Trial Outcomes & Findings for Ascertainment of EMR-based Clinical Covariates Among Patients Receiving Oral and Non-insulin Injected Hypoglycemic Therapy (NCT NCT02140645)
NCT ID: NCT02140645
Last Updated: 2017-02-08
Results Overview
The missing EMR characteristic smoking defined as current, unknown, versus past/never smoker. The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic smoking was the dependent variable and all claims-based covariates were included as independent variables. The estimated value represented is actually prediction accuracy defined by C-statistics.
COMPLETED
166613 participants
Up to 20 months
2017-02-08
Participant Flow
Existing data cohort design using data from the MarketScan database from May 2011 through December 2012. 492963 potential patients were identified in the database, but after removing patients who violated inclusion and exclusion criteria 166613 patients were actually analysed in the study.
Participant milestones
| Measure |
Linagliptin 1
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
|
Any Other DPP-4
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
|
Linagliptin 2
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
|
Pioglitazone
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
|
Linagliptin 3
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
|
Second Generation Sulfonylurea
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5732
|
64695
|
4441
|
14363
|
3436
|
73946
|
|
Overall Study
COMPLETED
|
243
|
3041
|
205
|
530
|
150
|
3050
|
|
Overall Study
NOT COMPLETED
|
5489
|
61654
|
4236
|
13833
|
3286
|
70896
|
Reasons for withdrawal
| Measure |
Linagliptin 1
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
|
Any Other DPP-4
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
|
Linagliptin 2
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
|
Pioglitazone
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
|
Linagliptin 3
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
|
Second Generation Sulfonylurea
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
|
|---|---|---|---|---|---|---|
|
Overall Study
Not linked
|
5489
|
61654
|
4236
|
13833
|
3286
|
70896
|
Baseline Characteristics
Ascertainment of EMR-based Clinical Covariates Among Patients Receiving Oral and Non-insulin Injected Hypoglycemic Therapy
Baseline characteristics by cohort
| Measure |
Linagliptin 1
n=243 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
|
Any Other DPP-4
n=3041 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
|
Linagliptin 2
n=205 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
|
Pioglitazone
n=530 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
|
Linagliptin 3
n=150 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
|
Second Generation Sulfonylurea
n=3050 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
|
Total
n=7219 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
56.1 Years
STANDARD_DEVIATION 11.6 • n=99 Participants
|
54.8 Years
STANDARD_DEVIATION 11.2 • n=107 Participants
|
55.2 Years
STANDARD_DEVIATION 11.7 • n=206 Participants
|
54.7 Years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
54.7 Years
STANDARD_DEVIATION 11.8 • n=31 Participants
|
54.8 Years
STANDARD_DEVIATION 11.7 • n=30 Participants
|
54.9 Years
STANDARD_DEVIATION 11.5 • n=3 Participants
|
|
Gender
Female
|
118 Participants
n=99 Participants
|
1310 Participants
n=107 Participants
|
101 Participants
n=206 Participants
|
194 Participants
n=7 Participants
|
74 Participants
n=31 Participants
|
1332 Participants
n=30 Participants
|
3129 Participants
n=3 Participants
|
|
Gender
Male
|
125 Participants
n=99 Participants
|
1731 Participants
n=107 Participants
|
104 Participants
n=206 Participants
|
336 Participants
n=7 Participants
|
76 Participants
n=31 Participants
|
1718 Participants
n=30 Participants
|
4090 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Up to 20 monthsPopulation: All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.
The missing EMR characteristic smoking defined as current, unknown, versus past/never smoker. The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic smoking was the dependent variable and all claims-based covariates were included as independent variables. The estimated value represented is actually prediction accuracy defined by C-statistics.
