Active Surveillance Research Program for the Assessment of the Safety and the Effectiveness of Linagliptin
Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT02197078
Collaborator
Eli Lilly and Company (Industry)
189,426
1
54.9
3448.4
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
189426 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Active Surveillance Research Program for the Assessment of the Safety and the Effectiveness of Linagliptin
Actual Study Start Date
:
Jul 30, 2014
Actual Primary Completion Date
:
Feb 26, 2019
Actual Study Completion Date
:
Feb 26, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Glitazones
|
|
| Linagliptin
|
|
| Sulfonylurea
|
|
| Within-class comparators
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Major Adverse Cardiovascular Event [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)
- Number of Participants With Coronary Revascularization [Up to 5 years and 7 month]
Number of participants with coronary revascularization (elective and non-elective procedure)
- Number of Participants With Acute Coronary Syndrome [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.
- Number of Participants With Stroke [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 Outcome Measures
- Number of Participants With Heart Failure Hospitalization [Up to 5 years and 7 months]
Number of participants with heart failure hospitalization
- Number of Participants With Incident End Stage Renal Disease [Up to 5 years and 7 months]
Number of participants with incident end stage renal disease (ESRD)
- Number of Participants With Acute Renal Failure [Up to 5 years and 7 months]
Number of participants with acute renal failure
- Number of Participants With Acute Renal Failure Requiring Dialysis [Up to 5 years and 7 months]
Number of patients with acute renal failure requiring dialysis
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02120 |
Sponsors and Collaborators
- Boehringer Ingelheim
- Eli Lilly and Company
Investigators
- Study Chair: Boehringer Ingelheim, Boehringer Ingelheim
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02197078
Other Study ID Numbers:
- 1218.163
First Posted:
Jul 22, 2014
Last Update Posted:
Apr 2, 2020
Last Verified:
Mar 1, 2020
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 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. |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | Other DPP-4I - Clinformatics | Linagliptin 1 - Clinformatics | Pioglitazone - Clinformatics | Linagliptin 2 - Clinformatics | 2nd Gen SUs - Clinformatics | Linagliptin 3 - Clinformatics | Other DPP-4I - MarketScan | Linagliptin 1 - MarketScan | Pioglitazone - MarketScan | Linagliptin 2 - MarketScan | 2nd Gen SUs - MarketScan | Linagliptin 3 - MarketScan |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database |
| Period Title: Overall Study | ||||||||||||
| STARTED | 14688 | 14688 | 10614 | 10614 | 9538 | 9538 | 25135 | 25135 | 18996 | 18996 | 15742 | 15742 |
| COMPLETED | 14688 | 14688 | 10614 | 10614 | 9538 | 9538 | 25135 | 25135 | 18996 | 18996 | 15742 | 15742 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Other DPP-4I - Clinformatics | Linagliptin 1 - Clinformatics | Pioglitazone - Clinformatics | Linagliptin 2 - Clinformatics | 2nd Gen SUs - Clinformatics | Linagliptin 3 - Clinformatics | Other DPP-4I - MarketScan | Linagliptin 1 - MarketScan | Pioglitazone - MarketScan | Linagliptin 2 - MarketScan | 2nd Gen SUs - MarketScan | Linagliptin 3 - MarketScan | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database | Total of all reporting groups |
| Overall Participants | 14688 | 14688 | 10614 | 10614 | 9538 | 9538 | 25135 | 25135 | 18996 | 18996 | 15742 | 15742 | 189426 |
| Age (Years) [Mean (Standard Deviation) ] | |||||||||||||
| Mean (Standard Deviation) [Years] |
56.31
(12.45)
|
56.30
(12.35)
|
56.53
(12.48)
|
56.77
(12.54)
|
55.03
(12.18)
|
55.00
(12.21)
|
55.25
(11.26)
|
55.27
(11.36)
|
54.71
(11.22)
|
54.73
(11.28)
|
54.41
(11.28)
|
54.40
(11.31)
|
55.39
(11.83)
|
| Sex: Female, Male (Count of Participants) | |||||||||||||
| Female |
6118
41.7%
|
6098
41.5%
|
4266
40.2%
|
4337
40.9%
|
3985
41.8%
|
3968
41.6%
|
10377
41.3%
|
10309
41%
|
7805
41.1%
|
7850
41.3%
|
6527
41.5%
|
6582
41.8%
|
78222
41.3%
|
| Male |
8570
58.3%
|
8590
58.5%
|
6348
59.8%
|
6277
59.1%
|
