To Evaluate 24-hr Glucose After OD vs BD AZD1656

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Type II Diabetes

Treatments: Drug: AZD1656

Study type: Interventional

Funder types: Industry

Identifiers

NCT00819884

D1020C00017

Details and patient eligibility

About

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

Enrollment: 36 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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36 participants in 2 patient groups

1

Experimental group

Description:

twice daily during 4 days

Treatment:

Drug: AZD1656

2

Experimental group

Description:

once daily during 4 days

Treatment:

Drug: AZD1656