Trial Outcomes & Findings for Effect of Empagliflozin Kinetics on Renal Glucose Reabsorption in Patients With Type II Diabetes and Healthy Controls (NCT NCT01867307)

Last Updated: 2017-05-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

Baseline and Day 14

Results posted on

2017-05-11

Participant Flow

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)

Participant milestones

Participant milestones
Measure	T2DM Patients Oral administration of empagliflozin (25 mg once daily) in patients with type 2 diabetes mellitus for 14 days	Healthy Subjects Oral administration of empagliflozin (25 mg once daily) in healthy subjects for 14 days
Overall Study STARTED	18	19
Overall Study COMPLETED	15	16
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	T2DM Patients Oral administration of empagliflozin (25 mg once daily) in patients with type 2 diabetes mellitus for 14 days	Healthy Subjects Oral administration of empagliflozin (25 mg once daily) in healthy subjects for 14 days
Overall Study Protocol Violation	2	0
Overall Study Other Adverse Event	1	3

Baseline Characteristics

Effect of Empagliflozin Kinetics on Renal Glucose Reabsorption in Patients With Type II Diabetes and Healthy Controls

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	T2DM Patients n=18 Participants Oral administration of empagliflozin (25 mg once daily) in patients with type 2 diabetes mellitus for 14 days	Healthy Subjects n=19 Participants Oral administration of empagliflozin (25 mg once daily) in healthy subjects for 14 days	Total n=37 Participants Total of all reporting groups
Age, Continuous	55.1 years STANDARD_DEVIATION 5.5 • n=5 Participants	56.7 years STANDARD_DEVIATION 6.3 • n=7 Participants	55.9 years STANDARD_DEVIATION 5.9 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	T2DM Patients n=15 Participants Oral administration of empagliflozin (25 mg once daily) in patients with type 2 diabetes mellitus for 14 days	Healthy Subjects n=15 Participants Oral administration of empagliflozin (25 mg once daily) in healthy subjects for 14 days
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	-256.9 (milligram / minute/ 1.73 square meters) Standard Deviation 100.0

Adverse Events

T2DM Patients

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Healthy Subjects

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER

Measure	T2DM Patients n=18 participants at risk Oral administration of empagliflozin (25 mg once daily) in patients with type 2 diabetes mellitus for 14 days	Healthy Subjects n=19 participants at risk Oral administration of empagliflozin (25 mg once daily) in healthy subjects for 14 days
Infections and infestations Genital infection fungal	5.6% 1/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	5.3% 1/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days
Infections and infestations Sinusitis	0.00% 0/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	5.3% 1/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days
Metabolism and nutrition disorders Dehydration	0.00% 0/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	5.3% 1/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days
Psychiatric disorders Anxiety	5.6% 1/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	0.00% 0/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days
Nervous system disorders Headache	0.00% 0/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	10.5% 2/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days
Nervous system disorders Dizziness	5.6% 1/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	0.00% 0/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days
Nervous system disorders Loss of consciousness	0.00% 0/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	5.3% 1/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days
Cardiac disorders Palpitations	5.6% 1/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	5.3% 1/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days
Vascular disorders Phlebitis	0.00% 0/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	10.5% 2/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days
Gastrointestinal disorders Dry mouth	22.2% 4/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	0.00% 0/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days
Gastrointestinal disorders Vomiting	0.00% 0/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	15.8% 3/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days
Gastrointestinal disorders Nausea	5.6% 1/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	10.5% 2/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days
Gastrointestinal disorders Abdominal pain upper	5.6% 1/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	5.3% 1/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days
Gastrointestinal disorders Flatulence	5.6% 1/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	0.00% 0/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days
Gastrointestinal disorders Toothache	0.00% 0/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	5.3% 1/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days
Skin and subcutaneous tissue disorders Erythema	11.1% 2/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	21.1% 4/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days
Skin and subcutaneous tissue disorders Dry skin	5.6% 1/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	0.00% 0/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days
Skin and subcutaneous tissue disorders Rash	5.6% 1/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	5.3% 1/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days
Musculoskeletal and connective tissue disorders Muscle spasms	5.6% 1/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	36.8% 7/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days
Musculoskeletal and connective tissue disorders Arthralgia	5.6% 1/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	5.3% 1/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days
Musculoskeletal and connective tissue disorders Back pain	5.6% 1/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	5.3% 1/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days
Musculoskeletal and connective tissue disorders Joint swelling	5.6% 1/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	0.00% 0/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	5.3% 1/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	5.3% 1/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days
Renal and urinary disorders Pollakiuria	50.0% 9/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	31.6% 6/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days
Renal and urinary disorders Micturition urgency	0.00% 0/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	5.3% 1/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days
Renal and urinary disorders Nocturia	0.00% 0/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	5.3% 1/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days
Renal and urinary disorders Polyuria	0.00% 0/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	5.3% 1/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days
General disorders Pain	5.6% 1/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	10.5% 2/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days
General disorders Swelling	5.6% 1/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	10.5% 2/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days
General disorders Asthenia	5.6% 1/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	0.00% 0/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days
General disorders Pyrexia	5.6% 1/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	0.00% 0/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days
General disorders Infusion site swelling	0.00% 0/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	5.3% 1/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days
General disorders Peripheral swelling	0.00% 0/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	5.3% 1/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days
Investigations Body temperature increased	5.6% 1/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	0.00% 0/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days
Investigations Urine output increased	0.00% 0/18 • From first drug administration through the residual effect and/or follow-up period, up to 21 days	5.3% 1/19 • From first drug administration through the residual effect and/or follow-up period, up to 21 days