Type 2 Diabetes Mellitus
Conditions
Keywords
Diabetes, Ipragliflozin, GLP-1 receptor agonist
Brief 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.
Detailed description
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.
Interventions
DRUGIpragliflozin
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Waist circumference | 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 | — |
| Self-measured blood glucose | at 0, 20, 52-week | 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 |
| Adverse events (AEs), vital signs, and laboratory tests | All treatment period | — |
| Serum leptin | 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 | — |
Countries
Japan
Outcome results
None listed