Trial Outcomes & Findings for Active Surveillance Research Program for the Assessment of the Safety and the Effectiveness of Linagliptin (NCT NCT02197078)

Results Overview

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)

Recruitment status

COMPLETED

Target enrollment

189426 participants

Primary outcome timeframe

Up to 5 years and 7 months

Results posted on

2020-04-02

Participant Flow

From Clinformatics and MarketScan source data, patients with a recorded diagnosis of type 2 diabetes mellitus (T2DM) who initiated linagliptin, sitagliptin, saxagliptin, alogliptin, pioglitazone, or 2nd generation sulfonylureas were identified between May 2011 and December 2016.

Only participants with no use of a medication in the same class or comparator class during the 6 months prior to index date, who were at least 18 years of age and enrolled for a minimum of 6 months in the data source before treatment initiation were included.

Participant milestones

Participant milestones
Measure	Other DPP-4I - Clinformatics 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database	Linagliptin 1 - Clinformatics 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database	Pioglitazone - Clinformatics 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database	Linagliptin 2 - Clinformatics 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database	2nd Gen SUs - Clinformatics 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database	Linagliptin 3 - Clinformatics 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database	Other DPP-4I - MarketScan 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database	Linagliptin 1 - MarketScan 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database	Pioglitazone - MarketScan 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database	Linagliptin 2 - MarketScan 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database	2nd Gen SUs - MarketScan 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database	Linagliptin 3 - MarketScan 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database
Overall Study STARTED	14688	14688	10614	10614	9538	9538	25135	25135	18996	18996	15742	15742
Overall Study COMPLETED	14688	14688	10614	10614	9538	9538	25135	25135	18996	18996	15742	15742
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Other DPP-4I - Clinformatics n=14688 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database	Linagliptin 1 - Clinformatics n=14688 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database	Pioglitazone - Clinformatics n=10614 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database	Linagliptin 2 - Clinformatics n=10614 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database	2nd Gen SUs - Clinformatics n=9538 Participants 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database	Linagliptin 3 - Clinformatics n=9538 Participants 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database	Other DPP-4I - MarketScan n=25135 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database	Linagliptin 1 - MarketScan n=25135 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database	Pioglitazone - MarketScan n=18996 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database	Linagliptin 2 - MarketScan n=18996 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database	2nd Gen SUs - MarketScan n=15742 Participants 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database	Linagliptin 3 - MarketScan n=15742 Participants 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database	Total n=189426 Participants Total of all reporting groups
Age, Continuous	56.31 Years STANDARD_DEVIATION 12.45 • n=14688 Participants	56.30 Years STANDARD_DEVIATION 12.35 • n=14688 Participants	56.53 Years STANDARD_DEVIATION 12.48 • n=10614 Participants	56.77 Years STANDARD_DEVIATION 12.54 • n=10614 Participants	55.03 Years STANDARD_DEVIATION 12.18 • n=9538 Participants	55.00 Years STANDARD_DEVIATION 12.21 • n=9538 Participants	55.25 Years STANDARD_DEVIATION 11.26 • n=25135 Participants	55.27 Years STANDARD_DEVIATION 11.36 • n=25135 Participants	54.71 Years STANDARD_DEVIATION 11.22 • n=18996 Participants	54.73 Years STANDARD_DEVIATION 11.28 • n=18996 Participants	54.41 Years STANDARD_DEVIATION 11.28 • n=15742 Participants	54.40 Years STANDARD_DEVIATION 11.31 • n=15742 Participants	55.39 Years STANDARD_DEVIATION 11.83 • n=189426 Participants
Sex: Female, Male Female	6118 Participants n=14688 Participants	6098 Participants n=14688 Participants	4266 Participants n=10614 Participants	4337 Participants n=10614 Participants	3985 Participants n=9538 Participants	3968 Participants n=9538 Participants	10377 Participants n=25135 Participants	10309 Participants n=25135 Participants	7805 Participants n=18996 Participants	7850 Participants n=18996 Participants	6527 Participants n=15742 Participants	6582 Participants n=15742 Participants	78222 Participants n=189426 Participants
Sex: Female, Male Male	8570 Participants n=14688 Participants	8590 Participants n=14688 Participants	6348 Participants n=10614 Participants	6277 Participants n=10614 Participants	5553 Participants n=9538 Participants	5570 Participants n=9538 Participants	14758 Participants n=25135 Participants	14826 Participants n=25135 Participants	11191 Participants n=18996 Participants	11146 Participants n=18996 Participants	9215 Participants n=15742 Participants	9160 Participants n=15742 Participants	111204 Participants n=189426 Participants
Race and Ethnicity Not Collected	—	—	—	—	—	—	—	—	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Up to 5 years and 7 months

Population: 1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016

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)

Outcome measures

Outcome measures
Measure	Other DPP-4I - Clinformatics n=14688 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database	Linagliptin 1 - Clinformatics n=14688 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database	Pioglitazone - Clinformatics n=10614 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database	Linagliptin 2 - Clinformatics n=10614 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database	2nd Gen SUs - Clinformatics n=9538 Participants 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database	Linagliptin 3 - Clinformatics n=9538 Participants 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database	Other DPP-4I - MarketScan n=25135 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database	Linagliptin 1 - MarketScan n=25135 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database	Pioglitazone - MarketScan n=18996 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database	Linagliptin 2 - MarketScan n=18996 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database	2nd Gen SUs - MarketScan n=15742 Participants 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database	Linagliptin 3 - MarketScan n=15742 Participants 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database
Number of Participants With Major Adverse Cardiovascular Event	165 Participants	151 Participants	120 Participants	102 Participants	127 Participants	82 Participants	403 Participants	369 Participants	262 Participants	270 Participants	259 Participants	194 Participants

PRIMARY outcome

Timeframe: Up to 5 years and 7 month

Population: 1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016.

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

Outcome measures

Outcome measures
Measure	Other DPP-4I - Clinformatics n=14688 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database	Linagliptin 1 - Clinformatics n=14688 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database	Pioglitazone - Clinformatics n=10614 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database	Linagliptin 2 - Clinformatics n=10614 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database	2nd Gen SUs - Clinformatics n=9538 Participants 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database	Linagliptin 3 - Clinformatics n=9538 Participants 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database	Other DPP-4I - MarketScan n=25135 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database	Linagliptin 1 - MarketScan n=25135 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database	Pioglitazone - MarketScan n=18996 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database	Linagliptin 2 - MarketScan n=18996 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database	2nd Gen SUs - MarketScan n=15742 Participants 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database	Linagliptin 3 - MarketScan n=15742 Participants 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database
Number of Participants With Coronary Revascularization	82 Participants	81 Participants	67 Participants	54 Participants	67 Participants	46 Participants	181 Participants	181 Participants	129 Participants	133 Participants	125 Participants	94 Participants

PRIMARY outcome

Timeframe: Up to 5 years and 7 months

Population: 1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016.

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

Outcome measures

Outcome measures
Measure	Other DPP-4I - Clinformatics n=14688 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database	Linagliptin 1 - Clinformatics n=14688 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database	Pioglitazone - Clinformatics n=10614 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database	Linagliptin 2 - Clinformatics n=10614 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database	2nd Gen SUs - Clinformatics n=9538 Participants 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database	Linagliptin 3 - Clinformatics n=9538 Participants 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database	Other DPP-4I - MarketScan n=25135 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database	Linagliptin 1 - MarketScan n=25135 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database	Pioglitazone - MarketScan n=18996 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database	Linagliptin 2 - MarketScan n=18996 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database	2nd Gen SUs - MarketScan n=15742 Participants 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database	Linagliptin 3 - MarketScan n=15742 Participants 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database
Number of Participants With Acute Coronary Syndrome	93 Participants	72 Participants	76 Participants	48 Participants	72 Participants	43 Participants	238 Participants	221 Participants	163 Participants	160 Participants	161 Participants	115 Participants

PRIMARY outcome

Timeframe: Up to 5 years and 7 months

Population: 1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016.

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

Outcome measures

Outcome measures
Measure	Other DPP-4I - Clinformatics n=14688 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database	Linagliptin 1 - Clinformatics n=14688 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database	Pioglitazone - Clinformatics n=10614 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database	Linagliptin 2 - Clinformatics n=10614 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database	2nd Gen SUs - Clinformatics n=9538 Participants 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database	Linagliptin 3 - Clinformatics n=9538 Participants 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database	Other DPP-4I - MarketScan n=25135 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database	Linagliptin 1 - MarketScan n=25135 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database	Pioglitazone - MarketScan n=18996 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database	Linagliptin 2 - MarketScan n=18996 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database	2nd Gen SUs - MarketScan n=15742 Participants 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database	Linagliptin 3 - MarketScan n=15742 Participants 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database
Number of Participants With Stroke	42 Participants	42 Participants	30 Participants	30 Participants	37 Participants	16 Participants	113 Participants	104 Participants	66 Participants	74 Participants	76 Participants	53 Participants

SECONDARY outcome

Timeframe: Up to 5 years and 7 months

Population: 1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016.

