N/A
N=4,055
DIA_CENTRAL:T2D Treatment Pattern in Central Europe
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT03807440 ↗Enrolled (actual)
4,055
Serious AEs
1.1%
Results posted
Dec 2023
Primary outcome: Primary: Number of Patients in Each Category of First Prescription of a Respective Modern Type 2 Diabetes (T2D) Medication According to Prescribing Specialist — 815; 1073; 78; 244 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Empagliflozin (Drug); Sodium Glucose Transporter 2 inhibitor (Drug); Dipeptidyl-peptidase 4 inhibitor (Drug); Glucagon-like peptide 1 agonist (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients in Each Category of First Prescription of a Respective Modern Type 2 Diabetes (T2D) Medication According to Prescribing Specialist |
815; 1073; 78; 244; 333; 7 | — |
| PRIMARY Number of Patients Initiated on a Modern Type 2 Diabetes (T2D) Medication Who Also Received Concomitant T2D Medications at Study Index Date 1 According to Prescribing Specialist |
1349; 1794; 81; 626; 513; 17 | — |
| PRIMARY Number of Patients Initiated on a Modern Type 2 Diabetes (T2D) Medication Who Also Received Concomitant Cardiovascular Disease (CVD) and/or Chronic Kidney Disease (CKD) Medication at Study Index Date 1 According to Prescribing Specialist |
1256; 1536; 87; 983; 1327; 82 | — |
| PRIMARY Baseline Characteristic: Age According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist |
61.5; 65.3; 55.8; 62.0 | <.0001 sig |
| PRIMARY Baseline Characteristic: Number of Patients in Each Category of Gender According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist |
432; 334; 37; 140; 383; 170 | <.0001 sig |
| PRIMARY Baseline Characteristic: Body Mass Index (BMI) According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist |
33.3; 31.3; 36.7; 34.3 | <.0001 sig |
| PRIMARY Baseline Characteristic: Number of Patients in Each Category of Race According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist |
10; 7; 1; 5; 805; 497 | 0.8071 |
| PRIMARY Baseline Characteristic: Age According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist |
63.0; 67.2; 59.2; 62.3 | <.0001 sig |
| PRIMARY Baseline Characteristic: Number of Patients in Each Category of Gender According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist |
433; 297; 135; 140; 640; 327 | 0.0042 sig |
| PRIMARY Body Mass Index (BMI) According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist |
33.3; 31.0; 36.2; 32.8 | <.0001 sig |
| PRIMARY Baseline Characteristic: Number of Patients in Each Category of Race According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist |
3; 0; 1; 0; 1070; 624 | 0.3990 |
| PRIMARY Baseline Characteristic: Age According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist |
64.4; 70.9; 54.0; 65.0 | 0.0605 |
| PRIMARY Baseline Characteristic: Number of Patients in Each Category of Gender According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist |
35; 8; 0; 2; 43; 8 | 0.6329 |
| PRIMARY Body Mass Index (BMI) According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist |
30.8; 29.9; 25.8; 30.7 | 0.5233 |
| PRIMARY Baseline Characteristic: Number of Patients in Each Category of Race According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist |
0; 0; 0; 0; 78; 16 | — |
| PRIMARY Time Since Diagnosis of Type 2 Diabetes (T2D) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist |
9.1; 9.1; 9.2; 9.8 | 0.3662 |
| PRIMARY Time Since Diagnosis of Type 2 Diabetes (T2D) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist |
10.7; 10.4; 10.1; 10.1 | 0.5110 |
| PRIMARY Time Since Diagnosis of Type 2 Diabetes (T2D) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist |
6.7; 9.7; 6.0; 10.9 | 0.0921 |
| PRIMARY Clinical Parameter Relevant for Type 2 Diabetes (T2D): Percentage of Glycosylated Hemoglobin (HbA1c [%]) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist |
8.5; 8.1; 8.2; 8.5 | <.0001 sig |
| PRIMARY Clinical Parameter Relevant for T2D: Number of Patients in Each Category of Percentage of Glycosylated Hemoglobin (HbA1c) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist |
453; 339; 56; 138; 349; 138 | <.0001 sig |
| PRIMARY Clinical Parameter Relevant for Type 2 Diabetes (T2D): Percentage of Glycosylated Hemoglobin (HbA1c [%]) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist |
8.2; 7.9; 8.4; 8.6 | <.0001 sig |
| PRIMARY Clinical Parameter Relevant for Type 2 Diabetes (T2D): Number of Patients in Each Category of Percentage of Glycosylated Hemoglobin (HbA1c) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist |
642; 453; 162; 183; 278; 123 | <.0001 sig |
| PRIMARY Clinical Parameter Relevant for Type 2 Diabetes (T2D): Percentage of Glycosylated Hemoglobin (HbA1c [%]) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist |
7.9; 8.1; 7.4; 8.5 | 0.3201 |
