Diabetes Mellitus, Type 2
Conditions
Brief summary
Appropriate use of oral antidiabetic drugs (OADs) including dose-reduction is important for patient's safety in T2DM patients with renal impairment (RI). However, there are insufficient data on dose adjustment in accordance with the prescription pattern and the risk of RI of OADs, in particular Dipeptidyl-peptidase-4 inhibitors, in clinical practice in Japan. Therefore, we will investigate OADs usage conditions and dose selection in T2DM patients with RI in clinical practice in Japan
Interventions
DRUGoral antidiabetic drugs
OADs usage conditions and dose selection in T2DM patients
Sponsors
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
* Patients with T2DM (ICD code: E11 or E14). * Patients must have their first prescription (defined as index date\*) for any study drugs between 01/01/2014 and 30/09/2016. * Patients must have at least 6 months enrolment verified by the presence of any record except for the study drug prescriptions within the database (look back period) prior to the index date for each drug.
Exclusion criteria
* Patients who were under 40 years at the time of diagnosis of diabetes. * Patients with record of type 1 diabetes mellitus. * Patients who prescribed the study drugs during 6 month prior to index date for each drug. * Patients whose mean visit interval are more than 92 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Comorbidities by OAD Classes. | On the index month | 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. |
| Number of Index Dates | From 1st January 2014 to 30th September 2016 (At index date) | 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. |
| Age (Years) | From 1st January 2014 to 30th September 2016 (At index date) | 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. |
| Sex (Male/Female) | From 1st January 2014 to 30th September 2016 (At index date) | 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. |
| Estimated Glomerular Filtration Rate (eGFR) | Within 6 months from index date | 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. |
| Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level | Within 6 months from index date | 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. |
| Percentage of Concomitant Medications by OAD Classes | On the index month | 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. |
| Percentage of Previous Medications (Premedications) by OAD Classes. | On the index month | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages | Within 6 months from index date | 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. |
Countries
Japan
Participant flow
Recruitment details
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 .
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 162,116 |
| Total | 162,116 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | <6 month history | 245,900 |
| Overall Study | Aged <40 years | 14,209 |
| Overall Study | At least one claim with T2DM | 61,299 |
| Overall Study | Average hospital visit interval >92 days | 10,779 |
| Overall Study | Having no claim of study drugs | 29,282 |
Baseline characteristics
| Characteristic | Oral Antibiotic Drugs | — |
|---|---|---|
| Age, Continuous | 70.7 Years STANDARD_DEVIATION 11.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 63055 Participants | — |
| Sex: Female, Male Male | 99061 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Age (Years)
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group G1 | Age (Years) | 71.6 Years | Standard Deviation 11 |
| Group G2 | Age (Years) | 66.5 Years | Standard Deviation 11 |
| Group G3 | Age (Years) | 72 Years | Standard Deviation 11.1 |
| Group G4+ | Age (Years) | 71.4 Years | Standard Deviation 10.8 |
| Total | Age (Years) | 71.4 Years | Standard Deviation 10.8 |
| Thiazolidinedione (TZD) | Age (Years) | 69.7 Years | Standard Deviation 11.4 |
| Total | Age (Years) | 70.7 Years | Standard Deviation 11.2 |
Primary
Estimated Glomerular Filtration Rate (eGFR)
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.
Time frame: Within 6 months from index date
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group G1 | Estimated Glomerular Filtration Rate (eGFR) | 63 millilitre/minute/1.73 meter^2 | Standard Deviation 28.8 |
| Group G2 | Estimated Glomerular Filtration Rate (eGFR) | 74 millilitre/minute/1.73 meter^2 | Standard Deviation 23.9 |
| Group G3 | Estimated Glomerular Filtration Rate (eGFR) | 67.4 millilitre/minute/1.73 meter^2 | Standard Deviation 26.4 |
| Group G4+ | Estimated Glomerular Filtration Rate (eGFR) | 60.1 millilitre/minute/1.73 meter^2 | Standard Deviation 29.4 |
| Total | Estimated Glomerular Filtration Rate (eGFR) | 59.5 millilitre/minute/1.73 meter^2 | Standard Deviation 30.2 |
| Thiazolidinedione (TZD) | Estimated Glomerular Filtration Rate (eGFR) | 69.7 millilitre/minute/1.73 meter^2 | Standard Deviation 23.7 |
| Total | Estimated Glomerular Filtration Rate (eGFR) | 65.2 millilitre/minute/1.73 meter^2 | Standard Deviation 28.1 |
Primary
Number of Index Dates
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group G1 | Number of Index Dates | Dipeptidyl-peptidase 4 inhibitor (DPP4i) | 91634 Number of Prescriptions |
| Group G1 | Number of Index Dates | Biguanides (BG) | 33238 Number of Prescriptions |
| Group G1 | Number of Index Dates | Sulfonylurea (SU) | 28211 Number of Prescriptions |
| Group G1 | Number of Index Dates | α-glucosidase (AGI) | 26192 Number of Prescriptions |
| Group G1 | Number of Index Dates | Glinide | 16787 Number of Prescriptions |
| Group G1 | Number of Index Dates | Thiazolidinedione (TZD) | 10344 Number of Prescriptions |
Primary
Percentage of Comorbidities by OAD Classes.
