The Efficacy and Safety study in patients with type 2 diabetes mellitus - SUNSHINE
Study identifier:D1680L00008
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A multicenter, single arm, cohort study to evaluate the Efficacy and Safety of saxagliptin 5mg, once daily for 24 weeks, in patients with type 2 diabetes mellitus
Medical condition
Diabetes Mellitus, Non-Insulin-Dependent
Phase
Phase 4
Healthy volunteers
No
Study drug
Saxagliptin
Sex
All
Actual Enrollment
2165
Study type
Interventional
Age
18 Years - 99 Years
Date
Study Start Date: 01 Nov 2012
Primary Completion Date: 01 May 2014
Study Completion Date: 01 May 2014
Study design
Allocation: Non-randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Jun 2015 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Open label Saxagliptin, oral 5mg once a day(Q. D.) | Drug: Saxagliptin oral, 5 mg once a day (Q.D.) Other Name: Onglyza |
Contacts
Investigators
Principal Investigator
Simon Fisher
AstraZeneca
