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Empagliflozin add-on to Insulin in Type 1 Diabetes Mellitus Over 28 Days

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ClinicalTrials.gov Identifier: NCT01969747
Recruitment Status : Completed
First Posted : October 25, 2013
Results First Posted : April 8, 2015
Last Update Posted : April 8, 2015
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 1
Interventions Drug: Empagliflozin medium placebo
Drug: Empagliflozin low placebo
Drug: Empagliflozin high placebo
Drug: Empagliflozin medium
Drug: Empagliflozin low
Drug: Empagliflozin high
Enrollment 75
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Empagliflozin 2.5 mg Empagliflozin 10 mg Empagliflozin 25 mg
Hide Arm/Group Description Placebo tablet; oral administration once daily Empagliflozin 2.5 mg tablet; oral administration once daily Empagliflozin 10 mg tablet; oral administration once daily Empagliflozin 25 mg tablet; oral administration once daily
Period Title: Overall Study
Started 19 19 19 18
Completed 19 19 19 18
Not Completed 0 0 0 0
Arm/Group Title Placebo Empagliflozin 2.5 mg Empagliflozin 10 mg Empagliflozin 25 mg Total
Hide Arm/Group Description Placebo tablet; oral administration once daily Empagliflozin 2.5 mg tablet; oral administration once daily Empagliflozin 10 mg tablet; oral administration once daily Empagliflozin 25 mg tablet; oral administration once daily Total of all reporting groups
Overall Number of Baseline Participants 19 19 19 18 75
Hide Baseline Analysis Population Description
Full analysis set (FAS): all patients randomised, treated with at least one dose of study drug, had a baseline UGE (g/24 h) and a UGE (g/24 h) on Day 1 or Day 7.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 19 participants 19 participants 18 participants 75 participants
40.5  (10.6) 41.9  (12.4) 39.6  (11.6) 41.9  (9.7) 41.0  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 19 participants 18 participants 75 participants
Female
6
  31.6%
4
  21.1%
4
  21.1%
8
  44.4%
22
  29.3%
Male
13
  68.4%
15
  78.9%
15
  78.9%
10
  55.6%
53
  70.7%
1.Primary Outcome
Title Change From Baseline in 24 h UGE (g/24 h) After Seven Days of Treatment With Empagliflozin 2.5 mg, 10 mg, or 25 mg, or Placebo
Hide Description

Change of urinary glucose excretion (UGE) (g/24 h) from baseline (refers to the last measurement prior to the first intake of any randomised trial medication) after seven days of treatment with empagliflozin 2.5 mg, 10 mg, or 25 mg, or placebo.

The treatment effect was estimated on the basis of the least square mean treatment difference at Day 7 extracted from the primary analysis model.

The primary endpoint is exploratory.

Time Frame baseline (Day -1) and 7 days after first drug administration (Day 7)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Full analysis set (FAS): all patients randomised, treated with at least one dose of study drug, had a baseline UGE (g/24 h) and a UGE (g/24 h) on Day 1 or Day 7.

The last observation carried forward (LOCF) approach was used as the primary method of imputation for missing data.

Arm/Group Title Placebo Empagliflozin 2.5 mg Empagliflozin 10 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Placebo tablet; oral administration once daily
Empagliflozin 2.5 mg tablet; oral administration once daily
Empagliflozin 10 mg tablet; oral administration once daily
Empagliflozin 25 mg tablet; oral administration once daily
Overall Number of Participants Analyzed 19 19 19 18
Mean (Standard Error)
Unit of Measure: g/24h
-3.56  (4.27) 72.45  (7.01) 103.33  (6.68) 101.79  (6.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Empagliflozin 2.5 mg
Comments Comparison of Empagliflozin 2.5 mg with Placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean
Estimated Value 76.09
Confidence Interval (2-Sided) 95%
58.60 to 93.59
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.77
Estimation Comments The model includes baseline UGE as linear covariate(s) and treatment as fixed effect(s).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Empagliflozin 10 mg
Comments Comparison of Empagliflozin 10 mg with Placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean
Estimated Value 106.39
Confidence Interval (2-Sided) 95%
88.73 to 124.05
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.85
Estimation Comments The model includes baseline UGE as linear covariate(s) and treatment as fixed effect(s).
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Empagliflozin 25 mg
Comments Comparison of Empagliflozin 25 mg with Placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean
Estimated Value 104.81
Confidence Interval (2-Sided) 95%
86.88 to 122.74
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.99
Estimation Comments The model includes baseline UGE as linear covariate(s) and treatment as fixed effect(s).
Time Frame From first drug administration until 7 days after last drug administration (Day 35)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Empagliflozin 2.5 mg Empagliflozin 10 mg Empagliflozin 25 mg
Hide Arm/Group Description Placebo tablet; oral administration once daily Empagliflozin 2.5 mg tablet; oral administration once daily Empagliflozin 10 mg tablet; oral administration once daily Empagliflozin 25 mg tablet; oral administration once daily
All-Cause Mortality
Placebo Empagliflozin 2.5 mg Empagliflozin 10 mg Empagliflozin 25 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Empagliflozin 2.5 mg Empagliflozin 10 mg Empagliflozin 25 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/19 (5.26%)   0/19 (0.00%)   0/19 (0.00%)   0/18 (0.00%) 
Metabolism and nutrition disorders         
Hypoglycaemia  1  1/19 (5.26%)  0/19 (0.00%)  0/19 (0.00%)  0/18 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Empagliflozin 2.5 mg Empagliflozin 10 mg Empagliflozin 25 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/19 (89.47%)   17/19 (89.47%)   15/19 (78.95%)   18/18 (100.00%) 
Gastrointestinal disorders         
Constipation  1  1/19 (5.26%)  1/19 (5.26%)  0/19 (0.00%)  1/18 (5.56%) 
Diarrhoea  1  0/19 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  1/18 (5.56%) 
Nausea  1  1/19 (5.26%)  1/19 (5.26%)  0/19 (0.00%)  1/18 (5.56%) 
Vomiting  1  0/19 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  1/18 (5.56%) 
Abdominal pain upper  1  0/19 (0.00%)  0/19 (0.00%)  1/19 (5.26%)  0/18 (0.00%) 
General disorders         
Application site erythema  1  0/19 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  1/18 (5.56%) 
Infections and infestations         
Nasopharyngitis  1  5/19 (26.32%)  2/19 (10.53%)  0/19 (0.00%)  1/18 (5.56%) 
Urinary tract infection  1  0/19 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  1/18 (5.56%) 
Injury, poisoning and procedural complications         
Contusion  1  1/19 (5.26%)  0/19 (0.00%)  0/19 (0.00%)  0/18 (0.00%) 
Metabolism and nutrition disorders         
Hypoglycaemia  1  17/19 (89.47%)  16/19 (84.21%)  13/19 (68.42%)  17/18 (94.44%) 
Polydipsia  1  0/19 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  1/18 (5.56%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/19 (0.00%)  0/19 (0.00%)  2/19 (10.53%)  0/18 (0.00%) 
Back pain  1  2/19 (10.53%)  1/19 (5.26%)  1/19 (5.26%)  0/18 (0.00%) 
Neck pain  1  1/19 (5.26%)  0/19 (0.00%)  0/19 (0.00%)  0/18 (0.00%) 
Nervous system disorders         
Headache  1  3/19 (15.79%)  0/19 (0.00%)  2/19 (10.53%)  6/18 (33.33%) 
Dysgeusia  1  0/19 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  1/18 (5.56%) 
Lumbar radiculopathy  1  1/19 (5.26%)  0/19 (0.00%)  0/19 (0.00%)  0/18 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Epistaxis  1  0/19 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  1/18 (5.56%) 
Oropharyngeal pain  1  0/19 (0.00%)  0/19 (0.00%)  1/19 (5.26%)  0/18 (0.00%) 
Skin and subcutaneous tissue disorders         
Rash erythematous  1  0/19 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  1/18 (5.56%) 
Vascular disorders         
Phlebitis  1  0/19 (0.00%)  0/19 (0.00%)  1/19 (5.26%)  1/18 (5.56%) 
Haematoma  1  0/19 (0.00%)  0/19 (0.00%)  1/19 (5.26%)  0/18 (0.00%) 
Thrombophlebitis  1  0/19 (0.00%)  0/19 (0.00%)  1/19 (5.26%)  0/18 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 17.0
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.
Other - 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: NCT01969747     History of Changes
Other Study ID Numbers: 1245.78
2011-004354-25 ( EudraCT Number: EudraCT )
First Submitted: October 22, 2013
First Posted: October 25, 2013
Results First Submitted: March 23, 2015
Results First Posted: April 8, 2015
Last Update Posted: April 8, 2015