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Post Prandial Glucose (PPG) Study of Empagliflozin in Japanese Patients With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01947855
Recruitment Status : Completed
First Posted : September 23, 2013
Results First Posted : December 24, 2014
Last Update Posted : December 24, 2014
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 2
Interventions Drug: Placebo
Drug: Empagliflozin
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Empagliflozin 10 mg Empagliflozin 25 mg
Hide Arm/Group Description Placebo tablets matching empagliflozin 10 mg or 25 mg tablets Empagliflozin 10 mg oral administration once daily Empagliflozin 25mg oral administration once daily
Period Title: Overall Study
Started 21 20 19
Completed 20 20 19
Not Completed 1 0 0
Reason Not Completed
Withdrawal by Subject             1             0             0
Arm/Group Title Placebo Empagliflozin 10 mg Empagliflozin 25 mg Total
Hide Arm/Group Description Placebo tablets matching empagliflozin 10 mg or 25 mg tablets Empagliflozin 10 mg oral administration once daily Empagliflozin 25mg oral administration once daily Total of all reporting groups
Overall Number of Baseline Participants 21 20 19 60
Hide Baseline Analysis Population Description
Full analysis set: all patients treated with at least 1 dose of randomised study drug, and with a baseline AUC1-4h for plasma glucose.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 20 participants 19 participants 60 participants
60.7  (10.8) 64.8  (5.9) 62.6  (7.8) 62.7  (8.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 20 participants 19 participants 60 participants
Female
4
  19.0%
6
  30.0%
3
  15.8%
13
  21.7%
Male
17
  81.0%
14
  70.0%
16
  84.2%
47
  78.3%
1.Primary Outcome
Title Change in Area Under the Concentration-time Curve (AUC1-4h) for Postprandial Plasma Glucose From Baseline After 28 Days of Treatment
Hide Description The primary endpoint is the change in AUC1-4h for postprandial plasma glucose based on meal tolerance test from baseline after 28 days of treatment. Baseline refers to the last observation prior to administration of randomised study medication.
Time Frame 1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day -1 (baseline), and 1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Placebo Empagliflozin 10 mg Empagliflozin 25 mg
Hide Arm/Group Description:
Placebo tablets matching empagliflozin 10 mg or 25 mg tablets
Empagliflozin 10 mg oral administration once daily
Empagliflozin 25mg oral administration once daily
Overall Number of Participants Analyzed 20 20 19
Least Squares Mean (Standard Error)
Unit of Measure: mg*h/dL
-18.07  (13.89) -103.56  (14.24) -122.94  (14.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Empagliflozin 25 mg
Comments Difference calculated as empa 25 mg minus placebo. The analyses will be performed sequentially compared with placebo from high dose of empagliflozin and the full significance level (5%) will be maintained by the hierarchical procedure.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Model includes treatment, number of previous antidiabetic medication, baseline renal function, baseline HbA1c and baseline AUC1-4h for plasma glucose.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -104.87
Confidence Interval (2-Sided) 95%
-144.77 to -64.97
Parameter Dispersion
Type: Standard Error of the mean
Value: 19.88
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Empagliflozin 10 mg
Comments Difference calculated as empa 10 mg minus placebo. The analyses will be performed sequentially compared with placebo from high dose of empagliflozin and the full significance level (5%) will be maintained by the hierarchical procedure.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Model includes treatment, number of previous antidiabetic medication, baseline renal function, baseline HbA1c and baseline AUC1-4h for plasma glucose.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -85.49
Confidence Interval (2-Sided) 95%
-126.01 to -44.97
Parameter Dispersion
Type: Standard Error of the mean
Value: 20.18
Estimation Comments [Not Specified]
Time Frame between the first drug intake of study medication and 7 days after last drug intake of study medication, up to 35 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Empagliflozin 10 mg Empagliflozin 25 mg
Hide Arm/Group Description Placebo tablets matching empagliflozin 10 mg or 25 mg tablets Empagliflozin 10 mg oral administration once daily Empagliflozin 25mg oral administration once daily
All-Cause Mortality
Placebo Empagliflozin 10 mg Empagliflozin 25 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Empagliflozin 10 mg Empagliflozin 25 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/20 (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%
Placebo Empagliflozin 10 mg Empagliflozin 25 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/21 (4.76%)   2/20 (10.00%)   3/19 (15.79%) 
Gastrointestinal disorders       
Anal inflammation  1  0/21 (0.00%)  0/20 (0.00%)  1/19 (5.26%) 
Infections and infestations       
Nasopharyngitis  1  1/21 (4.76%)  2/20 (10.00%)  0/19 (0.00%) 
Renal and urinary disorders       
Pollakiuria  1  0/21 (0.00%)  0/20 (0.00%)  1/19 (5.26%) 
Reproductive system and breast disorders       
Bartholinitis  1  0/21 (0.00%)  0/20 (0.00%)  1/19 (5.26%) 
Skin and subcutaneous tissue disorders       
Rash pruritic  1  0/21 (0.00%)  0/20 (0.00%)  1/19 (5.26%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 16.1
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.
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 Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01947855     History of Changes
Other Study ID Numbers: 1245.35
First Submitted: September 18, 2013
First Posted: September 23, 2013
Results First Submitted: December 16, 2014
Results First Posted: December 24, 2014
Last Update Posted: December 24, 2014