Clinical trial NCT01316094: A Study to Assess Efficacy and Safety of ASP1941 in Diabetic Patients With Renal Impairment
Official title: Long-term Study of ASP1941 - Long-term Study in Patients With Type 2 Diabetes Mellitus With Decreased Renal Function (Japanese)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: Pharmacokinetics
ASP1941
Renal impairment
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2011-03-16
Enrollment: 165
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to assess the effect of renal function on the efficacy and safety of ASP1941 in type 2 diabetic patients with mild to moderate renal impairment.

Detailed description: This study will be conducted in patients with type 2 diabetes mellitus and mild to moderate renal impairment who have inadequate glycemic control on an exercise program and stable diet, or one oral hypoglycemic agent.

The severity of the reduction in renal function in each subject will be classified according to the glomerular filtration rate (GFR) estimated using the Japanese GFR estimation equation. Subjects will start with a screening period, followed by a single-blind placebo run-in period, and will be randomized to the ASP1941 groups or the placebo group at a ratio of 2:1. For randomization, subjects will be stratified according to the severity of the reduction in renal function. In a treatment period, subject will receive study drug or placebo for 24 weeks under double-blind conditions.

At 24 week, subjects who are willing to continue participation in the study will receive study drug for another 28 weeks in an open label condition. ASP1941 can be increased. After completion of the study drug administration, a follow-up period will be provided.

Eligibility criteria: Inclusion Criteria:

* type 2 diabetes mellitus patient
* subject has been on an exercise program and stable diet, or one oral hypoglycemic agent (alpha-glucosidase inhibitor, sulfonylurea agent and pioglitazone)
* estimated GFR value based on the Japanese GFR estimation equation of ≥ 30 mL/min/1.73 m2 and \< 90 mL/min/1.73 m2
* HbA1C value between 6.5 and 8.5%
* body mass index (BMI) 29.0 - 45.0 kg/m2

Exclusion Criteria:

* type 1 diabetes mellitus patients
* proliferative diabetic retinopathy
* subject has received insulin within 12 weeks before the study
* subject has a chronic disease which requires the continuous use of adrenocortical steroids, immunosuppressant, and loop diuretic
* serum creatinine \> upper limit of normal
* proteinuria (albumin/creatinine ratio \> 300mg/g)
* dysuria and/or urinary tract infection, genital infection
* significant renal, hepatic or cardiovascular diseases
* severe gastrointestinal diseases

Primary outcomes:
measure: changes in Hemoglobin A1c (HbA1c)
timeFrame: baseline and 24 weeks
Secondary outcomes:
measure: changes in fasting plasma glucose
timeFrame: baseline and 24 weeks
measure: changes in fasting serum insulin level
timeFrame: baseline and 24 weeks
measure: changes in eGFR (estimated glomerular filtration rate)
timeFrame: baseline and 52 weeks
measure: safety assessed by the incidence of adverse events, vital signs, laboratory tests and 12-lead ECGs
timeFrame: for 52 weeks
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Chugoku
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Kyushu
country: Japan
city: Shikoku
country: Japan
city: Touhoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Central Contact
role: STUDY_CHAIR
References:
citation: Kashiwagi A, Shestakova MV, Ito Y, Noguchi M, Wilpshaar W, Yoshida S, Wilding JPH. Safety of Ipragliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Phase II/III/IV Clinical Trials. Diabetes Ther. 2019 Dec;10(6):2201-2217. doi: 10.1007/s13300-019-00699-8. Epub 2019 Oct 12.