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Type 2 Diabetes MellitusPhase 4NCT02175784

A Study to Assess the Efficacy and Safety of Ipragliflozin in Combination With Insulin in Subjects With Type 2 Diabetes Mellitus

A Phase 4 study testing ipragliflozin in people with Type 2 Diabetes Mellitus, 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 purpose of this study is to assess the efficacy (superiority to placebo) of ipragliflozin based on the changes in HbA1C, as well as its safety, in patients with type 2 diabetes mellitus in combination with an insulin preparation once daily for 16 weeks. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
ipragliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
262 participants
Where
8 sitesJapan
Study dates
31 Mar 2014to 7 Dec 2015
Phase
Phase 4
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject has been diagnosed with type 2 diabetes mellitus for at least 12 weeks (84 days) at signing of informed consent.
  • Subject takes constant dosage and administration of insulin preparation for more than 6 weeks (42 days)
  • Subject has an HbA1C value between 7.5 and 10.0% at Visit 2 and the difference of HbA1C value within ± 1.0% between Visit 1 and Visit 2
  • Subject has a body mass index (BMI) 20.0 - 45.0 kg/m2

Who cannot join

  • Subject has type 1 diabetes mellitus
  • Subject has proliferative diabetic retinopathy
  • Subject has a history of clinically significant renal disease such as renovascular occlusive disease, nephrectomy and/or renal transplant
  • Subject has a history of recurrent urinary tract infection (more than three times within before 24 weeks of obtaining informed consent)
  • Subject has a symptomatic urinary tract infection or symptomatic genital infection
  • Subject has chronic disease which requires the continuous use of adrenocortical steroids and immunosuppressant (oral medication, injection, or inhalation)
Show all 16Show fewer
  • Subject has a history of cerebral vascular attack, unstable angina, myocardial infarction, vascular intervention, and heart disease (NYHA Class III-IV) within 1 year (52 weeks) prior to Visit 1
  • Subject has unstable psychiatric disorder
  • Female subject who is currently pregnant or lactating, or who is possibly pregnant
  • Male and pre-menopausal female subject who cannot use an appropriate contraception during the study
  • Subject has severe infection, perioperative, or serious trauma
  • Subject has drug addiction or alcohol abuse
  • Subject has a history of malignant tumors (except for those who have not received treatment for malignant tumors for at least 5 years before informed consent acquisition and was not considered to have recurrence)
  • Subject has a history of an allergy with ipragliflozin and/or similar drugs (study drugs possessing SGLT 2 inhibitory action)
  • Subject has participated in another clinical study, post marketing study, or medical equipment study within 12 weeks (84 days) before providing written informed consent, or who is currently participating in any of those studies
  • Subject is unable, unwilling to adhere to compliances such as hospital visits and dose instruction specified in this study

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

    Kanto

  • Study site

    Kyushu

  • Study site

    Shikoku

  • Study site

    Tōhoku

Other trials in Japan

About this study

Official title: Postmarketing Clinical Study of Ipragliflozin - Double-blind, Parallel-group Study in Combination With Insulin in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to assess the efficacy (superiority to placebo) of ipragliflozin based on the changes in HbA1C, as well as its safety, in patients with type 2 diabetes mellitus in combination with an insulin preparation once daily for 16 weeks. The long-term (52 weeks) safety and the persistence of the efficacy will also be evaluated.

Read the detailed description

This study consists of two parts. First part is a placebo-controlled multicenter, double-blind, parallel group study, in which subjects will receive ipragliflozin or placebo once daily in combination with an insulin preparation for 16 weeks. Second part is a multicenter, open-label period (36 weeks) with no placebo group. The dose of ipragliflozin can be doubled in combination with an insulin preparation during the second part.

Being tested
ipragliflozin, placebo
Keywords
Blood glucose, insulin, ipragliflozin, SGLT2 inhibitor
Medical subject headings
Diabetes Mellitus, Type 2, Insulin Resistance

What participants receive

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

  • ipragliflozinDrug

    Also called ASP1941, Suglat

    oral

  • placeboDrug

    oral

Study groups in NCT02175784
Study groupRoleWhat they receive
ipragliflozin groupExperimentaloral
Receives: Drug: ipragliflozin
placebo groupExperimentaloral
Receives: Drug: placebo

What is being measured

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

  1. Change in HbA1C from baseline

    Measured: Baseline and Week 16

Secondary outcomes (8)

  1. Fasting plasma glucose

    Measured: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

  2. Leptin concentration

    Measured: Baseline, Week 2, 4, 8, 12, 16, 24, 36, 52

  3. Fructosamine concentration

    Measured: Baseline, Week 2, 4, 8, 12, 16, 24, 36, 52

  4. Adiponectin concentration

    Measured: Baseline, Week 2, 4, 8, 12, 16, 24, 36, 52

  5. Body weight

    Measured: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

  6. Waist circumference

    Measured: Baseline, Week 16, 24, 52

  7. Blood glucose values of self monitoring

    written in a diary

    Measured: Baseline, Week 8, 16, 24, 52

  8. Safety assessed by the adverse events, vital signs. and laboratory tests

    Measured: Up to 52 Weeks

Timeline

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

  1. First posted26 Jun 2014 (estimated)
  2. Study start31 Mar 2014
  3. Primary completion31 Mar 2015
  4. Study completion7 Dec 2015

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
262 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02175784
Sponsor's protocol ID
1941-CL-0131
Status last verified
Nov 2024
First submitted
25 Jun 2014
Last updated
8 Nov 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Publications

  • Kashiwagi A, Shestakova MV, Ito Y, Noguchi M, Wilpshaar W, Yoshida S, Wilding JPH. Safety of Ipragliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Phase II/III/IV Clinical Trials. Diabetes Ther. 2019 Dec;10(6):2201-2217. doi: 10.1007/s13300-019-00699-8. Epub 2019 Oct 12.

    PubMed 31606880

  • Ishihara H, Yamaguchi S, Nakao I, Asahina S, Sakatani T. Efficacy and safety of ipragliflozin as add-on therapy to insulin in Japanese patients with type 2 diabetes mellitus (IOLITE): a 36-week, open-label extension of a 16-week, randomized, placebo-controlled, double-blind study. Diabetol Int. 2018 Jul 16;10(1):37-50. doi: 10.1007/s13340-018-0359-x. eCollection 2019 Jan.

    PubMed 30800562

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ipragliflozin in people with Type 2 Diabetes Mellitus, 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 4 inclusion and 16 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 8 Nov 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Change in HbA1C from baseline (time frame: Baseline and Week 16). 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 NCT02175784, which also lists 2 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 8 Nov 2024.

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