024. 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?

Incidence of cardiovascular adverse events (time frame: Up to 3 years). The study lists 2 primary outcomes in all. 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 NCT02479399, which also lists 5 linked publications.

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 22 Oct 2024.

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