Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
University of Pennsylvania
Information provided by (Responsible Party):
Bristol-Myers Squibb Identifier:
First received: June 20, 2011
Last updated: February 2, 2015
Last verified: February 2015

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.

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 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: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
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.


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).


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
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 identifier: NCT01377935

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

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb Identifier: NCT01377935     History of Changes
Other Study ID Numbers: CV181-157
Study First Received: June 20, 2011
Last Updated: February 2, 2015
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Acute Kidney Injury
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Kidney Diseases
Metabolic Diseases
Renal Insufficiency
Urologic Diseases
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on February 25, 2015