Active Surveillance Research Program for the Assessment of the Safety and the Effectiveness of Linagliptin

Study Results

Results available

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

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

189426 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-30

Study Completion Date

2019-02-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This protocol is for a series of comparative effectiveness and safety analyses within periodically updated cohorts of patients initiating linagliptin, other DPP-4 inhibitors, and other oral hypoglycemic medications, followed longitudinally for the occurrence of a variety of health outcomes. The primary analysis will be conducted among patients without prior within-class medication use.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Oral and Non-insulin Injected Hypoglycemic Therapy Utilization Patterns

NCT02138097

Diabetes Mellitus, Type 2

COMPLETED

Safety and Efficacy of Linagliptin in Type-2-diabetes Mellitus Patients With Moderate to Severe Renal Impairment

NCT01087502

Diabetes Mellitus, Type 2

COMPLETED PHASE3

Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes

NCT00954447

Diabetes Mellitus, Type 2

COMPLETED PHASE3

Efficacy and Safety of Linagliptin in Elderly Patients With Type 2 Diabetes

NCT01084005

Diabetes Mellitus, Type 2

COMPLETED PHASE3

Real World Glycemic Effectiveness of Linagliptin

NCT03338803

Diabetes Mellitus, Type 2

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Glitazones

No interventions assigned to this group

Linagliptin

No interventions assigned to this group

Sulfonylurea

No interventions assigned to this group

Within-class comparators

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* A dispensing of an oral hypoglycemic medication
* A diagnosis of type 2 diabetes mellitus (T2DM)

Exclusion Criteria

* less than 18 years old
* 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
* secondary diabetes
* history of cancer
* end-stage renal disease (ESRD)
* HIV
* organ transplant

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No