Oral and Non-insulin Injected Hypoglycemic Therapy Utilization Patterns

NCT ID: NCT02138097

Last Updated: 2015-10-06

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

615067 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-08-31

Brief Summary

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This protocol is for a series of descriptive analyses conducted within a cohort of patients using linagliptin, other dipeptidyl peptidase-4 (DPP-4) inhibitors, and other oral and non-insulin injected hypoglycemic medications between May 2011 and July 2012.

Understanding 1) the existing utilization patterns for linagliptin, sitagliptin, saxagliptin, and other oral and non-insulin injected hypoglycemic agents and (2) the differences in utilization patterns between these agents will help with the design, analysis and interpretation of comparative effectiveness and safety studies of linagliptin, other DPP-4 inhibitors, and other agents.

The study will provide an overview of existing utilization patterns for linagliptin, other dipeptidyl peptidase-4 (DPP-4) inhibitors, other oral and non-insulin injected hypoglycemic agents, in order to detect potential selective prescribing patterns that might lead to channeling bias.

Detailed Description

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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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Glitazones

No interventions assigned to this group

Linagliptin

No interventions assigned to this group

Meglitinides

No interventions assigned to this group

Metformin

No interventions assigned to this group

Non-insulin injectables

No interventions assigned to this group

Saxagliptin

No interventions assigned to this group

Sitagliptin

No interventions assigned to this group

Sulfonylurea

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* diagnosis of type 2 diabetes mellitus
* a dispensing of an oral or non-insulin injected hypoglycemic medication between May 2011 and June 2012
* at least 6 months enrolment in the database preceding the date of the first dispensing

Exclusion Criteria

* age \< 18
* missing or ambiguous age or sex information
* at least one diagnosis of type 1 diabetes mellitus or secondary diabetes
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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1218.161.1 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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1218.161

Identifier Type: -

Identifier Source: org_study_id

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