Type 2 DiabetesNCT03050619
Characteristics of Empagliflozin Initiators
An observational study of Type 2 Diabetes, run by Boehringer Ingelheim at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Empagliflozin, Other SGLT2 inhibitors and Other non-insulin GLDs
- How many people
- 31,908 participants
- Where
- 1 siteGermany
- Study dates
- 10 Sep 2016to 14 Oct 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: New users of empagliflozin and other non-insulin GLDs in the UK CPRD between 1 Aug 2014 to 1 Sep 2015
Who may be able to join
- 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.
Who cannot join
- There is no exclusion criterion in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characteristics of Patients Initiating Empagliflozin or Other Non-insulin Glucose Lowering Drugs in the United Kingdom
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.
Read the detailed description
Study Design:
cross sectional
- Conditions
- Type 2 Diabetes
- Being tested
- Empagliflozin, Other SGLT2 inhibitors, Other non-insulin GLDs
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpagliflozinDrug
Other SGLT2 inhibitorsDrug
Other non-insulin GLDsDrug
metformin, sulfonylureas, DPP-4 inhibitors, GLP-1 agonists
| Study group | Role | What they receive |
|---|---|---|
| New users of Empagliflozin | New users of empagliflozin Receives: Drug: Empagliflozin | |
| New users of Other SGLT2 inhibitors | New users of other SGLT2 inhibitors Receives: Drug: Other SGLT2 inhibitors | |
| New users of Other non-insulin GLDs | New users of other non-insulin GLDs Receives: Drug: Other non-insulin GLDs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Characteristics of Adults (as Measured by Demographics) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK
Baseline characteristics of adults (as measured by demographics) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) are presented.
Measured: Baseline
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
Baseline characteristics of adults (as measured by life style factors (smoking and alcohol use)) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) are presented. NA= NR (Not Reported) (variables for which patient counts were <5)
Measured: Baseline
Baseline Characteristics of Adults (as Measured by Life Style Factors (BMI)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK
Baseline characteristics of adults (as measured by life style factors (BMI)) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) is presented. Mean and standard deviation (SD) of body mass index (BMI) measured is presented along with number of subjects with available data.
Measured: Baseline
Baseline Characteristics of Adults (as Measured by Life Style Factors (Blood Pressure)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK
Baseline characteristics of adults (as measured by life style factors (blood pressure)) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) is presented. Mean and standard deviation (SD) of Systolic blood pressure (SBP) and Diastolic blood pressure (DBP) measured is presented along with number of subjects with available data.
Measured: Baseline
Baseline Characteristics of Adults (as Measured by Glycated Haemoglobin (HbA1c)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK
Baseline characteristics of adults (as measured by glycated haemoglobin (HbA1c)) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) is presented. Mean and standard deviation (SD) of glycated haemoglobin (HbA1c) measured is presented along with number of subjects with available data.
Measured: Baseline
Baseline Characteristics of Adults (as Measured by Laboratory Tests) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK
Baseline characteristics of adults (as measured by laboratory tests) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) are presented. Mean and standard deviation (SD) of total cholesterol (TC), high-density lipoproteins level (HDL), Low-density lipoprotein level (LDL) and triglyceride level (TG) measured are presented along with number of subjects with available data.
Measured: Baseline
Baseline Characteristics of Adults (as Measured by Estimated Glomerular Filtration Rate (eGFR)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK
Baseline characteristics of adults (as measured by estimated glomerular filtration rate (eGFR)) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) is presented. Mean and standard deviation (SD) of estimated glomerular filtration rate (eGFR) measured is presented along with number of subjects with available data.
Measured: Baseline
Baseline Characteristics of Adults (as Measured by Creatinine Serum (SCR)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK
Baseline characteristics of adults (as measured by by creatinine serum (SCR)) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) is presented. Mean and standard deviation (SD) of creatinine serum (SCR) measured is presented along with number of subjects with available data.
Measured: Baseline
Baseline Characteristics of Adults (as Measured by Comorbidities) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK
Baseline characteristics of adults (as measured by comorbidities) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) are presented.
Measured: Baseline
Baseline Characteristics of Adults (as Measured by Concomitant Medications) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK
Baseline characteristics of adults (as measured by concomitant medications) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) are presented. Subjects taking medication up to 60 days before index date are presented.
Measured: Baseline
Secondary outcomes (11)
Extent of Off-label Use
To assess off-label use the number of study participants without a recorded diagnosis of T2DM was calculated for each exposure category (people with other types of diabetes, people without diabetes, people younger than 18 years old, and women during pregnancy and breastfeeding). For the assessment of drug use during the pregnancy and breastfeeding period, the look-back period was 270 days (9 months) before and including the index date. To assess the use in pediatric population, the study participants were stratified by age into adults (≥18 years of age) and pediatrics (<18 years of age).
