N/A
Completed N=166,613
Ascertainment of EMR-based Clinical Covariates Among Patients Receiving Oral and Non-insulin Injected Hypoglycemic Therapy
Source: ClinicalTrials.gov NCT02140645 ↗Enrolled (actual)
166,613
Serious AEs
—
Results posted
Feb 2017
Primary outcomePrimary: Missing EMR (Electronic Medical Record) Characteristic: Smoking — 9.1; 7.6; 10.7; 7.9 Percentage of participants
Summary
The objective of this study is to identify EMR-based clinical covariates and quantify their association with the prescribing of each specific type 2 diabetes (T2DM) medication under investigation. This will include an assessment of how well these covariates are captured through claims data proxies, and their potential to confound comparative research of T2DM medications.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Missing EMR (Electronic Medical Record) Characteristic: Smoking |
9.1; 7.6; 10.7; 7.9; 11.3; 9.4 | — |
| PRIMARY Missing EMR Characteristic: Duration of Diabetes |
11.9; 13.7; 12.7; 11.1; 16.0; 15.4 | — |
| PRIMARY Missing EMR Characteristic: Duration of Diabetes (Continuous) |
3.5; 3.1; 3.4; 3.5; 3.0; 2.9 | — |
| PRIMARY Missing EMR Characteristic: BMI (Body Mass Index) |
0.4; 0.1; 0.5; 0.0; 0.7; 0.1 | — |
| PRIMARY Missing EMR Characteristic: BMI (Continuous) |
36.3; 35.5; 36.1; 34.2; 36.6; 35.1 | — |
| PRIMARY Missing EMR Characteristic: HbA1c (Hemoglobin A1c (Glycosylated Hemoglobin)) |
8.2; 8.6; 8.3; 9.0; 8.0; 8.8 | — |
| PRIMARY Missing EMR Characteristic: eGFR (Glomerular Filtration Rate) |
103.8; 107.0; 104.9; 108.7; 105.5; 106.8 | — |
| PRIMARY Missing EMR Characteristic: Total Cholesterol |
188.8; 177.6; 189.7; 185.8; 194.6; 185.8 | — |
| PRIMARY Missing EMR Characteristic: Systolic BP (Blood Pressure) |
130.2; 129.7; 131.0; 131.5; 131.2; 131.3 | — |
| PRIMARY Missing EMR Characteristic: Diastolic BP |
79.5; 78.8; 80.0; 79.3; 80.0; 79.6 | — |
| PRIMARY Binary EMR Characteristic: Neuropathy |
9.9; 10.0; 10.7; 11.3; 12.0; 11.0 | — |
| PRIMARY Binary EMR Characteristic: Nephropathy |
5.8; 3.2; 5.9; 4.3; 4.7; 3.0 | — |
| PRIMARY Binary EMR Characteristic: Retinopathy |
1.2; 1.9; 1.0; 2.8; 1.3; 1.7 | — |
| PRIMARY Binary EMR Characteristic: Pancreatitis |
0.8; 0.5; 1.0; 0.2; 0.7; 0.5 | — |
Eligibility Criteria
Inclusion criteria
- Dispensing of an oral or non-insulin injected hypoglycemic medication between May 2011 and June 2012
- Diagnosis of type 2 diabetes mellitus
- Presence of electronic medical records (for the EMR-based subset)
Exclusion criteria
- Age <18 at T2DM medication initiation
- 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
- Prior use of the index drug
Data sourced from ClinicalTrials.gov (NCT02140645). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.