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

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

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-01-31

Brief Summary

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

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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

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

AZD1656

Group Type EXPERIMENTAL

AZD1656

Intervention Type DRUG

Dose titration of oral suspension to a tolerable dose given twice daily for 10 days.

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Dose titration of oral suspension to a tolerable dose given twice daily for 10 days.

Interventions

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AZD1656

Dose titration of oral suspension to a tolerable dose given twice daily for 10 days.

Intervention Type DRUG

Placebo

Dose titration of oral suspension to a tolerable dose given twice daily for 10 days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female (with non child-bearing potential)
* Diagnosed diabetes Mellitus patients treated with metformin alone or one other anti-diabetic drugs. Stable blood sugar control indicated by no changed treatment within 3 months prior to study start.t
* HbA1c \<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