Text Size

Risk of Acute Kidney Injury 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:
NCT01377935
First received: June 20, 2011
Last updated: December 15, 2011
Last verified: December 2011
History of Changes
  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:

Drug Information available for: Saxagliptin
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Hospital admission for acute kidney injury [ Time Frame: 52 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 113505
Study Start Date: January 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 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

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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01377935

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

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01377935     History of Changes
Other Study ID Numbers: CV181-157
Study First Received: June 20, 2011
Last Updated: December 15, 2011
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013