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A Study to Evaluate Safety, Tolerability and P-Glucose After Multiple Ascending Oral Doses of AZD1656 in Type 2 Diabetes

NCT ID: NCT00747175

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

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-04-30

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

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

3 (alt.4) gradually increasing repeated oral doses of AZD1656 given to 3 (alt.4) groups (6 on active and 2 on placebo in each group)

Group Type EXPERIMENTAL

AZD1656

Intervention Type DRUG

Dose titration to 3 (alt 4) increasing dose-steps with oral suspension, 8 days treatment

2

Oral dose of AZD1656 titrated during 3 days to a tolerable dose (15 on active and 5 on placebo)

Group Type EXPERIMENTAL

AZD1656

Intervention Type DRUG

Dose titration of oral suspension to a tolerable dose, 1 month treatment

Interventions

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AZD1656

Dose titration to 3 (alt 4) increasing dose-steps with oral suspension, 8 days treatment

Intervention Type DRUG

AZD1656

Dose titration of oral suspension to a tolerable dose, 1 month treatment

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or surgically sterile female of non-childbearing potential (post-menopausal, ie natural or induced menopause with last menstruation \>1 year ago and LH and FSH in the post-menopausal range, and/or have undergone hysterectomy and/or bilateral oophorectomy
* Diagnosed diabetes Mellitus patients treated with diet and exercise alone or with up to two oral anti-diabetic drugs. Stable glycemic control indicated by no changed treatment within 3 months prior to enrollment
* HbA1c ≤10.5 % 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 ischemic heart disease, stroke, transitorisk ischemic attack or symptomatic peripheral vascular disease
* Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results. Positive test of Hepatitis B surface antigen, antibodies to HIV virus and antibodies to Hepatitis C virus
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, Prof

Role: STUDY_DIRECTOR

AstraZeneca R&D Mölndal, SE-431 83 Mölndal, Sweden

Marcus Hompesch, 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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D1020C00002

Identifier Type: -

Identifier Source: org_study_id