To evaluate safety and tolerability after multiple oral doses of AZD1656 in type 2 diabetes patients on top of insulin
Study identifier:D1020C00014
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 after Multiple Ascending Oral Doses of AZD1656 in subjects with T2DM treated with Insulin
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 Sept 2008
Primary Completion Date: 01 Mar 2009
Study Completion Date: 01 Mar 2009
Study design
Allocation: Randomized
Endpoint Classification: Safety 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 | Drug: AZD1656 Dose titration of oral suspension to a tolerable dose in 2-3 dose steps. Investigational product given twice daily for eight days. |
| Placebo Comparator: 2 | Drug: Placebo Dosing to match AZD1656 |
Contacts
Investigators
Principal Investigator
Klas Malmberg
AstraZeneca R&D Mölndal