| PRIMARY Clinical Parameter Relevant for Type 2 Diabetes (T2D): Number of Patients in Each Category of Percentage of Glycosylated Hemoglobin (HbA1c) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist |
36; 11; 1; 3; 14; 4 | 0.3288 |
| PRIMARY 10-year Risk for Fatal Cardiovascular Disease (CVD) According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist |
6.4; 5.6; 4.3; 6.0 | 0.0130 sig |
| PRIMARY 10-year Risk for Fatal Cardiovascular Disease (CVD) According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist |
7.0; 7.0; 5.4; 6.5 | 0.0026 sig |
| PRIMARY 10-year Risk for Fatal Cardiovascular Disease (CVD) According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist |
8.9; 9.4; 5.0; 3.8 | 0.3978 |
| PRIMARY Number of Patients Per Type of Medical Specialty of Other Physicians Involved in Treatment Decision According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist |
56; 36; 1; 11; 0; 0 | 0.0055 sig |
| PRIMARY Number of Patients Per Type of Medical Specialty of Other Physicians Involved in Treatment Decision According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist |
3; 0; 0; 0; 74; 35 | <.0001 sig |
| PRIMARY Number of Patients Per Type of Medical Specialty of Other Physicians Involved in Treatment Decision According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist |
19; 0; 0; 0; 10; 1 | 0.0399 sig |
| SECONDARY Number of Patients With Any Type of Cardiovascular Disease (CVD) |
1485 | — |
| SECONDARY Number of Patients With Chronic Kidney Disease (CKD) by Physician's Assessment |
586 | — |
| SECONDARY Number of Patients With Documentation of Estimated Glomerular Filtration Rate (eGFR) / Urine Albumin Creatinine Ratio (UACR) Status |
3175 | — |
| SECONDARY Number of Patients With Chronic Kidney Disease (CKD) by Estimated Glomerular Filtration Rate (eGFR) and Urine Albumin Creatinine Ratio (UACR) Status |
886 | — |
| SECONDARY Number of Patients in Each Category of the Different Types of Cardiovascular Disease |
450; 3558; 47; 525; 3471; 59 | — |
| SECONDARY Number of Patients in Each Category of the Different Types of Congestive Heart Failure (CHF) - Confirmed by Echocardiography |
245; 86; 90 | — |
| SECONDARY Number of Patients With Any Type of Cardiovascular Disease (CVD) and Without CVD According to Prescribing Specialist |
736; 656; 93; 916; 1645; 9 | — |
| SECONDARY Number of Patients With Chronic Kidney (CKD) (Patients for Whom CKD Was Reported as a Comorbidity) or Without CKD by Physician's Assessment According to Prescribing Specialist |
327; 244; 15; 1325; 2057; 87 | — |
| SECONDARY Number of Patients With Chronic Kidney Disease (CKD) by eGFR and UACR Status According to Prescribing Specialist |
508; 358; 20 | — |
| SECONDARY Number of Patients With or Without at Least One Cardiovascular Disease (CVD) Type According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1 |
812; 398; 75; 200; 1154; 746 | — |
| SECONDARY Number of Patients in Each Category of Different Types of Cardiovascular Disease (CVD) According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1 |
276; 91; 22; 61; 1667; 1039 | — |
| SECONDARY Number of Patients in Each Category of Congestive Heart Failure (CHF) Confirmed by Echocardiography According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1 |
164; 42; 9; 30; 36; 39 | — |
| SECONDARY Number of Patients With or Without at Least One Cardiovascular Disease (CVD) Type According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication From by Endocrinologist |
380; 229; 28; 99; 435; 275 | — |
| SECONDARY Number of Patients With or Without at Least One Cardiovascular Disease (CVD) Type According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist |
362; 154; 46; 94; 711; 470 | — |
| SECONDARY Number of Patients With or Without at Least One Cardiovascular Disease (CVD) Type According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist |
70; 15; 1; 7; 8; 1 | — |
| SECONDARY Number of Patients With Chronic Kidney (CKD) or Without CKD by Physician's Assessment According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1 |
221; 289; 26; 50; 1745; 855 | — |
| SECONDARY Number of Patients With Chronic Kidney (CKD) and Without CKD by eGFR and UACR Status According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1 |
386; 365; 50; 85; 1182; 542 | — |
| SECONDARY Number of Patients in Each Category of Employment Status According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1 |
966; 433; 229; 302; 878; 639 | <.0001 sig |
| SECONDARY Number of Patients in Each Category of Family Status According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1 |
124; 86; 26; 42; 1339; 668 | <.0001 sig |
| SECONDARY Number of Patients in Each Category of Insurance Status According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1 |