Outcome measures
| Measure |
Linagliptin 1
n=243 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
|
Any Other DPP-4
n=3041 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
|
Linagliptin 2
n=205 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
|
Pioglitazone
n=530 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
|
Linagliptin 3
n=150 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
|
Second Generation Sulfonylurea
n=3050 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
|
|---|---|---|---|---|---|---|
|
Missing EMR (Electronic Medical Record) Characteristic: Smoking
Past
|
12.3 Percentage of participants
|
12.2 Percentage of participants
|
12.2 Percentage of participants
|
10.2 Percentage of participants
|
10.7 Percentage of participants
|
10.9 Percentage of participants
|
|
Missing EMR (Electronic Medical Record) Characteristic: Smoking
Current
|
9.1 Percentage of participants
|
7.6 Percentage of participants
|
10.7 Percentage of participants
|
7.9 Percentage of participants
|
11.3 Percentage of participants
|
9.4 Percentage of participants
|
|
Missing EMR (Electronic Medical Record) Characteristic: Smoking
Never
|
32.9 Percentage of participants
|
35.5 Percentage of participants
|
32.7 Percentage of participants
|
30.8 Percentage of participants
|
34.7 Percentage of participants
|
33.3 Percentage of participants
|
|
Missing EMR (Electronic Medical Record) Characteristic: Smoking
Unknown
|
5.8 Percentage of participants
|
4.9 Percentage of participants
|
6.3 Percentage of participants
|
5.1 Percentage of participants
|
6.0 Percentage of participants
|
6.5 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 20 monthsPopulation: All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.
The missing EMR characteristic duration of diabetes defined as \>7, 5-6, 3-5, 1-3, \<1 (in years) in duration. The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic duration of diabetes was the dependent variable and all claims-based covariates were included as independent variables. The estimated value represented is actually prediction accuracy defined by C-statistics.
Outcome measures
| Measure |
Linagliptin 1
n=243 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
|
Any Other DPP-4
n=3041 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
|
Linagliptin 2
n=205 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
|
Pioglitazone
n=530 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
|
Linagliptin 3
n=150 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
|
Second Generation Sulfonylurea
n=3050 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
|
|---|---|---|---|---|---|---|
|
Missing EMR Characteristic: Duration of Diabetes
1.00-2.99 years
|
11.5 Percentage of participants
|
14.2 Percentage of participants
|
11.2 Percentage of participants
|
10.0 Percentage of participants
|
12.7 Percentage of participants
|
13.6 Percentage of participants
|
|
Missing EMR Characteristic: Duration of Diabetes
7+ years
|
5.3 Percentage of participants
|
5.3 Percentage of participants
|
5.4 Percentage of participants
|
5.8 Percentage of participants
|
5.3 Percentage of participants
|
4.8 Percentage of participants
|
|
Missing EMR Characteristic: Duration of Diabetes
Less than 1 year
|
11.9 Percentage of participants
|
13.7 Percentage of participants
|
12.7 Percentage of participants
|
11.1 Percentage of participants
|
16.0 Percentage of participants
|
15.4 Percentage of participants
|
|
Missing EMR Characteristic: Duration of Diabetes
3.00-4.99 years
|
7.8 Percentage of participants
|
7.8 Percentage of participants
|
7.8 Percentage of participants
|
8.3 Percentage of participants
|
7.3 Percentage of participants
|
8.4 Percentage of participants
|
|
Missing EMR Characteristic: Duration of Diabetes
5.00-6.99 years
|
4.9 Percentage of participants
|
5.1 Percentage of participants
|
3.9 Percentage of participants
|
5.7 Percentage of participants
|
4.0 Percentage of participants
|
4.8 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 20 monthsPopulation: All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.
The missing EMR characteristic duration of diabetes defined as starting year/starting age of diabetes. Linear regression models were ran using a prioritized list of claims-based covariates as predictors and the value of select EMR-based clinical characteristics duration of diabetes as continuous outcomes. The estimated value represented is actually prediction accuracy defined by R-squared.
Outcome measures
| Measure |
Linagliptin 1
n=243 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
|
Any Other DPP-4
n=3041 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
|
Linagliptin 2
n=205 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
|
Pioglitazone
n=530 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
|
Linagliptin 3
n=150 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
|
Second Generation Sulfonylurea
n=3050 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
|
|---|---|---|---|---|---|---|
|
Missing EMR Characteristic: Duration of Diabetes (Continuous)
|
3.5 Months
Standard Deviation 3.7
|
3.1 Months
Standard Deviation 3.3
|
3.4 Months
Standard Deviation 3.7
|
3.5 Months
Standard Deviation 3.1
|
3.0 Months
Standard Deviation 3.4
|
2.9 Months
Standard Deviation 3.0
|
PRIMARY outcome
Timeframe: Up to 20 monthsPopulation: All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.
