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

NCT01377935 | Completed

• 1 other identifier: CV181-157
• Study Type: observational
• Target: 113,505
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Hospital admission for acute kidney injury

  52 months

Secondary Outcomes (6)

• 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

Study Arms (2)

Patients exposed to Saxagliptin

Patients exposed to OAD in classes other than DPP4 inhibitors

OAD - Oral Antidiabetic Drug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead
• Bristol-Myers Squibb: collaborator
• University of Pennsylvania: collaborator

Related Publications (2)

• 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.

  PMID: 28878934 DERIVED

• 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.

  PMID: 25889498 DERIVED

Related Links

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2011
• First Posted: June 22, 2011
• Study Start: August 1, 2009
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 20, 2016

Record last verified: 2016-09