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

NCT ID: NCT02140645

Last Updated: 2017-02-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

166613 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-03-31

Brief Summary

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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.

Detailed Description

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Purpose:

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Linagliptin1

T2DM patients initiating Linagliptin (DPP-4 comparison)

linagliptin

Intervention Type DRUG

non-randomized

Other DPP4

T2DM patients initiating a non-linagliptin DPP-4 inhibitor

No interventions assigned to this group

Linagliptin2

T2DM patients initiating Linagliptin (glitizaone comparison)

No interventions assigned to this group

Glitazones

T2DM patients initiating Thiazolidinediones (glitazones)

No interventions assigned to this group

Sulfonylurea

T2DM patients initiating any medication in the Sulfonylurea class

No interventions assigned to this group

Linagliptin3

T2DM patients initiating Linagliptin (Sulfonylurea comparison)

No interventions assigned to this group

Interventions

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linagliptin

non-randomized

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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1218.162

Identifier Type: -

Identifier Source: org_study_id

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