5553
58.2%
|
5570
58.4%
|
14758
58.7%
|
14826
59%
|
11191
58.9%
|
11146
58.7%
|
9215
58.5%
|
9160
58.2%
|
111204
58.7%
|
| Race and Ethnicity Not Collected (Count of Participants) | |||||||||||||
| Count of Participants [Participants] |
0
0%
|
||||||||||||
Outcome Measures
| Title | Number of Participants With Major Adverse Cardiovascular Event |
|---|---|
| Description | 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) |
| Time Frame | Up to 5 years and 7 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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 |
| Arm/Group Title | Other DPP-4I - Clinformatics | Linagliptin 1 - Clinformatics | Pioglitazone - Clinformatics | Linagliptin 2 - Clinformatics | 2nd Gen SUs - Clinformatics | Linagliptin 3 - Clinformatics | Other DPP-4I - MarketScan | Linagliptin 1 - MarketScan | Pioglitazone - MarketScan | Linagliptin 2 - MarketScan | 2nd Gen SUs - MarketScan | Linagliptin 3 - MarketScan |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database |
| Measure Participants | 14688 | 14688 | 10614 | 10614 | 9538 | 9538 | 25135 | 25135 | 18996 | 18996 | 15742 | 15742 |
| Number [Participants] |
165
1.1%
|
151
1%
|
120
1.1%
|
102
1%
|
127
1.3%
|
82
0.9%
|
403
1.6%
|
369
1.5%
|
262
1.4%
|
270
1.4%
|
259
1.6%
|
194
1.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Other DPP-4I - Clinformatics, Linagliptin 1 - Clinformatics |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.82 | |
| Confidence Interval |
(2-Sided) 95% 0.66 to 1.03 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pioglitazone - Clinformatics, Linagliptin 2 - Clinformatics |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.85 | |
| Confidence Interval |
(2-Sided) 95% 0.65 to 1.10 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | 2nd Gen SUs - Clinformatics, Linagliptin 3 - Clinformatics |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.65 | |
| Confidence Interval |
(2-Sided) 95% 0.49 to 0.86 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Other DPP-4I - MarketScan, Linagliptin 1 - MarketScan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.95 | |
| Confidence Interval |
(2-Sided) 95% 0.83 to 1.10 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pioglitazone - MarketScan, Linagliptin 2 - MarketScan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.01 | |
| Confidence Interval |
(2-Sided) 95% 0.85 to 1.19 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | 2nd Gen SUs - MarketScan, Linagliptin 3 - MarketScan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.80 | |
| Confidence Interval |
(2-Sided) 95% 0.66 to 0.96 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Coronary Revascularization |
|---|---|
| Description | Number of participants with coronary revascularization (elective and non-elective procedure) |
| Time Frame | Up to 5 years and 7 month |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Other DPP-4I - Clinformatics | Linagliptin 1 - Clinformatics | Pioglitazone - Clinformatics | Linagliptin 2 - Clinformatics | 2nd Gen SUs - Clinformatics | Linagliptin 3 - Clinformatics | Other DPP-4I - MarketScan | Linagliptin 1 - MarketScan | Pioglitazone - MarketScan | Linagliptin 2 - MarketScan | 2nd Gen SUs - MarketScan | Linagliptin 3 - MarketScan |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database |
| Measure Participants | 14688 | 14688 | 10614 | 10614 | 9538 | 9538 | 25135 | 25135 | 18996 | 18996 | 15742 | 15742 |
| Number [Participants] |
82
0.6%
|
81
0.6%
|
67
0.6%
|
54
0.5%
|
67
0.7%
|
46
0.5%
|
181
0.7%
|
181
0.7%
|
129
0.7%
|
133
0.7%
|
125
0.8%
|
94
0.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Other DPP-4I - Clinformatics, Linagliptin 1 - Clinformatics |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.90 | |
| Confidence Interval |
(2-Sided) 95% 0.66 to 1.23 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pioglitazone - Clinformatics, Linagliptin 2 - Clinformatics |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.81 | |
| Confidence Interval |
(2-Sided) 95% 0.57 to 1.16 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | 2nd Gen SUs - Clinformatics, Linagliptin 3 - Clinformatics |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.70 | |
| Confidence Interval |
