Drug to Drug Interaction Study With ASP1941 and Metformin
Phase 1
Completed
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT01302145
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
A study to investigate the effect on safety, pharmacokinetics and pharmacodynamics when ASP1941 is administered as add-on therapy to metformin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
- Subjects with type 2 diabetes
- Stable disease under metformin monotherapy (between 1500-3000
mg/day) or dual therapy with metformin (1500-3000 mg/day) and a Sulfonylureum Derivative (SUD) for at least 3 months
- Fasting Serum Glucose: 7-11.5 mmol/l (after wash-out)
- Stable Fasting Blood Glucose (FBG) at the end of wash-out
- BMI between 18.5 and 40.0 kg/m2, inclusive
Exclusion Criteria
- Subjects with type 1 diabetes
- Any diabetes related macro-complications, painful diabetic neuropathy, diabetic macular edema or diabetic proliferative retinopathy
- Clinical significant renal disease (CLcr <60 ml/min as assessed during a 24h creatinine clearance on Day-2
- Recent evidence (e.g. within the last 6 months) of severe hypoglycemia, for example plasma glucose <3 mmol/l (<55 mg/dl) or requiring hospitalization
- Pulse <40 or >90; Systolic Blood Pressure >160 mmHg; Diastolic Blood Pressure > 100 mmHg
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ASP1941 + metformin ASP1941 Oral Placebo + metformin Placebo Oral ASP1941 + metformin Metformin Oral Placebo + metformin Metformin Oral
- Primary Outcome Measures
Name Time Method Safety assessed by incidence of adverse events, vital signs, 12-lead ECG and glucose monitoring 5 weeks
- Secondary Outcome Measures
Name Time Method Pharmacodynamics assessed by serum glucose change 5 weeks Pharmacokinetics assessed by metformin plasma concentration change 5 weeks