Status:
COMPLETED
Safety and Tolerability After Four Weeks of Treatment With AZD1656 in Patients With Type 2 Diabetes
Lead Sponsor:
AstraZeneca
Conditions:
Type II Diabetes
Eligibility:
All Genders
30-75 years
Phase:
PHASE2
Brief Summary
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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00856908
Start Date
February 1 2009
End Date
August 1 2009
Last Update
December 6 2012
Active Locations (1)
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1
Research Site
Chula Vista, California, United States