Status:
COMPLETED
Japan Dose Regimen Study of AZD1656 in Japanese Type 2 Diabetes Mellitus Patients
Lead Sponsor:
AstraZeneca
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to compare the effect on glucose control of 3 different AZD1656 dosing regimens with placebo in Japanese type 2 diabetes mellitus (T2DM) patients, as evaluated by the chan...
Eligibility Criteria
Inclusion
- women of non-childbearing potential.
- Provision of informed consent prior to any study specific procedures
- Naïve T2DM patients with HbA1c ≥ 7.5% but ≤ 10% or T2DM Patients treated with one or two oral anti-hyperglycaemic agent(s) with HbA1c ≥ 7.5% but ≤ 9.5% at enrolment visit (Visit1)
Exclusion
- Clinically relevant medical history or concurrent disease such as cardiovascular disease, renal disease, hepatic disease and haematological disease.
- The investigator(s) judged that the Subject should not participate in the study according to screening test or medical history.
- Participation in another clinical trial and/or intake of another investigational drug within the last 30 days prior to enrolment visit
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT01152385
Start Date
May 1 2010
End Date
May 1 2011
Last Update
August 27 2012
Active Locations (3)
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1
Research Site
Osaka, Japan
2
Research Site
Suita, Japan
3
Research Site
Tokyo, Japan