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Risk of Acute Kidney Injury Among Patients With Type 2 Diabetes Exposed to Oral Antidiabetic Treatments

This study has been completed.
Sponsor:
Collaborators:
Bristol-Myers Squibb
University of Pennsylvania
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01377935
First received: June 20, 2011
Last updated: September 19, 2016
Last verified: September 2016

June 20, 2011
September 19, 2016
August 2009
December 2015   (final data collection date for primary outcome measure)
Hospital admission for acute kidney injury [ Time Frame: 52 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01377935 on ClinicalTrials.gov Archive Site
  • Deaths due to acute kidney injury [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Deaths due to acute kidney injury [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Deaths due to acute kidney injury [ Time Frame: 54 months ] [ Designated as safety issue: Yes ]
  • Hospitalizations for acute kidney injury and/or death due to acute kidney injury [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Hospitalizations for acute kidney injury and/or death due to acute kidney injury [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Hospitalizations for acute kidney injury and/or death due to acute kidney injury [ Time Frame: 54 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Risk of Acute Kidney Injury Among Patients With Type 2 Diabetes Exposed to Oral Antidiabetic Treatments
Comparison of Risk of Hospitalization for Acute Kidney Injury Between Patients With Type 2 Diabetes Initiating Saxagliptin and Those Initiating Other Oral Antidiabetic Treatments
The purpose of this study is to compare the incidence of hospitalization for acute kidney injury among patients with type 2 diabetes who are new initiators of Saxagliptin and those who are new initiators of other oral antidiabetic drugs in classes other than Dipeptidyl peptidase IV (DPP4) inhibitors.

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.

This will be a prospectively-designed database cohort study comparing hospitalizations for acute kidney injury among new initiators of Saxagliptin compared to those who are new initiators of OADs in classes other than DPP4 inhibitors. The study time frame will be from 2009 through 2014.

Observational
Observational Model: Cohort
Not Provided
Not Provided
Non-Probability Sample
This study will 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).
Diabetes Mellitus, Type 2
Not Provided
  • Patients exposed to Saxagliptin
  • Patients exposed to OAD in classes other than DPP4 inhibitors
    OAD - Oral Antidiabetic Drug
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
113505
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years of age or older
  • Newly prescribed Saxagliptin or an OAD in a class other than DPP4 inhibitors
  • Enrolled in the respective database for at least 180 days prior to the first prescription of new OAD

Exclusion Criteria:

  • Patients identified with a diagnostic code for acute kidney injury within the 180-day baseline period
  • Patients with DPP4 inhibitor exposure during the baseline period
  • Patients currently using Exenatide or Insulin
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01377935
CV181-157
No
Not Provided
Not Provided
AstraZeneca
AstraZeneca
  • Bristol-Myers Squibb
  • University of Pennsylvania
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
AstraZeneca
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP