A Study to Observe the Effectiveness of Empagliflozin, Other SGLT-2 Inhibitors, or DPP-4 Inhibitors in Patients With Type 2 Diabetes
Study Details
Study Description
Brief Summary
Non-interventional, multi-country cohort study using existing data and including adults (≥18 years) with a diagnosis of Type 2 diabetes mellitus.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Patients with T2DM
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Drug: Subjects treated with Empagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitor
Empagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitor
Drug: Subjects treated with Dipeptidyl peptidase-4 (DPP-4) inhibitor
Dipeptidyl peptidase-4 (DPP-4) inhibitor
|
Outcome Measures
Primary Outcome Measures
- Number of participants hospitalized for heart failure [up to 4.5 years]
- Number of participants with all-cause mortality [up to 4.5 years]
- Number of participants with both hospitalization for heart failure and all cause mortality [up to 4.5 years]
- Number of participants with myocardial infraction (MI), stroke, all cause mortality [up to 4.5 years]
Secondary Outcome Measures
- Number of participants with Cardiovascular mortality [up to 4.5 years]
- Number of participants with a composite outcome including hospitalization for heart failure and cardiovascular (CV) mortality [up to 4.5 years]
- Number of participants with 3-point major adverse cardiovascular (CV) events (MACE), defined as a composite outcome including myocardial infarction (MI),stroke, and cardiovascular (CV) mortality [up to 4.5 years]
- Number of participants with coronary revascularization procedure [up to 4.5 years]
- Number of participants with end-stage renal disease (ESRD) [up to 4.5 years]
- Number of participants with estimated glomerular filtration rate (eGFR) decline [up to 4.5 years]
- Number of participants with progression from normoalbuminuria to micro- or macroalbuminuria [up to 4.5 years]
- Number of participants with a composite outcome including eGFR decline and progression to micro- or macroalbuminuria [up to 4.5 years]
- Number of participants with bone fracture [up to 4.5 years]
- Number of participants with diabetic ketoacidosis [up to 4.5 years]
- Number of participants with severe hypoglycemia [up to 4.5 years]
- Number of participants with lower-limb amputation [up to 4.5 years]
- Number of participants with acute kidney injury requiring dialysis [up to 4.5 years]
- Healthcare resource utilization [up to 4.5 years]
- Cost of care [up to 4.5 years]
Costs of HCRU
Eligibility Criteria
Criteria
Inclusion Criteria:
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Dispensation or any other record of empagliflozin, any SGLT-2 inhibitor, or any DPP-4 inhibitor use during the study period
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No dispensation or any other record of any other SGLT-2 inhibitor or DPP-4 inhibitor use during the preceding 12 months including at index date
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Having a diagnosis of T2DM before the index date, based on ICD-10 codes or other available data
Exclusion Criteria:
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Aged <18 years on the first dispensation date or date of the first record of empagliflozin, any SGLT-2 inhibitor or any DPP-4 inhibitor use
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Type 1 diabetes mellitus
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Secondary diabetes
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Gestational diabetes
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Having a diagnosis of ESRD during the 12 months before the index date
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<12 months of available data before the index date, and/or no complete history of drug dispensations/other records of the drug use during this period
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Missing or ambiguous data on age or sex
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Steno Diabetes Center Copenhagen, Department of Clinical Epidemiology | Gentofte | Denmark | 2820 | |
2 | Helsinki University Hospital | Helsinki | Finland | 00029 | |
3 | University of Ulm, Institute for Epidemiology and medical biometry | Ulm | Germany | 89081 | |
4 | Maccabi Healthcare Services | Tel Aviv | Israel | 6812509 | |
5 | Gifu University | Gifu | Japan | 501-1193 | |
6 | Ajou University Hospital | Suwon | Korea, Republic of | 16499 | |
7 | Oslo University Hospital, Department of Clinical Lipidology | Oslo | Norway | 0424 | |
8 | Oslo University Hospital, Department of Cardiology | Oslo | Norway | 0450 | |
9 | Instituto de Investigación Sanitaria INCLIVA | Valencia | Spain | 46010 | |
10 | TFS Trial Form Support International AB | Lund | Sweden | 223 63 | |
11 | Quantify Research AB | Stockholm | Sweden | 112 21 | |
12 | Taiwan Society for Pharmacoeconomics and Outcome Research (TaSPOR) | Taipei City | Taiwan | 100 | |
13 | Leicester Real World Evidence Unit, Leicester general Hospital | Leicester | United Kingdom | LE5 4PW |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
- Study Chair: Kimberly G Brodovicz, (203) 448-1937, kimberly.brodovicz@boehringer-ingelheim.com
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 1245-0195