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.
Time frame: On the index month
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group G1 | Percentage of Comorbidities by OAD Classes. | Heart failure (in %) | 25 Percentage of Comorbidities |
| Group G1 | Percentage of Comorbidities by OAD Classes. | Diabetic foot (in %) | 9 Percentage of Comorbidities |
| Group G1 | Percentage of Comorbidities by OAD Classes. | Hypertension (in %) | 69 Percentage of Comorbidities |
| Group G1 | Percentage of Comorbidities by OAD Classes. | Renal impairment (in %) | 19 Percentage of Comorbidities |
| Group G1 | Percentage of Comorbidities by OAD Classes. | Stroke (in %) | 26 Percentage of Comorbidities |
| Group G1 | Percentage of Comorbidities by OAD Classes. | Myocardial infarction (in %) | 14 Percentage of Comorbidities |
| Group G1 | Percentage of Comorbidities by OAD Classes. | Ischemic heart disease (in %) | 30 Percentage of Comorbidities |
| Group G2 | Percentage of Comorbidities by OAD Classes. | Hypertension (in %) | 66 Percentage of Comorbidities |
| Group G2 | Percentage of Comorbidities by OAD Classes. | Stroke (in %) | 22 Percentage of Comorbidities |
| Group G2 | Percentage of Comorbidities by OAD Classes. | Renal impairment (in %) | 10 Percentage of Comorbidities |
| Group G2 | Percentage of Comorbidities by OAD Classes. | Diabetic foot (in %) | 8 Percentage of Comorbidities |
| Group G2 | Percentage of Comorbidities by OAD Classes. | Ischemic heart disease (in %) | 27 Percentage of Comorbidities |
| Group G2 | Percentage of Comorbidities by OAD Classes. | Myocardial infarction (in %) | 13 Percentage of Comorbidities |
| Group G2 | Percentage of Comorbidities by OAD Classes. | Heart failure (in %) | 19 Percentage of Comorbidities |
| Group G3 | Percentage of Comorbidities by OAD Classes. | Heart failure (in %) | 23 Percentage of Comorbidities |
| Group G3 | Percentage of Comorbidities by OAD Classes. | Stroke (in %) | 26 Percentage of Comorbidities |
| Group G3 | Percentage of Comorbidities by OAD Classes. | Hypertension (in %) | 66 Percentage of Comorbidities |
| Group G3 | Percentage of Comorbidities by OAD Classes. | Ischemic heart disease (in %) | 29 Percentage of Comorbidities |
| Group G3 | Percentage of Comorbidities by OAD Classes. | Diabetic foot (in %) | 9 Percentage of Comorbidities |
| Group G3 | Percentage of Comorbidities by OAD Classes. | Myocardial infarction (in %) | 14 Percentage of Comorbidities |
| Group G3 | Percentage of Comorbidities by OAD Classes. | Renal impairment (in %) | 14 Percentage of Comorbidities |
| Group G4+ | Percentage of Comorbidities by OAD Classes. | Renal impairment (in %) | 23 Percentage of Comorbidities |
| Group G4+ | Percentage of Comorbidities by OAD Classes. | Myocardial infarction (in %) | 15 Percentage of Comorbidities |
| Group G4+ | Percentage of Comorbidities by OAD Classes. | Heart failure (in %) | 27 Percentage of Comorbidities |
| Group G4+ | Percentage of Comorbidities by OAD Classes. | Hypertension (in %) | 70 Percentage of Comorbidities |
