Overview

To Evaluate 24-hr Glucose After OD vs BD AZD1656

Status:
Completed
Trial end date:
2009-05-01
Target enrollment:
0
Participant gender:
All
Summary
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
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Criteria
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