Safety and tolerability of AZD1656 in Type 2 diabetes Mellitus (T2DM) patients treated with metformin and sulfonylurea
Study identifier:D1020C00026
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A randomized, single-blind, placebo-controlled, phase I study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD1656 compared to placebo in T2DM patients treated with metformin and sulfonylurea
Medical condition
Type II diabetes mellitus
Phase
Phase 1
Healthy volunteers
No
Study drug
AZD1656, Placebo
Sex
All
Actual Enrollment
75
Study type
Interventional
Age
30 Years - 75 Years
Date
Study Start Date: 01 Oct 2009
Primary Completion Date: 01 Feb 2010
Study Completion Date: 01 Feb 2010
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group 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: AZD1656 | Drug: AZD1656 Dose titration of oral suspension of AZD165 during 3 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 6 days |
| Placebo Comparator: Placebo | Drug: Placebo Dose titration of oral suspension of placebo during 3 days given twice daily. Subjects will thereafter be for another 6 days |
Contacts
Investigators
Principal Investigator
Klas Malmberg
AstraZeneca R&D Mölndal, SE-431 83 Mölndal, Sweden