The missing EMR characteristic BMI defined as not obese, overweight, obese, severe obesity. The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic BMI was the dependent variable and all claims-based covariates were included as independent variables. The estimated value represented is actually prediction accuracy defined by C-statistics.
Outcome measures
| Measure |
Linagliptin 1
n=243 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
|
Any Other DPP-4
n=3041 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
|
Linagliptin 2
n=205 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
|
Pioglitazone
n=530 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
|
Linagliptin 3
n=150 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
|
Second Generation Sulfonylurea
n=3050 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
|
|---|---|---|---|---|---|---|
|
Missing EMR Characteristic: BMI (Body Mass Index)
Underweight
|
0.4 Percentage of participants
|
0.1 Percentage of participants
|
0.5 Percentage of participants
|
0.0 Percentage of participants
|
0.7 Percentage of participants
|
0.1 Percentage of participants
|
|
Missing EMR Characteristic: BMI (Body Mass Index)
Normal
|
2.1 Percentage of participants
|
3.9 Percentage of participants
|
2.0 Percentage of participants
|
3.4 Percentage of participants
|
2.7 Percentage of participants
|
4.0 Percentage of participants
|
|
Missing EMR Characteristic: BMI (Body Mass Index)
Overweight
|
11.5 Percentage of participants
|
11.8 Percentage of participants
|
13.7 Percentage of participants
|
15.5 Percentage of participants
|
10.7 Percentage of participants
|
14.0 Percentage of participants
|
|
Missing EMR Characteristic: BMI (Body Mass Index)
Obese
|
35.4 Percentage of participants
|
35.1 Percentage of participants
|
35.1 Percentage of participants
|
29.6 Percentage of participants
|
36.0 Percentage of participants
|
34.2 Percentage of participants
|
|
Missing EMR Characteristic: BMI (Body Mass Index)
Severe Obesity
|
16.5 Percentage of participants
|
15.5 Percentage of participants
|
16.1 Percentage of participants
|
10.9 Percentage of participants
|
16.0 Percentage of participants
|
15.4 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 20 monthsPopulation: All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.
The missing EMR characteristic BMI is BMI value. Linear regression models were ran using a prioritized list of claims-based covariates as predictors and the value of select EMR-based clinical characteristics BMI as continuous outcomes. The estimated value represented is actually prediction accuracy defined by R-squared.
Outcome measures
| Measure |
Linagliptin 1
n=243 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
|
Any Other DPP-4
n=3041 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
|
Linagliptin 2
n=205 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
|
Pioglitazone
n=530 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
|
Linagliptin 3
n=150 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
|
Second Generation Sulfonylurea
n=3050 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
|
|---|---|---|---|---|---|---|
|
Missing EMR Characteristic: BMI (Continuous)
|
36.3 Kg/m^2
Standard Deviation 8.5
|
35.5 Kg/m^2
Standard Deviation 8.0
|
36.1 Kg/m^2
Standard Deviation 8.8
|
34.2 Kg/m^2
Standard Deviation 7.0
|
36.6 Kg/m^2
Standard Deviation 9.2
|
35.1 Kg/m^2
Standard Deviation 7.8
|
PRIMARY outcome
Timeframe: Up to 20 monthsPopulation: All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.
The missing EMR characteristic HbA1c defined as value in 6 months prior to and including index date. The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic HbA1c was the dependent variable and all claims-based covariates were included as independent variables. The estimated value represented is actually prediction accuracy defined by C-statistics.
Outcome measures
| Measure |
Linagliptin 1
n=243 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
|
Any Other DPP-4
n=3041 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
|
Linagliptin 2
n=205 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
|
Pioglitazone
n=530 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
|
Linagliptin 3
n=150 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
|
Second Generation Sulfonylurea
n=3050 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
|
|---|---|---|---|---|---|---|
|
Missing EMR Characteristic: HbA1c (Hemoglobin A1c (Glycosylated Hemoglobin))
|
8.2 Percentage
Standard Deviation 1.4
|
8.6 Percentage
Standard Deviation 1.9
|
8.3 Percentage
Standard Deviation 1.4
|
9.0 Percentage
Standard Deviation 2.2
|
8.0 Percentage
Standard Deviation 1.5
|
8.8 Percentage
Standard Deviation 2.0
|
PRIMARY outcome
Timeframe: Upto 20 monthsPopulation: All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.
