Clinical trial NCT01086293: Risk of Acute Liver Failure Among Patients With Type 2 Diabetes Exposed to Oral Antidiabetic Treatments
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
name: University of Pennsylvania
First posted: 2010-03-15
Enrollment: 113505
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will be carried out using databases containing administrative claims data (HealthCore Integrated Research DatabaseSM (HIRD) and Medicare in the U.S.) and electronic medical records (General Practice Research Database (GPRD) and The Health Improvement Network (THIN) in the UK). The US population includes patients from health plans in the northeast, southeastern, mid-Atlantic, central, mid-western, and western regions (HIRD) as well as US citizens 65 years of age and older (Medicare). The UK population includes patients seeking medical care from general practitioners (GPRD and THIN)

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants hospitalized with a diagnosis of acute liver failure
timeFrame: 18-months
measure: Number of participants hospitalized with a diagnosis of acute liver failure
timeFrame: 36-months
measure: Number of participants hospitalized with a diagnosis of acute liver failure
timeFrame: 54-months
Secondary outcomes:
measure: Deaths due to acute liver failure
timeFrame: 18, 36 and 54 months
measure: Hospitalizations with acute liver failure and/or death due to acute liver failure
timeFrame: 18, 36 and 54 months
measure: Hospitalizations with acute liver injury
timeFrame: 18, 36 and 54 months
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Lo Re V, Carbonari DM, Saine ME, Newcomb CW, Roy JA, Liu Q, Wu Q, Cardillo S, Haynes K, Kimmel SE, Reese PP, Margolis DJ, Apter AJ, Reddy KR, Hennessy S, Bhullar H, Gallagher AM, Esposito DB, Strom BL. Postauthorization safety study of the DPP-4 inhibitor saxagliptin: a large-scale multinational family of cohort studies of five outcomes. BMJ Open Diabetes Res Care. 2017 Jul 31;5(1):e000400. doi: 10.1136/bmjdrc-2017-000400. eCollection 2017.
citation: Saine ME, Carbonari DM, Newcomb CW, Nezamzadeh MS, Haynes K, Roy JA, Cardillo S, Hennessy S, Holick CN, Esposito DB, Gallagher AM, Bhullar H, Strom BL, Lo Re V 3rd. Determinants of saxagliptin use among patients with type 2 diabetes mellitus treated with oral anti-diabetic drugs. BMC Pharmacol Toxicol. 2015 Apr 2;16:8. doi: 10.1186/s40360-015-0007-z.