A Study to Assess the Efficacy and Safety of Ipragliflozin in Combination With Insulin in Subjects With Type 2 Diabetes Mellitus
Postmarketing Clinical Study of Ipragliflozin - Double-blind, Parallel-group Study in Combination With Insulin in Patients With Type 2 Diabetes Mellitus
1 other identifier
interventional
262
1 country
8
Brief 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. The long-term (52 weeks) safety and the persistence of the efficacy will also be evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 type-2-diabetes-mellitus
Started Mar 2014
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 31, 2014
CompletedFirst Submitted
Initial submission to the registry
June 25, 2014
CompletedFirst Posted
Study publicly available on registry
June 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 7, 2015
CompletedNovember 8, 2024
November 1, 2024
1 year
June 25, 2014
November 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1C from baseline
Baseline and Week 16
Secondary Outcomes (8)
Fasting plasma glucose
Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Leptin concentration
Baseline, Week 2, 4, 8, 12, 16, 24, 36, 52
Fructosamine concentration
Baseline, Week 2, 4, 8, 12, 16, 24, 36, 52
Adiponectin concentration
Baseline, Week 2, 4, 8, 12, 16, 24, 36, 52
Body weight
Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
- +3 more secondary outcomes
Study Arms (2)
ipragliflozin group
EXPERIMENTALoral
placebo group
EXPERIMENTALoral
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Unknown Facility
Chugoku, Japan
Unknown Facility
Chūbu, Japan
Unknown Facility
Hokkaido, Japan
Unknown Facility
Kansai, Japan
Unknown Facility
Kanto, Japan
Unknown Facility
Kyushu, Japan
Unknown Facility
Shikoku, Japan
Unknown Facility
Tōhoku, Japan
Related Publications (2)
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.
PMID: 31606880DERIVEDIshihara 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.
PMID: 30800562DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Inc
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2014
First Posted
June 26, 2014
Study Start
March 31, 2014
Primary Completion
March 31, 2015
Study Completion
December 7, 2015
Last Updated
November 8, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
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/.