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

NCT ID: NCT02847091

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-29
• Study Completion Date: 2017-11-09

Brief 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.

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 will be administered orally for 24 weeks.

Group Type: EXPERIMENTAL

Ipragliflozin

Intervention Type: DRUG

Oral administration, 50mg once daily

Insulin

Intervention Type: DRUG

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).

Interventions

Ipragliflozin

Oral administration, 50mg once daily

Intervention Type: DRUG

Insulin

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).

Intervention Type: DRUG

Other Intervention Names

ASP1941; Suglat

Eligibility Criteria

Inclusion Criteria

• 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.

• 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.

Exclusion Criteria

• 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.
• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 74 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

Site JP00007

Gunma, , Japan

Site JP00008

Hiroshima, , Japan

Site JP00009

Hyōgo, , Japan

Site JP00010

Kanagawa, , Japan

Site JP00003

Mie, , Japan

Site JP00004

Osaka, , Japan

Site JP00015

Shiga, , Japan

Site JP00002

Tochigi, , Japan

Site JP00005

Tochigi, , Japan

Site JP00013

Tochigi, , Japan

Site JP00001

Tokyo, , Japan

Site JP00006

Tokyo, , Japan

Site JP00011

Tokyo, , Japan

Site JP00012

Tokyo, , Japan

Site JP00014

Tokyo, , Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 31552641 (View on PubMed)

Related Links

https://astellasclinicalstudyresults.com/study.aspx?ID=281

Link to results on the Astellas Clinical Study Results website

Other Identifiers

1941-MA-3054

Identifier Type: -

Identifier Source: org_study_id