The missing EMR characteristic eGFR defined as value in 6 months prior to and including index date. The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic eGFR was the dependent variable and all claims-based covariates were included as independent variables. The estimated value represented is actually prediction accuracy defined by C-statistics.
Outcome measures
| Measure |
Linagliptin 1
n=243 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
|
Any Other DPP-4
n=3041 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
|
Linagliptin 2
n=205 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
|
Pioglitazone
n=530 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
|
Linagliptin 3
n=150 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
|
Second Generation Sulfonylurea
n=3050 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
|
|---|---|---|---|---|---|---|
|
Missing EMR Characteristic: eGFR (Glomerular Filtration Rate)
|
103.8 ml/min per 1.73 m^2
Standard Deviation 19.2
|
107.0 ml/min per 1.73 m^2
Standard Deviation 18.0
|
104.9 ml/min per 1.73 m^2
Standard Deviation 18.7
|
108.7 ml/min per 1.73 m^2
Standard Deviation 19.3
|
105.5 ml/min per 1.73 m^2
Standard Deviation 18.5
|
106.8 ml/min per 1.73 m^2
Standard Deviation 18.7
|
PRIMARY outcome
Timeframe: Up to 20 monthsPopulation: All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.
The missing EMR characteristic total cholesterol defined as value in 6 months prior to and including index date. The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic total cholesterol was the dependent variable and all claims-based covariates were included as independent variables. The estimated value represented is actually prediction accuracy defined by C-statistics.
Outcome measures
| Measure |
Linagliptin 1
n=243 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
|
Any Other DPP-4
n=3041 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
|
Linagliptin 2
n=205 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
|
Pioglitazone
n=530 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
|
Linagliptin 3
n=150 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
|
Second Generation Sulfonylurea
n=3050 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
|
|---|---|---|---|---|---|---|
|
Missing EMR Characteristic: Total Cholesterol
|
188.8 mg/dl
Standard Deviation 59.7
|
177.6 mg/dl
Standard Deviation 47.0
|
189.7 mg/dl
Standard Deviation 62.9
|
185.8 mg/dl
Standard Deviation 58.8
|
194.6 mg/dl
Standard Deviation 53.1
|
185.8 mg/dl
Standard Deviation 50.8
|
PRIMARY outcome
Timeframe: Up to 20 monthsPopulation: All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.
The missing EMR characteristic systolic BP defined as value in 6 months prior to and including index date. The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic systolic BP was the dependent variable and all claims-based covariates were included as independent variables. The estimated value represented is actually prediction accuracy defined by C-statistics.
Outcome measures
| Measure |
Linagliptin 1
n=243 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
|
Any Other DPP-4
n=3041 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
|
Linagliptin 2
n=205 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
|
Pioglitazone
n=530 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
|
Linagliptin 3
n=150 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
|
Second Generation Sulfonylurea
n=3050 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
|
|---|---|---|---|---|---|---|
|
Missing EMR Characteristic: Systolic BP (Blood Pressure)
|
130.2 mmHg
Standard Deviation 16.3
|
129.7 mmHg
Standard Deviation 15.7
|
131.0 mmHg
Standard Deviation 16.1
|
131.5 mmHg
Standard Deviation 17.2
|
131.2 mmHg
Standard Deviation 17.3
|
131.3 mmHg
Standard Deviation 17.0
|
PRIMARY outcome
Timeframe: Up to 20 monthsPopulation: All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.
The missing EMR characteristic diastolic BP defined as value in 6 months prior to and including index date. The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic diastolic BP was the dependent variable and all claims-based covariates were included as independent variables. The estimated value represented is actually prediction accuracy defined by C-statistics.
