Diabetes Mellitus, Type 2, Healthy
Conditions
Brief summary
Single center, 14-day, open-label trial to examine the effect of 25 mg q.d. empagliflozin on kinetics of renal glucose reabsorption in patients diagnosed with type 2 diabetes mellitus and healthy controls
Interventions
DRUGEmpagliflozin
DRUGBI 10773
open label
Sponsors
Eli Lilly and Company
Boehringer Ingelheim
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. T2DM patients and healthy controls aged =18 to \<70 at Visit 1. 2. Patients diagnosed with T2DM according to the American Diabetes Association criteria prior to informed consent who are drug-naïve 3. T2DM patients on a stable dose of allowed concomitant medications (as determined by investigator) for 30 days prior to entering the study. 4. T2DM patients with HbA1c between \>7 and \<10.0% (\>53 mmol/mol and \<86 mmol/mol) at Visit
Exclusion criteria
1. Patients with type 1 diabetes mellitus. 2. Patients with uncontrolled hyperglycemia with a fasting plasma glucose level greater than 240 mg/dl after an overnight fast. 3. Patients with a history of clinically significant heart disease (New York Heart Classification greater than class 3; more than non-specific ST-T wave changes on the ECG), peripheral vascular disease (history of claudication), or pulmonary disease as determined by investigator. 4. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline of Renal Tubular Maximum Reabsorptive Capacity for Glucose (TmG) at End of Empagliflozin Treatment (Day 14) | Baseline and Day 14 | Change from baseline of renal tubular maximum reabsorptive capacity for glucose (TmG) at end of empagliflozin treatment (Day 14). Per-protocol set (PPS): PPS consisted of all subjects and patients in the TS who completed the treatment day 14 clamping study without any relevant deviations either in their treatment regimen or in the performance and timing of the measurements. |
Countries
United States
Participant flow
Recruitment details
39 subjects were enrolled in the trial; 37 subjects were treated with the trial treatment, 2 subjects were not treated with the trial treatment (1 subject from type 2 diabetes mellitus (T2DM) patients arm and 1 subject from the Healthy subjects arm were not treated)
Participants by arm
| Arm | Count |
|---|---|
| T2DM Patients Oral administration of empagliflozin (25 mg once daily) in patients with type 2 diabetes mellitus for 14 days | 18 |
| Healthy Subjects Oral administration of empagliflozin (25 mg once daily) in healthy subjects for 14 days | 19 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Other Adverse Event | 1 | 3 |
| Overall Study | Protocol Violation | 2 | 0 |
Baseline characteristics
| Characteristic | T2DM Patients | Healthy Subjects | Total |
|---|---|---|---|
| Age, Continuous | 55.1 years STANDARD_DEVIATION 5.5 | 56.7 years STANDARD_DEVIATION 6.3 | 55.9 years STANDARD_DEVIATION 5.9 |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male Male | 13 Participants | 12 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 18 | 16 / 19 |
| serious Total, serious adverse events | 0 / 18 | 0 / 19 |
Outcome results
Primary
Change From Baseline of Renal Tubular Maximum Reabsorptive Capacity for Glucose (TmG) at End of Empagliflozin Treatment (Day 14)
Change from baseline of renal tubular maximum reabsorptive capacity for glucose (TmG) at end of empagliflozin treatment (Day 14). Per-protocol set (PPS): PPS consisted of all subjects and patients in the TS who completed the treatment day 14 clamping study without any relevant deviations either in their treatment regimen or in the performance and timing of the measurements.
Time frame: Baseline and Day 14
Population: Analysable set (AS): This data set is based on the PPS and excluded all primary endpoint and exploratory endpoint data for one healthy subject due to outlying values that were identified in the subject's TmG and urine splay data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T2DM Patients | Change From Baseline of Renal Tubular Maximum Reabsorptive Capacity for Glucose (TmG) at End of Empagliflozin Treatment (Day 14) | -321.7 (milligram / minute/ 1.73 square meters) | Standard Deviation 214.9 |
| Healthy Subjects | Change From Baseline of Renal Tubular Maximum Reabsorptive Capacity for Glucose (TmG) at End of Empagliflozin Treatment (Day 14) | -256.9 (milligram / minute/ 1.73 square meters) | Standard Deviation 100 |
Comparison: Point estimates of the changes from baseline and 95% Confidence interval around the estimates on treatment day 14 were computed.p-value: <0.000195% CI: [-440.6, -202.7]Paired t- test
Comparison: Point estimates of the changes from baseline and 95% Confidence interval around the estimates on treatment day 14 were computed.p-value: <0.000195% CI: [-312.3, -201.5]Paired t-test