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)

• Status: Completed
• Trial end date: 2016-07-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Ipragliflozin

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.