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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:
ClinicalTrials.gov Identifier:
NCT01377935
First Posted: June 22, 2011
Last Update Posted: September 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Bristol-Myers Squibb
University of Pennsylvania
Information provided by (Responsible Party):
AstraZeneca
  Purpose
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.

Condition
Diabetes Mellitus, Type 2

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Comparison of Risk of Hospitalization for Acute Kidney Injury 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 AstraZeneca:

Primary Outcome Measures:
  • Hospital admission for acute kidney injury [ Time Frame: 52 months ]

Secondary Outcome Measures:
  • Deaths due to acute kidney injury [ Time Frame: 18 months ]
  • Deaths due to acute kidney injury [ Time Frame: 36 months ]
  • Deaths due to acute kidney injury [ Time Frame: 54 months ]
  • Hospitalizations for acute kidney injury and/or death due to acute kidney injury [ Time Frame: 18 months ]
  • Hospitalizations for acute kidney injury and/or death due to acute kidney injury [ Time Frame: 36 months ]
  • Hospitalizations for acute kidney injury and/or death due to acute kidney injury [ Time Frame: 54 months ]

Enrollment: 113505
Study Start Date: August 2009
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients exposed to Saxagliptin
Patients exposed to OAD in classes other than DPP4 inhibitors
OAD - Oral Antidiabetic Drug

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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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).
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01377935


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01377935     History of Changes
Other Study ID Numbers: CV181-157
First Submitted: June 20, 2011
First Posted: June 22, 2011
Last Update Posted: September 20, 2016
Last Verified: September 2016

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