(2-Sided) 95% 0.48 to 1.01 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Other DPP-4I - MarketScan, Linagliptin 1 - MarketScan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.04 | |
| Confidence Interval |
(2-Sided) 95% 0.85 to 1.28 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pioglitazone - MarketScan, Linagliptin 2 - MarketScan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.01 | |
| Confidence Interval |
(2-Sided) 95% 0.79 to 1.28 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | 2nd Gen SUs - MarketScan, Linagliptin 3 - MarketScan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.81 | |
| Confidence Interval |
(2-Sided) 95% 0.62 to 1.06 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Acute Coronary Syndrome |
|---|---|
| Description | Number of participants with acute coronary syndrome (ACS). The definition for ACS included acute myocardial infarction (MI), but acute MI was not assessed separately. |
| Time Frame | Up to 5 years and 7 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Other DPP-4I - Clinformatics | Linagliptin 1 - Clinformatics | Pioglitazone - Clinformatics | Linagliptin 2 - Clinformatics | 2nd Gen SUs - Clinformatics | Linagliptin 3 - Clinformatics | Other DPP-4I - MarketScan | Linagliptin 1 - MarketScan | Pioglitazone - MarketScan | Linagliptin 2 - MarketScan | 2nd Gen SUs - MarketScan | Linagliptin 3 - MarketScan |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database |
| Measure Participants | 14688 | 14688 | 10614 | 10614 | 9538 | 9538 | 25135 | 25135 | 18996 | 18996 | 15742 | 15742 |
| Number [Participants] |
93
0.6%
|
72
0.5%
|
76
0.7%
|
48
0.5%
|
72
0.8%
|
43
0.5%
|
238
0.9%
|
221
0.9%
|
163
0.9%
|
160
0.8%
|
161
1%
|
115
0.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Other DPP-4I - Clinformatics, Linagliptin 1 - Clinformatics |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.69 | |
| Confidence Interval |
(2-Sided) 95% 0.51 to 0.94 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pioglitazone - Clinformatics, Linagliptin 2 - Clinformatics |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.63 | |
| Confidence Interval |
(2-Sided) 95% 0.44 to 0.90 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | 2nd Gen SUs - Clinformatics, Linagliptin 3 - Clinformatics |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.60 | |
| Confidence Interval |
(2-Sided) 95% 0.41 to 0.88 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Other DPP-4I - MarketScan, Linagliptin 1 - MarketScan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.97 | |
| Confidence Interval |
(2-Sided) 95% 0.81 to 1.17 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pioglitazone - MarketScan, Linagliptin 2 - MarketScan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.96 | |
| Confidence Interval |
(2-Sided) 95% 0.77 to 1.19 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | 2nd Gen SUs - MarketScan, Linagliptin 3 - MarketScan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.76 | |
| Confidence Interval |
(2-Sided) 95% 0.60 to 0.97 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Stroke |
|---|---|
| Description | Number of participants with ischemic or hemorrhagic stroke. Both types of stroke were included in the definition for stroke, but were not assessed separately |
| Time Frame | Up to 5 years and 7 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Other DPP-4I - Clinformatics | Linagliptin 1 - Clinformatics | Pioglitazone - Clinformatics | Linagliptin 2 - Clinformatics | 2nd Gen SUs - Clinformatics | Linagliptin 3 - Clinformatics | Other DPP-4I - MarketScan | Linagliptin 1 - MarketScan | Pioglitazone - MarketScan | Linagliptin 2 - MarketScan | 2nd Gen SUs - MarketScan | Linagliptin 3 - MarketScan |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database |
| Measure Participants | 14688 | 14688 | 10614 | 10614 | 9538 | 9538 | 25135 | 25135 | 18996 | 18996 | 15742 | 15742 |
| Number [Participants] |
42
0.3%
|
42
0.3%
|
30
0.3%
|
30
0.3%
|
37
0.4%
|
16
0.2%
|
113
0.4%
|
104
0.4%
|
66
0.3%
|
74
0.4%
|
76
0.5%
|
53
0.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Other DPP-4I - Clinformatics, Linagliptin 1 - Clinformatics |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.89 | |
| Confidence Interval |
(2-Sided) 95% 0.58 to 1.38 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pioglitazone - Clinformatics, Linagliptin 2 - Clinformatics |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.99 | |
| Confidence Interval |
(2-Sided) 95% 0.60 to 1.64 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | 2nd Gen SUs - Clinformatics, Linagliptin 3 - Clinformatics |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.44 | |
| Confidence Interval |
(2-Sided) 95% 0.24 to 0.78 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Other DPP-4I - MarketScan, Linagliptin 1 - MarketScan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.96 | |
| Confidence Interval |
(2-Sided) 95% 0.73 to 1.25 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pioglitazone - MarketScan, Linagliptin 2 - MarketScan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.09 | |
| Confidence Interval |
(2-Sided) 95% 0.78 to 1.52 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | 2nd Gen SUs - MarketScan, Linagliptin 3 - MarketScan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.74 | |
| Confidence Interval |
(2-Sided) 95% 0.52 to 1.05 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Heart Failure Hospitalization |
|---|---|
| Description | Number of participants with heart failure hospitalization |
| Time Frame | Up to 5 years and 7 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Other DPP-4I - Clinformatics | Linagliptin 1 - Clinformatics | Pioglitazone - Clinformatics | Linagliptin 2 - Clinformatics | 2nd Gen SUs - Clinformatics | Linagliptin 3 - Clinformatics | Other DPP-4I - MarketScan | Linagliptin 1 - MarketScan | Pioglitazone - MarketScan | Linagliptin 2 - MarketScan | 2nd Gen SUs - MarketScan | Linagliptin 3 - MarketScan |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database |
| Measure Participants | 14688 | 14688 | 10614 | 10614 | 9538 | 9538 | 25135 | 25135 | 18996 | 18996 | 15742 | 15742 |
| Number [Participants] |
53
0.4%
|
90
0.6%
|
27
0.3%
|
51
0.5%
|
43
0.5%
|
47
0.5%
|
117
0.5%
|
111
0.4%
|
58
0.3%
|
65
0.3%
|
66
0.4%
|
49
0.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Other DPP-4I - Clinformatics, Linagliptin 1 - Clinformatics |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.55 | |
| Confidence Interval |
(2-Sided) 95% 1.10 to 2.18 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pioglitazone - Clinformatics, Linagliptin 2 - Clinformatics |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.90 | |
| Confidence Interval |
(2-Sided) 95% 1.19 to 3.03 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | 2nd Gen SUs - Clinformatics, Linagliptin 3 - Clinformatics |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.11 | |
| Confidence Interval |
(2-Sided) 95% 0.73 to 1.68 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Other DPP-4I - MarketScan, Linagliptin 1 - MarketScan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.99 | |
| Confidence Interval |
(2-Sided) 95% 0.76 to 1.29 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pioglitazone - MarketScan, Linagliptin 2 - MarketScan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.10 | |
| Confidence Interval |
(2-Sided) 95% 0.77 to 1.56 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | 2nd Gen SUs - MarketScan, Linagliptin 3 - MarketScan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.79 | |
| Confidence Interval |
(2-Sided) 95% 0.54 to 1.14 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Incident End Stage Renal Disease |
|---|---|
| Description | Number of participants with incident end stage renal disease (ESRD) |
| Time Frame | Up to 5 years and 7 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Other DPP-4I - Clinformatics | Linagliptin 1 - Clinformatics | Pioglitazone - Clinformatics | Linagliptin 2 - Clinformatics | 2nd Gen SUs - Clinformatics | Linagliptin 3 - Clinformatics | Other DPP-4I - MarketScan | Linagliptin 1 - MarketScan | Pioglitazone - MarketScan | Linagliptin 2 - MarketScan | 2nd Gen SUs - MarketScan | Linagliptin 3 - MarketScan |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database |
| Measure Participants | 14472 | 14472 | 10467 | 10467 | 9422 | 9422 | 24714 | 24741 | 18689 | 18689 | 15500 | 15500 |
| Number [Participants] |
49
0.3%
|
75
0.5%
|
28
0.3%
|
48
0.5%
|
38
0.4%
|
43
0.5%
|
90
0.4%
|
116
0.5%
|
39
0.2%
|
61
0.3%
|
53
0.3%
|
57
0.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Other DPP-4I - Clinformatics, Linagliptin 1 - Clinformatics |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.40 | |
| Confidence Interval |
(2-Sided) 95% 0.97 to 2.00 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pioglitazone - Clinformatics, Linagliptin 2 - Clinformatics |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.71 | |
| Confidence Interval |
(2-Sided) 95% 1.07 to 2.72 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | 2nd Gen SUs - Clinformatics, Linagliptin 3 - Clinformatics |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.16 | |
| Confidence Interval |
(2-Sided) 95% 0.75 to 1.79 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Other DPP-4I - MarketScan, Linagliptin 1 - MarketScan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.34 | |
| Confidence Interval |
(2-Sided) 95% 1.01 to 1.76 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pioglitazone - MarketScan, Linagliptin 2 - MarketScan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.52 | |
| Confidence Interval |
(2-Sided) 95% 1.02 to 2.27 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | 2nd Gen SUs - MarketScan, Linagliptin 3 - MarketScan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.17 | |
| Confidence Interval |
(2-Sided) 95% 0.81 to 1.71 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Acute Renal Failure |
|---|---|
| Description | Number of participants with acute renal failure |
| Time Frame | Up to 5 years and 7 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Other DPP-4I - Clinformatics | Linagliptin 1 - Clinformatics | Pioglitazone - Clinformatics | Linagliptin 2 - Clinformatics | 2nd Gen SUs - Clinformatics | Linagliptin 3 - Clinformatics | Other DPP-4I - MarketScan | Linagliptin 1 - MarketScan | Pioglitazone - MarketScan | Linagliptin 2 - MarketScan | 2nd Gen SUs - MarketScan | Linagliptin 3 - MarketScan |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database |
| Measure Participants | 14688 | 14688 | 10614 | 10614 | 9538 | 9538 | 25135 | 25135 | 18996 | 18996 | 15742 | 15742 |
| Number [Participants] |
222
1.5%
|
300
2%
|
152
1.4%
|
198
1.9%
|
163
1.7%
|
167
1.8%
|
433
1.7%
|
430
1.7%
|
240
1.3%
|
263
1.4%
|
238
1.5%
|
200
1.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Other DPP-4I - Clinformatics, Linagliptin 1 - Clinformatics |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.24 | |
| Confidence Interval |
(2-Sided) 95% 1.04 to 1.47 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pioglitazone - Clinformatics, Linagliptin 2 - Clinformatics |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.31 | |
| Confidence Interval |
(2-Sided) 95% 1.06 to 1.61 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | 2nd Gen SUs - Clinformatics, Linagliptin 3 - Clinformatics |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.04 | |
| Confidence Interval |
(2-Sided) 95% 0.84 to 1.29 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Other DPP-4I - MarketScan, Linagliptin 1 - MarketScan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.04 | |
| Confidence Interval |
(2-Sided) 95% 0.91 to 1.19 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pioglitazone - MarketScan, Linagliptin 2 - MarketScan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.07 | |
| Confidence Interval |
(2-Sided) 95% 0.90 to 1.27 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | 2nd Gen SUs - MarketScan, Linagliptin 3 - MarketScan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.91 | |
| Confidence Interval |
(2-Sided) 95% 0.75 to 1.09 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Acute Renal Failure Requiring Dialysis |
|---|---|
| Description | Number of patients with acute renal failure requiring dialysis |
| Time Frame | Up to 5 years and 7 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Other DPP-4I - Clinformatics | Linagliptin 1 - Clinformatics | Pioglitazone - Clinformatics | Linagliptin 2 - Clinformatics | 2nd Gen SUs - Clinformatics | Linagliptin 3 - Clinformatics | Other DPP-4I - MarketScan | Linagliptin 1 - MarketScan | Pioglitazone - MarketScan | Linagliptin 2 - MarketScan | 2nd Gen SUs - MarketScan | Linagliptin 3 - MarketScan |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database |
| Measure Participants | 14688 | 14688 | 10614 | 10614 | 9538 | 9538 | 25135 | 25135 | 18996 | 18996 | 15742 | 15742 |
