N/A N=31,908

Characteristics of Empagliflozin Initiators

Type 2 Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT03050619 ↗

Enrolled (actual)

31,908

Serious AEs

—

Results posted

Jan 2019

Primary outcome: Primary: Baseline Characteristics of Adults (as Measured by Demographics) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK — 5.45; 1.76; 1.44; 3.03 Percentage of Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Empagliflozin (Drug); Other SGLT2 inhibitors (Drug); Other non-insulin GLDs (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: Oct 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Baseline Characteristics of Adults (as Measured by Demographics) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK	5.45; 1.76; 1.44; 3.03; 2.68; 3.20	—
PRIMARY Baseline Characteristics of Adults (as Measured by Life Style Factors (Smoking and Alcohol Use)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK	22.73; 18.08; 18.24; 20.67; 20.17; 18.53	—
PRIMARY Baseline Characteristics of Adults (as Measured by Life Style Factors (BMI)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK	35.43; 35.24; 32.13; 32.99; 31.61; 37.68	—
PRIMARY Baseline Characteristics of Adults (as Measured by Life Style Factors (Blood Pressure)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK	130.75; 133.52; 133.45; 135.02; 132.72; 133.84	—
PRIMARY Baseline Characteristics of Adults (as Measured by Glycated Haemoglobin (HbA1c)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK	77.34; 79.52; 73.83; 70.35; 78.05; 80.68	—
PRIMARY Baseline Characteristics of Adults (as Measured by Laboratory Tests) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK	4.22; 4.33; 4.29; 4.89; 4.53; 4.37	—
PRIMARY Baseline Characteristics of Adults (as Measured by Estimated Glomerular Filtration Rate (eGFR)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK	95.46; 93.42; 80.68; 87.64; 84.95; 90.27	—
PRIMARY Baseline Characteristics of Adults (as Measured by Creatinine Serum (SCR)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK	72.16; 74.52; 88.46; 78.46; 83.10; 77.16	—
PRIMARY Baseline Characteristics of Adults (as Measured by Comorbidities) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK	34.55; 34.14; 33.62; 13.11; 24.36; 34.81	—
PRIMARY Baseline Characteristics of Adults (as Measured by Concomitant Medications) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK	15.45; 17.64; 5.95; 2.34; 2.26; 18.18	—
SECONDARY Extent of Off-label Use	0; 4; 2; 581; 8; 0	—
SECONDARY Baseline Characteristics (as Measured by Demographics) of Patients Starting Index Prescriptions Off-label	NA; 2.60; 0.88; 11.44; 2.51; 4.10	—
SECONDARY Baseline Characteristics (as Measured by Life Style Factors (Smoking and Alcohol Use)) of Patients Starting Index Prescriptions Off-label	NA; 23.99; 16.34; 22.21; 22.59; 13.93	—
SECONDARY Baseline Characteristics (as Measured by Life Style Factors (BMI)) of Patients Starting Index Prescriptions Off-label	33.29; 34.71; 31.73; 32.40; 30.81; 36.50	—
SECONDARY Baseline Characteristics (as Measured by Life Style Factors (Blood Pressure)) of Patients Starting Index Prescriptions Off-label	131.43; 133.94; 134.41; 134.95; 130.86; 133.18	—
SECONDARY Baseline Characteristics (as Measured b Yglycated Haemoglobin (HbA1c)) of Patients Starting Index Prescriptions Off-label	79.69; 82.17; 74.70; 72.29; 79.21; 83.23	—
SECONDARY Baseline Characteristics (as Measured by Laboratory Tests) of Patients Starting Index Prescriptions Off-label	3.96; 4.33; 4.25; 4.95; 4.49; 4.40	—
SECONDARY Baseline Characteristics (as Measured by Estimated Glomerular Filtration Rate (eGFR)) of Patients Starting Index Prescriptions Off-label	91.05; 93.23; 78.52; 89.36; 82.31; 85.57	—
SECONDARY Baseline Characteristics (as Measured by Creatinine Serum (SCR)) of Patients Starting Index Prescriptions Off-label	74.21; 74.10; 92.89; 78.21; 87.41; 81.97	—
SECONDARY Baseline Characteristics (as Measured by Comorbidities) of Patients Starting Index Prescriptions Off-label	NA; 47.69; 37.26; 14.59; 27.41; 40.98	—
SECONDARY Baseline Characteristics (as Measured by Concomitant Medications) of Patients Starting Index Prescriptions Off-label	NA; 33.82; 12.13; 9.25; 3.77; 36.07	—

Summary

Empagliflozin, a sodium glucose cotransporter 2 (SGLT-2) inhibitor, was launched in the United Kingdom (UK) in August 2014. It can be expected that patients initiating empagliflozin may differ in their characteristics from patients initiating other glucose lowering drugs (GLDs) that have been on the market longer (e.g. patients may have poorer glucose control). Therefore, the proposed study aims to characterize patients with T2DM in the UK initiating empagliflozin in terms of baseline characteristics, concomitant medications, and comorbidities compared to patients with type 2 diabetes mellitus (T2DM) initiating other SGLT-2 inhibitors or other non-insulin GLDs. Due to the mode of action, some patients taking empagliflozin have experienced weight loss in clinical trials. A theoretical possibility exists that empagliflozin may be used by patients without T2DM. Therefore, this study also aims to assess the potential off-label use of empagliflozin compared to other non-insulin GLDs.

Eligibility Criteria

Inclusion criteria

All patients will be required to meet all of the following criteria:

At least 12 months of continuous registration prior to the index date in a practice contributing up to standard (UTS) data to the Clinical Practice Research Datalink (CPRD). Infants younger than 1 year will not be required to have 12 months of continuous UTS registration in the CPRD.
A new user of one of the index prescriptions (empagliflozin, other SGLT2 inhibitor, or non-insulin GLDs) or a fixed dose combination (FDC) with metformin.

Exclusion criteria

There is no exclusion criterion in this study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03050619). 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.