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CompletedNCT01086293Updated Sep 20, 2016

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

An observational study in Diabetes Mellitus, Type 2, sponsored by AstraZeneca. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-20.

Sponsored by AstraZeneca · Observational

Study type
Observational
Model
Cohort
Enrollment
113,505
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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

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Conditions studied

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In context

Liver Failure

445 studies on the registry are indexed under Liver Failure; 69 are open to participants now.

This study's enrollment of 113,505 is above the median of 129 across 146 observational studies indexed under Liver Failure.

Browse Liver Failure studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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)

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

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
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Study design

Observational model
Cohort
Enrollment
113,505 participants (actual)

Groups and cohorts

  • Patients exposed to Saxagliptin
  • Patients exposed to oral antidiabetic drugs (not Saxagliptin)
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What researchers measure

Primary outcomes

  1. Number of participants hospitalized with a diagnosis of acute liver failure

    Time frame: 18-months

  2. Number of participants hospitalized with a diagnosis of acute liver failure

    Time frame: 36-months

  3. Number of participants hospitalized with a diagnosis of acute liver failure

    Time frame: 54-months

Secondary outcomes

  1. Deaths due to acute liver failure

    Time frame: 18, 36 and 54 months

  2. Hospitalizations with acute liver failure and/or death due to acute liver failure

    Time frame: 18, 36 and 54 months

  3. Hospitalizations with acute liver injury

    Time frame: 18, 36 and 54 months

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 28878934 ↗
  • 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. PubMed 25889498 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01086293
Lead sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb, University of Pennsylvania
Responsible party
Sponsor
First posted
Mar 15, 2010
Start date
Jan 2010
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Sep 20, 2016

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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