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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02140645
First received: May 14, 2014
Last updated: November 12, 2014
Last verified: November 2014
  Purpose

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.


Condition
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)

Resource links provided by NLM:


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 ]

Estimated Enrollment: 10000
Study Start Date: May 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Glitazones
Linagliptin
Metformin
Non-insulin injected
Saxagliptin
Sitagliptin
Sulfonylurea

Detailed Description:

Purpose:

  Eligibility

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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: NCT02140645

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

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02140645     History of Changes
Other Study ID Numbers: 1218.162
Study First Received: May 14, 2014
Last Updated: November 12, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 25, 2014