Trial Outcomes & Findings for Clinical Characteristics and Practice Patterns of Type 2 Diabetes Mellitus Patients Treated With OADs in Japan: Analysis of Medical and Health Care Database of the MDV (NCT NCT03092752)
NCT ID: NCT03092752
Last Updated: 2019-07-05
Results Overview
The date at which patients having their first prescription for any study drugs between 1st January 2014 and 30th September 2016 is defined as index date. Results observed were based on index dates used for comparing drugs between the classes. The reported data represent the number of time a prescription was written between 1st January 2014 and 30th September 2016.
Recruitment status
COMPLETED
Target enrollment
162116 participants
Primary outcome timeframe
From 1st January 2014 to 30th September 2016 (At index date)
Results posted on
2019-07-05
Participant Flow
This was a retrospective observational cohort study. The data was taken from Medical Data Vision (MDV) database for the duration from 1st January 2014 to 30th September 2016 .
The data of 523585 patients was available in the MDV database having a diagnosis of Type 2 Diabetes Mellitus (T2DM) of which data of 162116 eligible patients was included in this study.
Participant milestones
| Measure |
Oral Antibiotic Drugs
Patients with type 2 diabetes mellitus (T2DM) were treated with oral antibiotic drugs (OAD) such as Dipeptidyl-peptidase 4 inhibitors, sulfonylureas, biguanides, thiazolidinediones, α-glucosidase and glinides as per prescription in Japan.
|
|---|---|
|
Overall Study
STARTED
|
523585
|
|
Overall Study
COMPLETED
|
162116
|
|
Overall Study
NOT COMPLETED
|
361469
|
Reasons for withdrawal
| Measure |
Oral Antibiotic Drugs
Patients with type 2 diabetes mellitus (T2DM) were treated with oral antibiotic drugs (OAD) such as Dipeptidyl-peptidase 4 inhibitors, sulfonylureas, biguanides, thiazolidinediones, α-glucosidase and glinides as per prescription in Japan.
|
|---|---|
|
Overall Study
Aged <40 years
|
14209
|
|
Overall Study
At least one claim with T2DM
|
61299
|
|
Overall Study
Having no claim of study drugs
|
29282
|
|
Overall Study
Average hospital visit interval >92 days
|
10779
|
|
Overall Study
<6 month history
|
245900
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Oral Antibiotic Drugs
n=162116 Participants
Patients with type 2 diabetes mellitus (T2DM) were treated with oral antibiotic drugs (OAD) such as Dipeptidyl-peptidase 4 inhibitors, sulfonylureas, biguanides, thiazolidinediones, α-glucosidase and glinides as per prescription in Japan.
|
|---|---|
|
Age, Continuous
|
70.7 Years
STANDARD_DEVIATION 11.1 • n=162116 Participants
|
|
Sex: Female, Male
Female
|
63055 Participants
n=162116 Participants
|
|
Sex: Female, Male
Male
|
99061 Participants
n=162116 Participants
|
PRIMARY outcome
Timeframe: From 1st January 2014 to 30th September 2016 (At index date)Population: All index dates computed from patients included in the study were considered for this analysis. Some patients were prescribed for more than one study drug and thus we can observe more number of index dates than number of patients.
The date at which patients having their first prescription for any study drugs between 1st January 2014 and 30th September 2016 is defined as index date. Results observed were based on index dates used for comparing drugs between the classes. The reported data represent the number of time a prescription was written between 1st January 2014 and 30th September 2016.
Outcome measures
| Measure |
Group G1
n=162116 Participants
The group 1 (G1) contains patients (prescribed for OADs) with renal function stage as normal. Normal renal function stage is defined based on serum creatinine value for males between 0.6 milligram per deciLitre and 1.2 milligram per deciLitre and that for females is between 0.4 milligram per deciLitre and 0.9 milligram per deciLitre.
|
Group G2
The group 2 (G2) contains patients (prescribed for OADs) with renal function stage as mild. Mild renal function stage is defined based on serum creatinine value for males between 1.2 milligram per deciLitre and 1.4 milligram per deciLitre and that for females is between 0.9 milligram per deciLitre and 1.2 milligram per deciLitre.
|
Group G3
The group 3 (G3) contains patients (prescribed for OADs) with renal function stage as moderate. Moderate renal function stage is defined based on serum creatinine value for males between 1.4 milligram per deciLitre and 2.4 milligram per deciLitre and that for females is between 1.2 milligram per deciLitre and 2.0 milligram per deciLitre.
