To study safety, tolerability, pharmacokinetics and pharmacodynamics of AZD1656 in Japanese Type 2 Diabetes Mellitus (T2DM) patients - JMAD
Study identifier:D1020C00004
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Randomized, Single-blind, Placebo-Controlled, Multi-centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics after Multiple Ascending Oral Doses of AZD1656 in Japanese T2DM Patients
Medical condition
Type 2 Diabetes
Phase
Phase 1
Healthy volunteers
No
Study drug
AZD1656, Placebo
Sex
All
Actual Enrollment
24
Study type
Interventional
Age
30 Years - 75 Years
Date
Study Start Date: 01 May 2009
Primary Completion Date: -
Study Completion Date: 01 Oct 2009
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: A 3 gradually increasing repeated oral doses of AZD1656 given to 3 groups (6 on active substance in each group) | Drug: AZD1656 Three increasing dose-steps with oral suspension, 8 days treatment |
| Placebo Comparator: B Placebo oral suspension given to 3 groups (2 on placebo in each group) | Drug: Placebo Placebo oral suspension, 8 days treatment |
Contacts
Investigators
Principal Investigator
Klas Malmberg
AstraZeneca R&D Mölndal
