Trial Outcomes & Findings for Real World Glycemic Effectiveness of Linagliptin (NCT NCT03338803)
NCT ID: NCT03338803
Last Updated: 2019-05-06
Results Overview
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.
COMPLETED
11001 participants
Baseline and 60 to 180 days
2019-05-06
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
11001
|
|
Overall Study
COMPLETED
|
11001
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Real World Glycemic Effectiveness of Linagliptin
Baseline characteristics by cohort
| Measure |
Patients With Written Prescription for Initiating Linagliptin
n=11001 Participants
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.
|
|---|---|
|
Age, Continuous
|
64.30 Years
STANDARD_DEVIATION 11.37 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5603 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5398 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
927 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9550 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
524 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
241 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1455 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8645 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
660 Participants
n=5 Participants
|
|
Estimated glomerular filtration rate (eGFR)
<30
|
679 participants
n=5 Participants
|
|
Estimated glomerular filtration rate (eGFR)
30 to 44
|
1646 participants
n=5 Participants
|
|
Estimated glomerular filtration rate (eGFR)
45 to 59
|
1727 participants
n=5 Participants
|
|
Estimated glomerular filtration rate (eGFR)
60 to 89
|
3256 participants
n=5 Participants
|
|
Estimated glomerular filtration rate (eGFR)
≥ 90
|
2603 participants
n=5 Participants
|
|
Estimated glomerular filtration rate (eGFR)
eGFR not available
|
1090 participants
n=5 Participants
|
|
Age categories
40 to 54 years
|
2325 participants
n=5 Participants
|
|
Age categories
55 to 64 years
|
3332 participants
n=5 Participants
|
|
Age categories
65 to 74 years
|
3077 participants
n=5 Participants
|
|
Age categories
75 years and above
|
2267 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 60 to 180 daysPopulation: Patients with a written prescription for linagliptin were identified during an identification period starting on 01 January 2012 and ending on 30 September 2016.
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.
Outcome measures
| Measure |
Patients With Written Prescription for Initiating Linagliptin
n=11001 Participants
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.
|
|---|---|
|
Change in Glycosylated Hemoglobin (HbA1c) Across Age Categories
Age 40 to 54 years
|
-0.65 Percentage (%)
Standard Deviation 1.65
|
|
Change in Glycosylated Hemoglobin (HbA1c) Across Age Categories
Age 75+ years
|
-0.36 Percentage (%)
Standard Deviation 1.21
|
|
Change in Glycosylated Hemoglobin (HbA1c) Across Age Categories
Overall
|
-0.51 Percentage (%)
Standard Deviation 1.46
|
|
Change in Glycosylated Hemoglobin (HbA1c) Across Age Categories
Age 55 to 64 years
|
-0.59 Percentage (%)
Standard Deviation 1.54
|
|
Change in Glycosylated Hemoglobin (HbA1c) Across Age Categories
Age 65 to 74 years
|
-0.43 Percentage (%)
Standard Deviation 1.36
|
PRIMARY outcome
Timeframe: Baseline and 60 to 180 daysPopulation: Patients with a written prescription for linagliptin were identified during an identification period starting on 01 January 2012 and ending on 30 September 2016.
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).
Outcome measures
| Measure |
Patients With Written Prescription for Initiating Linagliptin
n=11001 Participants
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.
|
|---|---|
|
Change in Glycosylated Hemoglobin (HbA1c) Across Renal Function Categories
Overall
|
-0.51 Percentage (%)
Standard Deviation 1.46
|
|
Change in Glycosylated Hemoglobin (HbA1c) Across Renal Function Categories
eGFR<30
|
-0.22 Percentage (%)
Standard Deviation 1.46
|
|
Change in Glycosylated Hemoglobin (HbA1c) Across Renal Function Categories
eGFR 30 to 44
|
-0.33 Percentage (%)
Standard Deviation 1.34
|
|
Change in Glycosylated Hemoglobin (HbA1c) Across Renal Function Categories
eGFR 45 to 59
|
-0.47 Percentage (%)
Standard Deviation 1.42
|
|
Change in Glycosylated Hemoglobin (HbA1c) Across Renal Function Categories
eGFR 60 to 89
|
-0.55 Percentage (%)
Standard Deviation 1.44
|
|
Change in Glycosylated Hemoglobin (HbA1c) Across Renal Function Categories
eGFR ≥ 90
|
-0.70 Percentage (%)
Standard Deviation 1.58
|
|
Change in Glycosylated Hemoglobin (HbA1c) Across Renal Function Categories
eGFR not available
|
-0.45 Percentage (%)
Standard Deviation 1.40
|
SECONDARY outcome
Timeframe: 60 to 180 daysPopulation: Patients with a written prescription for linagliptin were identified during an identification period starting on 01 January 2012 and ending on 30 September 2016.
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).
Outcome measures
| Measure |
Patients With Written Prescription for Initiating Linagliptin
n=11001 Participants
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.
|
|---|---|
|
Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across the Pre-defined Age Categories
Overall
|
35.72 Percentage of patients (%)
|
|
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 (%)
|
|
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 (%)
|
|
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 (%)
|
|
Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across the Pre-defined Age Categories
Age 75+ years
|
38.55 Percentage of patients (%)
|
SECONDARY outcome
Timeframe: 60 to 180 daysPopulation: Patients with a written prescription for linagliptin were identified during an identification period starting on 01 January 2012 and ending on 30 September 2016.
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).
Outcome measures
| Measure |
Patients With Written Prescription for Initiating Linagliptin
n=11001 Participants
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.
|
|---|---|
|
Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across Renal Function Categories
eGFR 30 to 44
|
38.88 Percentage of patients (%)
|
|
Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across Renal Function Categories
eGFR 45 to 59
|
40.19 Percentage of patients (%)
|
|
Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across Renal Function Categories
Overall
|
35.72 Percentage of patients (%)
|
|
Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across Renal Function Categories
eGFR<30
|
46.69 Percentage of patients (%)
|
|
Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across Renal Function Categories
eGFR 60 to 89
|
35.75 Percentage of patients (%)
|
|
Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across Renal Function Categories
eGFR ≥ 90
|
30.12 Percentage of patients (%)
|
|
Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across Renal Function Categories
eGFR not available
|
30.37 Percentage of patients (%)
|
Adverse Events
Patients With Written Prescription for Initiating Linagliptin
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Centre
Boehringer Ingelheim
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