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

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ClinicalTrials.gov Identifier: NCT01867307
Recruitment Status : Completed
First Posted : June 4, 2013
Results First Posted : May 11, 2017
Last Update Posted : May 11, 2017
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Diabetes Mellitus, Type 2
Healthy
Interventions Drug: Empagliflozin
Drug: BI 10773
Enrollment 39
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)
Pre-assignment Details  
Arm/Group Title T2DM Patients Healthy Subjects
Hide Arm/Group Description Oral administration of empagliflozin (25 mg once daily) in patients with type 2 diabetes mellitus for 14 days Oral administration of empagliflozin (25 mg once daily) in healthy subjects for 14 days
Period Title: Overall Study
Started 18 [1] 19 [1]
Completed 15 16
Not Completed 3 3
Reason Not Completed
Protocol Violation             2             0
Other Adverse Event             1             3
[1]
Started are the treated patients
Arm/Group Title T2DM Patients Healthy Subjects Total
Hide Arm/Group Description Oral administration of empagliflozin (25 mg once daily) in patients with type 2 diabetes mellitus for 14 days Oral administration of empagliflozin (25 mg once daily) in healthy subjects for 14 days Total of all reporting groups
Overall Number of Baseline Participants 18 19 37
Hide Baseline Analysis Population Description
The treated set (TS) consisted of all subjects and patients who were treated with at least one dose of empagliflozin.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 19 participants 37 participants
55.1  (5.5) 56.7  (6.3) 55.9  (5.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 19 participants 37 participants
Female
5
  27.8%
7
  36.8%
12
  32.4%
Male
13
  72.2%
12
  63.2%
25
  67.6%
1.Primary Outcome
Title Change From Baseline of Renal Tubular Maximum Reabsorptive Capacity for Glucose (TmG) at End of Empagliflozin Treatment (Day 14)
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title T2DM Patients Healthy Subjects
Hide Arm/Group Description:
Oral administration of empagliflozin (25 mg once daily) in patients with type 2 diabetes mellitus for 14 days
Oral administration of empagliflozin (25 mg once daily) in healthy subjects for 14 days
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: (milligram / minute/ 1.73 square meters)
-321.7  (214.9) -256.9  (100.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T2DM Patients
Comments Point estimates of the changes from baseline and 95% Confidence interval around the estimates on treatment day 14 were computed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P−value is from a paired t−test.
Method Paired t- test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -220.0
Confidence Interval (2-Sided) 95%
-440.6 to -202.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 55.5
Estimation Comments Difference calculated as (Day 14 - baseline) values
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Healthy Subjects
Comments Point estimates of the changes from baseline and 95% Confidence interval around the estimates on treatment day 14 were computed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P−value is from a paired t−test
Method Paired t-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -234.0
Confidence Interval (2-Sided) 95%
-312.3 to -201.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 25.8
Estimation Comments Difference calculated as (Day 14 - baseline) values
Time Frame From first drug administration through the residual effect and/or follow-up period, up to 21 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title T2DM Patients Healthy Subjects
Hide Arm/Group Description Oral administration of empagliflozin (25 mg once daily) in patients with type 2 diabetes mellitus for 14 days Oral administration of empagliflozin (25 mg once daily) in healthy subjects for 14 days
All-Cause Mortality
T2DM Patients Healthy Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
T2DM Patients Healthy Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
T2DM Patients Healthy Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   14/18 (77.78%)   16/19 (84.21%) 
Cardiac disorders     
Palpitations  1  1/18 (5.56%)  1/19 (5.26%) 
Gastrointestinal disorders     
Dry mouth  1  4/18 (22.22%)  0/19 (0.00%) 
Vomiting  1  0/18 (0.00%)  3/19 (15.79%) 
Nausea  1  1/18 (5.56%)  2/19 (10.53%) 
Abdominal pain upper  1  1/18 (5.56%)  1/19 (5.26%) 
Flatulence  1  1/18 (5.56%)  0/19 (0.00%) 
Toothache  1  0/18 (0.00%)  1/19 (5.26%) 
General disorders     
Pain  1  1/18 (5.56%)  2/19 (10.53%) 
Swelling  1  1/18 (5.56%)  2/19 (10.53%) 
Asthenia  1  1/18 (5.56%)  0/19 (0.00%) 
Pyrexia  1  1/18 (5.56%)  0/19 (0.00%) 
Infusion site swelling  1  0/18 (0.00%)  1/19 (5.26%) 
Peripheral swelling  1  0/18 (0.00%)  1/19 (5.26%) 
Infections and infestations     
Genital infection fungal  1  1/18 (5.56%)  1/19 (5.26%) 
Sinusitis  1  0/18 (0.00%)  1/19 (5.26%) 
Investigations     
Body temperature increased  1  1/18 (5.56%)  0/19 (0.00%) 
Urine output increased  1  0/18 (0.00%)  1/19 (5.26%) 
Metabolism and nutrition disorders     
Dehydration  1  0/18 (0.00%)  1/19 (5.26%) 
Musculoskeletal and connective tissue disorders     
Muscle spasms  1  1/18 (5.56%)  7/19 (36.84%) 
Arthralgia  1  1/18 (5.56%)  1/19 (5.26%) 
Back pain  1  1/18 (5.56%)  1/19 (5.26%) 
Joint swelling  1  1/18 (5.56%)  0/19 (0.00%) 
Pain in extremity  1  0/18 (0.00%)  1/19 (5.26%) 
Pain in jaw  1  0/18 (0.00%)  1/19 (5.26%) 
Nervous system disorders     
Headache  1  0/18 (0.00%)  2/19 (10.53%) 
Dizziness  1  1/18 (5.56%)  0/19 (0.00%) 
Loss of consciousness  1  0/18 (0.00%)  1/19 (5.26%) 
Psychiatric disorders     
Anxiety  1  1/18 (5.56%)  0/19 (0.00%) 
Renal and urinary disorders     
Pollakiuria  1  9/18 (50.00%)  6/19 (31.58%) 
Micturition urgency  1  0/18 (0.00%)  1/19 (5.26%) 
Nocturia  1  0/18 (0.00%)  1/19 (5.26%) 
Polyuria  1  0/18 (0.00%)  1/19 (5.26%) 
Skin and subcutaneous tissue disorders     
Erythema  1  2/18 (11.11%)  4/19 (21.05%) 
Dry skin  1  1/18 (5.56%)  0/19 (0.00%) 
Rash  1  1/18 (5.56%)  1/19 (5.26%) 
Vascular disorders     
Phlebitis  1  0/18 (0.00%)  2/19 (10.53%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01867307     History of Changes
Other Study ID Numbers: 1245.66
First Submitted: May 21, 2013
First Posted: June 4, 2013
Results First Submitted: March 31, 2017
Results First Posted: May 11, 2017
Last Update Posted: May 11, 2017