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Study of Ipragliflozin in Patients With Type 2 Diabetes Mellitus Receiving Insulin Therapy | Clinical Trials | Clareo Health

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

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

NCT02847091•Astellas Pharma Inc

View on ClinicalTrials.gov

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.

Eligibility

Age

20 - 74 years

Sex

ALL

Healthy Volunteers

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.
+5 more criteria

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.
+8 more criteria

Locations (15)

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

Key Dates

Start Date

July 29, 2016

Primary Completion Date

November 9, 2017

Completion Date

November 9, 2017

Last Updated

November 12, 2024

Enrollment

103

ACTUAL participants

Conditions

Type 2 Diabetes Mellitus

Interventions

Ipragliflozin

DRUG

Insulin

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITINGNA

Achieving Routine Intervention and Screening for Emotional Health

NCT06887049

Type 2 Diabetes Mellitus (T2DM)Diabetes Distress

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Achieving Routine Intervention and Screening for Emotional Health

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