| Group G4+ | Percentage of Comorbidities by OAD Classes. | Ischemic heart disease (in %) | 33 Percentage of Comorbidities |
| Group G4+ | Percentage of Comorbidities by OAD Classes. | Stroke (in %) | 26 Percentage of Comorbidities |
| Group G4+ | Percentage of Comorbidities by OAD Classes. | Diabetic foot (in %) | 10 Percentage of Comorbidities |
| Total | Percentage of Comorbidities by OAD Classes. | Stroke (in %) | 27 Percentage of Comorbidities |
| Total | Percentage of Comorbidities by OAD Classes. | Renal impairment (in %) | 26 Percentage of Comorbidities |
| Total | Percentage of Comorbidities by OAD Classes. | Hypertension (in %) | 73 Percentage of Comorbidities |
| Total | Percentage of Comorbidities by OAD Classes. | Ischemic heart disease (in %) | 33 Percentage of Comorbidities |
| Total | Percentage of Comorbidities by OAD Classes. | Myocardial infarction (in %) | 14 Percentage of Comorbidities |
| Total | Percentage of Comorbidities by OAD Classes. | Heart failure (in %) | 28 Percentage of Comorbidities |
| Total | Percentage of Comorbidities by OAD Classes. | Diabetic foot (in %) | 14 Percentage of Comorbidities |
| Thiazolidinedione (TZD) | Percentage of Comorbidities by OAD Classes. | Renal impairment (in %) | 11 Percentage of Comorbidities |
| Thiazolidinedione (TZD) | Percentage of Comorbidities by OAD Classes. | Diabetic foot (in %) | 8 Percentage of Comorbidities |
| Thiazolidinedione (TZD) | Percentage of Comorbidities by OAD Classes. | Hypertension (in %) | 68 Percentage of Comorbidities |
| Thiazolidinedione (TZD) | Percentage of Comorbidities by OAD Classes. | Ischemic heart disease (in %) | 28 Percentage of Comorbidities |
| Thiazolidinedione (TZD) | Percentage of Comorbidities by OAD Classes. | Myocardial infarction (in %) | 12 Percentage of Comorbidities |
| Thiazolidinedione (TZD) | Percentage of Comorbidities by OAD Classes. | Heart failure (in %) | 19 Percentage of Comorbidities |
| Thiazolidinedione (TZD) | Percentage of Comorbidities by OAD Classes. | Stroke (in %) | 25 Percentage of Comorbidities |
| Total | Percentage of Comorbidities by OAD Classes. | Stroke (in %) | 25 Percentage of Comorbidities |
| Total | Percentage of Comorbidities by OAD Classes. | Renal impairment (in %) | 18 Percentage of Comorbidities |
| Total | Percentage of Comorbidities by OAD Classes. | Heart failure (in %) | 24 Percentage of Comorbidities |
| Total | Percentage of Comorbidities by OAD Classes. | Myocardial infarction (in %) | 14 Percentage of Comorbidities |
| Total | Percentage of Comorbidities by OAD Classes. | Ischemic heart disease (in %) | 30 Percentage of Comorbidities |
| Total | Percentage of Comorbidities by OAD Classes. | Hypertension (in %) | 68 Percentage of Comorbidities |
| Total | Percentage of Comorbidities by OAD Classes. | Diabetic foot (in %) | 9 Percentage of Comorbidities |
Primary
Percentage of Concomitant Medications by OAD Classes
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.