|
Group G4+
The group 4+ (G4+) contains patients (prescribed for OADs) with renal function stage as severe or end stage kidney disease (ESKD). Severe or ESKD renal function stage is defined based on serum creatinine value greater than 2.4 milligram per deciLitre for males and greater than 2.0 milligram per deciLitre for females.
|
Total
Total for all participants
|
Thiazolidinedione (TZD)
Patients with type 2 diabetes mellitus (T2DM) were treated with oral antibiotic drug (OAD), Thiazolidinediones (TZD), as per prescription in Japan.
|
Total
Total for all participants
|
|---|---|---|---|---|---|---|---|
|
Number of Index Dates
Dipeptidyl-peptidase 4 inhibitor (DPP4i)
|
91634 Number of Prescriptions
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Index Dates
Biguanides (BG)
|
33238 Number of Prescriptions
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Index Dates
Sulfonylurea (SU)
|
28211 Number of Prescriptions
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Index Dates
α-glucosidase (AGI)
|
26192 Number of Prescriptions
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Index Dates
Glinide
|
16787 Number of Prescriptions
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Index Dates
Thiazolidinedione (TZD)
|
10344 Number of Prescriptions
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From 1st January 2014 to 30th September 2016 (At index date)Population: All index dates computed from patients included in the study were considered for this analysis. Some patients were prescribed for more than one study drug and thus we can observe more number of index dates than number of patients.
Age of all patients in years calculated for index dates computed from patients in the database. Analysis was done based on index dates used for comparing drugs between the classes. The reported data represent the number of time a prescription was written between 1st January 2014 and 30th September 2016.
Outcome measures
| Measure |
Group G1
n=91634 Participants
The group 1 (G1) contains patients (prescribed for OADs) with renal function stage as normal. Normal renal function stage is defined based on serum creatinine value for males between 0.6 milligram per deciLitre and 1.2 milligram per deciLitre and that for females is between 0.4 milligram per deciLitre and 0.9 milligram per deciLitre.
|
Group G2
n=33238 Participants
The group 2 (G2) contains patients (prescribed for OADs) with renal function stage as mild. Mild renal function stage is defined based on serum creatinine value for males between 1.2 milligram per deciLitre and 1.4 milligram per deciLitre and that for females is between 0.9 milligram per deciLitre and 1.2 milligram per deciLitre.
|
Group G3
n=28211 Participants
The group 3 (G3) contains patients (prescribed for OADs) with renal function stage as moderate. Moderate renal function stage is defined based on serum creatinine value for males between 1.4 milligram per deciLitre and 2.4 milligram per deciLitre and that for females is between 1.2 milligram per deciLitre and 2.0 milligram per deciLitre.
|
Group G4+
n=26192 Participants
The group 4+ (G4+) contains patients (prescribed for OADs) with renal function stage as severe or end stage kidney disease (ESKD). Severe or ESKD renal function stage is defined based on serum creatinine value greater than 2.4 milligram per deciLitre for males and greater than 2.0 milligram per deciLitre for females.
|
Total
n=16787 Participants
Total for all participants
|
Thiazolidinedione (TZD)
n=10344 Participants
Patients with type 2 diabetes mellitus (T2DM) were treated with oral antibiotic drug (OAD), Thiazolidinediones (TZD), as per prescription in Japan.
|
Total
n=206406 Participants
Total for all participants
|
|---|---|---|---|---|---|---|---|
|
Age (Years)
|
71.6 Years
Standard Deviation 11
|
66.5 Years
Standard Deviation 11
|
72 Years
Standard Deviation 11.1
|
71.4 Years
Standard Deviation 10.8
|
71.4 Years
Standard Deviation 10.8
|
69.7 Years
Standard Deviation 11.4
|
70.7 Years
Standard Deviation 11.2
|
PRIMARY outcome
Timeframe: From 1st January 2014 to 30th September 2016 (At index date)Population: All index dates computed from patients included in the study were considered for this analysis. Some patients were prescribed for more than one study drug and thus we can observe more number of index dates than number of patients.
Gender of all patients observed for index dates computed from patients in the database. Results observed were based on index dates used for comparing drugs between the classes. The reported data represent the number of time a prescription was written between 1st January 2014 and 30th September 2016.
Outcome measures
| Measure |
Group G1
n=91634 Participants
The group 1 (G1) contains patients (prescribed for OADs) with renal function stage as normal. Normal renal function stage is defined based on serum creatinine value for males between 0.6 milligram per deciLitre and 1.2 milligram per deciLitre and that for females is between 0.4 milligram per deciLitre and 0.9 milligram per deciLitre.
|
Group G2
n=33238 Participants
The group 2 (G2) contains patients (prescribed for OADs) with renal function stage as mild. Mild renal function stage is defined based on serum creatinine value for males between 1.2 milligram per deciLitre and 1.4 milligram per deciLitre and that for females is between 0.9 milligram per deciLitre and 1.2 milligram per deciLitre.
|
Group G3
n=28211 Participants
The group 3 (G3) contains patients (prescribed for OADs) with renal function stage as moderate. Moderate renal function stage is defined based on serum creatinine value for males between 1.4 milligram per deciLitre and 2.4 milligram per deciLitre and that for females is between 1.2 milligram per deciLitre and 2.0 milligram per deciLitre.
|
Group G4+
n=26192 Participants
The group 4+ (G4+) contains patients (prescribed for OADs) with renal function stage as severe or end stage kidney disease (ESKD). Severe or ESKD renal function stage is defined based on serum creatinine value greater than 2.4 milligram per deciLitre for males and greater than 2.0 milligram per deciLitre for females.
|
Total
n=16787 Participants
Total for all participants
|
Thiazolidinedione (TZD)
n=10344 Participants
Patients with type 2 diabetes mellitus (T2DM) were treated with oral antibiotic drug (OAD), Thiazolidinediones (TZD), as per prescription in Japan.
|
Total
n=206406 Participants
Total for all participants
|
|---|---|---|---|---|---|---|---|
|
Sex (Male/Female)
Female
|
36018 Participants
|
12681 Participants
|
10940 Participants
|
9951 Participants
|
6549 Participants
|
3854 Participants
|
79993 Participants
|
|
Sex (Male/Female)
Male
|
55616 Participants
|
20557 Participants
|
17271 Participants
|
16241 Participants
|
10238 Participants
|
6490 Participants
|
126413 Participants
|
PRIMARY outcome
Timeframe: Within 6 months from index datePopulation: All index dates computed from patients with eGFR data included in the study were considered for this analysis. Some patients were prescribed for more than one study drug and thus we can observe more number of index dates than number of patients.
Estimated glomerular filtration rate (eGFR) was calculated based on the age at index date and the latest serum creatinine at index date (or during the observation period) using formula eGFR millilitre/minute/1.73 meter\^2 (mL/min/1.73 m\^2) = 194 × (Creatinine)\^-1.094 × (age in year)\^-0.287 (× 0.739 if female). Analysis was done based on index dates used for comparing drugs between the classes.
Outcome measures
| Measure |
Group G1
n=11446 Participants
The group 1 (G1) contains patients (prescribed for OADs) with renal function stage as normal. Normal renal function stage is defined based on serum creatinine value for males between 0.6 milligram per deciLitre and 1.2 milligram per deciLitre and that for females is between 0.4 milligram per deciLitre and 0.9 milligram per deciLitre.
|
Group G2
n=3523 Participants
The group 2 (G2) contains patients (prescribed for OADs) with renal function stage as mild. Mild renal function stage is defined based on serum creatinine value for males between 1.2 milligram per deciLitre and 1.4 milligram per deciLitre and that for females is between 0.9 milligram per deciLitre and 1.2 milligram per deciLitre.
|
Group G3
n=3274 Participants
The group 3 (G3) contains patients (prescribed for OADs) with renal function stage as moderate. Moderate renal function stage is defined based on serum creatinine value for males between 1.4 milligram per deciLitre and 2.4 milligram per deciLitre and that for females is between 1.2 milligram per deciLitre and 2.0 milligram per deciLitre.
|
Group G4+
n=3147 Participants
The group 4+ (G4+) contains patients (prescribed for OADs) with renal function stage as severe or end stage kidney disease (ESKD). Severe or ESKD renal function stage is defined based on serum creatinine value greater than 2.4 milligram per deciLitre for males and greater than 2.0 milligram per deciLitre for females.
|
Total
n=1890 Participants
Total for all participants
|
Thiazolidinedione (TZD)
n=1306 Participants
Patients with type 2 diabetes mellitus (T2DM) were treated with oral antibiotic drug (OAD), Thiazolidinediones (TZD), as per prescription in Japan.
|
Total
n=25386 Participants
Total for all participants
|
|---|---|---|---|---|---|---|---|
|
Estimated Glomerular Filtration Rate (eGFR)
|
63 millilitre/minute/1.73 meter^2
Standard Deviation 28.8
|
74 millilitre/minute/1.73 meter^2
Standard Deviation 23.9
|
67.4 millilitre/minute/1.73 meter^2
Standard Deviation 26.4
|
60.1 millilitre/minute/1.73 meter^2
Standard Deviation 29.4
|
59.5 millilitre/minute/1.73 meter^2
Standard Deviation 30.2
|
69.7 millilitre/minute/1.73 meter^2
Standard Deviation 23.7
|
65.2 millilitre/minute/1.73 meter^2
Standard Deviation 28.1
|
PRIMARY outcome
Timeframe: Within 6 months from index datePopulation: All index dates computed from patients with eGFR data included in the study were considered for this analysis. Some patients were prescribed for more than one study drug and thus we can observe more number of index dates than number of patients.
Renal impairment (RI) is a common complication in patients with type 2 diabetes mellitus (T2DM). Results observed were based on index dates used for comparing drugs between the classes.
Outcome measures
| Measure |
Group G1
n=11446 Participants
The group 1 (G1) contains patients (prescribed for OADs) with renal function stage as normal. Normal renal function stage is defined based on serum creatinine value for males between 0.6 milligram per deciLitre and 1.2 milligram per deciLitre and that for females is between 0.4 milligram per deciLitre and 0.9 milligram per deciLitre.
|
Group G2
n=4323 Participants
The group 2 (G2) contains patients (prescribed for OADs) with renal function stage as mild. Mild renal function stage is defined based on serum creatinine value for males between 1.2 milligram per deciLitre and 1.4 milligram per deciLitre and that for females is between 0.9 milligram per deciLitre and 1.2 milligram per deciLitre.
|
Group G3
n=3274 Participants
The group 3 (G3) contains patients (prescribed for OADs) with renal function stage as moderate. Moderate renal function stage is defined based on serum creatinine value for males between 1.4 milligram per deciLitre and 2.4 milligram per deciLitre and that for females is between 1.2 milligram per deciLitre and 2.0 milligram per deciLitre.
|
Group G4+
n=3147 Participants
The group 4+ (G4+) contains patients (prescribed for OADs) with renal function stage as severe or end stage kidney disease (ESKD). Severe or ESKD renal function stage is defined based on serum creatinine value greater than 2.4 milligram per deciLitre for males and greater than 2.0 milligram per deciLitre for females.
|
Total
n=1890 Participants
Total for all participants
|
Thiazolidinedione (TZD)
n=1306 Participants
Patients with type 2 diabetes mellitus (T2DM) were treated with oral antibiotic drug (OAD), Thiazolidinediones (TZD), as per prescription in Japan.
|
Total
n=25386 Participants
Total for all participants
|
|---|---|---|---|---|---|---|---|
|
Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level
90 < eGFR
|
1592 Participants
|
838 Participants
|
530 Participants
|
429 Participants
|
252 Participants
|
227 Participants
|
3868 Participants
|
|
Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level
60 < eGFR < 90
|
4877 Participants
|
2373 Participants
|
1446 Participants
|
1175 Participants
|
691 Participants
|
626 Participants
|
11188 Participants
|
|
Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level
30 < eGFR < 60
|
3566 Participants
|
1045 Participants
|
1090 Participants
|
1055 Participants
|
610 Participants
|
410 Participants
|
7776 Participants
|
|
Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level
eGFR < 30
|
1411 Participants
|
67 Participants
|
208 Participants
|
488 Participants
|
337 Participants
|
43 Participants
|
2554 Participants
|
PRIMARY outcome
Timeframe: On the index monthPopulation: All index dates computed from patients included in the study were considered for this analysis. Some patients were prescribed for more than one study drug and thus we can observe more number of index dates than number of patients.
Concomitant medication is the drug prescribed other than drug under study in the OAD class on index date. Results observed were based on index dates used for comparing drugs between the classes.
Outcome measures
| Measure |
Group G1
n=91634 Participants
The group 1 (G1) contains patients (prescribed for OADs) with renal function stage as normal. Normal renal function stage is defined based on serum creatinine value for males between 0.6 milligram per deciLitre and 1.2 milligram per deciLitre and that for females is between 0.4 milligram per deciLitre and 0.9 milligram per deciLitre.
|
Group G2
n=33238 Participants
The group 2 (G2) contains patients (prescribed for OADs) with renal function stage as mild. Mild renal function stage is defined based on serum creatinine value for males between 1.2 milligram per deciLitre and 1.4 milligram per deciLitre and that for females is between 0.9 milligram per deciLitre and 1.2 milligram per deciLitre.
|
Group G3
n=28211 Participants
The group 3 (G3) contains patients (prescribed for OADs) with renal function stage as moderate. Moderate renal function stage is defined based on serum creatinine value for males between 1.4 milligram per deciLitre and 2.4 milligram per deciLitre and that for females is between 1.2 milligram per deciLitre and 2.0 milligram per deciLitre.
|
Group G4+
n=26192 Participants
The group 4+ (G4+) contains patients (prescribed for OADs) with renal function stage as severe or end stage kidney disease (ESKD). Severe or ESKD renal function stage is defined based on serum creatinine value greater than 2.4 milligram per deciLitre for males and greater than 2.0 milligram per deciLitre for females.
|
Total
n=16787 Participants
Total for all participants
|
Thiazolidinedione (TZD)
n=10344 Participants
Patients with type 2 diabetes mellitus (T2DM) were treated with oral antibiotic drug (OAD), Thiazolidinediones (TZD), as per prescription in Japan.
|
Total
n=206406 Participants
Total for all participants
|
|---|---|---|---|---|---|---|---|
|
Percentage of Concomitant Medications by OAD Classes
Use of DPP-4 inhibitors (in %)
|
3 Percentage of Prescriptions
|
40 Percentage of Prescriptions
|
32 Percentage of Prescriptions
|
37 Percentage of Prescriptions
|
56 Percentage of Prescriptions
|
34 Percentage of Prescriptions
|
23 Percentage of Prescriptions
|
|
Percentage of Concomitant Medications by OAD Classes
Use of Biguanides (BG) (in %)
|
9 Percentage of Prescriptions
|
0 Percentage of Prescriptions
|
11 Percentage of Prescriptions
|
12 Percentage of Prescriptions
|
20 Percentage of Prescriptions
|
19 Percentage of Prescriptions
|
10 Percentage of Prescriptions
|
|
Percentage of Concomitant Medications by OAD Classes
Use of Sulfonylurea (SU) (in %)
|
9 Percentage of Prescriptions
|
17 Percentage of Prescriptions
|
1 Percentage of Prescriptions
|
13 Percentage of Prescriptions
|
4 Percentage of Prescriptions
|
21 Percentage of Prescriptions
|
10 Percentage of Prescriptions
|
|
Percentage of Concomitant Medications by OAD Classes
Use of α-glucosidase (AGI) (in %)
|
8 Percentage of Prescriptions
|
9 Percentage of Prescriptions
|
6 Percentage of Prescriptions
|
2 Percentage of Prescriptions
|
16 Percentage of Prescriptions
|
10 Percentage of Prescriptions
|
8 Percentage of Prescriptions
|
|
Percentage of Concomitant Medications by OAD Classes
Use of Glinide (in %)
|
2 Percentage of Prescriptions
|
3 Percentage of Prescriptions
|
1 Percentage of Prescriptions
|
4 Percentage of Prescriptions
|
4 Percentage of Prescriptions
|
4 Percentage of Prescriptions
|
3 Percentage of Prescriptions
|
|
Percentage of Concomitant Medications by OAD Classes
Use of Thiazolidinedione (TZD) (in %)
|
2 Percentage of Prescriptions
|
4 Percentage of Prescriptions
|
2 Percentage of Prescriptions
|
3 Percentage of Prescriptions
|
6 Percentage of Prescriptions
|
1 Percentage of Prescriptions
|
3 Percentage of Prescriptions
|
|
Percentage of Concomitant Medications by OAD Classes
Use of Insulin (in %)
|
27 Percentage of Prescriptions
|
23 Percentage of Prescriptions
|
25 Percentage of Prescriptions
|
31 Percentage of Prescriptions
|
37 Percentage of Prescriptions
|
24 Percentage of Prescriptions
|
27 Percentage of Prescriptions
|
PRIMARY outcome
Timeframe: On the index monthPopulation: All index dates computed from patients included in the study were considered for this analysis. Some patients were prescribed for more than one study drug and thus we can observe more number of index dates than number of patients.
Previous medication is the drug prescribed other than drug under study in the OAD class before index date. Results observed were based on index dates used for comparing drugs between the classes
Outcome measures
| Measure |
Group G1
n=91634 Participants
The group 1 (G1) contains patients (prescribed for OADs) with renal function stage as normal. Normal renal function stage is defined based on serum creatinine value for males between 0.6 milligram per deciLitre and 1.2 milligram per deciLitre and that for females is between 0.4 milligram per deciLitre and 0.9 milligram per deciLitre.
|
Group G2
n=33238 Participants
The group 2 (G2) contains patients (prescribed for OADs) with renal function stage as mild. Mild renal function stage is defined based on serum creatinine value for males between 1.2 milligram per deciLitre and 1.4 milligram per deciLitre and that for females is between 0.9 milligram per deciLitre and 1.2 milligram per deciLitre.
|
Group G3
n=28211 Participants
The group 3 (G3) contains patients (prescribed for OADs) with renal function stage as moderate. Moderate renal function stage is defined based on serum creatinine value for males between 1.4 milligram per deciLitre and 2.4 milligram per deciLitre and that for females is between 1.2 milligram per deciLitre and 2.0 milligram per deciLitre.
|
Group G4+
n=26192 Participants
The group 4+ (G4+) contains patients (prescribed for OADs) with renal function stage as severe or end stage kidney disease (ESKD). Severe or ESKD renal function stage is defined based on serum creatinine value greater than 2.4 milligram per deciLitre for males and greater than 2.0 milligram per deciLitre for females.
|
Total
n=16787 Participants
Total for all participants
|
Thiazolidinedione (TZD)
n=10344 Participants
Patients with type 2 diabetes mellitus (T2DM) were treated with oral antibiotic drug (OAD), Thiazolidinediones (TZD), as per prescription in Japan.
|
Total
n=206406 Participants
Total for all participants
|
|---|---|---|---|---|---|---|---|
|
Percentage of Previous Medications (Premedications) by OAD Classes.
Use of DPP4 inhibitors (in %)
|
0 Percentage of Prescriptions
|
3 Percentage of Prescriptions
|
2 Percentage of Prescriptions
|
1 Percentage of Prescriptions
|
3 Percentage of Prescriptions
|
8 Percentage of Prescriptions
|
1 Percentage of Prescriptions
|
|
Percentage of Previous Medications (Premedications) by OAD Classes.
Use of Biguanides (BG) (in %)
|
2 Percentage of Prescriptions
|
0 Percentage of Prescriptions
|
1 Percentage of Prescriptions
|
2 Percentage of Prescriptions
|
3 Percentage of Prescriptions
|
2 Percentage of Prescriptions
|
1 Percentage of Prescriptions
|
|
Percentage of Previous Medications (Premedications) by OAD Classes.
Use of Sulfonylurea (SU) (in %)
|
3 Percentage of Prescriptions
|
2 Percentage of Prescriptions
|
0 Percentage of Prescriptions
|
3 Percentage of Prescriptions
|
19 Percentage of Prescriptions
|
2 Percentage of Prescriptions
|
4 Percentage of Prescriptions
|
|
Percentage of Previous Medications (Premedications) by OAD Classes.
Use of α-glucosidase (AGI) (in %)
|
2 Percentage of Prescriptions
|
2 Percentage of Prescriptions
|
1 Percentage of Prescriptions
|
0 Percentage of Prescriptions
|
8 Percentage of Prescriptions
|
1 Percentage of Prescriptions
|
2 Percentage of Prescriptions
|
|
Percentage of Previous Medications (Premedications) by OAD Classes.
Use of Glinide (in %)
|
1 Percentage of Prescriptions
|
1 Percentage of Prescriptions
|
3 Percentage of Prescriptions
|
2 Percentage of Prescriptions
|
0 Percentage of Prescriptions
|
0 Percentage of Prescriptions
|
1 Percentage of Prescriptions
|
|
Percentage of Previous Medications (Premedications) by OAD Classes.
Use of Thiazolidinedione (TZD) (in %)
|
2 Percentage of Prescriptions
|
2 Percentage of Prescriptions
|
1 Percentage of Prescriptions
|
1 Percentage of Prescriptions
|
1 Percentage of Prescriptions
|
0 Percentage of Prescriptions
|
1 Percentage of Prescriptions
|
|
Percentage of Previous Medications (Premedications) by OAD Classes.
Use of Insulin (in%)
|
9 Percentage of Prescriptions
|
7 Percentage of Prescriptions
|
12 Percentage of Prescriptions
|
10 Percentage of Prescriptions
|
12 Percentage of Prescriptions
|
8 Percentage of Prescriptions
|
9 Percentage of Prescriptions
|
PRIMARY outcome
Timeframe: On the index monthPopulation: All index dates computed from patients included in the study were considered for this analysis. Some patients were prescribed for more than one study drug and thus we can observe more number of index dates than number of patients.
The additional diseases co-occuring, defined by International classification of Diseases, tenth revision (ICD-10) code. Results observed were based on index dates used for comparing drugs between the classes.
Outcome measures
| Measure |
Group G1
n=91634 Participants
The group 1 (G1) contains patients (prescribed for OADs) with renal function stage as normal. Normal renal function stage is defined based on serum creatinine value for males between 0.6 milligram per deciLitre and 1.2 milligram per deciLitre and that for females is between 0.4 milligram per deciLitre and 0.9 milligram per deciLitre.
|
Group G2
n=33238 Participants
The group 2 (G2) contains patients (prescribed for OADs) with renal function stage as mild. Mild renal function stage is defined based on serum creatinine value for males between 1.2 milligram per deciLitre and 1.4 milligram per deciLitre and that for females is between 0.9 milligram per deciLitre and 1.2 milligram per deciLitre.
|
Group G3
n=28211 Participants
The group 3 (G3) contains patients (prescribed for OADs) with renal function stage as moderate. Moderate renal function stage is defined based on serum creatinine value for males between 1.4 milligram per deciLitre and 2.4 milligram per deciLitre and that for females is between 1.2 milligram per deciLitre and 2.0 milligram per deciLitre.
|
Group G4+
n=26192 Participants
The group 4+ (G4+) contains patients (prescribed for OADs) with renal function stage as severe or end stage kidney disease (ESKD). Severe or ESKD renal function stage is defined based on serum creatinine value greater than 2.4 milligram per deciLitre for males and greater than 2.0 milligram per deciLitre for females.
|
Total
n=16787 Participants
Total for all participants
|
Thiazolidinedione (TZD)
n=10344 Participants
Patients with type 2 diabetes mellitus (T2DM) were treated with oral antibiotic drug (OAD), Thiazolidinediones (TZD), as per prescription in Japan.
|
Total
n=206406 Participants
Total for all participants
|
|---|---|---|---|---|---|---|---|
|
Percentage of Comorbidities by OAD Classes.
Hypertension (in %)
|
69 Percentage of Comorbidities
|
66 Percentage of Comorbidities
|
66 Percentage of Comorbidities
|
70 Percentage of Comorbidities
|
73 Percentage of Comorbidities
|
68 Percentage of Comorbidities
|
68 Percentage of Comorbidities
|
|
Percentage of Comorbidities by OAD Classes.
Ischemic heart disease (in %)
|
30 Percentage of Comorbidities
|
27 Percentage of Comorbidities
|
29 Percentage of Comorbidities
|
33 Percentage of Comorbidities
|
33 Percentage of Comorbidities
|
28 Percentage of Comorbidities
|
30 Percentage of Comorbidities
|
|
Percentage of Comorbidities by OAD Classes.
Myocardial infarction (in %)
|
14 Percentage of Comorbidities
|
13 Percentage of Comorbidities
|
14 Percentage of Comorbidities
|
15 Percentage of Comorbidities
|
14 Percentage of Comorbidities
|
12 Percentage of Comorbidities
|
14 Percentage of Comorbidities
|
|
Percentage of Comorbidities by OAD Classes.
Heart failure (in %)
|
25 Percentage of Comorbidities
|
19 Percentage of Comorbidities
|
23 Percentage of Comorbidities
|
27 Percentage of Comorbidities
|
28 Percentage of Comorbidities
|
19 Percentage of Comorbidities
|
24 Percentage of Comorbidities
|
|
Percentage of Comorbidities by OAD Classes.
Stroke (in %)
|
26 Percentage of Comorbidities
|
22 Percentage of Comorbidities
|
26 Percentage of Comorbidities
|
26 Percentage of Comorbidities
|
27 Percentage of Comorbidities
|
25 Percentage of Comorbidities
|
25 Percentage of Comorbidities
|
|
Percentage of Comorbidities by OAD Classes.
Renal impairment (in %)
|
19 Percentage of Comorbidities
|
10 Percentage of Comorbidities
|
14 Percentage of Comorbidities
|
23 Percentage of Comorbidities
|
26 Percentage of Comorbidities
|
11 Percentage of Comorbidities
|
18 Percentage of Comorbidities
|
|
Percentage of Comorbidities by OAD Classes.
Diabetic foot (in %)
|
9 Percentage of Comorbidities
|
8 Percentage of Comorbidities
|
9 Percentage of Comorbidities
|
10 Percentage of Comorbidities
|
14 Percentage of Comorbidities
|
8 Percentage of Comorbidities
|
9 Percentage of Comorbidities
|
SECONDARY outcome
Timeframe: Within 6 months from index datePopulation: All index dates computed from patients with eGFR data, included in the study were considered for this analysis. Some patients were prescribed for more than one study drug and thus we can observe more number of index dates than number of patients.
This outcome observes number of index dates for each class of OAD as per RI classes. RI classes were defined based on eGFR values. Results observed were based on index dates used for comparing drugs between the classes.
Outcome measures
| Measure |
Group G1
n=3868 Participants
The group 1 (G1) contains patients (prescribed for OADs) with renal function stage as normal. Normal renal function stage is defined based on serum creatinine value for males between 0.6 milligram per deciLitre and 1.2 milligram per deciLitre and that for females is between 0.4 milligram per deciLitre and 0.9 milligram per deciLitre.
|
Group G2
n=11188 Participants
The group 2 (G2) contains patients (prescribed for OADs) with renal function stage as mild. Mild renal function stage is defined based on serum creatinine value for males between 1.2 milligram per deciLitre and 1.4 milligram per deciLitre and that for females is between 0.9 milligram per deciLitre and 1.2 milligram per deciLitre.
|
Group G3
n=7776 Participants
The group 3 (G3) contains patients (prescribed for OADs) with renal function stage as moderate. Moderate renal function stage is defined based on serum creatinine value for males between 1.4 milligram per deciLitre and 2.4 milligram per deciLitre and that for females is between 1.2 milligram per deciLitre and 2.0 milligram per deciLitre.
|
Group G4+
n=2554 Participants
The group 4+ (G4+) contains patients (prescribed for OADs) with renal function stage as severe or end stage kidney disease (ESKD). Severe or ESKD renal function stage is defined based on serum creatinine value greater than 2.4 milligram per deciLitre for males and greater than 2.0 milligram per deciLitre for females.
|
Total
n=206406 Participants
Total for all participants
|
Thiazolidinedione (TZD)
Patients with type 2 diabetes mellitus (T2DM) were treated with oral antibiotic drug (OAD), Thiazolidinediones (TZD), as per prescription in Japan.
|
Total
Total for all participants
|
|---|---|---|---|---|---|---|---|
|
Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages
α-glucosidase (AGI)
|
429 Prescriptions
|
1175 Prescriptions
|
1055 Prescriptions
|
488 Prescriptions
|
3147 Prescriptions
|
—
|
—
|
|
Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages
DPP4 inhibitors
|
1592 Prescriptions
|
4877 Prescriptions
|
3566 Prescriptions
|
1411 Prescriptions
|
11446 Prescriptions
|
—
|
—
|
|
Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages
Biguanides (BG)
|
838 Prescriptions
|
2373 Prescriptions
|
1045 Prescriptions
|
67 Prescriptions
|
4323 Prescriptions
|
—
|
—
|
|
Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages
Sulfonylurea (SU)
|
530 Prescriptions
|
1446 Prescriptions
|
1090 Prescriptions
|
208 Prescriptions
|
3274 Prescriptions
|
—
|
—
|
|
Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages
Glinide
|
252 Prescriptions
|
691 Prescriptions
|
610 Prescriptions
|
337 Prescriptions
|
1890 Prescriptions
|
—
|
—
|
|
Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages
Thiazolidinedione (TZD)
|
227 Prescriptions
|
626 Prescriptions
|
410 Prescriptions
|
43 Prescriptions
|
1306 Prescriptions
|
—
|
—
|
Adverse Events
Dipeptidyl-peptidase 4 Inhibitor (DPP4i)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Biguanides (BG)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sulfonylurea (SU)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
α-glucosidase (AGI)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Glinide
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Thiazolidinedione (TZD)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place