Diabetes Mellitus, Type 2
Conditions
Brief summary
A non-interventional cohort study using existing data from patients in the Optum Clinical Database which contains electronic health record (EHR) data from providers across the United States to determine whether there is comparable effectiveness of linagliptin on glycemic effectiveness
Interventions
DRUGLinagliptin
drug
Sponsors
Eli Lilly and Company
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 1 written prescription for linagliptin (Tradjenta®, Jentadueto®, or Jentadueto XR®)in the EHR (electronic health record) data during the identification period * ≥ 40 years of age based on the year of the index date * First active date in the EHR is ≥ 180 days prior to the index date * ≥ 1 diagnosis code representing Type 2 diabetes (T2DM) in the EHR data during the 180-day pre-index period or on the index date * ≥ 1 HbA1c value during the 180-day pre-index period or on the index date * ≥ 1 HbA1c value 60 to 180 days after the index date
Exclusion criteria
* ≥ 1 written prescription, medication administration or medication history record for linagliptin or other dipeptidyl peptidase (DPP-4) inhibitor in the EHR data during the 180-day pre-index period * ≥ 1 written prescription or medication administration for a new antihyperglycemic medication other than linagliptin on the index date New antihyperglycemic medication will be defined as a written prescription or medication administration for any antihyperglycemic medication that was not present in the patient's written prescription, medication administration, or medication history records during the 180-day pre-index period. Individual antihyperglycemic medications will be distinguished by generic name using the column labelled Medication Name in Tables 2 through 13. Combination products containing two generic ingredients will be considered as two distinct antihyperglycemic medications Note: This exclusion criterion is designed to exclude patients from the study sample if they start a new antihyperglycemic medication other than linagliptin on the index date. Patients that start a new antihyperglycemic medication in the follow-up period will not be removed from the study sample to avoid creating a biased sample. Addition of a new antihyperglycemic medication during follow-up will be evaluated through the sensitivity analysis described in Section 9.7.4.4. While we will be capturing additions of new therapies, discontinuation of linagliptin is not able to be accurately measured in electronic record data. The electronic record data capture prescriptions written by a prescriber, but it is not possible to know if patients received and adhered to their medication and there are no structured data fields to identify if and when a medication was discontinued by the patient or the provider * ≥ 1 diagnosis code or procedure code representing renal transplant, solid organ transplant, or bone marrow transplant in the EHR data during the 180-day pre-index period or on the index date * ≥ 1 diagnosis code representing malignancy in the EHR data during the 180-day preindex period or on the index date
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycosylated Hemoglobin (HbA1c) Across Age Categories | Baseline and 60 to 180 days | Change in HbA1c among adults with type 2 diabetes mellitus (T2DM) within the 60 to 180 days following initiation of linagliptin across pre-defined age categories (40 to 54 years, 40 to 54 years, 65 to 74 years and 75+ years). Change in HbA1c, was calculated for each patient by subtracting the patient's last (most recent) HbA1c value during the pre-index period (including the index date) from the patient's last (most recent) HbA1c value 60 to 180 days after the index date. |
| Change in Glycosylated Hemoglobin (HbA1c) Across Renal Function Categories | Baseline and 60 to 180 days | Change in HbA1c among adults with type 2 diabetes mellitus (T2DM) within the 60 to 180 days following initiation of linagliptin across pre-defined renal function categories. Change in HbA1c, was calculated for each patient by subtracting the patient's last (most recent) HbA1c value during the pre-index period (including the index date) from the patient's last (most recent) HbA1c value 60 to 180 days after the index date. Renal function categories were presented based on patients with a pre-index estimated glomerular filtration rate (eGFR) value (eGFR\<30, eGFR 30 to 44, eGFR 45 to 59, eGFR 60 to 89, eGFR ≥ 90 milliliter/ minute/1.73 meter\^2 and eGFR not available). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across the Pre-defined Age Categories | 60 to 180 days | Percentage of adults with T2DM who achieve HbA1c \< 7.0% within the 60 to 180 days following initiation of linagliptin across pre-defined age categories (40 to 54 years, 40 to 54 years, 65 to 74 years and 75+ years). |
| Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across Renal Function Categories | 60 to 180 days | Percentage of adults with T2DM who achieve HbA1c \< 7.0% within the 60 to 180 days following initiation of linagliptin across pre-defined renal function categories. Renal function categories were presented based on patients with a pre-index estimated glomerular filtration rate (eGFR) value (eGFR\<30, eGFR 30 to 44, eGFR 45 to 59, eGFR 60 to 89, eGFR ≥ 90 milliliter/ minute /1.73 meter\^2 and eGFR not available). |
Countries
United States
Participant flow
Recruitment details
Non-interventional, retrospective cohort study using existing data from patients in the Optum Clinical Database which contains electronic health record (EHR) data for the period of 01 July 2011 through 31 March 2017.