Time frame: On the index month
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group G1 | Percentage of Concomitant Medications by OAD Classes | Use of Sulfonylurea (SU) (in %) | 9 Percentage of Prescriptions |
| Group G1 | Percentage of Concomitant Medications by OAD Classes | Use of DPP-4 inhibitors (in %) | 3 Percentage of Prescriptions |
| Group G1 | Percentage of Concomitant Medications by OAD Classes | Use of Biguanides (BG) (in %) | 9 Percentage of Prescriptions |
| Group G1 | Percentage of Concomitant Medications by OAD Classes | Use of Insulin (in %) | 27 Percentage of Prescriptions |
| Group G1 | Percentage of Concomitant Medications by OAD Classes | Use of Thiazolidinedione (TZD) (in %) | 2 Percentage of Prescriptions |
| Group G1 | Percentage of Concomitant Medications by OAD Classes | Use of Glinide (in %) | 2 Percentage of Prescriptions |
| Group G1 | Percentage of Concomitant Medications by OAD Classes | Use of α-glucosidase (AGI) (in %) | 8 Percentage of Prescriptions |
| Group G2 | Percentage of Concomitant Medications by OAD Classes | Use of Biguanides (BG) (in %) | 0 Percentage of Prescriptions |
| Group G2 | Percentage of Concomitant Medications by OAD Classes | Use of Glinide (in %) | 3 Percentage of Prescriptions |
| Group G2 | Percentage of Concomitant Medications by OAD Classes | Use of DPP-4 inhibitors (in %) | 40 Percentage of Prescriptions |
| Group G2 | Percentage of Concomitant Medications by OAD Classes | Use of Sulfonylurea (SU) (in %) | 17 Percentage of Prescriptions |
| Group G2 | Percentage of Concomitant Medications by OAD Classes | Use of α-glucosidase (AGI) (in %) | 9 Percentage of Prescriptions |
| Group G2 | Percentage of Concomitant Medications by OAD Classes | Use of Thiazolidinedione (TZD) (in %) | 4 Percentage of Prescriptions |
| Group G2 | Percentage of Concomitant Medications by OAD Classes | Use of Insulin (in %) | 23 Percentage of Prescriptions |
| Group G3 | Percentage of Concomitant Medications by OAD Classes | Use of Thiazolidinedione (TZD) (in %) | 2 Percentage of Prescriptions |
| Group G3 | Percentage of Concomitant Medications by OAD Classes | Use of Glinide (in %) | 1 Percentage of Prescriptions |
| Group G3 | Percentage of Concomitant Medications by OAD Classes | Use of α-glucosidase (AGI) (in %) | 6 Percentage of Prescriptions |
| Group G3 | Percentage of Concomitant Medications by OAD Classes | Use of DPP-4 inhibitors (in %) | 32 Percentage of Prescriptions |
| Group G3 | Percentage of Concomitant Medications by OAD Classes | Use of Biguanides (BG) (in %) | 11 Percentage of Prescriptions |
| Group G3 | Percentage of Concomitant Medications by OAD Classes | Use of Insulin (in %) | 25 Percentage of Prescriptions |
| Group G3 | Percentage of Concomitant Medications by OAD Classes | Use of Sulfonylurea (SU) (in %) | 1 Percentage of Prescriptions |
| Group G4+ | Percentage of Concomitant Medications by OAD Classes | Use of Glinide (in %) | 4 Percentage of Prescriptions |
| Group G4+ | Percentage of Concomitant Medications by OAD Classes | Use of DPP-4 inhibitors (in %) | 37 Percentage of Prescriptions |
| Group G4+ | Percentage of Concomitant Medications by OAD Classes | Use of Insulin (in %) | 31 Percentage of Prescriptions |
| Group G4+ | Percentage of Concomitant Medications by OAD Classes | Use of Sulfonylurea (SU) (in %) | 13 Percentage of Prescriptions |
| Group G4+ | Percentage of Concomitant Medications by OAD Classes | Use of α-glucosidase (AGI) (in %) | 2 Percentage of Prescriptions |
| Group G4+ | Percentage of Concomitant Medications by OAD Classes | Use of Biguanides (BG) (in %) | 12 Percentage of Prescriptions |
| Group G4+ | Percentage of Concomitant Medications by OAD Classes | Use of Thiazolidinedione (TZD) (in %) | 3 Percentage of Prescriptions |
| Total | Percentage of Concomitant Medications by OAD Classes | Use of Sulfonylurea (SU) (in %) | 4 Percentage of Prescriptions |
| Total | Percentage of Concomitant Medications by OAD Classes | Use of DPP-4 inhibitors (in %) | 56 Percentage of Prescriptions |
| Total | Percentage of Concomitant Medications by OAD Classes | Use of Thiazolidinedione (TZD) (in %) | 6 Percentage of Prescriptions |
| Total | Percentage of Concomitant Medications by OAD Classes | Use of Biguanides (BG) (in %) | 20 Percentage of Prescriptions |
| Total | Percentage of Concomitant Medications by OAD Classes | Use of Glinide (in %) | 4 Percentage of Prescriptions |
| Total | Percentage of Concomitant Medications by OAD Classes | Use of α-glucosidase (AGI) (in %) | 16 Percentage of Prescriptions |
| Total | Percentage of Concomitant Medications by OAD Classes | Use of Insulin (in %) | 37 Percentage of Prescriptions |
| Thiazolidinedione (TZD) | Percentage of Concomitant Medications by OAD Classes | Use of Sulfonylurea (SU) (in %) | 21 Percentage of Prescriptions |
| Thiazolidinedione (TZD) | Percentage of Concomitant Medications by OAD Classes | Use of α-glucosidase (AGI) (in %) | 10 Percentage of Prescriptions |
| Thiazolidinedione (TZD) | Percentage of Concomitant Medications by OAD Classes | Use of Glinide (in %) | 4 Percentage of Prescriptions |
