Investigate the Effect of AZD1656 on the Pharmacokinetics and Pharmacodynamics of Warfarin in Type 2 Diabetes Mellitus (T2DM) Patients

AstraZeneca16 enrolled

Overview

The purpose of this study is to determine whether AZD1656 will affect the Pharmacokinetics and Pharmacodynamics of Warfarin in T2DM patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

WarfarinDRUG

Oral tablet od on Day 4

PlaceboDRUG

Oral tablet bd, stepwise increased

AZD1656DRUG

Oral tablet bd, stepwise increased

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Research Site

London, United Kingdom

Outcomes

Primary Outcomes

To evaluate the pharmacokinetics of warfarin after a single dose when administered alone and in combination with AZD1656 at steady state by assessment of AUC and Cmax of both enantiomers of warfarin (S- and R-warfarin).

Time frame: Serial PK blood samples will be taken on days 4-10 during the treatment periods

Secondary Outcomes

To evaluate the anticoagulant activity of warfarin upon co-administration with AZD1656 by assessment of prothrombin time (PT) and international normalised ratio (INR).

Time frame: Serial blood samples for warfarin PD measurements will be taken on days 4-10 during the treatment periods

To evaluate the safety of AZD1656 in combination with warfarin by assessment of electrocardiogram, weight, pulse, blood pressure, laboratory variables (including 7-point glucose), physical examination and adverse events

Time frame: Safety assessments will be monitored throughout the study, from screening visit until follow up visit.

To describe the pharmacokinetics of AZD1656 and its metabolite during concomitant warfarin administration by assessment of AUC0-24, Cmax, Ctrough, tmax, t1/2 and CL/F (AZD1656 only).

Time frame: Serial PK blood samples will be taken on days 4-10 during the treatment periods

Data from ClinicalTrials.gov

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