Status:
COMPLETED
A Study to Evaluate Safety, Tolerability and P-Glucose After Multiple Ascending Oral Doses of AZD1656 in Type 2 Diabetes
Lead Sponsor:
AstraZeneca
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
30-75 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess safety and tolerability of AZD1656 after multiple repeated oral doses in patients with type 2 diabetes
Eligibility Criteria
Inclusion
- Male or surgically sterile female of non-childbearing potential (post-menopausal, ie natural or induced menopause with last menstruation \>1 year ago and LH and FSH in the post-menopausal range, and/or have undergone hysterectomy and/or bilateral oophorectomy
- Diagnosed diabetes Mellitus patients treated with diet and exercise alone or with up to two oral anti-diabetic drugs. Stable glycemic control indicated by no changed treatment within 3 months prior to enrollment
- HbA1c ≤10.5 % at screening (HbA1c value according to international DCCT standard)
Exclusion
- Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP
- History ischemic heart disease, stroke, transitorisk ischemic attack or symptomatic peripheral vascular disease
- Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results. Positive test of Hepatitis B surface antigen, antibodies to HIV virus and antibodies to Hepatitis C virus
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2009
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00747175
Start Date
August 1 2008
End Date
April 1 2009
Last Update
December 3 2010
Active Locations (1)
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1
Research Site
Chula Vista, California, United States