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Study To Assess the Pharmacokinetics of AZD1656 During Coadministration With Simvastatin

NCT ID: NCT01096940

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

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-08-31

Brief Summary

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To assess the pharmacokinetics of AZD1656 during coadministration with Simvastatin.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Keywords

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Type 2 Diabetes Mellitus Glucose lowering

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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2

Simvastatin

Group Type EXPERIMENTAL

simvastatin

Intervention Type DRUG

Oral tablet, single dose

3

AZD1656 + simvastatin

Group Type EXPERIMENTAL

AZD1656

Intervention Type DRUG

Oral tablet, BID dose

simvastatin

Intervention Type DRUG

Oral tablet, single dose

1

AZD1656

Group Type EXPERIMENTAL

AZD1656

Intervention Type DRUG

Oral tablet, BID dose

Interventions

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AZD1656

Oral tablet, BID dose

Intervention Type DRUG

simvastatin

Oral tablet, single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with a clinical diagnosis of T2DM for at least 1 year, treated with any metformin or metformin with one other oral anti-diabetic drug (OAD)
* Body mass index between greater than or equal to 19 and less than or equal to 42 kg/m2
* HbA1c greater than 6.5% at enrollment

Exclusion Criteria

* Clinically significant illness or clinically relevant trauma, as judged by the Investigator, within 2 weeks before the first administration of the IP
* Significant cardiovascular event within the last 6 months prior to enrollment (eg, myocardial infarction/acute coronary syndrome, revascularisation procedure, stroke or transient ischaemic attack) or heart failure New York Heart Association (NYHA) class III-IV
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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Jolene K. Berg, MD

Role: PRINCIPAL_INVESTIGATOR

Cetero Research, Inc.

Stanko Skrtic

Role: STUDY_DIRECTOR

AstraZeneca

Mirjana Kujacic

Role: STUDY_CHAIR

AstraZeneca

Locations

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Research Site

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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D1020C00029

Identifier Type: -

Identifier Source: org_study_id