To Evaluate the Hormonal Response to Low Blood Sugar After a Single Oral Dose of AZD1656 Suspension

NCT ID: NCT00790153

Last Updated: 2009-04-10

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

2008-11-30

Study Completion Date

2009-02-28

Brief Summary

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To evaluate the hormonal response to low blood sugar after a single oral dose of AZD1656 suspension.

Detailed Description

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Conditions

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Type 2 Diabetes

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

Group Type ACTIVE_COMPARATOR

AZD1656

Intervention Type DRUG

Single dose oral suspension given at one occasion.

2

Insulin

Group Type ACTIVE_COMPARATOR

Insulin

Intervention Type DRUG

Insulin infusion given during 3 hours at one occasion.

Interventions

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Insulin

Insulin infusion given during 3 hours at one occasion.

Intervention Type DRUG

AZD1656

Single dose oral suspension given at one occasion.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male volunteers.
* Clinically normal physical findings (incl. Electrocardiogram (ECG)) and laboratory values as judged by the investigator.
* Have a body mass index (BMI) ≥19 and ≤30

Exclusion Criteria

* Clinically significant illness or clinically relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the investigational product
* Intake of any prescribed medicine and OTC drugs (including herbals, vitamins and minerals), except for occasional paracetamol or nasal spray for nasal congestion, within two weeks before the first administration of the investigational product.
* Daily use of nicotine containing substances.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Pharmaceuticals

Principal Investigators

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Klas Malmberg, MD, PhD, Prof

Role: STUDY_DIRECTOR

AstraZeneca R&D Mölndal

Linda Morrow, MD

Role: PRINCIPAL_INVESTIGATOR

Profil Institute for Clinical Research, Inc.

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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D1020C00012

Identifier Type: -

Identifier Source: org_study_id

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