Measured: Baseline
Baseline Characteristics (as Measured by Demographics) of Patients Starting Index Prescriptions Off-label
Baseline characteristics of patients (as measured by demographics) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label are presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains <5 events should be reported to protect patient confidentiality. Since empagliflozin group reported <5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category.
Measured: Baseline
Baseline Characteristics (as Measured by Life Style Factors (Smoking and Alcohol Use)) of Patients Starting Index Prescriptions Off-label
Baseline characteristics of patients (as measured by life style factors (smoking and alcohol use)) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label are presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains <5 events should be reported to protect patient confidentiality. Since empagliflozin group reported <5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category. NA= NR (Not Reported) (variables for which patient counts were <5)
Measured: Baseline
Baseline Characteristics (as Measured by Life Style Factors (BMI)) of Patients Starting Index Prescriptions Off-label
Baseline characteristics of patients (as measured by life style factors (BMI)) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label is presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains <5 events should be reported to protect patient confidentiality. Since empagliflozin group reported <5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category.
Measured: Baseline
Baseline Characteristics (as Measured by Life Style Factors (Blood Pressure)) of Patients Starting Index Prescriptions Off-label
Baseline characteristics of patients (as measured by life style factors (blood pressure)) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label is presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains <5 events should be reported to protect patient confidentiality. Since empagliflozin group reported <5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category.
Measured: Baseline
Baseline Characteristics (as Measured b Yglycated Haemoglobin (HbA1c)) of Patients Starting Index Prescriptions Off-label
Baseline characteristics of patients (as measured by glycated haemoglobin (HbA1c)) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label is presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains <5 events should be reported to protect patient confidentiality. Since empagliflozin group reported <5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category.
Measured: Baseline
Baseline Characteristics (as Measured by Laboratory Tests) of Patients Starting Index Prescriptions Off-label
Baseline characteristics of patients (as measured by laboratory tests) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label are presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains <5 events should be reported to protect patient confidentiality. Since empagliflozin group reported <5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category.
Measured: Baseline
Baseline Characteristics (as Measured by Estimated Glomerular Filtration Rate (eGFR)) of Patients Starting Index Prescriptions Off-label
Baseline characteristics of patients (as measured by estimated glomerular filtration rate (eGFR)) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label is presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains <5 events should be reported to protect patient confidentiality. Since empagliflozin group reported <5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category.
Measured: Baseline
Baseline Characteristics (as Measured by Creatinine Serum (SCR)) of Patients Starting Index Prescriptions Off-label
Baseline characteristics of patients (as measured by creatinine serum (SCR)) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label is presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains <5 events should be reported to protect patient confidentiality. Since empagliflozin group reported <5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category.
Measured: Baseline
Baseline Characteristics (as Measured by Comorbidities) of Patients Starting Index Prescriptions Off-label
Baseline characteristics of patients (as measured by comorbidities) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label are presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains <5 events should be reported to protect patient confidentiality. Since empagliflozin group reported <5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category.
Measured: Baseline
Baseline Characteristics (as Measured by Concomitant Medications) of Patients Starting Index Prescriptions Off-label
Baseline characteristics of patients (as measured by concomitant medications) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label are presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains <5 events should be reported to protect patient confidentiality. Since empagliflozin group reported <5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category. Subjects taking medication up to 60 days before index date are presented.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start10 Sep 2016
- Primary completion14 Oct 2016
- Study completion14 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 31,908 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050619
- Sponsor's protocol ID
- 1245.122
- Status last verified
- Aug 2018
- First submitted
- 25 Aug 2016
- Last updated
- 25 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Patients Initiating Empagliflozin or Other Non-insulin Glucose Lowering Drugs in the United Kingdom
- ClinicalTrials.gov ID
- NCT03050619
- Acronym / sponsor ID
- 1245.122
- Conditions
- Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31,908 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- 10 Sep 2016 (actual)
- Primary completion
- 14 Oct 2016 (actual)
- Study completion
- 14 Oct 2016 (actual)
- First posted
- 13 Feb 2017 (actual)
- Results
- Posted 25 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Design:
cross sectional
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| New users of Empagliflozin | – | Drug: EmpagliflozinNew users of empagliflozin |
| New users of Other SGLT2 inhibitors | – | Drug: Other SGLT2 inhibitorsNew users of other SGLT2 inhibitors |
| New users of Other non-insulin GLDs | – | Drug: Other non-insulin GLDsNew users of other non-insulin GLDs |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- New users of empagliflozin and other non-insulin GLDs in the UK CPRD between 1 Aug 2014 to 1 Sep 2015
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- There is no exclusion criterion in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin | Drug | New users of Empagliflozin |
| Other SGLT2 inhibitors | Drug | New users of Other SGLT2 inhibitors |
| Other non-insulin GLDsmetformin, sulfonylureas, DPP-4 inhibitors, GLP-1 agonists | Drug | New users of Other non-insulin GLDs |
Primary outcome
Baseline Characteristics of Adults (as Measured by Demographics) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK
Time frame: Baseline
Baseline characteristics of adults (as measured by demographics) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) are presented.