| Thiazolidinedione (TZD) | Percentage of Concomitant Medications by OAD Classes | Use of Insulin (in %) | 24 Percentage of Prescriptions |
| Thiazolidinedione (TZD) | Percentage of Concomitant Medications by OAD Classes | Use of Thiazolidinedione (TZD) (in %) | 1 Percentage of Prescriptions |
| Thiazolidinedione (TZD) | Percentage of Concomitant Medications by OAD Classes | Use of Biguanides (BG) (in %) | 19 Percentage of Prescriptions |
| Thiazolidinedione (TZD) | Percentage of Concomitant Medications by OAD Classes | Use of DPP-4 inhibitors (in %) | 34 Percentage of Prescriptions |
| Total | Percentage of Concomitant Medications by OAD Classes | Use of α-glucosidase (AGI) (in %) | 8 Percentage of Prescriptions |
| Total | Percentage of Concomitant Medications by OAD Classes | Use of Insulin (in %) | 27 Percentage of Prescriptions |
| Total | Percentage of Concomitant Medications by OAD Classes | Use of Glinide (in %) | 3 Percentage of Prescriptions |
| Total | Percentage of Concomitant Medications by OAD Classes | Use of DPP-4 inhibitors (in %) | 23 Percentage of Prescriptions |
| Total | Percentage of Concomitant Medications by OAD Classes | Use of Biguanides (BG) (in %) | 10 Percentage of Prescriptions |
| Total | Percentage of Concomitant Medications by OAD Classes | Use of Sulfonylurea (SU) (in %) | 10 Percentage of Prescriptions |
| Total | Percentage of Concomitant Medications by OAD Classes | Use of Thiazolidinedione (TZD) (in %) | 3 Percentage of Prescriptions |
Primary
Percentage of Previous Medications (Premedications) by OAD Classes.
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
Time frame: On the index month
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group G1 | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of α-glucosidase (AGI) (in %) | 2 Percentage of Prescriptions |
| Group G1 | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of Insulin (in%) | 9 Percentage of Prescriptions |
| Group G1 | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of Biguanides (BG) (in %) | 2 Percentage of Prescriptions |
| Group G1 | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of DPP4 inhibitors (in %) | 0 Percentage of Prescriptions |
| Group G1 | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of Thiazolidinedione (TZD) (in %) | 2 Percentage of Prescriptions |
| Group G1 | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of Sulfonylurea (SU) (in %) | 3 Percentage of Prescriptions |
| Group G1 | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of Glinide (in %) | 1 Percentage of Prescriptions |
| Group G2 | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of Insulin (in%) | 7 Percentage of Prescriptions |
| Group G2 | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of Glinide (in %) | 1 Percentage of Prescriptions |
| Group G2 | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of Biguanides (BG) (in %) | 0 Percentage of Prescriptions |
| Group G2 | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of DPP4 inhibitors (in %) | 3 Percentage of Prescriptions |
| Group G2 | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of Thiazolidinedione (TZD) (in %) | 2 Percentage of Prescriptions |
| Group G2 | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of α-glucosidase (AGI) (in %) | 2 Percentage of Prescriptions |
| Group G2 | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of Sulfonylurea (SU) (in %) | 2 Percentage of Prescriptions |
| Group G3 | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of DPP4 inhibitors (in %) | 2 Percentage of Prescriptions |
| Group G3 | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of Glinide (in %) | 3 Percentage of Prescriptions |
| Group G3 | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of Sulfonylurea (SU) (in %) | 0 Percentage of Prescriptions |
| Group G3 | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of α-glucosidase (AGI) (in %) | 1 Percentage of Prescriptions |
| Group G3 | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of Biguanides (BG) (in %) | 1 Percentage of Prescriptions |
| Group G3 | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of Insulin (in%) | 12 Percentage of Prescriptions |
| Group G3 | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of Thiazolidinedione (TZD) (in %) | 1 Percentage of Prescriptions |
| Group G4+ | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of α-glucosidase (AGI) (in %) | 0 Percentage of Prescriptions |
| Group G4+ | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of DPP4 inhibitors (in %) | 1 Percentage of Prescriptions |
| Group G4+ | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of Biguanides (BG) (in %) | 2 Percentage of Prescriptions |
| Group G4+ | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of Sulfonylurea (SU) (in %) | 3 Percentage of Prescriptions |
| Group G4+ | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of Glinide (in %) | 2 Percentage of Prescriptions |
| Group G4+ | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of Thiazolidinedione (TZD) (in %) | 1 Percentage of Prescriptions |
| Group G4+ | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of Insulin (in%) | 10 Percentage of Prescriptions |
| Total | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of Insulin (in%) | 12 Percentage of Prescriptions |
