Ascertainment of EMR-based Clinical Covariates Among Patients Receiving Oral and Non-insulin Injected Hypoglycemic Therapy

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Association of Clinical Covariates With Non-insulin Diabetes Medication Initiation Using Electronic Medical Records (EMR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02140645
• Other study ID #: 1218.162
• Status: Completed
• Phase: N/A
• First received: May 14, 2014
• Last updated: April 15, 2015
• Start date: May 2014
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The objective of this study is to identify EMR-based clinical covariates and quantify their association with the prescribing of each specific type 2 diabetes (T2DM) medication under investigation. This will include an assessment of how well these covariates are captured through claims data proxies, and their potential to confound comparative research of T2DM medications.

Description:

Purpose:

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4800
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Dispensing of an oral or non-insulin injected hypoglycemic medication between May 2011 and June 2012

• Diagnosis of type 2 diabetes mellitus

• Presence of electronic medical records (for the EMR-based subset)

Exclusion criteria:

• Age <18 at T2DM medication initiation

• Missing or ambiguous age or sex information

• At least one diagnosis of type 1 diabetes mellitus

• Less than 6 months enrolment in the database preceding the date of the first dispensing

• Prior use of the index drug

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Locations

Country	Name	City	State
United States	1218.162.1 Boehringer Ingelheim Investigational Site	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any note of albuminuria		at least 6 months	No
Primary	Any note of proteinuria		at least 6 months	No
Primary	Blood pressure (diastolic), mmHg		at least 6 months	No
Primary	Proportion of smokers in following categories: current, past, never, not noted		at least 6 months	No
Primary	Alcohol consumption in following categories: none, moderate, high, not noted		at least 6 months	No
Primary	Mean BMI, kg/m2		at least 6 months	No
Primary	Mean duration of diabetes, years		at least 6 months	No
Primary	Mean HbA1c level, %		at least 6 months	No
Primary	Mean estimated glomerular filtration rate, ml/min		at least 6 months	No
Primary	Any note of cirrhosis, ascites, jaundice, hepatic failure, drug induced liver disease, hepatocellular disease		at least 6 months	No
Primary	Prior cancer		at least 6 months	No
Primary	Mean total cholesterol, mg/dL		at least 6 months	No
Primary	Blood pressure (systolic), mmHg		at least 6 months	No
Primary	Mean ankle-brachial index		at least 6 months	No
Primary	Any note of diminished pulse at the foot		at least 6 months	No
Primary	Any note of neuropathy		at least 6 months	No
Primary	Any note of nephropathy		at least 6 months	No
Primary	Any note of retinopathy		at least 6 months	No
Primary	Prior stroke		at least 6 months	No
Primary	Pre-existing coronary artery disease, angina, myocardial infarction		at least 6 months	No
Primary	History of gallstones		at least 6 months	No
Primary	History of pancreatitis		at least 6 months	No