To Evaluate 24-hr Glucose After OD vs BD AZD1656

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-05-31

Brief Summary

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The purpose of this study is to compare the 24-hour glucose profiles in diabetic patients treated with metformin following once daily and twice daily oral dosing

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Detailed Description

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Conditions

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Type II Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

twice daily during 4 days

Group Type EXPERIMENTAL

AZD1656

Intervention Type DRUG

Oral suspension

2

once daily during 4 days

Group Type EXPERIMENTAL

AZD1656

Intervention Type DRUG

Oral suspension

Interventions

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AZD1656

Oral suspension

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* type II diabetes patients, female with non child-bearing potential
* Type 2 Diabetes Mellitus (T2DM) diagnosis confirmed by C-peptide \>0.3nmol/L and no Glutamic acid decarboxylase (GAD) antibodies at enrolment (screening)
* Treatment with metformin as single therapy for T2DM for at least 30 days prior to enrolment and the metformin dose must have been unchanged during this period

Exclusion Criteria

* History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease
* Any clinically significant abnormality identified on physical examination, laboratory test or ECG, which in the judgement of investigator would compromise the subject's 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