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

Boehringer Ingelheim logo

Boehringer Ingelheim

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: linagliptin

Study type

Observational

Funder types

Industry

Identifiers

NCT02140645
1218.162

Details and patient eligibility

About

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.

Full description

Purpose:

Enrollment

166,613 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

166,613 participants in 6 patient groups

Linagliptin1
Description:
T2DM patients initiating Linagliptin (DPP-4 comparison)
Treatment:
Drug: linagliptin
Other DPP4
Description:
T2DM patients initiating a non-linagliptin DPP-4 inhibitor
Linagliptin2
Description:
T2DM patients initiating Linagliptin (glitizaone comparison)
Glitazones
Description:
T2DM patients initiating Thiazolidinediones (glitazones)
Sulfonylurea
Description:
T2DM patients initiating any medication in the Sulfonylurea class
Linagliptin3
Description:
T2DM patients initiating Linagliptin (Sulfonylurea comparison)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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