Evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in Type 2 Diabetes Mellitus (TD2M) Patients
Study identifier:D1020C00009
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A 4-month, Randomized, Double-blind, Placebo- and Active-Controlled, Multi-centre, Parallel-Group study, with an optional 2-month extension, to Evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in Type 2 Diabetes Mellitus Patients
Medical condition
Type II diabetes mellitus
Phase
Phase 2
Healthy volunteers
No
Study drug
AZD1656, Placebo, Glipizide
Sex
All
Actual Enrollment
530
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Oct 2009
Primary Completion Date: 01 Feb 2011
Study Completion Date: 01 Feb 2011
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2012 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 AZD1656 | Drug: AZD1656 Different doses of AZD1656 administered to 5 groups of patients |
| Experimental: 2 AZD1656 | Drug: AZD1656 Different doses of AZD1656 administered to 5 groups of patients |
| Experimental: 3 AZD1656 | Drug: AZD1656 Different doses of AZD1656 administered to 5 groups of patients |
| Experimental: 4 AZD1656 | Drug: AZD1656 Different doses of AZD1656 administered to 5 groups of patients |
| Experimental: 5 AZD1656 | Drug: AZD1656 Different doses of AZD1656 administered to 5 groups of patients |
| Placebo Comparator: 6 | Drug: Placebo AZD1656 placebo and glipizide placebo administered to 1 group of patients |
| Active Comparator: 7 Glipizide administered to 1 group of patients | Drug: Glipizide Glipizide administered to 1 group of patients |
Contacts
Investigators
Principal Investigator
Eva Johnsson
AstraZeneca R&D Mölndal
