Post-Marketing Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Ipragliflozin in Combination With GLP-1 Receptor Agonists in Japanese Patients With Type 2 Diabetes Mellitus (T2DM)

NCT ID: NCT02291874

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-08
• Study Completion Date: 2016-07-07

Brief Summary

Purpose of this study is to evaluate the Long-term Safety, Tolerability, and Efficacy of Ipragliflozin in Combination with GLP-1 Receptor Agonists in Japanese Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control with GLP-1 Receptor Agonists.

Detailed Description

This is a multicenter, open-label study in patients with T2DM who have inadequate glycemic control with GLP-1 receptor agonists for at least 6 weeks prior to Visit 1 (Week -6).

Patients on monotherapy with Victoza® or on combination therapy with GLP-1 receptor agonists and sulfonylurea (SU) are eligible. Patients on combination therapy with GLP-1 receptor agonists and non-SU hypoglycemic agents can also be included; however, these patients must undergo washout of the non-SU hypoglycemic agents administered with GLP-1 receptor agonists.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ipragliflozin group

Ipragliflozin treatment

Group Type: EXPERIMENTAL

Ipragliflozin

Intervention Type: DRUG

oral

Interventions

Ipragliflozin

oral

Intervention Type: DRUG

Other Intervention Names

Suglat tablet; ASP1941

Eligibility Criteria

Inclusion Criteria

• The subject has a diagnosis of T2DM that was determined at least 12 weeks (84 days) before providing informed consent.
• The subject has been receiving the same GLP-1 receptor agonist at a fixed dose and mode of administration for at least 6 weeks (42 days) prior to Visit 1.
• If on therapy with a concomitant SU, the subject has been receiving the same SU at a fixed dose and mode of administration for at least 6 weeks (42 days) prior to Visit 1.
• The subject has HbA1c levels of ≥7.5% but ≤10.5% at Visit 2, and the difference in HbA1c levels between Visit 1 and Visit 2 is within ±1.0%.
• The subject has a BMI of ≥20.0 kg/m2 but ≤45.0 kg/m2 at Visit 2.
• If on therapy with a concomitant SU, the subject has fasting plasma glucose levels of ≥126 mg/dL at Visit 2.

Exclusion Criteria

• The subject has T1DM.
• The subject has symptoms of dysuria, anuria, oliguria, or urinary retention.
• The subject has proliferative retinopathy.
• The subject has a history of clinically significant renal diseases such as renovascular occlusive disease, nephrectomy, or renal transplant.
• The subject has a history of pancreatitis.
• The subject has a history of recurrent urinary tract infections (≥3 episodes within 24 weeks before providing informed consent).
• The subject has a symptomatic urinary tract infection or symptomatic genital infection.
• The subject has a chronic disease that requires the continuous use of adrenocortical steroids and immunosuppressants (oral, injectable, or inhalational medications).
• The subject has a history of cerebral vascular attack, unstable angina, myocardial infarction, vascular intervention, or serious heart disease (NYHA Class III-IV) within 1 year (52 weeks) prior to Visit 1, or the subject has heart disease or cerebral vascular disease that, as per the judgment of the investigator or sub-investigator, may interfere with the treatment with ipragliflozin or safety evaluation of this study.
• The subject has an unstable psychiatric disorder.
• The subject is a female who is currently pregnant or lactating or could be pregnant.
• The subject is unable or unwilling to practice an appropriate contraception method during the study.
• The subject has severe infection, perioperative or serious trauma.
• The subject has drug addiction or abuses alcohol.
• The subject has a history of malignant tumors (except when he/she has been free from treatment for at least 5 years before providing informed consent and is not considered to have any recurrence).
• The subject has a history of allergy to ipragliflozin or similar drugs that have an SGLT2 inhibitory action.
• The subject has participated in a clinical study of an investigational product or medical device or post-marketing study within 12 weeks (84 days) before providing informed consent or is currently participating in any of these studies.
• The subject is unable or unwilling, or does not agree, to comply with the study requirements, including the hospital visits, dose instructions, and the subject's responsibilities.

• 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

Countries

Japan

References

Ishihara H, Yamaguchi S, Nakao I, Sakatani T. Ipragliflozin Add-on Therapy to a GLP-1 Receptor Agonist in Japanese Patients with Type 2 Diabetes (AGATE): A 52-Week Open-Label Study. Diabetes Ther. 2018 Aug;9(4):1549-1567. doi: 10.1007/s13300-018-0455-8. Epub 2018 Jun 20.

Reference Type: DERIVED

PMID: 29926400 (View on PubMed)

Related Links

https://www.astellasclinicalstudyresults.com/study.aspx?ID=220

Link to results on Astellas Clinical Study Results website

Other Identifiers

1941-CL-0132

Identifier Type: -

Identifier Source: org_study_id