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)

Conditions: Type 2 Diabetes Mellitus

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.

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.

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.

Keywords: diabetes ipragliflozin glp-1 receptor agonist