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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
AstraZeneca
University of Pennsylvania
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01086293
First received: March 11, 2010
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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.


Condition
Diabetes Mellitus, Type 2

Study Type: Observational
Study Design: Observational Model: Cohort
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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Number of participants hospitalized with a diagnosis of acute liver failure [ Time Frame: 18-months ] [ Designated as safety issue: Yes ]
  • Number of participants hospitalized with a diagnosis of acute liver failure [ Time Frame: 36-months ] [ Designated as safety issue: Yes ]
  • Number of participants hospitalized with a diagnosis of acute liver failure [ Time Frame: 54-months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Deaths due to acute liver failure [ Time Frame: 18, 36 and 54 months ] [ Designated as safety issue: Yes ]
  • Hospitalizations with acute liver failure and/or death due to acute liver failure [ Time Frame: 18, 36 and 54 months ] [ Designated as safety issue: Yes ]
  • Hospitalizations with acute liver injury [ Time Frame: 18, 36 and 54 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 113505
Study Start Date: January 2010
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients exposed to Saxagliptin
Patients exposed to oral antidiabetic drugs (not Saxagliptin)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01086293

Sponsors and Collaborators
Bristol-Myers Squibb
AstraZeneca
University of Pennsylvania
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01086293     History of Changes
Other Study ID Numbers: CV181-100
Study First Received: March 11, 2010
Last Updated: August 19, 2014
Health Authority: United States: Institutional Review Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Liver Failure
Liver Failure, Acute
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Saxagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014