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

This study has been completed.
Information provided by (Responsible Party):
Boehringer Ingelheim Identifier:
First received: May 14, 2014
Last updated: April 15, 2015
Last verified: April 2015
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.

Diabetes Mellitus, Type 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Association of Clinical Covariates With Non-insulin Diabetes Medication Initiation Using Electronic Medical Records (EMR)

Further study details as provided by Boehringer Ingelheim:

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

Enrollment: 4800
Study Start Date: May 2014
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Non-insulin injected

Detailed Description:

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
T2DM patients aged 18 or older, initiating antidiabetic treatment after at least 6 months of continuous enrollment

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
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Please refer to this study by its identifier: NCT02140645

United States, Massachusetts
1218.162.1 Boehringer Ingelheim Investigational Site
Boston, Massachusetts, United States
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim Identifier: NCT02140645     History of Changes
Other Study ID Numbers: 1218.162 
Study First Received: May 14, 2014
Last Updated: April 15, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases processed this record on May 25, 2016