Number of participants with heart failure hospitalization

Outcome measures

Outcome measures
Measure	Other DPP-4I - Clinformatics n=14688 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database	Linagliptin 1 - Clinformatics n=14688 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database	Pioglitazone - Clinformatics n=10614 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database	Linagliptin 2 - Clinformatics n=10614 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database	2nd Gen SUs - Clinformatics n=9538 Participants 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database	Linagliptin 3 - Clinformatics n=9538 Participants 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database	Other DPP-4I - MarketScan n=25135 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database	Linagliptin 1 - MarketScan n=25135 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database	Pioglitazone - MarketScan n=18996 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database	Linagliptin 2 - MarketScan n=18996 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database	2nd Gen SUs - MarketScan n=15742 Participants 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database	Linagliptin 3 - MarketScan n=15742 Participants 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database
Number of Participants With Heart Failure Hospitalization	53 Participants	90 Participants	27 Participants	51 Participants	43 Participants	47 Participants	117 Participants	111 Participants	58 Participants	65 Participants	66 Participants	49 Participants

SECONDARY outcome

Timeframe: Up to 5 years and 7 months

Population: 1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016. For this outcome only, patients with ESRD at any time prior to and including the day of treatment initiation were excluded.

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

Outcome measures

Outcome measures
Measure	Other DPP-4I - Clinformatics n=14472 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database	Linagliptin 1 - Clinformatics n=14472 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database	Pioglitazone - Clinformatics n=10467 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database	Linagliptin 2 - Clinformatics n=10467 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database	2nd Gen SUs - Clinformatics n=9422 Participants 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database	Linagliptin 3 - Clinformatics n=9422 Participants 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database	Other DPP-4I - MarketScan n=24714 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database	Linagliptin 1 - MarketScan n=24741 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database	Pioglitazone - MarketScan n=18689 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database	Linagliptin 2 - MarketScan n=18689 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database	2nd Gen SUs - MarketScan n=15500 Participants 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database	Linagliptin 3 - MarketScan n=15500 Participants 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database
Number of Participants With Incident End Stage Renal Disease	49 Participants	75 Participants	28 Participants	48 Participants	38 Participants	43 Participants	90 Participants	116 Participants	39 Participants	61 Participants	53 Participants	57 Participants

SECONDARY outcome

Timeframe: Up to 5 years and 7 months

Population: 1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016.

Number of participants with acute renal failure

Outcome measures

Outcome measures
Measure	Other DPP-4I - Clinformatics n=14688 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database	Linagliptin 1 - Clinformatics n=14688 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database	Pioglitazone - Clinformatics n=10614 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database	Linagliptin 2 - Clinformatics n=10614 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database	2nd Gen SUs - Clinformatics n=9538 Participants 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database	Linagliptin 3 - Clinformatics n=9538 Participants 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database	Other DPP-4I - MarketScan n=25135 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database	Linagliptin 1 - MarketScan n=25135 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database	Pioglitazone - MarketScan n=18996 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database	Linagliptin 2 - MarketScan n=18996 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database	2nd Gen SUs - MarketScan n=15742 Participants 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database	Linagliptin 3 - MarketScan n=15742 Participants 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database
Number of Participants With Acute Renal Failure	222 Participants	300 Participants	152 Participants	198 Participants	163 Participants	167 Participants	433 Participants	430 Participants	240 Participants	263 Participants	238 Participants	200 Participants

SECONDARY outcome

Timeframe: Up to 5 years and 7 months

Population: 1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016.

Number of patients with acute renal failure requiring dialysis

Outcome measures

Outcome measures
Measure	Other DPP-4I - Clinformatics n=14688 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database	Linagliptin 1 - Clinformatics n=14688 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database	Pioglitazone - Clinformatics n=10614 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database	Linagliptin 2 - Clinformatics n=10614 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database	2nd Gen SUs - Clinformatics n=9538 Participants 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database	Linagliptin 3 - Clinformatics n=9538 Participants 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database	Other DPP-4I - MarketScan n=25135 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database	Linagliptin 1 - MarketScan n=25135 Participants 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database	Pioglitazone - MarketScan n=18996 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database	Linagliptin 2 - MarketScan n=18996 Participants 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database	2nd Gen SUs - MarketScan n=15742 Participants 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database	Linagliptin 3 - MarketScan n=15742 Participants 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database
Number of Participants With Acute Renal Failure Requiring Dialysis	7 Participants	13 Participants	6 Participants	10 Participants	5 Participants	9 Participants	14 Participants	16 Participants	9 Participants	9 Participants	7 Participants	11 Participants

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim, Call Centre

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place