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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:
AstraZeneca
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
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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| 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
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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 ClinicalTrials.gov identifier: NCT01377935
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | June 20, 2011 |
| Last Updated: | September 19, 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 |
ClinicalTrials.gov processed this record on July 07, 2017