Status:
COMPLETED
To Evaluate Safety and Tolerability After Multiple Oral Doses of AZD1656 in Type 2 Diabetes Patients on Top of Insulin
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 on top of insulin.
Eligibility Criteria
Inclusion
- Female with non child-bearing potential
- Diagnosed Diabetes Mellitus patients treated with insulin alone or insulin in combination with other anti-diabetic drugs. Stable blood sugar control indicated by no changed treatment within 3 months prior to study start.
- HbA1c below or equal to 11 % 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 of ischemic heart disease, stroke, transitorisk ischemic attack or symptomatic peripheral vascular disease
- Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00768105
Start Date
September 1 2008
End Date
March 1 2009
Last Update
December 3 2010
Active Locations (1)
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1
Research Site
Chula Vista, California, United States