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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02197078
• Other study ID #: 1218.163
• Status: Completed
• Start date: July 30, 2014
• Est. completion date: February 26, 2019

Study information

• Verified date: March 2020
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189426
• Est. completion date: February 26, 2019
• Est. primary completion date: February 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boehringer Ingelheim	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Major Adverse Cardiovascular Event	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)	Up to 5 years and 7 months
Primary	Number of Participants With Coronary Revascularization	Number of participants with coronary revascularization (elective and non-elective procedure)	Up to 5 years and 7 month
Primary	Number of Participants With Acute Coronary Syndrome	Number of participants with acute coronary syndrome (ACS). The definition for ACS included acute myocardial infarction (MI), but acute MI was not assessed separately.	Up to 5 years and 7 months
Primary	Number of Participants With Stroke	Number of participants with ischemic or hemorrhagic stroke. Both types of stroke were included in the definition for stroke, but were not assessed separately	Up to 5 years and 7 months
Secondary	Number of Participants With Heart Failure Hospitalization	Number of participants with heart failure hospitalization	Up to 5 years and 7 months
Secondary	Number of Participants With Incident End Stage Renal Disease	Number of participants with incident end stage renal disease (ESRD)	Up to 5 years and 7 months
Secondary	Number of Participants With Acute Renal Failure	Number of participants with acute renal failure	Up to 5 years and 7 months
Secondary	Number of Participants With Acute Renal Failure Requiring Dialysis	Number of patients with acute renal failure requiring dialysis	Up to 5 years and 7 months

External Links

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