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

NCT ID: NCT01103609

Last Updated: 2010-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-08-31

Brief Summary

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

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Keywords

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Diabetes Type 2 Warfarin drug-drug interaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

twice daily on Day 1 to Day 10, with Warfarin on Day 4

Group Type EXPERIMENTAL

Warfarin

Intervention Type DRUG

Oral tablet od on Day 4

AZD1656

Intervention Type DRUG

Oral tablet bd, stepwise increased

2

twice daily on Day 1 to Day 10, with Warfarin on Day 4

Group Type PLACEBO_COMPARATOR

Warfarin

Intervention Type DRUG

Oral tablet od on Day 4

Placebo

Intervention Type DRUG

Oral tablet bd, stepwise increased

Interventions

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Warfarin

Oral tablet od on Day 4

Intervention Type DRUG

Placebo

Oral tablet bd, stepwise increased

Intervention Type DRUG

AZD1656

Oral tablet bd, stepwise increased

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Stanko Skrtic

Role: STUDY_DIRECTOR

AstraZeneca

James Ritter, Prof

Role: PRINCIPAL_INVESTIGATOR

Quintiles Drug Research Unit

Mirjana Kujacic

Role: STUDY_CHAIR

AstraZeneca

Locations

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Research Site

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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D1020C00027

Identifier Type: -

Identifier Source: org_study_id