Drug to Drug Interaction Study With ASP1941 and Metformin

• Status: Completed
• Trial end date: 2009-12-09
• Target enrollment: 0
• Participant gender: All

Summary

A study to investigate the effect on safety, pharmacokinetics and pharmacodynamics when ASP1941 is administered as add-on therapy to metformin.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Ipragliflozin; Metformin

Criteria

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