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Type 2 Diabetes MellitusPhase 4NCT02847091

Study of Ipragliflozin in Patients With Type 2 Diabetes Mellitus Receiving Insulin Therapy

A Phase 4 study testing Ipragliflozin and Insulin in people with Type 2 Diabetes Mellitus, run by Astellas Pharma Inc at 15 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 study is to assess the reduction in insulin dose from baseline at Week 24 while keeping the blood glucose levels controlled (maintaining HbA1c values) when ipragliflozin is administered once daily for 24 weeks in patients with type 2 diabetes mellitus receiving insulin therapy. Read more about this study

Who is it for?
Ages 20 to 74 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Ipragliflozin and Insulin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
103 participants
Where
15 sitesJapan
Study dates
29 Jul 2016to 9 Nov 2017
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 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject has been receiving insulin therapy for the treatment of diabetes mellitus.
  • The subject has type 2 diabetes mellitus and has been receiving insulin monotherapy or insulin therapy in combination with one or two oral hypoglycemic agents.
  • The subject has not modified diet or exercise therapies or dosage regimen of oral hypoglycemic agents, or has not switched to another pharmacotherapy for 12 weeks before Visit 1.
  • The subject has an HbA1c value between 6.5% and <8.0%.
  • The subject has a body mass index (BMI) of >23.0 kg/m2.
  • If the subject is a female, she must satisfy the following criteria. The subject is not of childbearing potential and satisfies any of the following criteria.
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  • The subject is post-menopausal (absence of menses for at least 1 year).
  • The subject is surgically sterile.
  • The subject is of childbearing potential but satisfies all of the following criteria:
  • The subject agrees not to get pregnant to 28 days after the last dose of the study drug.
  • The subject has a negative pregnancy test. The subject agrees to use two of the established contraceptive methods listed below to 28 days after the last dose of the study drug when having heterosexual intercourse.
  • If the subject is a female, she must agree not to breastfeed to 28 days after the last dose of the study drug.
  • If the subject is a female, she must agree not to donate their eggs during the period from the assessment to 28 days after the last dose of the study drug.
  • In case a male subject's spouse or partner is of childbearing potential, the subject must agree to use two of the established contraceptive methods to 28 days after the last dose of the study drug.
  • If the subject is a male, he must agree not to donate their sperm to 28 days after the last dose of the study drug.

Who cannot join

  • The subject has type 1 diabetes mellitus.
  • The subject has any symptom of dysuria, anuria, oliguria or urinary retention.
  • The subject has proliferative retinopathy.
  • The subject has diabetic ketoacidosis.
  • The subject has a history or complication of medically significant renal disease such as renovascular occlusive disease, nephrectomy and/or renal transplant.
  • The subject has a history of recurrent urinary tract infection.
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  • The subject has symptomatic urinary tract infection or symptomatic genital infection.
  • The subject has chronic disease(s) that require the continuous use of corticosteroids, immunosuppressants, etc.
  • The subject has a history of cerebral vascular attack, unstable angina, myocardial infarction, vascular intervention, and serious heart disease within 1 year (52 weeks) before signing of the informed consent.
  • The subject has a complication or surgical history of serious gastrointestinal disorder.
  • The subject has severe hepatic dysfunction.
  • The subject has uncontrolled blood pressure.
  • The subject has unstable psychiatric disorder.
  • The subject has severe infection or serious trauma, or perioperative.
  • The subject has drug addiction or alcohol abuse.
  • The subject has a history of malignant tumors.
  • The subject has a history of an allergy to ipragliflozin and/or similar drugs (drugs possessing SGLT2 inhibitory action).
  • The subject has used SGLT2 inhibitors, GLP-1 receptor agonists, sulfonylureas (SU), glinide agents, or insulin products other than long-acting insulin within 12 weeks before signing of the informed consent.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Japan15 sites

  • Site JP00007

    Gunma

  • Site JP00008

    Hiroshima

  • Site JP00009

    Hyōgo

  • Site JP00010

    Kanagawa

  • Site JP00003

    Mie

  • Site JP00004

    Osaka

  • Site JP00015

    Shiga

  • Site JP00002

    Tochigi

  • Site JP00005

    Tochigi

  • Site JP00013

    Tochigi

  • Site JP00001

    Tokyo

  • Site JP00006

    Tokyo

  • Site JP00011

    Tokyo

  • Site JP00012

    Tokyo

  • Site JP00014

    Tokyo

Other trials in Japan

About this study

Official title: Post-marketing Clinical Study of Ipragliflozin; Multicenter, Open-label Study to Assess the Efficacy of Ipragliflozin Add-on in Reducing Insulin Dose in Patients With Type 2 Diabetes Mellitus Receiving Insulin Therapy

The objective of this study is to assess the reduction in insulin dose from baseline at Week 24 while keeping the blood glucose levels controlled (maintaining HbA1c values) when ipragliflozin is administered once daily for 24 weeks in patients with type 2 diabetes mellitus receiving insulin therapy.

