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Completed

NCT Number: NCT02197078

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of Participants With Major Adverse Cardiovascular Event

    Time frame: Up to 5 years and 7 months

    Number of participants with major adverse cardiovascular event is presented by the number of patients reported a composite of:

    • Coronary revascularization (elective and non-elective procedure)
    • Acute coronary syndrome (ACS), including acute myocardial infarction (MI)
    • Stroke (Ischemic and hemorrhagic stroke)

  2. Number of Participants With Coronary Revascularization

    Time frame: Up to 5 years and 7 month

    Number of participants with coronary revascularization (elective and non-elective procedure)

  3. Number of Participants With Acute Coronary Syndrome

    Time frame: Up to 5 years and 7 months

    Number of participants with acute coronary syndrome (ACS). The definition for ACS included acute myocardial infarction (MI), but acute MI was not assessed separately.

  4. Number of Participants With Stroke

    Time frame: Up to 5 years and 7 months

    Number of participants with ischemic or hemorrhagic stroke. Both types of stroke were included in the definition for stroke, but were not assessed separately

Secondary outcomes

  1. Number of Participants With Heart Failure Hospitalization

    Time frame: Up to 5 years and 7 months

    Number of participants with heart failure hospitalization

  2. Number of Participants With Incident End Stage Renal Disease

    Time frame: Up to 5 years and 7 months

    Number of participants with incident end stage renal disease (ESRD)

  3. Number of Participants With Acute Renal Failure

    Time frame: Up to 5 years and 7 months

    Number of participants with acute renal failure

  4. Number of Participants With Acute Renal Failure Requiring Dialysis

    Time frame: Up to 5 years and 7 months

    Number of patients with acute renal failure requiring dialysis

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jul 22, 2014
Registry last updated
Apr 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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