50; 13; 3; 11; 1725; 1055 | 0.0008 sig |
| SECONDARY Number of Patients in Each Category of Employment Status According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist |
438; 199; 69; 128; 345; 286 | — |
| SECONDARY Number of Patients in Each Category of Family Status According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist |
55; 52; 7; 22; 566; 290 | <.0001 sig |
| SECONDARY Number of Patients in Each Category of Insurance Status According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist |
40; 12; 3; 11; 630; 438 | 0.0001 sig |
| SECONDARY Number of Patients in Each Category of Employment Status According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist |
491; 228; 159; 171; 500; 345 | <.0001 sig |
| SECONDARY Number of Patients in Each Category of Family Status According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist |
56; 33; 19; 19; 727; 368 | <.0001 sig |
| SECONDARY Number of Patients in Each Category of Insurance Status According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist |
2; 1; 0.0; 0.0; 1039; 603 | 0.9184 |
| SECONDARY Number of Patients in Each Category of Employment Status According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist |
37; 6; 1; 3; 33; 8 | 0.6967 |
| SECONDARY Number of Patients in Each Category of Family Status According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist |
13; 1; 0; 1; 46; 10 | 0.9414 |
| SECONDARY Number of Patients in Each Category of Insurance Status According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist |
8; 0; 0; 0; 56; 14 | 0.7837 |
| SECONDARY Number of Patients in Each Category of Status of Type 2 Diabetes (T2D) Medication at Index Date 2 According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1 |
134; 129; 38; 60; 1563; 924 | 0.0012 sig |
| SECONDARY Number of Patients in Each Category of Status of Type 2 Diabetes (T2D) Medication at Index Date 2 According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist |
42; 58; 17; 26; 689; 421 | <.0001 sig |
| SECONDARY Number of Patients in Each Category of Status of Type 2 Diabetes (T2D) Medication at Index Date 2 According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist |
87; 71; 21; 34; 819; 490 | 0.1906 |
| SECONDARY Number of Patients in Each Category of Status of Type 2 Diabetes (T2D) Medication at Index Date 2 According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist |
5; 0; 0; 0; 55; 13 | 0.6198 |
| SECONDARY Number of Patients in Each Category of Reason for Discontinuation of Type 2 Diabetes (T2D) Medication by Country |
17; 64; 9; 15; 30; 1 | — |
| SECONDARY Number of Patients in Each Category of Reason for Discontinuation of Type 2 Diabetes (T2D) Medication According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1 |
29; 67; 20; 19; 8; 7 | <.0001 sig |
| SECONDARY Number of Patients in Each Category of Reason for Discontinuation of Type 2 Diabetes (T2D) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist |
10; 26; 6; 2; 6; 6 | 0.0012 sig |
| SECONDARY Number of Patients in Each Category of Reason for Discontinuation of Type 2 Diabetes (T2D) Medication According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist |
17; 41; 14; 17; 0; 1 | <.0001 sig |
| SECONDARY Number of Patients in Each Category of Reason for Discontinuation of Type 2 Diabetes (T2D) Medication According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist |
2; 2; 0; 0; 0; 1 | — |
| SECONDARY Number of Patients for Each Type of Physician Specialties Involved in Decision for T2D Therapy Discontinuation According to Prescribing Specialist |
26; 0; 4; 0; 2; 0 | — |
| SECONDARY Time to Discontinuation of Type 2 Diabetes (T2D) Treatment According to Study Medication |
19.46; 18.28; 20.61; 14.04 | 0.0030 sig |
Summary
This is a non-interventional study using existing data including medical chart review.
Eligibility Criteria
Inclusion Criteria
- Written informed consent prior to participation
- Female and male patients age ≥ 18 years
- Patients with T2D diagnosis
- Patients who have been newly initiated (first ever use) with empagliflozin or other Sodium Glucose Transporter 2 inhibitor (SGLT2i), Dipeptidyl-peptidase 4 inhibitor (DPP4i) or Glucagon-like peptide 1 agonist (GLP1a) between September 2018 and December 2018 (study index date 1)
- Patients have been naïve to treatment with empagliflozin or other Sodium Glucose Transporter 2 inhibitor (SGLT2i), Dipeptidyl-peptidase 4 inhibitor (DPP4i) or Glucagon-like peptide 1 agonist (GLP1a) at study index date 1
Exclusion Criteria
- Patients age < 18 years
- Patients with diagnosis of other types of diabetes than T2D
- Patients who do not provide written consent to the terms of the study
Data sourced from ClinicalTrials.gov (NCT03807440). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.