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)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Postmarketing Clinical Study of Ipragliflozin - Long-term Study in Combination With GLP-1 Receptor Agonists in Patients With Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Ipragliflozin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ipragliflozin group<br>Ipragliflozin treatment | Drug: Ipragliflozin<br>* oral<br>* Other names: ASP1941;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week | 
| Fasting plasma glucose |  | at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting serum insulin |  | at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week | 
| Serum glucagon |  | at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week | 
| Serum glycoalbumin |  | at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week | 
| Serum leptin |  | at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week | 
| Serum adiponectin |  | at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week | 
| Body weight |  | 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week | 
| Waist circumference |  | at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week | 
| Self-measured blood glucose | Subjects measure blood glucose 7 times a day on any 3 days in a week before each scheduled visit and record the results in the patient diary | at 0, 20, 52-week | 
| Adverse events (AEs), vital signs, and laboratory tests |  | All treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Ipragliflozin, GLP-1 receptor agonist