Clinical trial NCT02291874: 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)
Official title: Postmarketing Clinical Study of Ipragliflozin - Long-term Study in Combination With GLP-1 Receptor Agonists in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes
Ipragliflozin
GLP-1 receptor agonist
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2014-11-17
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: HbA1c
timeFrame: at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week
measure: Fasting plasma glucose
timeFrame: at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week
Secondary outcomes:
measure: Fasting serum insulin
timeFrame: at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week
measure: Serum glucagon
timeFrame: at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week
measure: Serum glycoalbumin
timeFrame: at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week
measure: Serum leptin
timeFrame: at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week
measure: Serum adiponectin
timeFrame: at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week
measure: Body weight
timeFrame: 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week
measure: Waist circumference
timeFrame: at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week
measure: Self-measured blood glucose
timeFrame: at 0, 20, 52-week
measure: Adverse events (AEs), vital signs, and laboratory tests
timeFrame: All treatment period
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Chugoku
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kanto
country: Japan
city: Kyushu
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Ishihara H, Yamaguchi S, Nakao I, Sakatani T. Ipragliflozin Add-on Therapy to a GLP-1 Receptor Agonist in Japanese Patients with Type 2 Diabetes (AGATE): A 52-Week Open-Label Study. Diabetes Ther. 2018 Aug;9(4):1549-1567. doi: 10.1007/s13300-018-0455-8. Epub 2018 Jun 20.