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Trial record 11 of 187 for:    BI10773

Renal Impairment Study of Empagliflozin (BI10773) in Japanese Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT01581658
Recruitment Status : Completed
First Posted : April 20, 2012
Results First Posted : June 17, 2014
Last Update Posted : August 14, 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
Condition Diabetes Mellitus, Type 2
Intervention Drug: BI10773
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Normal Renal Function Mild Renal Impairment Moderate Renal Impairment Severe Renal Impairment
Hide Arm/Group Description 25 mg empagliflozin taken as a single dose for patients with normal renal function 25 mg empagliflozin taken as a single dose for patients with mild renal impairment 25 mg empagliflozin taken as a single dose for patients with moderate renal impairment 25 mg empagliflozin taken as a single dose for patients with severe renal impairment
Period Title: Overall Study
Started 8 8 8 8
Completed 8 8 8 8
Not Completed 0 0 0 0
Arm/Group Title Normal Renal Function Mild Renal Impairment Moderate Renal Impairment Severe Renal Impairment Total
Hide Arm/Group Description 25 mg empagliflozin taken as a single dose for patients with normal renal function 25 mg empagliflozin taken as a single dose for patients with mild renal impairment 25 mg empagliflozin taken as a single dose for patients with moderate renal impairment 25 mg empagliflozin taken as a single dose for patients with severe renal impairment Total of all reporting groups
Overall Number of Baseline Participants 8 8 8 8 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 8 participants 8 participants 32 participants
66.8  (3.1) 67.5  (4.4) 65.9  (5.5) 62.0  (7.9) 65.5  (5.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 8 participants 8 participants 32 participants
Female
4
  50.0%
3
  37.5%
0
   0.0%
2
  25.0%
9
  28.1%
Male
4
  50.0%
5
  62.5%
8
 100.0%
6
  75.0%
23
  71.9%
1.Primary Outcome
Title Change From Baseline in Total Urinary Glucose Excretion (UGE)
Hide Description change from baseline in total urinary glucose excretion (UGE) to 24 hours
Time Frame baseline and 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated patients who had complete urine sample (baseline and 24 hours) for analyses.
Arm/Group Title Normal Renal Function Mild Renal Impairment Moderate Renal Impairment Severe Renal Impairment
Hide Arm/Group Description:
25 mg empagliflozin taken as a single dose for patients with normal renal function
25 mg empagliflozin taken as a single dose for patients with mild renal impairment
25 mg empagliflozin taken as a single dose for patients with moderate renal impairment
25 mg empagliflozin taken as a single dose for patients with severe renal impairment
Overall Number of Participants Analyzed 8 6 8 7
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg
74969.3
(64978.6 to 84960.0)
62577.4
(50707.5 to 74447.4)
57889.0
(47855.9 to 67922.2)
23725.1
(12920.5 to 34529.7)
2.Primary Outcome
Title Area Under the Concentration Time Curve of the Analyte in Plasma
Hide Description Area under the concentration time curve of the analyte in plasma over the time interval from 0 to infinity
Time Frame Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated patients
Arm/Group Title Normal Renal Function Mild Renal Impairment Moderate Renal Impairment Severe Renal Impairment
Hide Arm/Group Description:
25 mg empagliflozin taken as a single dose for patients with normal renal function
25 mg empagliflozin taken as a single dose for patients with mild renal impairment
25 mg empagliflozin taken as a single dose for patients with moderate renal impairment
25 mg empagliflozin taken as a single dose for patients with severe renal impairment
Overall Number of Participants Analyzed 8 8 8 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
7480
(16.2%)
9630
(15.9%)
10800
(9.55%)
11400
(40.4%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Renal Function, Mild Renal Impairment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments The model includes fixed effect for the renal function group
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 128.82
Confidence Interval (2-Sided) 90%
105.962 to 156.604
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Normal Renal Function, Moderate Renal Impairment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments The model includes fixed effect for the renal function group
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 143.82
Confidence Interval (2-Sided) 90%
118.306 to 174.848
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Normal Renal Function, Severe Renal Impairment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments The model includes fixed effect for the renal function group
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 152.31
Confidence Interval (2-Sided) 90%
125.287 to 185.166
Estimation Comments [Not Specified]
3.Primary Outcome
Title Maximum Concentration
Hide Description Maximum concentration of the analyte in plasma
Time Frame Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated patients
Arm/Group Title Normal Renal Function Mild Renal Impairment Moderate Renal Impairment Severe Renal Impairment
Hide Arm/Group Description:
25 mg empagliflozin taken as a single dose for patients with normal renal function
25 mg empagliflozin taken as a single dose for patients with mild renal impairment
25 mg empagliflozin taken as a single dose for patients with moderate renal impairment
25 mg empagliflozin taken as a single dose for patients with severe renal impairment
Overall Number of Participants Analyzed 8 8 8 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
1050
(19.1%)
984
(30.8%)
971
(26.2%)
990
(43.8%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Renal Function, Mild Renal Impairment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments The model includes fixed effect for the renal function group
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 93.50
Confidence Interval (2-Sided) 90%
72.236 to 121.015
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Normal Renal Function, Moderate Renal Impairment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments The model includes fixed effect for the renal function group
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 92.18
Confidence Interval (2-Sided) 90%
71.216 to 119.305
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Normal Renal Function, Severe Renal Impairment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments The model includes fixed effect for the renal function group
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 94.01
Confidence Interval (2-Sided) 90%
72.630 to 121.674
Estimation Comments [Not Specified]
Time Frame From trial drug intake until the end-of-study examination visit, up to 12 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Normal Renal Function Mild Renal Impairment Moderate Renal Impairment Severe Renal Impairment
Hide Arm/Group Description 25 mg empagliflozin taken as a single dose for patients with normal renal function 25 mg empagliflozin taken as a single dose for patients with mild renal impairment 25 mg empagliflozin taken as a single dose for patients with moderate renal impairment 25 mg empagliflozin taken as a single dose for patients with severe renal impairment
All-Cause Mortality
Normal Renal Function Mild Renal Impairment Moderate Renal Impairment Severe Renal Impairment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Normal Renal Function Mild Renal Impairment Moderate Renal Impairment Severe Renal Impairment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Normal Renal Function Mild Renal Impairment Moderate Renal Impairment Severe Renal Impairment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%)   2/8 (25.00%)   0/8 (0.00%) 
Gastrointestinal disorders         
Abdominal distension  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 15.1
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.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01581658     History of Changes
Other Study ID Numbers: 1245.53
First Submitted: April 17, 2012
First Posted: April 20, 2012
Results First Submitted: May 16, 2014
Results First Posted: June 17, 2014
Last Update Posted: August 14, 2017