Risk of Hospitalization for Severe Hypersensitivity (including Severe Skin Reactions) in Patients with Type 2 Diabetes Exposed to Oral Antidiabetic Treatments

Study identifier:CV181-103

ClinicalTrials.gov identifier:NCT01086319

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Comparison of Risk of Hospitalization for Severe Hypersensitivity (including Severe Cutaneous Reactions) Between Patients with Type 2 Diabetes Initiating Saxagliptin and Those Initiating Other Oral Antidiabetic Treatments

Medical condition

Diabetes Mellitus, Type 2

Phase

Healthy volunteers

Study drug

Sex

All

Actual Enrollment

113505

Study type

Observational

Age

18 Years +

Date

Study Start Date: 01 Aug 2009

Primary Completion Date: 01 Dec 2015

Study Completion Date: 01 Dec 2015

Study design

Allocation: -
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -

Verification:

Verified 01 Sept 2016 by AstraZeneca Pharmaceuticals

Collaborators

Bristol Myers Squibb, University of Pennsylvania

Inclusion and exclusion criteria

No locations available

Arms	Assigned Interventions
Patients exposed to saxagliptin	-
Patients exposed to oral antidiabetic drugs (not saxagliptin)	-

Documents available

BMS Clinical Trials Disclosure
Download
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
Download
Investigator Inquiry form
Download
CSR Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

Bristol-Myers Squibb

Risk of Hospitalization for Severe Hypersensitivity (including Severe Skin Reactions) in Patients with Type 2 Diabetes Exposed to Oral Antidiabetic Treatments

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Investigator Inquiry form

CSR Synopsis

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator