Investigate the Effect of AZD1656 on the Pharmacokinetics of Pioglitazone and Vice Versa in Type 2 Diabetes Mellitus

NCT ID: NCT01082120

Last Updated: 2010-07-12

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

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-05-31

Brief Summary

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The purpose of this study is to determine whether administration of AZD1656 will affect the pharmacokinetics of Pioglitazone and vice versa in patients with Type 2 Diabetes Mellitus.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

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

AZD1656 day 1-5, AZD1656 + Pioglitazone day 6-10, Pioglitazone day 11-15

Group Type EXPERIMENTAL

AZD1656

Intervention Type DRUG

Tablets orally, twice daily for 10 days

Pioglitazone

Intervention Type DRUG

Tablet oral single dose for 10 days

2

Pioglitazone day 1-5, AZD1656 + Pioglitazone day 6-10, AZD1656 day 11-15

Group Type EXPERIMENTAL

AZD1656

Intervention Type DRUG

Tablets orally, twice daily for 10 days

Pioglitazone

Intervention Type DRUG

Tablet oral single dose for 10 days

Interventions

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AZD1656

Tablets orally, twice daily for 10 days

Intervention Type DRUG

Pioglitazone

Tablet oral single dose for 10 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with confirmed Type 2 Diabetes Mellitus for at least 1 year and treated with metformin alone or metformin and one other oral anti-diabetic drug
* Body mass index between ≥19 and ≤42 kg/m2.

Exclusion Criteria

* Impaired renal function
* Clinically significant illness or clinically relevant trauma.
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

Elaine Watkins, DO

Role: PRINCIPAL_INVESTIGATOR

Profil Institute for Clinical Research, Inc.

Mirjana Kujacic

Role: STUDY_CHAIR

AstraZeneca

Locations

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Research Site

Chula Vista, California, United States

Site Status

Countries

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United States

Other Identifiers

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D1020C00028

Identifier Type: -

Identifier Source: org_study_id

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