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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2

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.

• Study Type: Observational
• Enrollment (Actual): 113505

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients exposed to Saxagliptin
Patients exposed to OAD in classes other than DPP4 inhibitors; OAD - Oral Antidiabetic Drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hospital admission for acute kidney injury	52 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Deaths due to acute kidney injury	18 months
Deaths due to acute kidney injury	36 months
Deaths due to acute kidney injury	54 months
Hospitalizations for acute kidney injury and/or death due to acute kidney injury	18 months
Hospitalizations for acute kidney injury and/or death due to acute kidney injury	36 months
Hospitalizations for acute kidney injury and/or death due to acute kidney injury	54 months

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Bristol-Myers Squibb; University of Pennsylvania

Publications and helpful links

General 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.
• 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.

Helpful Links

• BMS Clinical Trials Disclosure
• For FDA Safety Alerts and Recalls refer to the following link
• CSR Synopsis

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: June 20, 2011
• First Submitted That Met QC Criteria: June 20, 2011
• First Posted (Estimate): June 22, 2011

Study Record Updates

• Last Update Posted (Estimate): September 20, 2016
• Last Update Submitted That Met QC Criteria: September 19, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Kidney Diseases; Urologic Diseases; Endocrine System Diseases; Renal Insufficiency; Diabetes Mellitus; Diabetes Mellitus, Type 2; Acute Kidney Injury
• Other Study ID Numbers: CV181-157