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To Evaluate Safety and Tolerability After Multiple Oral Doses of AZD1656 in Type 2 Diabetes Patients on Top of Insulin

NCT ID: NCT00768105

Last Updated: 2010-12-03

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-03-31

Brief Summary

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The purpose of this study is to assess safety and tolerability of AZD1656 after multiple repeated oral doses in patients with type 2 diabetes on top of insulin.

Detailed Description

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Conditions

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Type 2 Diabetes

Keywords

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Type 2 diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Group Type EXPERIMENTAL

AZD1656

Intervention Type DRUG

Dose titration of oral suspension to a tolerable dose in 2-3 dose steps. Investigational product given twice daily for eight days.

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Dosing to match AZD1656

Interventions

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AZD1656

Dose titration of oral suspension to a tolerable dose in 2-3 dose steps. Investigational product given twice daily for eight days.

Intervention Type DRUG

Placebo

Dosing to match AZD1656

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female with non child-bearing potential
* Diagnosed Diabetes Mellitus patients treated with insulin alone or insulin in combination with other anti-diabetic drugs. Stable blood sugar control indicated by no changed treatment within 3 months prior to study start.
* HbA1c below or equal to 11 % at screening (HbA1c value according to international DCCT standard)

Exclusion Criteria

* Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP
* History of ischemic heart disease, stroke, transitorisk ischemic attack or symptomatic peripheral vascular disease
* Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results.
Minimum Eligible Age

30 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 Pharmaceuticals

Principal Investigators

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Klas Malmberg, MD, PhD

Role: STUDY_DIRECTOR

AstraZeneca R&D Mölndal

Marcus Hompesch, MD

Role: PRINCIPAL_INVESTIGATOR

Profil Institut 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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D1020C00014

Identifier Type: -

Identifier Source: org_study_id