Evaluating Comparative Effectiveness of Empagliflozin in Type 2 Diabetes Population With and Without Chronic Kidney Disease

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Comparative Cardiovascular and Renal Effectiveness and Safety of Empagliflozin and Other SGLT2i in Patients With Type 2 Diabetes (T2D) With and Without Baseline Kidney Disease in the United States

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05465317
• Other study ID #: 1245-0228
• Status: Completed
• Start date: August 8, 2022
• Est. completion date: May 2, 2023

Study information

• Verified date: September 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary purpose of this research study is to determine the cardiovascular and renal effectiveness and safety of empagliflozin compared to dipeptidyl peptidase-4 inhibitors (DPP4i) in patients with Type 2 Diabetes Mellitus (T2DM) with and without established kidney disease.

The secondary purpose of this research study is to determine the cardiovascular and renal effectiveness and safety of any Sodium glucose co-transporter-2 inhibitors (SGLT2i) compared to Glucagon-like Peptide-1 Receptor Agonists (GLP1RA) in patients with T2DM.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30400
• Est. completion date: May 2, 2023
• Est. primary completion date: May 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Patients =18 years old

• Having a diagnosis of type 2 diabetes in 12 months before the index date (defined as the date of initiation of empagliflozin or Glucagon-like Peptide-1 Receptor Agonists (GLP1RA) or Dipeptidyl Peptidate-4 inhibitor (DPP4i), based on the cohort evaluated), based on International Classification of Diseases (ICD)-9 and -10 codes and other available data

• Record of prescription for empagliflozin, any Sodium glucose co-transporter-2 inhibitors (SGLT2i), any DPP4 inhibitor, or any GLP1RA use between 1 January 2015 and 31 December 2020, and

• No record of any prescription for the drugs being compared during the 12 months + 30-day grace preceding the index date period, i.e.,

• For the primary comparison of initiation of empagliflozin versus DPP4i, patients will not have any prescription for empagliflozin/any SGLT2i or DPP4i during the preceding 12 months + 30-day grace period.

• For the comparison of initiation of SGLT2i versus GLP1RA, patients will not have any prescription for SGLT2i or GLP1RA during the preceding 12 months + 30-day grace period.

• For the comparison of initiation of empagliflozin versus GLP1RA, patients will not have any prescription for empagliflozin/any SGLT2i or GLP1RA during the preceding 12 months + 30-day grace period.

Exclusion criteria:

• Aged <18 years on the first prescription date of the qualifying prescription,

• Pre-existing diagnosis of type 1 diabetes mellitus (T1DM) during the 12 months before the index date,

• Having a disqualifying diagnosis during the 12 months before the index date, defined as having at least one of the following: estimated glomerular filtration rate (eGFR) <30, dialysis, polycystic kidney disease or a kidney transplant,

• <12 months of available data before the index date, and/or no complete history of drug dispensations/other records of drug use during this period, defined as not having at least 1 ambulatory visit and at least 1 medication prescription during the preceding 12 months, and

• Missing or ambiguous data on serum creatinine in the 12 months prior to the index date or sex

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Kidney Diseases

Intervention

Drug:
• Empagliflozin
Empagliflozin
• Dipeptidyl Peptidate-4 inhibitors
Dipeptidyl Peptidate-4 inhibitors
• Sodium glucose co-transporter-2 inhibitors
Sodium glucose co-transporter-2 inhibitors
• Glucagon-like Peptide-1 Receptor Agonists
Glucagon-like Peptide-1 Receptor Agonists

Locations

Country	Name	City	State
United States	Duke Clinical Research Institute	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite outcome including: 40% decline in estimated glomerular filtration rate (eGFR), incident end-stage kidney disease (ESKD), all-cause mortality	40% decline in eGFR: at least 2 measurements during follow-up of at least a 40% decline relative to baseline separated by = 28 days ESKD definition: at least 1 kidney transplant or ESKD diagnosis/procedure or at least 2 dialysis diagnoses/procedures separated by = 28 days or eGFR<15 on 2 measurements separated by = 28 days	up to 2 years
Secondary	40% decline in eGFR		up to 2 years
Secondary	Incident end-stage kidney disease (ESKD)		up to 2 years
Secondary	Incident dialysis		up to 2 years
Secondary	Kidney transplant		up to 2 years
Secondary	Composite outcome including: hospitalization for heart failure and all-cause mortality		up to 2 years
Secondary	Incidence of hospitalization for heart failure		up to 2 years
Secondary	All-cause mortality		up to 2 years
Secondary	Composite outcome including: myocardial infarction (MI), stroke, all-cause mortality, coronary revascularization procedure		up to 2 years
Secondary	Composite outcome including: MI, stroke, all-cause mortality		up to 2 years
Secondary	Diabetic ketoacidosis		up to 2 years
Secondary	Severe hypoglycemia		up to 2 years
Secondary	Urinary tract cancer		up to 2 years
Secondary	Severe Urinary Tract Infections (UTI)		up to 2 years
Secondary	Acute kidney injury that requires dialysis		up to 2 years
Secondary	Genital Mycotic infection		up to 2 years

External Links

•   Related Info