| Number [Participants] |
7
0%
|
13
0.1%
|
6
0.1%
|
10
0.1%
|
5
0.1%
|
9
0.1%
|
14
0.1%
|
16
0.1%
|
9
0%
|
9
0%
|
7
0%
|
11
0.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Other DPP-4I - Clinformatics, Linagliptin 1 - Clinformatics |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.62 | |
| Confidence Interval |
(2-Sided) 95% 0.64 to 4.06 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pioglitazone - Clinformatics, Linagliptin 2 - Clinformatics |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.67 | |
| Confidence Interval |
(2-Sided) 95% 0.61 to 4.58 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | 2nd Gen SUs - Clinformatics, Linagliptin 3 - Clinformatics |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.84 | |
| Confidence Interval |
(2-Sided) 95% 0.62 to 5.48 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Other DPP-4I - MarketScan, Linagliptin 1 - MarketScan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.17 | |
| Confidence Interval |
(2-Sided) 95% 0.57 to 2.40 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pioglitazone - MarketScan, Linagliptin 2 - MarketScan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.96 | |
| Confidence Interval |
(2-Sided) 95% 0.38 to 2.43 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | 2nd Gen SUs - MarketScan, Linagliptin 3 - MarketScan |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.65 | |
| Confidence Interval |
(2-Sided) 95% 0.64 to 4.27 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | As this is a non-interventional study with secondary use of data retrieved from a US health claims database, safety monitoring and safety reporting on an individual case level is not applicable. | |||||||||||||||||||||||
| Arm/Group Title | Other DPP-4I - Clinformatics | Linagliptin 1 - Clinformatics | Pioglitazone - Clinformatics | Linagliptin 2 - Clinformatics | 2nd Gen SUs - Clinformatics | Linagliptin 3 - Clinformatics | Other DPP-4I - MarketScan | Linagliptin 1 - MarketScan | Pioglitazone - MarketScan | Linagliptin 2 - MarketScan | 2nd Gen SUs - MarketScan | Linagliptin 3 - MarketScan | ||||||||||||
| Arm/Group Description | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database | 1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database | ||||||||||||
All Cause Mortality |
||||||||||||||||||||||||
| Other DPP-4I - Clinformatics | Linagliptin 1 - Clinformatics | Pioglitazone - Clinformatics | Linagliptin 2 - Clinformatics | 2nd Gen SUs - Clinformatics | Linagliptin 3 - Clinformatics | Other DPP-4I - MarketScan | Linagliptin 1 - MarketScan | Pioglitazone - MarketScan | Linagliptin 2 - MarketScan | 2nd Gen SUs - MarketScan | Linagliptin 3 - MarketScan | |||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||||||
Serious Adverse Events |
||||||||||||||||||||||||
| Other DPP-4I - Clinformatics | Linagliptin 1 - Clinformatics | Pioglitazone - Clinformatics | Linagliptin 2 - Clinformatics | 2nd Gen SUs - Clinformatics | Linagliptin 3 - Clinformatics | Other DPP-4I - MarketScan | Linagliptin 1 - MarketScan | Pioglitazone - MarketScan | Linagliptin 2 - MarketScan | 2nd Gen SUs - MarketScan | Linagliptin 3 - MarketScan | |||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||||||||||
| Other DPP-4I - Clinformatics | Linagliptin 1 - Clinformatics | Pioglitazone - Clinformatics | Linagliptin 2 - Clinformatics | 2nd Gen SUs - Clinformatics | Linagliptin 3 - Clinformatics | Other DPP-4I - MarketScan | Linagliptin 1 - MarketScan | Pioglitazone - MarketScan | Linagliptin 2 - MarketScan | 2nd Gen SUs - MarketScan | Linagliptin 3 - MarketScan | |||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||||||
Limitations/Caveats
Pioglitazone is contraindicated among patients with heart failure and edema. This suggests pioglitazone may not be a proper comparator in the assessment of the association between linagliptin and heart failure hospitalization or renal outcomes.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Boehringer Ingelheim, Call Centre |
|---|---|
| Organization | Boehringer Ingelheim |
| Phone | 1-800-243-0127 |
| clintriage.rdg@boehringer-ingelheim.com |
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02197078
Other Study ID Numbers:
- 1218.163
First Posted:
Jul 22, 2014
Last Update Posted:
Apr 2, 2020
Last Verified:
Mar 1, 2020