Outcome measures
| Measure |
Linagliptin 1
n=243 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
|
Any Other DPP-4
n=3041 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
|
Linagliptin 2
n=205 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
|
Pioglitazone
n=530 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
|
Linagliptin 3
n=150 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
|
Second Generation Sulfonylurea
n=3050 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
|
|---|---|---|---|---|---|---|
|
Missing EMR Characteristic: Diastolic BP
|
79.5 mmHg
Standard Deviation 10.6
|
78.8 mmHg
Standard Deviation 10.0
|
80.0 mmHg
Standard Deviation 10.2
|
79.3 mmHg
Standard Deviation 10.6
|
80.0 mmHg
Standard Deviation 10.5
|
79.6 mmHg
Standard Deviation 10.5
|
PRIMARY outcome
Timeframe: Up to 20 monthsPopulation: All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.
The missing EMR characteristic neuropathy defined as participants with any note of diabetic neuropathy. The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic neuropathy was the dependent variable and all claims-based covariates were included as independent variables. The estimated value represented is actually prediction accuracy defined by C-statistics.
Outcome measures
| Measure |
Linagliptin 1
n=243 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
|
Any Other DPP-4
n=3041 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
|
Linagliptin 2
n=205 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
|
Pioglitazone
n=530 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
|
Linagliptin 3
n=150 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
|
Second Generation Sulfonylurea
n=3050 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
|
|---|---|---|---|---|---|---|
|
Binary EMR Characteristic: Neuropathy
|
9.9 Percentage of participants
|
10.0 Percentage of participants
|
10.7 Percentage of participants
|
11.3 Percentage of participants
|
12.0 Percentage of participants
|
11.0 Percentage of participants
|
PRIMARY outcome
Timeframe: Upto 20 monthsPopulation: All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.
The missing EMR characteristic nephropathy defined as participants with any note of diabetic nephropathy. The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic nephropathy was the dependent variable and all claims-based covariates were included as independent variables. The estimated value represented is actually prediction accuracy defined by C-statistics.
Outcome measures
| Measure |
Linagliptin 1
n=243 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
|
Any Other DPP-4
n=3041 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
|
Linagliptin 2
n=205 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
|
Pioglitazone
n=530 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
|
Linagliptin 3
n=150 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
|
Second Generation Sulfonylurea
n=3050 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
|
|---|---|---|---|---|---|---|
|
Binary EMR Characteristic: Nephropathy
|
5.8 Percentage of participants
|
3.2 Percentage of participants
|
5.9 Percentage of participants
|
4.3 Percentage of participants
|
4.7 Percentage of participants
|
3.0 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 20 monthsPopulation: All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.
The missing EMR characteristic retinopathy defined as participants with any note of diabetic retinopathy. The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic retinopathy was the dependent variable and all claims-based covariates were included as independent variables. The estimated value represented is actually prediction accuracy defined by C-statistics.
Outcome measures
| Measure |
Linagliptin 1
n=243 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
|
Any Other DPP-4
n=3041 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
|
Linagliptin 2
n=205 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
|
Pioglitazone
n=530 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
|
Linagliptin 3
n=150 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
|
Second Generation Sulfonylurea
n=3050 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
|
|---|---|---|---|---|---|---|
|
Binary EMR Characteristic: Retinopathy
|
1.2 Percentage of participants
|
1.9 Percentage of participants
|
1.0 Percentage of participants
|
2.8 Percentage of participants
|
1.3 Percentage of participants
|
1.7 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 20 monthsPopulation: All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.
The missing EMR characteristic pancreatitis defined as participants with any note of prior pancreatitis. The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic pancreatitis was the dependent variable and all claims-based covariates were included as independent variables. The estimated value represented is actually prediction accuracy defined by C-statistics.
Outcome measures
| Measure |
Linagliptin 1
n=243 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
|
Any Other DPP-4
n=3041 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
|
Linagliptin 2
n=205 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
|
Pioglitazone
n=530 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
|
Linagliptin 3
n=150 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
|
Second Generation Sulfonylurea
n=3050 Participants
Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
|
|---|---|---|---|---|---|---|
|
Binary EMR Characteristic: Pancreatitis
|
0.8 Percentage of participants
|
0.5 Percentage of participants
|
1.0 Percentage of participants
|
0.2 Percentage of participants
|
0.7 Percentage of participants
|
0.5 Percentage of participants
|
Adverse Events
MarketScan
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim (BI)
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER