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Safety and Efficacy of Empagliflozin (BI 10773) in Type 1 Diabetes Mellitus Patients With or Without Renal Hyperfiltration

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ClinicalTrials.gov Identifier: NCT01392560
Recruitment Status : Completed
First Posted : July 12, 2011
Results First Posted : June 17, 2014
Last Update Posted : June 17, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 1
Intervention Drug: BI 10773
Enrollment 52
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Empagliflozin (BI 10773) 25 mg
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Oral once daily

Empagliflozin 25 mg: Oral once daily

Period Title: Overall Study
Started 52
Completed 40
Not Completed 12
Reason Not Completed
Adverse Event             2
not entered             8
discontinued during placebo run-in             2
Arm/Group Title Empagliflozin (BI 10773) 25 mg
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Oral once daily

Empagliflozin 25 mg: Oral once daily

Overall Number of Baseline Participants 42
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Treated Set
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants
24.1  (5.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Female
22
  52.4%
Male
20
  47.6%
1.Primary Outcome
Title Change in Glomerular Filtration Rate (GFR) After 8 Weeks of Treatment With Empagliflozin Under Controlled Conditions of Euglycaemia and Hyperglycaemia
Hide Description The primary endpoint is change in glomerular filtration rate (GFR) after 8 weeks of treatment with empagliflozin under controlled conditions of euglycaemia and hyperglycaemia
Time Frame Baseline and 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol set for renal (PPS_RENAL) consists of all patients who were treated with study drug and had a baseline measurement and evaluable post-dosing renal data under the clamped hyperglycemia condition for the primary endpoint.
Arm/Group Title All Patients (Empagliflozin 25 mg) Hyperfilterers (Empagliflozin 25 mg) Non-hyperfilterers (Empagliflozin 25 mg)
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All patients (hyperfilterers and non-hyperfilterers)

Empagliflozin 25 mg: Oral once daily

Hyperfilterers

Empagliflozin 25 mg: Oral once daily

hyperfilterers = GFRs of ≥135 mL/min/1.73m2

Non-hyperfilterers

Empagliflozin 25 mg: Oral once daily

non-hyperfilterers = GFRs of ≥60 mL/min/1.73m2 to <135 mL/min/1.73m2

Overall Number of Participants Analyzed 40 27 13
Mean (Standard Error)
Unit of Measure: mL/min/1.73 m^2
Euglycaemia -19.6  (5.6) -33.4  (6.2) 9.0  (5.9)
Hyperglycaemia -30.8  (6.2) -44.5  (7.1) -2.4  (7.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Patients (Empagliflozin 25 mg)
Comments Test of the difference between baseline and end of treatment under euglycaemia condition for all patients
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0011
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean change from baseline
Estimated Value -19.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.6
Estimation Comments Estimated value = mean of end of treatment - baseline
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection All Patients (Empagliflozin 25 mg)
Comments Test the difference between baseline and end of treatment under hyperglycaemia condition for all patients
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean change from baseline
Estimated Value -30.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.2
Estimation Comments Estimated value = mean of end of treatment - baseline
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Hyperfilterers (Empagliflozin 25 mg)
Comments Test of the difference between baseline and end of treatment under euglycaemia condition for hyperfilterers
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Change from baseline
Estimated Value -33.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.2
Estimation Comments Estimated value = mean of end of treatment - baseline
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Hyperfilterers (Empagliflozin 25 mg)
Comments Test of the difference between baseline and end of treatment under hyperglycaemia condition for hyperfilterers
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean change from baseline
Estimated Value -44.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.1
Estimation Comments Estimated value = mean of end of treatment - baseline
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Non-hyperfilterers (Empagliflozin 25 mg)
Comments Test of the difference between baseline and end of treatment under euglycaemia condition for non-hyperfilterers
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1524
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean change from baseline
Estimated Value 9.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.9
Estimation Comments Estimated value = mean of end of treatment - baseline
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Non-hyperfilterers (Empagliflozin 25 mg)
Comments Test of the difference between baseline and end of treatment under hyperglycaemia condition for non-filterers
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7585
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean change from baseline
Estimated Value -2.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.7
Estimation Comments Estimated value = mean of end of treatment - baseline
Time Frame 8 weeks
Adverse Event Reporting Description All adverse events, serious and non-serious, occurring during the course of the clinical trial were to be collected, documented and reported to the sponsor by the investigator on the appropriate case reporting forms. Reporting was performed according to the specific definitions and instructions.
 
Arm/Group Title Empagliflozin 25 mg
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Oral once daily

Empagliflozin 25 mg: Oral once daily

All-Cause Mortality
Empagliflozin 25 mg
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Empagliflozin 25 mg
Affected / at Risk (%)
Total   3/42 (7.14%) 
Infections and infestations   
Gastroenteritis viral  1  1/42 (2.38%) 
Metabolism and nutrition disorders   
Diabetic ketoacidosis  1  2/42 (4.76%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Empagliflozin 25 mg
Affected / at Risk (%)
Total   42/42 (100.00%) 
Gastrointestinal disorders   
Abdominal pain  1  5/42 (11.90%) 
Dry mouth  1  7/42 (16.67%) 
Nausea  1  7/42 (16.67%) 
Vomiting  1  6/42 (14.29%) 
General disorders   
Thirst  1  31/42 (73.81%) 
Infections and infestations   
Genitourinary tract infection  1  6/42 (14.29%) 
Influenza  1  4/42 (9.52%) 
Nasopharyngitis  1  11/42 (26.19%) 
Metabolism and nutrition disorders   
Hypoglycaemia  1  40/42 (95.24%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  4/42 (9.52%) 
Nervous system disorders   
Dizziness  1  6/42 (14.29%) 
Headache  1  10/42 (23.81%) 
Renal and urinary disorders   
Pollakiuria  1  33/42 (78.57%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 16.0
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.
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: NCT01392560     History of Changes
Other Study ID Numbers: 1245.46
First Submitted: July 11, 2011
First Posted: July 12, 2011
Results First Submitted: May 16, 2014
Results First Posted: June 17, 2014
Last Update Posted: June 17, 2014