Investigate the Effect of AZD1656 on the Pharmacokinetics of Sitagliptin in Patients With Type 2 Diabetes Mellitus

NCT ID: NCT01095991

Last Updated: 2010-07-01

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-05-31

Brief Summary

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The purpose of this study is to evaluate the effects of AZD1656 on Sitagliptin pharmacokinetics 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 + Sitagliptin day 6-10, Sitagliptin day 11-15.

Group Type EXPERIMENTAL

AZD1656

Intervention Type DRUG

Oral tablet bd,

Sitagliptin

Intervention Type DRUG

Oral tablet od

2

Sitagliptin day 1-5, AZD1656 + Sitagliptin day 6-10, AZD1656 day 11-15.

Group Type EXPERIMENTAL

AZD1656

Intervention Type DRUG

Oral tablet bd,

Sitagliptin

Intervention Type DRUG

Oral tablet od

Interventions

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AZD1656

Oral tablet bd,

Intervention Type DRUG

Sitagliptin

Oral tablet od

Intervention Type DRUG

Other Intervention Names

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Januvia

Eligibility Criteria

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Inclusion Criteria

* Patients with confirmed type 2 diabetes mellitus for at least 2 months and treated with metformin.
* Body mass index between ≥19 and ≤42 kg/m2.

Exclusion Criteria

* Intake of another investigational drug within the last 30 days prior to enrolment.
* Clinically significant illness or clinically relevant trauma.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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 Molndal Sweden

Christoph Kapitza

Role: PRINCIPAL_INVESTIGATOR

Profil Institut für Stoffwechselforschung GmbH

Mirjana Kujacic

Role: STUDY_DIRECTOR

AstraZeneca Molndal Sweden

Locations

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Research Site

Neuss, , Germany

Site Status

Countries

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Germany

Other Identifiers

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D1020C00032

Identifier Type: -

Identifier Source: org_study_id

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