| Total | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of DPP4 inhibitors (in %) | 3 Percentage of Prescriptions |
| Total | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of α-glucosidase (AGI) (in %) | 8 Percentage of Prescriptions |
| Total | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of Sulfonylurea (SU) (in %) | 19 Percentage of Prescriptions |
| Total | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of Biguanides (BG) (in %) | 3 Percentage of Prescriptions |
| Total | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of Thiazolidinedione (TZD) (in %) | 1 Percentage of Prescriptions |
| Total | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of Glinide (in %) | 0 Percentage of Prescriptions |
| Thiazolidinedione (TZD) | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of Insulin (in%) | 8 Percentage of Prescriptions |
| Thiazolidinedione (TZD) | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of DPP4 inhibitors (in %) | 8 Percentage of Prescriptions |
| Thiazolidinedione (TZD) | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of Biguanides (BG) (in %) | 2 Percentage of Prescriptions |
| Thiazolidinedione (TZD) | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of Glinide (in %) | 0 Percentage of Prescriptions |
| Thiazolidinedione (TZD) | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of Thiazolidinedione (TZD) (in %) | 0 Percentage of Prescriptions |
| Thiazolidinedione (TZD) | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of α-glucosidase (AGI) (in %) | 1 Percentage of Prescriptions |
| Thiazolidinedione (TZD) | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of Sulfonylurea (SU) (in %) | 2 Percentage of Prescriptions |
| Total | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of α-glucosidase (AGI) (in %) | 2 Percentage of Prescriptions |
| Total | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of Glinide (in %) | 1 Percentage of Prescriptions |
| Total | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of Biguanides (BG) (in %) | 1 Percentage of Prescriptions |
| Total | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of Thiazolidinedione (TZD) (in %) | 1 Percentage of Prescriptions |
| Total | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of DPP4 inhibitors (in %) | 1 Percentage of Prescriptions |
| Total | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of Insulin (in%) | 9 Percentage of Prescriptions |
| Total | Percentage of Previous Medications (Premedications) by OAD Classes. | Use of Sulfonylurea (SU) (in %) | 4 Percentage of Prescriptions |
Primary
Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level
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.
Time frame: Within 6 months from index date
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group G1 | Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level | 30 < eGFR < 60 | 3566 Participants |
| Group G1 | Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level | eGFR < 30 | 1411 Participants |
| Group G1 | Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level | 90 < eGFR | 1592 Participants |
| Group G1 | Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level | 60 < eGFR < 90 | 4877 Participants |
| Group G2 | Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level | 30 < eGFR < 60 | 1045 Participants |
| Group G2 | Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level | 60 < eGFR < 90 | 2373 Participants |
| Group G2 | Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level | eGFR < 30 | 67 Participants |
| Group G2 | Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level | 90 < eGFR | 838 Participants |
| Group G3 | Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level | 60 < eGFR < 90 | 1446 Participants |
| Group G3 | Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level | 90 < eGFR | 530 Participants |
| Group G3 | Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level | eGFR < 30 | 208 Participants |
| Group G3 | Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level | 30 < eGFR < 60 | 1090 Participants |
| Group G4+ | Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level | 60 < eGFR < 90 | 1175 Participants |
| Group G4+ | Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level | eGFR < 30 | 488 Participants |
| Group G4+ | Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level | 90 < eGFR | 429 Participants |
| Group G4+ | Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level | 30 < eGFR < 60 | 1055 Participants |
| Total | Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level | 30 < eGFR < 60 | 610 Participants |
| Total | Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level | eGFR < 30 | 337 Participants |
| Total | Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level | 60 < eGFR < 90 | 691 Participants |
| Total | Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level | 90 < eGFR | 252 Participants |
| Thiazolidinedione (TZD) | Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level | 90 < eGFR | 227 Participants |
| Thiazolidinedione (TZD) | Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level | 60 < eGFR < 90 | 626 Participants |
