Diabetes Mellitus, Type 2
Conditions
Brief summary
This is a multi-center, randomised, double-blind, parallel-group, safety and efficacy study of empagliflozin as add-on to GLP-1 RA in Japanese patients with Type 2 Diabetes Mellitus with insufficient glycaemic control
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of type 2 diabetes mellitus * Male and female patients on diet and exercise regimen who are pre-treated with Liraglutide at 0.9 mg/day alone for at least 10 weeks prior to screening must be \>=7.0% and \<=10.0% at screening * Male and female patients on diet and exercise regimen who are pre-treated with Liraglutide at 0.9 mg/day and one of oral antidiabetic drug (OAD) for at least 10 weeks prior to Visit 1 must be \>=7.0% and \<=9.0% at screening and \>=7.0% and \<=10.0% at placebo run-in * Male and female patients on diet and exercise regimen who are pre-treated with OAD alone for at least 10 weeks prior to Visit 1 must be \>=7.0% and \<=10.0% at both screening and placebo run-in * Age at informed consent must be \>=20 years * BMI at screening must be \<=40 kg/m2 * Further inclusion criteria apply
Exclusion criteria
* Uncontrolled hyperglycaemia with a glucose values \>270 mg/dL (\>15.0 mmol/L) after an overnight fast during switch/washout/placebo run-in period and confirmed by a second measurement * Patients who are drug-naïve at screening visit or treat with any of insulin, thiazolidine dione, sodium-glucose co-transporter 2 (SGLT-2) inhibitor within 10 weeks prior to informed consent. * Acute coronary syndrome, stroke or transient ischemic attack within 12 weeks prior to informed consent * Indication of liver disease, defined by serum levels of either alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal as determined during screening and/or switch/washout/placebo run-in period * Impaired renal function, defined as estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73m2 (Japanese equation) as determined during screening and/or switch/washout/placebo run-in period * Further
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Drug-related Adverse Events (AEs) During 52 Weeks of Treatment | 52 weeks | Percentage of patients with drug-related Adverse events (AEs) during 52 weeks of treatment are presented |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in HbA1c After 52 Weeks of Treatment | baseline and 52 weeks | Change from baseline in HbA1c after 52 weeks of treatment is presented. Means presented are the adjusted means. |
Countries
Japan
Participant flow
Recruitment details
Patients were entered in the trial and randomised in a 1:1 ratio to receive treatment.
Pre-assignment details
All subjects were screened for eligibility to participate in the trial. Subjects attended specialist site which would then ensure that they (the subjects) met all strictly implemented inclusion/exclusion criteria. Subjects were not randomised to trial treatment if any one of the specific entry criteria was violated.
Participants by arm
| Arm | Count |
|---|---|
| Empagliflozin 10 mg Patients were orally administered film-coated tablet of Empagliflozin 10 milligram (mg) once daily in the morning for 52 weeks | 32 |
| Empagliflozin 25 mg Patients were orally administered film-coated tablet of Empagliflozin 25 mg once daily in the morning for 52 weeks | 33 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Other than the reason specified | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Empagliflozin 10 mg | Empagliflozin 25 mg | Total |
|---|---|---|---|
| Age, Continuous | 55.6 years STANDARD_DEVIATION 9.8 | 58.9 years STANDARD_DEVIATION 9.3 | 57.3 years STANDARD_DEVIATION 9.6 |
| Baseline glycosylated haemoglobin A1c (HbA1c) | 8.83 % of HbA1c STANDARD_DEVIATION 0.8 | 8.68 % of HbA1c STANDARD_DEVIATION 0.87 | 8.76 % of HbA1c STANDARD_DEVIATION 0.83 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 32 Participants | 33 Participants | 65 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 6 Participants | 11 Participants | 17 Participants |
| Sex: Female, Male Male | 26 Participants | 22 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 33 |
| other Total, other adverse events | 10 / 32 | 15 / 33 |
| serious Total, serious adverse events | 2 / 32 | 1 / 33 |
Outcome results
Primary
Percentage of Patients With Drug-related Adverse Events (AEs) During 52 Weeks of Treatment
Percentage of patients with drug-related Adverse events (AEs) during 52 weeks of treatment are presented
Time frame: 52 weeks
Population: The treated set (TS) consisted of all patients who were randomised and treated with at least 1 dose of the study drug. The assignment of patients to treatment group was based on the first study drug intake in the double-blind treatment period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Empagliflozin 10 mg | Percentage of Patients With Drug-related Adverse Events (AEs) During 52 Weeks of Treatment | 9.4 Percentage of participants |
| Empagliflozin 25 mg | Percentage of Patients With Drug-related Adverse Events (AEs) During 52 Weeks of Treatment | 21.2 Percentage of participants |
Secondary
Change From Baseline in HbA1c After 52 Weeks of Treatment
Change from baseline in HbA1c after 52 weeks of treatment is presented. Means presented are the adjusted means.
Time frame: baseline and 52 weeks
Population: Full Analysis Set (Observed cases (OC))
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Empagliflozin 10 mg | Change From Baseline in HbA1c After 52 Weeks of Treatment | -0.55 % of HbA1c | Standard Deviation 0.15 |
| Empagliflozin 25 mg | Change From Baseline in HbA1c After 52 Weeks of Treatment | -0.77 % of HbA1c | Standard Deviation 0.14 |