Japan dose Regimen study of AZD1656 in Japanese type 2 diabetes mellitus patients
Study identifier:D1020C00016
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A 4-month treatment, Randomized, Double-blind, Placebo-Controlled, Multi-centre, Parallel-Group Phase 2 study to Evaluate Efficacy, Safety and Tolerability of Different Dosing Regimens of AZD1656 as Monotherapy in Japanese Type 2 Diabetes Mellitus Patients
Medical condition
Type 2 Diabetes Mellitus
Phase
Phase 2
Healthy volunteers
No
Study drug
AZD1656, Placebo
Sex
All
Actual Enrollment
224
Study type
Interventional
Age
20 Years +
Date
Study Start Date: 01 May 2010
Primary Completion Date: 01 May 2011
Study Completion Date: 01 May 2011
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Jul 2012 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: high AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose) | Drug: AZD1656 Oral tablet administered twice daily during 4 months |
| Experimental: Middle AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose) | Drug: AZD1656 Oral tablet administered twice daily during 4 months |
| Experimental: low AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose) | Drug: AZD1656 Oral tablet administered twice daily during 4 months |
| Placebo Comparator: 4 | Drug: Placebo administered twice daily during 4 months |
Contacts
Investigators
Principal Investigator
Maria Leonsson-Zachrisson
AstraZeneca