Being tested
Ipragliflozin, Insulin
Keywords
Ipragliflozin, SGLT2 inhibitor, Type 2 diabetes mellitus, 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.

  • IpragliflozinDrug

    Also called ASP1941, Suglat

    Oral administration, 50mg once daily

  • InsulinDrug

    Patients are receiving insulin therapy from at least 12 weeks before Visit 1 (is allowed ±10% dose modification if clinically needed, and is reduced within a 20% to 40% range at Visit 1 and then is controlled up to Visit 8 based on criteria of this study).

Study groups in NCT02847091
Study groupRoleWhat they receive
Ipragliflozin GroupExperimentalIpragliflozin will be administered orally for 24 weeks.
Receives: Drug: Ipragliflozin; Drug: Insulin

What is being measured

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

  1. Change from baseline in insulin dose

    Measured: Baseline and Week 24

  2. Percent change from baseline in insulin dose

    Measured: Baseline and Week 24

Secondary outcomes (21)

  1. Change from baseline in insulin dose

    Measured: Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20 and the last assessment during the treatment period (up to Week 24)

  2. Percent change from baseline in insulin dose

    Measured: Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20 and the last assessment during the treatment period (up to Week 24)

  3. Change from baseline in HbA1c

    Measured: Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)

  4. Change from baseline in fasting plasma glucose

    Measured: Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)

  5. Change from baseline in cholesterol

    Measured: Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)

  6. Change from baseline in glycoalbumin

    Measured: Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)

  7. Change from baseline in leptin

    Measured: Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)

  8. Change from baseline in adiponectin

    Measured: Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)

  9. Change from baseline in glucagon

    Measured: Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)

  10. Change from baseline in C-peptide

    Measured: Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)

  11. Change from baseline in body weight

    Measured: Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)

  12. Change from baseline in waist circumference

    Measured: Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)

  13. Change from baseline in blood pressure

    Measured: Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)

  14. Change from baseline in DTSQ

    DTSQ: Diabetes treatment satisfaction questionnaire

    Measured: Baseline and Week 24 and the last assessment during the treatment period (up to Week 24)

  15. Number of subjects achieving withdrawal of insulin therapy

    Measured: Up to Week 24

  16. Percent of subjects achieving withdrawal of insulin therapy

    Measured: Up to Week 24

  17. Safety assessed by incidence of Adverse events

    Measured: Up to Week 24

  18. Safety assessed by blood pressure in a sitting position

    Measured: Up to Week 24

  19. Safety assessed by pulse rate in a sitting position

    Measured: Up to Week 24

  20. Safety assessed by Hematology

    Measured: Up to Week 24

  21. Safety assessed by biochemistry

    Measured: Up to Week 24

Timeline

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

  1. First posted28 Jul 2016 (estimated)
  2. Study start29 Jul 2016
  3. Primary completion9 Nov 2017
  4. Study completion9 Nov 2017

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02847091
Sponsor's protocol ID
1941-MA-3054
Status last verified
Nov 2024
First submitted
25 Jul 2016
Last updated
12 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

  • Ishihara H, Yamaguchi S, Sugitani T, Kosakai Y. Open-Label Study to Assess the Efficacy of Ipragliflozin for Reducing Insulin Dose in Patients with Type 2 Diabetes Mellitus Receiving Insulin Therapy. Clin Drug Investig. 2019 Dec;39(12):1213-1221. doi: 10.1007/s40261-019-00851-z.

    PubMed 31552641

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ipragliflozin and Insulin in people with Type 2 Diabetes Mellitus, run by Astellas Pharma Inc at 15 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 15 inclusion and 18 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 12 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 15 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 from baseline in insulin dose (time frame: Baseline and Week 24). 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 NCT02847091, 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 12 Nov 2024.

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