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
Time frame: Baseline
Baseline characteristics of adults (as measured by life style factors (smoking and alcohol use)) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) are presented. NA= NR (Not Reported) (variables for which patient counts were <5)
Baseline Characteristics of Adults (as Measured by Life Style Factors (BMI)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK
Time frame: Baseline
Baseline characteristics of adults (as measured by life style factors (BMI)) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) is presented. Mean and standard deviation (SD) of body mass index (BMI) measured is presented along with number of subjects with available data.
Baseline Characteristics of Adults (as Measured by Life Style Factors (Blood Pressure)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK
Time frame: Baseline
Baseline characteristics of adults (as measured by life style factors (blood pressure)) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) is presented. Mean and standard deviation (SD) of Systolic blood pressure (SBP) and Diastolic blood pressure (DBP) measured is presented along with number of subjects with available data.
Baseline Characteristics of Adults (as Measured by Glycated Haemoglobin (HbA1c)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK
Time frame: Baseline
Baseline characteristics of adults (as measured by glycated haemoglobin (HbA1c)) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) is presented. Mean and standard deviation (SD) of glycated haemoglobin (HbA1c) measured is presented along with number of subjects with available data.
Baseline Characteristics of Adults (as Measured by Laboratory Tests) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK
Time frame: Baseline
Baseline characteristics of adults (as measured by laboratory tests) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) are presented. Mean and standard deviation (SD) of total cholesterol (TC), high-density lipoproteins level (HDL), Low-density lipoprotein level (LDL) and triglyceride level (TG) measured are presented along with number of subjects with available data.
Baseline Characteristics of Adults (as Measured by Estimated Glomerular Filtration Rate (eGFR)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK
Time frame: Baseline
Baseline characteristics of adults (as measured by estimated glomerular filtration rate (eGFR)) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) is presented. Mean and standard deviation (SD) of estimated glomerular filtration rate (eGFR) measured is presented along with number of subjects with available data.
Baseline Characteristics of Adults (as Measured by Creatinine Serum (SCR)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK
Time frame: Baseline
Baseline characteristics of adults (as measured by by creatinine serum (SCR)) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) is presented. Mean and standard deviation (SD) of creatinine serum (SCR) measured is presented along with number of subjects with available data.
Baseline Characteristics of Adults (as Measured by Comorbidities) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK
Time frame: Baseline
Baseline characteristics of adults (as measured by comorbidities) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) are presented.
Baseline Characteristics of Adults (as Measured by Concomitant Medications) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK
Time frame: Baseline
Baseline characteristics of adults (as measured by concomitant medications) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) are presented. Subjects taking medication up to 60 days before index date are presented.
11 secondary outcomes
Extent of Off-label Use
Time frame: Baseline
Baseline Characteristics (as Measured by Demographics) of Patients Starting Index Prescriptions Off-label
Time frame: Baseline
Baseline Characteristics (as Measured by Life Style Factors (Smoking and Alcohol Use)) of Patients Starting Index Prescriptions Off-label
Time frame: Baseline
Baseline Characteristics (as Measured by Life Style Factors (BMI)) of Patients Starting Index Prescriptions Off-label
Time frame: Baseline
Baseline Characteristics (as Measured by Life Style Factors (Blood Pressure)) of Patients Starting Index Prescriptions Off-label
Time frame: Baseline
Baseline Characteristics (as Measured b Yglycated Haemoglobin (HbA1c)) of Patients Starting Index Prescriptions Off-label
Time frame: Baseline
Baseline Characteristics (as Measured by Laboratory Tests) of Patients Starting Index Prescriptions Off-label
Time frame: Baseline
Baseline Characteristics (as Measured by Estimated Glomerular Filtration Rate (eGFR)) of Patients Starting Index Prescriptions Off-label
Time frame: Baseline
Baseline Characteristics (as Measured by Creatinine Serum (SCR)) of Patients Starting Index Prescriptions Off-label
Time frame: Baseline
Baseline Characteristics (as Measured by Comorbidities) of Patients Starting Index Prescriptions Off-label
Time frame: Baseline
Baseline Characteristics (as Measured by Concomitant Medications) of Patients Starting Index Prescriptions Off-label
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Synopsis LinkLink provided by the sponsor.
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Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by Boehringer Ingelheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Characteristics of Adults (as Measured by Demographics) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK (time frame: Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2019.