Pre-assignment details
Type 2 diabetes mellitus (T2DM) patients with written prescription for initiating Linagliptin (Tradjenta®, Jentadueto®, or Jentadueto XR®) were identified during identification period starting on 01 January 2012 and ending on 30 September 2016. Aim was to describe real world glycemic-lowering effectiveness across range of ages and renal function.
Participants by arm
| Arm | Count |
|---|---|
| Patients With Written Prescription for Initiating Linagliptin Patients with a first written prescription for linagliptin were identified during an identification period starting on 01 January 2012 and ending on 30 September 2016. | 11,001 |
| Total | 11,001 |
Baseline characteristics
| Characteristic | Patients With Written Prescription for Initiating Linagliptin |
|---|---|
| Age categories 40 to 54 years | 2325 participants |
| Age categories 55 to 64 years | 3332 participants |
| Age categories 65 to 74 years | 3077 participants |
| Age categories 75 years and above | 2267 participants |
| Age, Continuous | 64.30 Years STANDARD_DEVIATION 11.37 |
| Estimated glomerular filtration rate (eGFR) <30 | 679 participants |
| Estimated glomerular filtration rate (eGFR) 30 to 44 | 1646 participants |
| Estimated glomerular filtration rate (eGFR) 45 to 59 | 1727 participants |
| Estimated glomerular filtration rate (eGFR) 60 to 89 | 3256 participants |
| Estimated glomerular filtration rate (eGFR) ≥ 90 | 2603 participants |
| Estimated glomerular filtration rate (eGFR) eGFR not available | 1090 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 927 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9550 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 524 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 241 Participants |
| Race (NIH/OMB) Black or African American | 1455 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 660 Participants |
| Race (NIH/OMB) White | 8645 Participants |
| Sex: Female, Male Female | 5603 Participants |
| Sex: Female, Male Male | 5398 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Change in Glycosylated Hemoglobin (HbA1c) Across Age Categories
Change in HbA1c among adults with type 2 diabetes mellitus (T2DM) within the 60 to 180 days following initiation of linagliptin across pre-defined age categories (40 to 54 years, 40 to 54 years, 65 to 74 years and 75+ years). Change in HbA1c, was calculated for each patient by subtracting the patient's last (most recent) HbA1c value during the pre-index period (including the index date) from the patient's last (most recent) HbA1c value 60 to 180 days after the index date.
Time frame: Baseline and 60 to 180 days
Population: Patients with a written prescription for linagliptin were identified during an identification period starting on 01 January 2012 and ending on 30 September 2016.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With Written Prescription for Initiating Linagliptin | Change in Glycosylated Hemoglobin (HbA1c) Across Age Categories | Overall | -0.51 Percentage (%) | Standard Deviation 1.46 |
| Patients With Written Prescription for Initiating Linagliptin | Change in Glycosylated Hemoglobin (HbA1c) Across Age Categories | Age 40 to 54 years | -0.65 Percentage (%) | Standard Deviation 1.65 |
| Patients With Written Prescription for Initiating Linagliptin | Change in Glycosylated Hemoglobin (HbA1c) Across Age Categories | Age 55 to 64 years | -0.59 Percentage (%) | Standard Deviation 1.54 |
| Patients With Written Prescription for Initiating Linagliptin | Change in Glycosylated Hemoglobin (HbA1c) Across Age Categories | Age 65 to 74 years | -0.43 Percentage (%) | Standard Deviation 1.36 |
| Patients With Written Prescription for Initiating Linagliptin | Change in Glycosylated Hemoglobin (HbA1c) Across Age Categories | Age 75+ years | -0.36 Percentage (%) | Standard Deviation 1.21 |
Primary
Change in Glycosylated Hemoglobin (HbA1c) Across Renal Function Categories
Change in HbA1c among adults with type 2 diabetes mellitus (T2DM) within the 60 to 180 days following initiation of linagliptin across pre-defined renal function categories. Change in HbA1c, was calculated for each patient by subtracting the patient's last (most recent) HbA1c value during the pre-index period (including the index date) from the patient's last (most recent) HbA1c value 60 to 180 days after the index date. Renal function categories were presented based on patients with a pre-index estimated glomerular filtration rate (eGFR) value (eGFR\<30, eGFR 30 to 44, eGFR 45 to 59, eGFR 60 to 89, eGFR ≥ 90 milliliter/ minute/1.73 meter\^2 and eGFR not available).
