Risk of Acute Liver Failure Among Patients With Type 2 Diabetes Exposed to Oral Antidiabetic Treatments

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Comparison of Risk of Hospitalization With Acute Liver Failure Between Patients With Type 2 Diabetes Initiating Saxagliptin and Those Initiating Other Oral Antidiabetic Treatments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01086293
• Other study ID #: CV181-100
• Status: Completed
• Phase: N/A
• First received: March 11, 2010
• Last updated: September 19, 2016
• Start date: January 2010
• Est. completion date: December 2015

Study information

• Verified date: September 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to compare the incidence of hospitalization with acute liver failure among patients with type 2 diabetes who are new users of Saxagliptin and those who are new users of other oral antidiabetic drugs.

Description:

Prospectively designed retrospective database study. This study will be conducted using administrative claims data and electronic medical records that are collected as part of routine clinical practice

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113505
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Newly prescribed Saxagliptin or an Oral Antidiabetic Drug (OAD) in a class other than Dipeptidyl peptidase IV (DPP4) inhibitors

• Enrolled in the respective database for at least 180 days prior to the first prescription of new OAD

• Have at least one diagnostic code for a type 2 diabetes-related condition

Exclusion Criteria:

• Patients identified with a diagnostic code for acute liver failure within the 180-day baseline period

• Patients with DPP4 inhibitor exposure during the baseline period

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Liver Failure
• Liver Failure, Acute

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb, University of Pennsylvania

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants hospitalized with a diagnosis of acute liver failure		18-months	Yes
Primary	Number of participants hospitalized with a diagnosis of acute liver failure		36-months	Yes
Primary	Number of participants hospitalized with a diagnosis of acute liver failure		54-months	Yes
Secondary	Deaths due to acute liver failure		18, 36 and 54 months	Yes
Secondary	Hospitalizations with acute liver failure and/or death due to acute liver failure		18, 36 and 54 months	Yes
Secondary	Hospitalizations with acute liver injury		18, 36 and 54 months	Yes

External Links

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