Trial · NCT02140645
Ascertainment of EMR-based Clinical Covariates Among Patients Receiving Oral and Non-insulin Injected Hypoglycemic Therapy
NCT02140645, Completed, Boehringer Ingelheim; results first posted 2017-02-08
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Ascertainment of EMR-based Clinical Covariates Among Patients Receiving Oral and Non-insulin Injected Hypoglycemic Therapy. Trials, record NCT02140645. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02140645
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ascertainment of EMR-based Clinical Covariates Among Patients Receiving Oral and Non-insulin Injected Hypoglycemic Therapy
- NCT number
- NCT02140645
- Status
- Completed
- Enrollment
- 166,613 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- linagliptin
- First posted
- 2014-05-16
- Last updated
- 2017-02-08
- Results first posted
- 2017-02-08
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Missing EMR (Electronic Medical Record) Characteristic: Smoking | Up to 20 months | 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. |
| Primary | Missing EMR Characteristic: Duration of Diabetes | Up to 20 months | 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. |
| Primary | Missing EMR Characteristic: Duration of Diabetes (Continuous) | Up to 20 months | 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. |
| Primary | Missing EMR Characteristic: BMI (Body Mass Index) | Up to 20 months | 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. |
| Primary | Missing EMR Characteristic: BMI (Continuous) | Up to 20 months | 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. |
| Primary | Missing EMR Characteristic: HbA1c (Hemoglobin A1c (Glycosylated Hemoglobin)) | Up to 20 months | 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. |
| Primary | Missing EMR Characteristic: eGFR (Glomerular Filtration Rate) | Upto 20 months | 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. |
| Primary | Missing EMR Characteristic: Total Cholesterol | Up to 20 months | 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. |
| Primary | Missing EMR Characteristic: Systolic BP (Blood Pressure) | Up to 20 months | 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. |
| Primary | Missing EMR Characteristic: Diastolic BP | Up to 20 months | 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Missing EMR (Electronic Medical Record) Characteristic: Smoking | Up to 20 months | All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available. | Percentage of participants | NUMBER |
| PRIMARY | Missing EMR Characteristic: Duration of Diabetes | Up to 20 months | All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available. | Percentage of participants | NUMBER |
| PRIMARY | Missing EMR Characteristic: Duration of Diabetes (Continuous) | Up to 20 months | All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available. | Months | MEAN |
| PRIMARY | Missing EMR Characteristic: BMI (Body Mass Index) | Up to 20 months | All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available. | Percentage of participants | NUMBER |
| PRIMARY | Missing EMR Characteristic: BMI (Continuous) | Up to 20 months | All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available. | Kg/m^2 | MEAN |
| PRIMARY | Missing EMR Characteristic: HbA1c (Hemoglobin A1c (Glycosylated Hemoglobin)) | Up to 20 months | All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available. | Percentage | MEAN |
| PRIMARY | Missing EMR Characteristic: eGFR (Glomerular Filtration Rate) | Upto 20 months | All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available. | ml/min per 1.73 m^2 | MEAN |
| PRIMARY | Missing EMR Characteristic: Total Cholesterol | Up to 20 months | All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available. | mg/dl | MEAN |
| PRIMARY | Missing EMR Characteristic: Systolic BP (Blood Pressure) | Up to 20 months | All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available. | mmHg | MEAN |
| PRIMARY | Missing EMR Characteristic: Diastolic BP | Up to 20 months | All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available. | mmHg | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group150
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Missing EMR (Electronic Medical Record) Characteristic: Smoking | Linagliptin 1 | Current | 9.1 | Percentage of participants | |
| Missing EMR (Electronic Medical Record) Characteristic: Smoking | Any Other DPP-4 | Current | 7.6 | Percentage of participants | |
| Missing EMR (Electronic Medical Record) Characteristic: Smoking | Linagliptin 2 | Current | 10.7 | Percentage of participants | |
| Missing EMR (Electronic Medical Record) Characteristic: Smoking | Pioglitazone | Current | 7.9 | Percentage of participants | |
| Missing EMR (Electronic Medical Record) Characteristic: Smoking | Linagliptin 3 | Current | 11.3 | Percentage of participants | |
| Missing EMR (Electronic Medical Record) Characteristic: Smoking | Second Generation Sulfonylurea | Current | 9.4 | Percentage of participants | |
| Missing EMR (Electronic Medical Record) Characteristic: Smoking | Linagliptin 1 | Past | 12.3 | Percentage of participants | |
| Missing EMR (Electronic Medical Record) Characteristic: Smoking | Any Other DPP-4 | Past | 12.2 | Percentage of participants | |
| Missing EMR (Electronic Medical Record) Characteristic: Smoking | Linagliptin 2 | Past | 12.2 | Percentage of participants | |
| Missing EMR (Electronic Medical Record) Characteristic: Smoking | Pioglitazone | Past | 10.2 | Percentage of participants |
1 to 10 of 150Source ClinicalTrials.gov
See all 150 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Linagliptin 1 | 5,732 | |
| Overall Study | STARTED | Any Other DPP-4 | 64,695 | |
| Overall Study | STARTED | Linagliptin 2 | 4,441 | |
| Overall Study | STARTED | Pioglitazone | 14,363 | |
| Overall Study | STARTED | Linagliptin 3 | 3,436 | |
| Overall Study | STARTED | Second Generation Sulfonylurea | 73,946 | |
| Overall Study | COMPLETED | Linagliptin 1 | 243 | |
| Overall Study | COMPLETED | Any Other DPP-4 | 3,041 | |
| Overall Study | COMPLETED | Linagliptin 2 | 205 | |
| Overall Study | COMPLETED | Pioglitazone | 530 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MarketScan | ||
| Total, other adverse events | MarketScan | 0 | 0 |
| Total, serious adverse events | MarketScan | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02140645
GET https://conductscience.org/api/trials/v1/NCT02140645/results?page=2