A study to evaluate safety, tolerability and P-Glucose after Multiple Ascending Oral Doses of AZD1656 in type 2 diabetes - MAD
Study identifier:D1020C00002
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Randomized, Single-Blind, Placebo-Controlled, Single-Centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics after Multiple Ascending Oral Doses of AZD1656 in T2DM Subjects
Medical condition
Type 2 Diabetes
Phase
Phase 1
Healthy volunteers
No
Study drug
AZD1656
Sex
All
Actual Enrollment
52
Study type
Interventional
Age
30 Years - 75 Years
Date
Study Start Date: 01 Aug 2008
Primary Completion Date: 01 Apr 2009
Study Completion Date: 01 Apr 2009
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial 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: 1 3 (alt.4) gradually increasing repeated oral doses of AZD1656 given to 3 (alt.4) groups (6 on active and 2 on placebo in each group) | Drug: AZD1656 Dose titration to 3 (alt 4) increasing dose-steps with oral suspension, 8 days treatment |
| Experimental: 2 Oral dose of AZD1656 titrated during 3 days to a tolerable dose (15 on active and 5 on placebo) | Drug: AZD1656 Dose titration of oral suspension to a tolerable dose, 1 month treatment |
Contacts
Investigators
Principal Investigator
Klas Malmberg
AstraZeneca R&D Mölndal, SE-431 83 Mölndal, Sweden