Time frame: Baseline and 60 to 180 days
Population: Patients with a written prescription for linagliptin were identified during an identification period starting on 01 January 2012 and ending on 30 September 2016.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With Written Prescription for Initiating Linagliptin | Change in Glycosylated Hemoglobin (HbA1c) Across Renal Function Categories | Overall | -0.51 Percentage (%) | Standard Deviation 1.46 |
| Patients With Written Prescription for Initiating Linagliptin | Change in Glycosylated Hemoglobin (HbA1c) Across Renal Function Categories | eGFR<30 | -0.22 Percentage (%) | Standard Deviation 1.46 |
| Patients With Written Prescription for Initiating Linagliptin | Change in Glycosylated Hemoglobin (HbA1c) Across Renal Function Categories | eGFR 30 to 44 | -0.33 Percentage (%) | Standard Deviation 1.34 |
| Patients With Written Prescription for Initiating Linagliptin | Change in Glycosylated Hemoglobin (HbA1c) Across Renal Function Categories | eGFR 45 to 59 | -0.47 Percentage (%) | Standard Deviation 1.42 |
| Patients With Written Prescription for Initiating Linagliptin | Change in Glycosylated Hemoglobin (HbA1c) Across Renal Function Categories | eGFR 60 to 89 | -0.55 Percentage (%) | Standard Deviation 1.44 |
| Patients With Written Prescription for Initiating Linagliptin | Change in Glycosylated Hemoglobin (HbA1c) Across Renal Function Categories | eGFR ≥ 90 | -0.70 Percentage (%) | Standard Deviation 1.58 |
| Patients With Written Prescription for Initiating Linagliptin | Change in Glycosylated Hemoglobin (HbA1c) Across Renal Function Categories | eGFR not available | -0.45 Percentage (%) | Standard Deviation 1.4 |
Secondary
Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across Renal Function Categories
Percentage of adults with T2DM who achieve HbA1c \< 7.0% within the 60 to 180 days following initiation of linagliptin across pre-defined renal function categories. Renal function categories were presented based on patients with a pre-index estimated glomerular filtration rate (eGFR) value (eGFR\<30, eGFR 30 to 44, eGFR 45 to 59, eGFR 60 to 89, eGFR ≥ 90 milliliter/ minute /1.73 meter\^2 and eGFR not available).
Time frame: 60 to 180 days
Population: Patients with a written prescription for linagliptin were identified during an identification period starting on 01 January 2012 and ending on 30 September 2016.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With Written Prescription for Initiating Linagliptin | Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across Renal Function Categories | Overall | 35.72 Percentage of patients (%) |
| Patients With Written Prescription for Initiating Linagliptin | Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across Renal Function Categories | eGFR<30 | 46.69 Percentage of patients (%) |
| Patients With Written Prescription for Initiating Linagliptin | Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across Renal Function Categories | eGFR 30 to 44 | 38.88 Percentage of patients (%) |
| Patients With Written Prescription for Initiating Linagliptin | Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across Renal Function Categories | eGFR 45 to 59 | 40.19 Percentage of patients (%) |
| Patients With Written Prescription for Initiating Linagliptin | Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across Renal Function Categories | eGFR 60 to 89 | 35.75 Percentage of patients (%) |
| Patients With Written Prescription for Initiating Linagliptin | Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across Renal Function Categories | eGFR ≥ 90 | 30.12 Percentage of patients (%) |
| Patients With Written Prescription for Initiating Linagliptin | Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across Renal Function Categories | eGFR not available | 30.37 Percentage of patients (%) |
Secondary
Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across the Pre-defined Age Categories
Percentage of adults with T2DM who achieve HbA1c \< 7.0% within the 60 to 180 days following initiation of linagliptin across pre-defined age categories (40 to 54 years, 40 to 54 years, 65 to 74 years and 75+ years).
Time frame: 60 to 180 days
Population: Patients with a written prescription for linagliptin were identified during an identification period starting on 01 January 2012 and ending on 30 September 2016.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With Written Prescription for Initiating Linagliptin | Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across the Pre-defined Age Categories | Overall | 35.72 Percentage of patients (%) |
| Patients With Written Prescription for Initiating Linagliptin | Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across the Pre-defined Age Categories | Age 40 to 54 years | 30.28 Percentage of patients (%) |
| Patients With Written Prescription for Initiating Linagliptin | Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across the Pre-defined Age Categories | Age 55 to 64 years | 35.59 Percentage of patients (%) |
| Patients With Written Prescription for Initiating Linagliptin | Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across the Pre-defined Age Categories | Age 65 to 74 years | 37.89 Percentage of patients (%) |
| Patients With Written Prescription for Initiating Linagliptin | Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across the Pre-defined Age Categories | Age 75+ years | 38.55 Percentage of patients (%) |