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Safety and Tolerability After Four Weeks of Treatment With AZD1656 in Patients With Type 2 Diabetes

NCT ID: NCT00856908

Last Updated: 2012-12-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-08-31

Brief Summary

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The purpose of this study is to assess the 1 month safety and tolerability after multiple oral doses of AZD1656 in patients with Type 2 Diabetes Mellitus Treated with Insulin

Detailed Description

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Conditions

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Type II Diabetes

Keywords

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Type II Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days

Group Type EXPERIMENTAL

AZD1656

Intervention Type DRUG

Tolerable dose given twice daily

2

Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tolerable dose given twice daily

Interventions

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AZD1656

Tolerable dose given twice daily

Intervention Type DRUG

Placebo

Tolerable dose given twice daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* type II diabetes patients, female with non child-bearing potential
* Subjects with T2DM diagnosis for at least one year, treated with insulin alone or insulin in combination with other anti-diabetic drugs. Subjects must have been treated with insulin the last 3 months prior to enrolment (screening)
* HbA1c \<11% at enrolment (screening) (HbA1c value according to international Diabetes Control and Complications Trial \[DCCT\] standard).
* FPG in the range of 7.0 to 13.0 mmol/L (126 to 234 mg/dL)

Exclusion Criteria

* History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease
* Use of glitazones, warfarin, amiodarone within 3 months prior to enrolment (screening) and use of potent CYP450 inhibitors, eg, ketoconazole and macrolide antibiotics within 14 days before randomisation.
* Any clinically significant abnormality identified on physical examination, laboratory tests or ECG, which in the judgment of the investigator would compromise the patients' safety or successful participation in the clinical study.
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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Responsibility Role SPONSOR

Principal Investigators

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Klas Malmberg, MD, PhD, Prof.

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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D1020C00020

Identifier Type: -

Identifier Source: org_study_id