Overview
Investigate the Effect of AZD1656 on the Pharmacokinetics and Pharmacodynamics of Warfarin in Type 2 Diabetes Mellitus (T2DM) Patients
Status:
Completed
Completed
Trial end date:
2010-08-01
2010-08-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to determine whether AZD1656 will affect the Pharmacokinetics and Pharmacodynamics of Warfarin in T2DM patients.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
AstraZenecaTreatments:
Warfarin
Criteria
Inclusion Criteria:- Clinical diagnosis of T2DM treated with at least 1000 mg metformin as a single
treatment or in combination with one other oral anti-diabetics for at least 2 months
prior to screening. Doses of anti-diabetic treatment stable for at least 1 month
- Fasting plasma glucose (FPG) at screening in the range of 6.0 to 15.0 mmol/L (108 to
270 mg/dL) and FPG in the range of 7.5 to 13.0 mmol/L (135 to 234 mg/dL) on Day 1
- Haemoglobin (Hb) A1c >6.5% at screening
Exclusion Criteria:
- Use of drugs with anticoagulant effects 3 weeks prior to first warfarin dosing
- Use of amiodarone within 3 months prior to screening and the use of potent CYP450
inhibitors
- Previous treatment with warfarin on clinical indication