Type 2 Diabetes Mellitus
Conditions
Keywords
ASP1941, Diabetes mellitus, pioglitazone
Brief summary
This study is to evaluate the efficacy and safety after concomitant administration of ASP1941 and pioglitazone in patients with diabetes mellitus.
Detailed description
This study is to evaluate the efficacy (HbA1c change from baseline) and safety of ASP1941 in combination with pioglitazone in subjects with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control with pioglitazone alone. The effects of ASP1941 are compared with those of placebo. Double blind period continues for 24 weeks followed by open period in each patient.
Interventions
DRUGipragliflozin
oral
DRUGPlacebo
oral
DRUGPioglitazone
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetic patients receiving pioglitazone mono-therapy for at least 4 weeks * HbA1c value between 7.0 and 9.5% * Body Mass Index (BMI) 20.0 - 45.0 kg/m2
Exclusion criteria
* Type 1 diabetes mellitus patients * 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 * Heart failure patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c | Baseline and for 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in fasting plasma glucose | Baseline and for 24 weeks |
| Change from baseline in fasting serum insulin | Baseline and for 24 weeks |
| Safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs) | For 52 weeks |
Countries
Japan
Outcome results
None listed