| Thiazolidinedione (TZD) | Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level | 30 < eGFR < 60 | 410 Participants |
| Thiazolidinedione (TZD) | Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level | eGFR < 30 | 43 Participants |
| Total | Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level | 90 < eGFR | 3868 Participants |
| Total | Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level | 60 < eGFR < 90 | 11188 Participants |
| Total | Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level | eGFR < 30 | 2554 Participants |
| Total | Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level | 30 < eGFR < 60 | 7776 Participants |
Primary
Sex (Male/Female)
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group G1 | Sex (Male/Female) | Male | 55616 Participants |
| Group G1 | Sex (Male/Female) | Female | 36018 Participants |
| Group G2 | Sex (Male/Female) | Male | 20557 Participants |
| Group G2 | Sex (Male/Female) | Female | 12681 Participants |
| Group G3 | Sex (Male/Female) | Female | 10940 Participants |
| Group G3 | Sex (Male/Female) | Male | 17271 Participants |
| Group G4+ | Sex (Male/Female) | Male | 16241 Participants |
| Group G4+ | Sex (Male/Female) | Female | 9951 Participants |
| Total | Sex (Male/Female) | Female | 6549 Participants |
| Total | Sex (Male/Female) | Male | 10238 Participants |
| Thiazolidinedione (TZD) | Sex (Male/Female) | Female | 3854 Participants |
| Thiazolidinedione (TZD) | Sex (Male/Female) | Male | 6490 Participants |
| Total | Sex (Male/Female) | Male | 126413 Participants |
| Total | Sex (Male/Female) | Female | 79993 Participants |
Secondary
Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages
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.
Time frame: Within 6 months from index date
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group G1 | Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages | Biguanides (BG) | 838 Prescriptions |
| Group G1 | Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages | Sulfonylurea (SU) | 530 Prescriptions |
| Group G1 | Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages | Thiazolidinedione (TZD) | 227 Prescriptions |
| Group G1 | Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages | DPP4 inhibitors | 1592 Prescriptions |
| Group G1 | Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages | Glinide | 252 Prescriptions |
| Group G1 | Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages | α-glucosidase (AGI) | 429 Prescriptions |
| Group G2 | Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages | DPP4 inhibitors | 4877 Prescriptions |
| Group G2 | Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages | Biguanides (BG) | 2373 Prescriptions |
| Group G2 | Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages | Sulfonylurea (SU) | 1446 Prescriptions |
| Group G2 | Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages | Thiazolidinedione (TZD) | 626 Prescriptions |
| Group G2 | Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages | Glinide | 691 Prescriptions |
| Group G2 | Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages | α-glucosidase (AGI) | 1175 Prescriptions |
| Group G3 | Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages | Sulfonylurea (SU) | 1090 Prescriptions |
| Group G3 | Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages | DPP4 inhibitors | 3566 Prescriptions |
| Group G3 | Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages | Biguanides (BG) | 1045 Prescriptions |
| Group G3 | Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages | α-glucosidase (AGI) | 1055 Prescriptions |
| Group G3 | Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages | Glinide | 610 Prescriptions |
| Group G3 | Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages | Thiazolidinedione (TZD) | 410 Prescriptions |
| Group G4+ | Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages | DPP4 inhibitors | 1411 Prescriptions |
| Group G4+ | Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages | Thiazolidinedione (TZD) | 43 Prescriptions |
| Group G4+ | Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages | α-glucosidase (AGI) | 488 Prescriptions |
| Group G4+ | Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages | Glinide | 337 Prescriptions |
| Group G4+ | Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages | Sulfonylurea (SU) | 208 Prescriptions |
| Group G4+ | Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages | Biguanides (BG) | 67 Prescriptions |
| Total | Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages | Sulfonylurea (SU) | 3274 Prescriptions |
| Total | Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages | DPP4 inhibitors | 11446 Prescriptions |
| Total | Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages | Thiazolidinedione (TZD) | 1306 Prescriptions |
| Total | Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages | Glinide | 1890 Prescriptions |
| Total | Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages | α-glucosidase (AGI) | 3147 Prescriptions |
| Total | Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages | Biguanides (BG) | 4323 Prescriptions |