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

NCT ID: NCT02175784

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 262 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-12-07

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.

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ipragliflozin group

oral

Group Type: EXPERIMENTAL

ipragliflozin

Intervention Type: DRUG

oral

placebo group

oral

Group Type: EXPERIMENTAL

placebo

Intervention Type: DRUG

oral

Interventions

ipragliflozin

oral

Intervention Type: DRUG

placebo

oral

Intervention Type: DRUG

Other Intervention Names

ASP1941; Suglat

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Subject is unable, unwilling to adhere to compliances such as hospital visits and dose instruction specified in this study

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

Chugoku, , Japan

Chūbu, , Japan

Hokkaido, , Japan

Kansai, , Japan

Kanto, , Japan

Kyushu, , Japan

Shikoku, , Japan

Tōhoku, , Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 31606880 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30800562 (View on PubMed)

Related Links

https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=171

Link to results on Astellas Clinical Study Results website

Other Identifiers

1941-CL-0131

Identifier Type: -

Identifier Source: org_study_id